DIA 2025 Global Annual Meeting: Full Schedule

11:00am EDT

#106: Real-World Evidence: First Choice or Last Resort?

Monday June 16, 2025 11:00am - 12:00pm EDT

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-512-L04-P; CME 1.00; RN 1.00

Opportunities and challenges for using RWE from the perspective of drug development, regulatory considerations, health technology assessments, clinician and patients will be discussed, including new collaborations between regulators and HTA.

Learning Objectives

Describe how RWE is being used through the medicinal product lifecycle by showing relevant examples; Evaluate the utility of RWE for benchmarking disease progress and/or to use as an external comparator; Explain the extent to which HTA and regulators collaborate on RW requirements.

Chair

Nancy Dreyer, PhD, MPH, FISPE

Speaker

RWE for Clinical Decision Support
Richard Gliklich, MD

Opportunities and Challenges in Using RWE from the Perspective of Drug Development
Brian Bradbury, DrSc, MA

How Regulators are Collaborating with Payers: Update on EMA-HTA Pilot Work
Patrice Verpillat, DrMed, MD, PhD, MPH

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief of the Scientific Advisory Board at OM1, and brings her experience having served as Chief Scientific Officer at IQVIA Real World Solutions, Global Chief of Scientific Affairs at Outcome Sciences and Quintiles, and CEO of Epidemiology Resources Inc. Her expertise... Read More →

Richard Gliklich

Founder & Chief Executive Officer, OM1, United States

Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Forum

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

11:00am EDT

#107: From Approval to Access: Integrating Patient Insights into Coverage Decisions

Monday June 16, 2025 11:00am - 12:00pm EDT

202A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-513-L04-P; CME 1.00; RN 1.00

Despite advances, patient engagement (PE) in post-approval access decisions remains limited, complex, and unclear. This session examines how patients can offer value-based insights and explores pathways to strengthen PE in product access decisions.

Learning Objectives

Identify existing opportunities to incorporate patient input into access determinations; Recognize patient-contributed information and data that could broaden the evidentiary base for CMS and other payers; Discuss the resources and frameworks needed for CMS to systematically and scientifically engage with patient communities.

Chair

June Cha, PhD, MPH

Speaker

Vital Voices from Patients in Access Determination
June Cha, PhD, MPH

Patients Engaging with CMS: Opportunities, challenges, and lessons learned
Kristi Martin, MA, MPA

Patient Perspectives: Are They Missing from Commercial Payer Drug Coverage Policies?
James Chambers, PhD, MPharm, MSc

How Breakthrough T1D has Engaged CMS
Campbell Hutton, MPH

Speakers

June Cha

Policy Director, FasterCures, Milken Institute, United States

June Cha is a policy director at FasterCures, Milken Institute Health. She brings decades of experience in infectious diseases research, non-profit, multilateral, and bilateral organizations, government, and the pharmaceutical industry, where she has focused on US and global health... Read More →

James Chambers

Professor, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, United States

James Chambers is a Professor at Tufts Medical Center’s Institute for Clinical Research and Health Policy Studies. His research focuses on insurance coverage of medical technology and the role of cost-effectiveness in U.S. health care.

Campbell Hutton

Senior Vice President, Global Advocacy, Breakthrough T1D, United States

Campbell Hutton, is Senior Vice President, Global Advocacy at Breakthrough T1D, a non-profit organization whose mission is to accelerate life-changing breakthroughs to cure, prevent and treat type 1 diabetes (T1D) and its complications. In her role she oversees the regulatory affairs... Read More →

Kristi Martin

Director, Camber Collective, United States

Kristi Martin is a seasoned health policy expert with over 20 years of experience in the public sector, private sector, and philanthropy. She is currently a Director at Camber Collective, a strategy consulting firm known for its analytic rigor and human-centered approach. Kristi began... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Patient Experience, Payers
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience,Payers
Tags Session

11:00am EDT

#109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized

Monday June 16, 2025 11:00am - 12:00pm EDT

152AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-515-L04-P; CME 1.00; RN 1.00

This forum will discuss Good Clinical Practice (GCP) inspection methods, collaboration and training among regulators and their inspectors as they respond to the evolving clinical trial regulatory landscape such as the implementation of ICH E6 R3 and novel trial methodologies

Learning Objectives

Describe the reasons why regulators may inspect clinical trials in different ways; Compare the various inspection approaches used by different regulators; Explain how regulators are harmonizing inspection approaches and collaborating to share information, resources, and training; Analyze how regulators are preparing to implement ICH E6 R3 and its implications for inspections and inspector training.

Chair

Mandy Kaur Budwal-Jagait, MSc

Speaker

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Adil Nashed

Panelist
Peter Twomey, MA, MPharm

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Kavita C. Dada, PharmD, RAC

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Reina Hayashi

Speakers

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States

Captain Kavita Dada, Pharm.D., RAC, is the Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at FDA's Center for Drug Evaluation and Research. With over 20 years of regulatory experience, she leads initiatives to modernize... Read More →

Reina Hayashi

Office of Non-clinical and Clinical Compliance, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Reina Hayashi currently serves as an inspector of the Office of Non-clinical and Clinical Compliance in the Pharmaceuticals and Medical Devices Agency (PMDA).

Adil Nashed

Drug Specialist, Health Canada, Canada

Adil Nashed graduated as a Veterinarian from University of Khartoum, Sudan.He successfully completed his Veterinary Internship in Vienna, Austria under the supervision of the University of Vienna. Adil also holds a post graduate diploma in Homeopathic Medicine and Science from the... Read More →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Forum

11:00am EDT

#111: Project Orbis: Six Years Later

Monday June 16, 2025 11:00am - 12:00pm EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-517-L04-P; CME 1.00; RN 1.00

In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.

Learning Objectives

Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative and explain how sponsors can benefit from participating in Project Orbis.

Chair

Sema Hashemi, MSc

Speaker

Panelist - Australia
Sarah Golding, MD

Panelist - Brazil
Marcelo Moreira, MS

Panelist - Canada
Melissa Hunt, MSc

Panelist - Israel
Michal Hirsh-Vexberg, PharmD

Panelist - Singapore
Anuradha Poonepalli, PhD

Panelist - Switzerland
Ulrich Peter Rohr, DrMed

Panelist - United States
R. Angelo De Claro, MD

Panelist - United States
Dianne Spillman

Speakers

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States

Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →

Sarah Golding

Senior Medical Officer - Oncology and Malignant Haematology Clinical Evaluation, Therapeutics Goods Administration, Australia

Dr. Sarah Golding is dual qualified; both as a medical doctor and a biomedical scientist with honours in biochemistry and molecular biology. Her 12 years' experience at Australia's Therapeutic Goods Administration (TGA) include 9 years in the clinical review and approval of oncology... Read More →

Sema Hashemi

Senior International Policy Advisor, FDA, United States

Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →

Michal Hirsh-Vexberg

Head of the Pharmaceuticals Registration Department, Medical Technology, Health, Israel Ministry of Health, Israel

Head of the Pharmaceuticals Registration Department at the Medical Technologies, Health Innovation, Information, and Research Directorate, Israel Ministry of Health. In charge of several units evaluating non-clinical and clinical data as part of MA applications and post-approval variations... Read More →

Melissa Hunt

Director, Health Canada, Canada

Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada... Read More →

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil

Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.

Anuradha Poonepalli

Regulatory Consultant/Clinical Lead, Health Products Regulation Grou, Singapore HSA, Singapore

Regulatory Consultant and clinical Lead at Health Sciences Authority (HSA), Singapore, with over 15 years of experience in regulation and clinical evaluation of medicinal products specialising in vaccines and oncology products. Medical training from Osmania Medical College, India... Read More →

Ulrich Rohr

Unit Head Clinical Review Hematology & Oncology, Swissmedic, Switzerland

Dianne Spillman

Associate Director, Global and Regulatory Outreach, OCE, FDA, United States

Dianne Spillman is the Associate Director for Global and Regulatory Outreach in the FDA's Oncology Center of Excellence (OCE). She holds a Bachelor of Science in Biology from Northeastern University, Boston, MA. Her government service spans over 30 years, with the majority in FDA... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulatory Collaboration, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Global Perspectives
Tags Forum

11:00am EDT

#112: Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation

Monday June 16, 2025 11:00am - 12:00pm EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-518-L04-P; CME 1.00; RN 1.00

Among the largest areas of concern with the Inflation Reduction Act (IRA) are potential unintended consequences to pharmaceutical innovation. This forum will convene industry experts to explore the impact of and potential adjustments to the IRA.

Learning Objectives

Discuss the unintended consequences of the IRA on innovation; Examine potential legislative solutions.

Chair

Sarah Martin, PhD, MS

Speaker

Panelist
Gregory Daniel, PhD, MPH

Industry Perspective
Ryan Gough

The Impacts of the Inflation Reduction Act on Biopharmaceutical Investment Decisions
Richard Xie, PhD

Early Signals of IRA Impact: Theoretical and Observed Unintended Consequences
Julie Ann Patterson, PharmD, PhD

Speakers

Gregory Daniel

Vice President, Head of Public Policy Innovation and Evidence, Eli Lilly and Company, United States

Gregory Daniel, PhD, MPH, is the Global Head of Public Policy at Eli Lilly & Company in Washington, D.C. Greg is also on the board of directors for the Innovation in Value Initiative (IVI), adjunct associate professor at the UNC Eshelman School of Pharmacy, and Visiting Expert at... Read More →

Ryan Gough

Partner, Senior Vice President, Public Affairs, Woodberry Associates and PACH, United States

Sarah Martin

Senior Director - Global Regulatory Policy (Oncology), Eli Lilly & Co., United States

Sarah currently serves as senior director of global regulatory policy for oncology at Lilly. She previously served as senior director of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America (PhRMA) where she led their regulatory advocacy efforts... Read More →

Julie Patterson

Senior Director of Research, National Pharmaceutical Council, United States

Julie Patterson, PharmD, PhD, is Senior Director of Research and Director of the NPC Enterprise Lab at the National Pharmaceutical Council. She designs and conducts policy-relevant research related to sustainable access to innovative biopharmaceuticals, often focusing on incentives... Read More →

Richard Xie

Senior Health Economist, RA Capital Management, United States

Richard Xie has over a decade of experience in conducting rigorous economic analyses to inform health policy issues. As a Senior Health Economist at RA Capital, he collaborates with diverse stakeholders to communicate the value of pharmaceutical innovation to payers, policymakers... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Payers
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Payers
Tags Forum

11:00am EDT

#113: Accelerating Global Access to Drugs for Chronic Diseases

Monday June 16, 2025 11:00am - 12:00pm EDT

Salon B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-677-L04-P; CME 1.00; RN 1.00

In a world increasingly burdened by chronic diseases, the timely access to effective medications is a critical component of global health initiatives. This conference session aims to explore strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy. We will delve into the innovative regulatory approaches that can pave the way for faster development and registration and more equitable access of these vital medications.

Learning Objectives

Describe the strategies for accelerating global access to drugs designed to treat chronic ailments that differentially impact public health and decrease life-expectancy.

Chair

Carlos Garner, PhD

Speaker

Panelist
Francisco Nogueira, MBA

Panelist
Naoyuki Yasuda, MSc

Panelist
Anantha Shekhar

Speakers

Carlos Garner

Vice-President Global Regulatory Affairs, Eli Lilly and Company, United States

Executive leader for Global Regulatory Affairs for Eli Lilly and Company. The organization is responsible for the regulatory leadership and strategic and operational support for human drugs, medical devices, and global manufacturing for Eli Lilly and Company. Dr. Garner leads Lilly’s... Read More →

Francisco Nogueira

Chief Executive Officer, Accumulus Synergy, United States

Francisco Nogueira is a highly accomplished and forward-thinking C-suite executive with over 25 years of impactful leadership in the pharmaceutical and health technology sectors. Known for his strategic insight and agility, Francisco has developed a reputation for excellence in drug... Read More →

Anantha Shekhar

Dean, School of Medicine, University of Pittsburgh, United States

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan

Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
Salon B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Non-CE
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Non-CE
Tags Session

11:00am EDT

#108: Advancing Innovation Through Essential Drug Delivery Outputs

Monday June 16, 2025 11:00am - 12:00pm EDT

204ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-514-L04-P; CME 1.00; RN 1.00

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Recognize the technology landscape for more complex drug delivery combination products, specific patient considerations informing design and clinical risk, and the role of new regulatory tools like Essential Drug Delivery Outputs; Discuss current challenges facing combination products to deliver advanced therapies (Cell & Gene) or biologics including submission expectations (IND, NDA/BLAs), verification, validation, Control Strategy, and post-market changes.

Chair

Rumi Raquel Young, MS

Speaker

Overview of complex combination product technologies and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development
James Bertram, PhD, MS, RAC

Industry Perspective on FDA Draft Guidance for Essential Drug Delivery Outputs
Chelsea O'Connell, MS, RAC

Patient Perspectives on Advanced Therapies and use of Complex Combination Products
Stephen Karpen, PharmD

Speakers

James Bertram

Director, Office of Combination Products, OC, FDA, United States

James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States

Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States

Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States

Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 10: RegCMC-Product Quality, Forum | 06: PersonalizedMed-ComboProd-Diagnostics, Forum

Level Intermediate
Keyword Digital Technology
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Digital Technology
Tags Forum

11:00am EDT

#114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives

Monday June 16, 2025 11:00am - 12:00pm EDT

146BC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-519-L04-P; CME 1.00; RN 1.00

This session will explore the critical role of Identification of Medicinal Products (IDMP) standards in addressing global healthcare challenges, such as pharmacovigilance, drug shortages, and medicinal product traceability.

Learning Objectives

Discuss how IDMP standards address drug shortages by enhancing supply chain transparency and traceability; Identify the challenges and opportunities in implementing IDMP globally, focusing on the need for regulatory collaboration and interoperability; Explain the significance of global identifiers, such as PhPID, in ensuring consistent product identification across regions.

Chair

Janis Bernat, MSc

Speaker

Introduction of Regulatory Levers to Address the Problem: Global Implementation of Identification of Medicinal Products Standards
Ron Fitzmartin, PhD, MBA

Panelist
Vada Perkins, DrSc, MSc

EMA Perspective
Isabel Chicharo, MPharm

ANVISA Perspective
Raphael Sanches Pereira, SR

HealthCare Professional Perspective on the Issue and Examples
Joseph Kannarkat, MD

Panelist
Peter Hjelmstrom, MD, PhD

Speakers

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland

Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →

Isabel Chicharo

Head of Regulatory Data Management, European Medicines Agency, Netherlands

I am responsible for Regulatory Master Data Management Services, currently on Substances, Products, Organisations and Referential data (also known as SPOR). I also coordinate the implementation of ISO IDMP in EU. I over 20 years of data management experience in the field of Medicines... Read More →

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre, Sweden

Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States

Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →

Raphael Sanches Pereira

General Manager of the Office for Medicines, ANVISA, Brazil

General Manager of the Office of Medicines, responsible for evaluations off small molecules registrations and post-approval changes requests. Previously manager of Office for Quality Evaluation for Registration of Small Molecules and Manager of Office for Quality Evaluation of Small... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 14: DIAmond, Forum

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Forum

2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases

Monday June 16, 2025 2:15pm - 3:15pm EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-521-L04-P; CME 1.00; RN 1.00

Master Protocols, including basket trials and umbrella trials, enable efficiencies in investigating multiple conditions or multiple treatments, respectively, under a single trial design. Applying Master Protocol trial designs to Cell & Gene therapies (CGTs) can streamline clinical and regulatory processes to speed the delivery of treatments to patients with rare diseases.

Learning Objectives

Identify barriers to and solutions for leveraging Master Protocol clinical trial designs to study Cell & Gene Therapies for rare diseases.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Thought Leader Perspective
Philip (P.J.) Brooks, PhD

Innovator Perspective
Kiran Musunuru, MD, PhD, MPH

Researcher Perspective
Jeff Allen, PhD

Speakers

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →

Kiran Musunuru

Professor of Medicine, University of Pennsylvania, United States

An actively practicing cardiologist and committed teacher, Kiran Musunuru, MD, PhD, MPH, ML, MRA, is Professor of Cardiovascular Medicine, Genetics, and Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the development of novel... Read More →

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, United States

Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 20 years and has been active in the DC policy arena for three... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Rare Disease, Clinical Trial Design, Cell and Gene Therapy
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Clinical Trial Design,Cell and Gene Therapy
Tags Forum

2:15pm EDT

#123: A Masterclass: Patient Recruitment Campaign Management

Monday June 16, 2025 2:15pm - 3:15pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-520-L04-P; CME 1.00; RN 1.00

Go beyond platitudes and qualitative advice on planning, deploying, and measuring the success of your recruitment campaign. Enjoy this Master Class in Recruitment Campaign Management from some of the industry's best minds

Learning Objectives

Discuss how to build an evidence based forecast for centralized patient recruitment campaigns; Describe ways to optimize channel mixes, vendor management, performance models, technology selection; Identify methods to measure and optimize campaign performance and ROI.

Chair

Chris Venezia

Speaker

Case Study Presentation
Helen West

Case Study Presentation
Gretchen Goller, MA

Case Study Presentation
Adrienne Walstrum, MSc

Case Study Presentation
Tom Julian

Speakers

Gretchen Goller

Head, Recruitment and Retention, Pfizer, United States

Gretchen leads the Patient Recruitment and Retention team at Pfizer working with a team of strategists and specialists to implement recruitment and retention programs on all Pfizer studies across therapeutic areas. Most recently Gretchen was the Head leading the Patient Recruitment... Read More →

Tom Julian

Assoc. Director Design and Innovation, Gilead Sciences, United States

At Gilead Sciences, Tom leads efforts to improve clinical trial design and implements technologies to improve trial efficiency and reduce costs. He is focused in Virology and Inflammation. Previously, at Bristol Myers Squibb, he worked on testing and scaling digital solutions to improve... Read More →

Chris Venezia

Chief Executive Officer, ProofPilot, United States

As the CEO., Chris Venezia brings more than 18 years of strong leadership experience to ProofPilot with a track record of success in product commercialization, patient recruitment, marketing, and sales. With his most recent role as the Chief Commercial Officer at Citeline Connect... Read More →

Adrienne Walstrum

Senior Director, Global Trial Optimization, Merck, United States

Adrienne Walstrum is a Senior Director with Global Trial Optimization (GTO). She has over 15 years of clinical trial operations experience, with the last 9 years spent at Merck within GTO. In Adrienne’s current role, she oversees GTO’s Recruitment & Retention Center of Excellence... Read More →

Helen West

Senior Director, Innovative Patient Recruitment, Evinova, United States

Helen West is a senior digital patient recruitment strategist with Evinova's Innovative Patient Recruitment group. Her background is in clinical operations, trial optimization and healthcare communications. She has lead patient recruitment strategies for more than 200 global studies... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session | 05: Patient-Impact-Product-Dev, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

2:15pm EDT

#130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management

Monday June 16, 2025 2:15pm - 3:15pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-527-L04-P; CME 1.00; RN 1.00

This forum will present: Health Authority (HA) expectations related to QbD, RBQM, and issue management. Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.

Learning Objectives

Discuss Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.

Chair

Michael Torok, PhD

Speaker

Industry Perspective
Michael Torok, PhD

FDA Perspective
Emily Gebbia, JD

Industry Perspective
Kevin Richards, MSc

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →

Kevin Richards

Senior Director, Clinical Quality, AstraZeneca, Canada

Lead the Global Clinical Quality organization at AstraZeneca leading quality compliance and GCP processes and teams. He established and also leads Study Quality Oversight, automated reporting, solutions and tools to help uplift study and organizational inspection readiness and compliance... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 03: Data-Tech, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

2:15pm EDT

#131: International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here

Monday June 16, 2025 2:15pm - 3:15pm EDT

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-528-L04-P; CME 1.00; RN 1.00

The International Council for Harmonisation (ICH) was established in 1990 by regulatory authorities and industries in the United States, Japan, and Europe with a mission to harmonize requirements for the development of medicines. Since, the Association was reformed in 2015 to establish ICH as a true global entity, increase participation from regulatory authorities and industry around the world and increase the implementation of ICH guidelines globally thereby speeding access to medicines for patients and supporting the global supply of medicines. It has been nearly 10 years since the ICH reforms were completed. In this session, Regulatory and Industry experts will reflect on how far we’ve come and the progress achieved in harmonizing scientific and technical requirements for the development of medicines since 1990. Speakers will share perspectives on the evolution of medicines development as a result of ICH guideline development. Further, speakers will exchange perspective on future opportunities for international regulatory harmonization with consideration of the increasing globalized nature of medicines development and navigating the evolving landscape and use of innovative approaches before turning it over to the audience to hear their ideas around how to promote international harmonization and continued global drug development and patient access to medicines.

Learning Objectives

Discuss progress in international harmonization of regulatory requirements for the development of medicines since ICH was established in 1990 and its increased global footprint following the reforms in 2015; Evaluate impact of ICH guidelines in global drug development; Identify future opportunities and how ICH can evolve to keep pace with innovation and further promote international regulatory harmonization and increased patient access to medicines.

Chair

Amanda Roache, MS

Speaker

US Regulatory Perspective on the Future of International Harmonization
Theresa Mullin, PhD

Industry Priorities for the Future of International Regulatory Harmonization
Wassim Nashabeh, PhD

ANVISA Perspective on International Global Harmonization and Future Opportunities
Marcelo Moreira, MS

EMA Perspective on ICH GCP Renovation and E6 Revision and Future Opportunities
Peter Twomey, MA, MPharm

Speakers

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil

Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.

Theresa Mullin

Associate Center Director - CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Wassim Nashabeh

Vice President, Global Head of Technical Regulatory Policy & International Ops, Genentech, A Member of the Roche Group, United States

Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific... Read More →

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Monday June 16, 2025 2:15pm - 3:15pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Regulator Perspectives, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Regulator Perspectives,Global Perspectives
Tags Forum

2:15pm EDT

#132: FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?

Monday June 16, 2025 2:15pm - 3:15pm EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-529-L04-P; CME 1.00; RN 1.00

The forum will explore key legislative proposals affecting FDA regulation of drugs and devices, while FDA and industry prepare to negotiate the next round of user fees and performance goals.

Learning Objectives

Describe key legislative initiatives that could alter FDA's regulation of drugs and medical devices; Discuss the interplay between current FDA legislative proposals and the upcoming FDA user fee negotiations and legislation; Recognize the impact of legislative proposals on FDA and regulated industries.

Chair

Jeffrey K. Francer, JD, MPA

Speaker

Panelist
Andrea Stern Ferris, MBA

Panelist
Barrett Tenbarge

Panelist
Elizabeth Jungman, JD, MPH

Speakers

Andrea Ferris

President and CEO, LUNGevity Foundation, United States

Andrea is the President and Chairman of LUNGevity Foundation, the nation's leading lung cancer non-profit. Andrea's strong business background combined with her connections to the worlds of research and advocacy have enabled her to build the preeminent patient advocacy organization... Read More →

Jeffrey Francer

Vice President, Head of Global Regulatory Policy & Strategy, Eli Lilly and Company, United States

Jeff Francer serves as Vice President, Head of Global Regulatory Policy & Strategy for Eli Lilly and Company. In this role, Jeff leads Lilly’s U.S. and international regulatory policy and research teams. Jeff has led and advised biopharmaceutical companies and policy makers for... Read More →

Elizabeth Jungman

Former FDA Chief of Staff, N/A, United States

Elizabeth Jungman, J.D., M.P.H., recently left the Food and Drug Administration, where she was Chief of Staff. Prior to that role Ms. Jungman was the Associate Center Director for Policy and Director of the Office of Regulatory Policy in FDA's Center for Drug Evaluation and Research... Read More →

Barrett Tenbarge

General Counsel, U.S. Senate HELP Committee, United States

Monday June 16, 2025 2:15pm - 3:15pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Forum

2:15pm EDT

#133: Health Canada Town Hall

Monday June 16, 2025 2:15pm - 3:15pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-530-L04-P; CME 1.00; RN 1.00

In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

Chair

Alysha Croker, PhD

Speaker

Panelist
Kelly Robinson, MSc

Panelist
Sophie Sommerer

Speakers

Alysha Croker

Director of the Centre for Policy, Pediatrics and International Collaboration, Health Canada, Canada

Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada

Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →

Sophie Sommerer

Director General, Health Canada, Canada

Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Session

2:15pm EDT

#125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence

Monday June 16, 2025 2:15pm - 3:15pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-522-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory guidance and frameworks on data quality and feasibility assessments of RWD sources to support RWE study proposals for health authority and HTA engagements. It will include information about how to leverage diverse sources of targeted RWD to support and improve the evolution of new therapies and indications for product safety, outcomes, reduction in label use, and help HC professionals and industry to create a knowledge base for use of RWD.

Learning Objectives

Examine the challenges and value of real-world data (RWD) in regulatory decision-making; Discuss the guidance on data quality and feasibility of RWD for real-world evidence (RWE) studies in health authority interactions; Recognize strategies to integrate RWD into dossier data for regulatory alignment; Identify challenges in standardizing data collection and sharing across industry, regulators, and academia for global acceptance.

Chair

Mehmet Burcu, PhD, MS, FISPE

Speaker

Data Quality Framework and EMA Regulatory Perspectives
Patrice Verpillat, DrMed, MD, PhD, MPH

Oncology Quality, Characterization, and Assessment of Real-world Data: US Regulatory Perspectives
Donna Rivera, PharmD, MSc, FISPE

Building Transparency and Reproducibility into the Practice of Real World Evidence Research
Shirley Wang, PhD, MSc, FISPE

Facilitating robust evidence: integrating digital health data into multi-modal datasets
Laura Lasiter, PhD

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

Laura Lasiter

Regulatory Affairs Director- Digital Health, Astrazeneca, United States

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States

Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →

Shirley Wang

Associate Professor of Medicine, Harvard Medical School, United States

Dr. Wang is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School. She co-led the 1st and 2nd joint task forces between ISPE and ISPOR, co-directs the REPEAT Initiative, a non-profit program with projects aimed at improving the transparency, reproducibility... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 03: Data-Tech, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

2:15pm EDT

#126: Best Practices for Navigating Divergent Regulatory Feedback

Monday June 16, 2025 2:15pm - 3:15pm EDT

151A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-523-L04-P; CME 1.00; RN 1.00

The ICH improved global drug development, but rising country-specific regulations increase complexity and costs for multinational submissions. This session explores key harmonization challenges, regulatory trends, and strategies to navigate diverse requirements for successful drug approvals. Effective communication between sponsors and regulatory agencies is critical for the successful development and approval of new medicines. This forum will explore the similarities and differences in how major global regulators—such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA)—engage with sponsors throughout the drug development lifecycle. We will delve into the formal channels and informal practices each regulatory body uses to guide sponsors, address compliance issues, and expedite approvals. Key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways, will be examined. At the same time, critical differences, including cultural approaches to engagement, the role of pre-submission meetings, and divergent regulatory timelines, will be highlighted. Through a comparative lens, this forum will also address how recent trends, such as digital transformation, the COVID-19 pandemic, and emerging policies on patient-centric drug development are shaping interactions with regulators worldwide. The session will provide attendees with practical insights into navigating global regulatory landscapes, fostering better communication with agencies, and optimizing regulatory strategies for successful drug approvals across diverse markets.

Learning Objectives

Identify the similarities and differences in how major global regulators (FDA, NMPA, PMDA, EMA) engage with sponsors throughout the drug development lifecycle; Analyze key similarities, such as scientific advice meetings, regulatory guidance documents, and the use of conditional approval pathways among different regulatory agencies; Recognize ways to gain practical insights into navigating global landscape.

Chair

Steve Sibley, MS

Speaker

EMA Perspective
Anabela Marcal, PharmD

Perspective on Best Practices for Navigating Divergent Regulatory Feedback - My Perspectives from Previous Experience at FDA
Namandjé Bumpus, PhD

Best Practices for Navigating Divergent Regulatory Feedback
Natalie Tolli, MS, RPh

Speakers

Namandjé Bumpus

Founding Principal, Bumpus Advising, United States

Dr. Namandjé N. Bumpus serves as a strategic advisor on regulatory science and policy. She is also a member of the Board of Directors of Recursion Pharmaceuticals, a clinical stage techbio company. Dr. Bumpus served at FDA from 2022-2024 first as the Chief Scientist and then as the... Read More →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States

With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Natalie Tolli

Vice President, Regulatory Intercontinental/RPI, AbbVie, Inc., United States

Natalie joined Abbott in 2000 and has held several positions at Abbott/AbbVie in Regulatory Affairs. Natalie assumed her current role as Vice President, Regulatory Affairs (Regulatory Intercontinental/Regulatory Policy & Intelligence) in 2018. Prior to joining AbbVie, Natalie was... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 04: MedAffairs-SciComm, Forum

Level Intermediate
Keyword Student Programming, Regulatory Convergence and Harmonization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming,Regulatory Convergence and Harmonization
Tags Forum

3:45pm EDT

#138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials

Monday June 16, 2025 3:45pm - 4:45pm EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-536-L04-P; CME 1.00; RN 1.00

In this session, speakers from industry, academia, and the US Food and Drug Administration (FDA) will discuss innovative use cases, experiences, and challenges of implementing linkage of traditional clinical trial data to RWD.

Learning Objectives

Discuss use cases of trial linkage to RWD and the benefits for patients, decision makers and sponsors; Explain requirements and best practices in implementing trial linkage to RWD; Describe current scientific and operational challenges and strategies to overcome them; Identify areas in need of further development to support the design and execution of global hybrid pragmatic studies.

Chair

Mehdi Najafzadeh, PhD

Speaker

Challenges and lessons in Linkage of RWD to Trials: An Academic Perspective
Elisabetta Patorno, DrPH, MD

Pragmatic Approaches in Hybrid Designs: Industry Perspective
Mehmet Burcu, PhD, MS, FISPE

Linkage of trials to RWD: Evolving landscape and overview of US regulatory guidance
Marie C. Bradley, PhD, MPH, MPharm

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States

Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as program lead for the FDA Advancing Real... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Mehdi Najafzadeh

Senior Director, Medidata Solutions, United States

Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →

Elisabetta Patorno

Associate Professor of Medicine, Brigham and Women's Hospital; Harvard Medical School, United States

Monday June 16, 2025 3:45pm - 4:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

3:45pm EDT

#139: Efficient Data Exchange: Drivers for End-to-End Standards Adoption

Monday June 16, 2025 3:45pm - 4:45pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-537-L04-P; CME 1.00; RN 1.00

Internal solutions for translation between regulatory frameworks to assure right use of control vocabularies to exchange data as structured components of submissions to Health Authorities, CMOs, CROs. Controlled vocabularies, ontologies. Presentation of AstraZeneca core data model to enable translation and mapping for data integration. Define use case for data exchange (with data products TLFs for CMC, iterative submissions by piloting the future representing data). vocabularies and business rules to enable data exchange. How everything connects to each Semantic Model Patient Centric vs. Study Centric for reuse scenarios - Amgen will present PQI Standards to build a regulatory filing. Map different regulatory standards frameworks to enable translation between frameworks (e.g., EMA and FDA) into messaging standards like HL7 FHIR. Reference Global Standard benefits (ICH M4Q, Q12, SPQS, IDMP and GSRS). A call for a solution – Interoperability as a Plan – open sources and sharing the standards – What would Dom do? Exchanging structured data everyone is using the same viewer in the Amgen use case. Regulatory Authorities and Industry must collaborate on solutions for development and application of standards to data. Platforms like Accumulus[2] to present the CMC data and translate from one set of standards to another for access for information. Finally we will discuss Digitial Equity and Transparency - one set of data, exposed in a variable output to HAs, supporting critical operations from source whilst maintaining the Digitial nature of data.

Learning Objectives

Analyze how regulatory digital data from divergent sources must meet varying ICH and Regulatory Authority standards; Identify gaps in applying external regulatory standards to internal industry data; Examine specific examples of gaps, such as enhanced granularity and differing regulatory frameworks (e.g., IDMP, XEVMPD, GSRS); Discuss AI and RWD Dimensions of interoperability.

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark, PhD

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS

Speakers

Rita Algorri

Associate Director, Global Regulatory Affairs (CMC), Amgen, United States

Rita Algorri, PhD is an Associate Director, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, she leads and orchestrates internal and external activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves... Read More →

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →

Mathew Woodwark

Head of Data Standards, Interoperability and Governance, AstraZeneca, United Kingdom

Mathew Woodwark, Head of Data Standards, Interoperability and Governance in the R&D Data Office, has a long interest in bringing data sets together. He instigated AstraZeneca's Science Data Foundation, providing analytics ready data for machine learning and AI, establishing R&D’s... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

3:45pm EDT

#141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development

Monday June 16, 2025 3:45pm - 4:45pm EDT

202A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-539-L04-P; CME 1.00; RN 1.00

A multi-stakeholder panel will discuss: regulatory pathways and consideration for early engagement with regulators, harmonization efforts to standardize use of PED, present frameworks to support Industry planning, and explore future opportunities.

Learning Objectives

Discuss regulatory pathways for early engagement to streamline PFDD; Examine regulatory considerations and harmonization efforts to standardize the collection and use of Patient Experience Data; Recognize how to evaluate frameworks available to support industry planning of PFDD studies; Describe best practices for ensuring successful patient-focused study planning and regulatory decision-making.

Chair

Pujita Vaidya, MPH

Speaker

FDA Perspective
Valentina Mantua

Patient-Experience Data in Development Programs and Regulatory Decision-Making
Juan Garcia-Burgos, MD, PhD

Patient Representative Perspective and Resources for Advancing PFDD
Silke Schoch, MA

Industry Perspective
Samantha Roberts, PhD

Speakers

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development... Read More →

Valentina Mantua

Associate Director of Regulatory Science, OND, CDER, FDA, United States

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States

Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →

Silke Schoch

Director, Research & Programs, National Health Council, United States

Silke Schoch is the Director of Research & Programs at the National Health Council. Ms. Schoch joined the National Health Council in 2017 and has been a project manager for many of the NHC’s patient engagement-focused projects including the Patient Experience Mapping Toolbox and... Read More →

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Patient Experience
Tags Session

3:45pm EDT

#142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience

Monday June 16, 2025 3:45pm - 4:45pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-540-L04-P; CME 1.00; RN 1.00

Addressing data gaps in drug development, especially capturing patient experiences in both rare and non-rare diseases, is crucial. From Proof of Concept to Proof of Value, integrated evidence planning and incorporating patient voices in Target Product Profile (TPP) creation drive comprehensive evidence generation.

Learning Objectives

Discuss the utility in global drug development context, including post-marketing efforts; Identify strategies to create a patient informed comprehensive Target Product Profile; Recognize strategies outlined in the interactive guide to align PAG and industry efforts in creating a comprehensive Target Product Profile.

Chair

Agathe Le Lay, PhD, MSc

Speaker

What are we Missing: Potential Data Gaps in Drug Development and the Importance of Capturing Lived Experience in rare and non-rare Diseases
Kristin Hatcher, MEd

From Proof of Concept to Proof of Value: An Industry Approach to Integrated Evidence Planning Throughout the Product Lifecycle
Agathe Le Lay, PhD, MSc

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Patricia Roselle

New Strategies and Practices to Incorporate the Patient Voice in TPP Creation
Bruce E. Miller, PhD

Panelist
Martine Zimmermann, PharmD

Speakers

Kristin Hatcher

Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate, Global Liver Institute/Alpha One Patient, United States

Agathe Le Lay

Global Head of Value Evidence & Patient Insights, H. Lundbeck A/S, Denmark

Agathe Le Lay is the Global Head of Value Evidence and Patient Insights at H. Lundbeck A/S, and is responsible for leading a global team responsible for the strategic planning and delivery of scientific evidence supporting R&D assets as well in-line brands. Agathe is an expert in... Read More →

Bruce Miller

Chief Scientific Officer, COPD Foundation, United States

Dr. Miller is the Chief Scientific Officer of the COPD Foundation overseeing its patient-focused research programs. Inclusion of patient partners is a requirement for any research activity the foundation supports. Dr. Miller has been a participant in the Paladin Consortium since its... Read More →

Patricia Roselle

Head of Patient Stakeholder Engagement, Sanofi, United States

Patricia leads a global team of Patient Engagement Leads within the Patient Informed Development & Health Value Translation unit within R&D at Sanofi, using patient insights to drive a patient disease strategy and to guide Research & Development decision making. Ultimately, we aim... Read More →

Martine Zimmermann

Senior Vice President, Head of Global Regulatory Affairs, Ipsen , France

Dr Zimmermann joined Ipsen in January 2023 as SVP, Head of Regulatory & Quality R&D, based in France and since January 2024, SVP, Head of Global Regulatory Affairs. . She has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion Pharmaceuticals... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Rare Disease, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Patient Experience
Tags Session

3:45pm EDT

#143: Ethics in the Era of Precision Medicine and Advancing Technologies

Monday June 16, 2025 3:45pm - 4:45pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-541-L04-P; CME 1.00; RN 1.00

Precision medicine integrates advanced technology and healthcare to tailor treatments to individuals, aiming to enhance outcomes. However, the rise of artificial intelligence (AI) and advanced technologies in this field introduces new ethical complexities. Privacy, informed consent, and social justice remain central concerns, but evolving technologies brings additional challenges, such as biases in algorithmic predictions and the transparency of decision-making processes. AI-driven models used to predict treatment outcomes or develop personalized care plans can reflect societal biases if trained on unrepresentative or flawed data. This raises concerns about fairness, as patients could be unjustly stratified based on genetic, racial, or socioeconomic factors. Precision medicine, which stratifies patients by genetic profiles, risks perpetuating discrimination or exacerbating health disparities.

Learning Objectives

Discuss the bioethical impact within the next generation of medicine; Recognize the importance of the inclusion of diverse, representative populations and handling of incidental findings.; Discuss how pharmaceutical company possesses its own data that can be explored, which is specific to their organization and reflective of their trial designs; Describe methods that have potential to enhance patient safety in RCTs by leveraging these unique datasets.

Chair

James Wabby, MHS

Speaker

Panelist
Robert Danny Huntington, Esq, JD

Panelist
Scott Schell, MD, PhD, MBA, MPH

Panelist
Ann Marie Hake, MD

Panelist
Chris Schneiderman, MPH

Speakers

Ann Marie Hake

Executive Director, Medical – Digital Health, Eli Lilly and Company, United States

Ann Marie Hake is a board-certified Neurologist with fellowship training in neurodegenerative diseases and postgraduate training in medical informatics. In her current role at Lilly, she is a clinical research physician in the Digital Health R&D group, as well as the Vice Chair of... Read More →

Robert Huntington

Lawyer, ROTHWELL, FIGG, ERNST & MANBECK, P.C. , United States

Danny Huntington is involved in all phases of intellectual property law, including United States and foreign patent prosecution, litigation in the federal courts, licensing, and general client counseling. He has extensive experience with patent interferences and inter partes proceedings... Read More →

Scott Schell

Chief Medical Officer, Cognizant, United States

Scott R. Schell, PhD, MD, MBA, is a distinguished professional with a wealth of experience in healthcare and life sciences. He is a surgical oncologist and PhD Immunologist with deep expertise in pharma, precision therapies, and population health practices. Dr. Schell has held significant... Read More →

Chris Schneiderman

Director, Data & Digital Convergence Catalyst, Abbvie, United States

Chris Schneiderman is an epidemiologist, earning his Master's degree in Public Health from the University of Illinois at Chicago and has spent nearly two decades in roles of increasing responsibility with AbbVie. He currently serves as the Director, Data & Digital Convergence at AbbVie... Read More →

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Session

Level Intermediate
Keyword Bioethics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Bioethics
Tags Session

3:45pm EDT

#145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How

Monday June 16, 2025 3:45pm - 4:45pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-543-L04-P; CME 1.00; RN 1.00

This session will cover the different ways clinical trials can be operationalized in clinical care, the benefits and challenges of the various approaches, and the applicability of good clinical practice requirements to them.

Learning Objectives

Describe key elements of the design and conduct of trials integrated into clinical care; Outline the various operational approaches for such trials, including the benefits and challenges; Discuss the applicability of good clinical practice requirements to various operational approaches.

Chair

Emily Gebbia, JD

Speaker

Site Perspective
Grant Huang, PhD, MPH

FDA Perspective
Emily Gebbia, JD

Industry Perspective
Robert DiCicco, PharmD

MHRA Perspective
Jason Wakelin-Smith

Speakers

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States

Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States

Grant Huang

Deputy Director, VA Cooperative Studies Program, United States

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Session

3:45pm EDT

#146: FDA Accelerated Approval Program: Putting Withdrawals in Context

Monday June 16, 2025 3:45pm - 4:45pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-544-L04-P; CME 1.00; RN 1.00

The FDA Accelerated Approval Program has been criticized for employing lower regulatory standards than traditional approval, undue delays in withdrawing therapies approved under Accelerated Approval for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence . Of specific focus for critics has been withdrawn treatments, which are being used as examples of the program’s ineffectiveness and basis for proposed changes. However, the purpose of the program is to allow acceptable risk in order to address patients with a large unmet need. The small percentage of drugs whose clinical benefit is ultimately not confirmed should not be viewed as a failure of the accelerated approval program. Rather, they represent an expected trade-off in expediting drug development that benefits patients with serious or life-threatening diseases. Withdrawals make up a small percentage of the total number of therapies approved under Accelerated Approval and do not reflect overall management of the program over its 30-year history, particularly improvements seen in the last decade in the time from accelerated approval to conversion. In addition, the reasons for the withdrawals are complex and need to be understood within the context of the overall impact on patient outcomes due to early access enabled by the program.

Learning Objectives

Examine the reasons for product withdrawals after Accelerated Approval and identify the different situations where a withdrawal may occur; Recognize clinical impact including life years gained and uptake after Accelerated Approval of oncology products that were later withdrawn; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of AAP and withdrawals.

Chair

Bridget Doherty, MPH, MS

Speaker

Industry Perspective
Kevin Bugin, PhD, MS, RAC

Non-Profit Perspective
Jeff Allen, PhD

Speakers

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States

Dr. Kevin Bugin is the head of global regulatory affairs and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson Innovative Medicine, United States

Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

3:45pm EDT

#148: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

Monday June 16, 2025 3:45pm - 4:45pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-546-L04-P; CME 1.00; RN 1.00

This session will focus on assessing the effectiveness of current regulatory collaboration efforts and identifying how those principles can be applied to chronic disease areas outside of oncology, such as metabolic disease and obesity.

Learning Objectives

Describe the impact of global regulatory collaboration on patient outcomes; Discuss risks associated with chronic disease and its impact on society as a whole; Identify innovative ways to address chronic disease through regulatory innovation and collaboration.

Chair

Brad Jordan, PhD

Speaker

Project ORBIS and ACCESS Experience
Melissa Hunt, MSc

Panelist
Magda Bujar, PhD, MSc

Applying Learnings from Project ORBIS
R. Angelo De Claro, MD

Industry Perspective
Laura Mccary-Bloss, PhD

Speakers

Julian Beach

Interim Executive Director of Healthcare Quality and Access (HQA), MHRA, United Kingdom

Magda Bujar

Associate Director, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom

Dr Magda Bujar is Associate Director, Regulatory Programme and Strategic Partnerships and has over 10 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those... Read More →

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States

Melissa Hunt

Director, Health Canada, Canada

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.

Laura Mccary-Bloss

Vice President Global Regulatory Affairs, Amgen, Inc., United States

Laura is the Global Regulatory Therapeutic Area Head at Amgen for the Inflammation and Rare Disease product portfolio, which includes products across the development and commercialization lifecycle. Laura has been with Amgen since 1998. She has worked in several leadership roles in... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration
Tags Session

3:45pm EDT

#149: WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation

Monday June 16, 2025 3:45pm - 4:45pm EDT

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-547-L04-P; CME 1.00; RN 1.00

Explore WHO-led initiatives and global collaborations driving regulatory harmonization and innovation to ensure equitable access to medical products. This session highlights strategic efforts to address shared challenges and advance global health.

Learning Objectives

Discuss the progress and challenges in achieving regulatory convergence and harmonization; Recognize the role of regulatory reliance and collaboration in facilitating access to medical products; Discuss international partner’s perspective on navigating regulatory landscapes to enhance global health equity.

Chair

Hiiti Sillo, MSc, RPh

Speaker

CIP Network and its role in Advancing Global and Regional Regulatory Harmonization, Collaboration, and Work-Sharing
Jude Nwokike, MPH, MSc, RPh, RAC

Regulatory Harmonization: Advancing Global Health through Collaboration
Marion Laumonier, MSc

Shaping Global Health Research and Development through WHO Resources and Coordinated Scientific Advice
Mercedes Perez Gonzalez, MSc

Speakers

Mercedes Perez Gonzalez

Technical officer, WHO, Switzerland

Mercedes Perez Gonzalez serves as a Technical Officer in the Science Division of WHO, focusing on optimizing WHO's R&D activities, including the development of target product profiles for health products and coordinating WHO's scientific advice for product developers of medicines... Read More →

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland

Marion Laumonier is Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →

Jude Nwokike

Vice President, Global Health & Manufacturing Services, USP, United States

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland

Mr Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO Department of Regulation and Prequalification. In this role, he coordinates WHO strategies for strengthening national and regional regulatory systems for medical products, including promoting regulatory harmonization... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Student Programming
Tags Session

3:45pm EDT

#140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders

Monday June 16, 2025 3:45pm - 4:45pm EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-538-L04-P; CME 1.00; RN 1.00

The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content

Learning Objectives

Recognize the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explain Customization and Multi-View Capabilities; Discuss how to evaluate the Impact on Decision-Making and Efficiency for Key Roles; Describe ways to examine Multi-Format Exchange of Protocol Information.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Digital Protocol Template: Industry Perspective
Vivian Combs, MS

Digital Protocol Template: Regulatory Perspective
Y. Veronica Pei, MD, MEd, MPH

Speakers

Vivian Combs

Executive Director, Clinical Trial Foundations, Eli Lilly and Company, United States

Vivian Combs is a full-time Process Owner within Eli Lilly and Company's Clinical Trial Foundations organization, where she is focused on medical writing, content reuse, and automation. She recently completed her duties as the rapporteur for the ICH M11 CESHarP (Clinical Electronic... Read More →

Ron Fitzmartin

Principal Consultant, Decision Analytics, United States

Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 04: MedAffairs-SciComm, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

3:45pm EDT

#144: Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management

Monday June 16, 2025 3:45pm - 4:45pm EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-542-L04-P; CME 1.00; PDU 1.00 PMI 2166OVTGM7; RN 1.00

Explore strategies for high complexity projects, focusing on collaborations, regulatory submissions and asset integration. Gain insights on stakeholder management, risk mitigation, strategic planning to turn potential chaos into streamlined success.

Learning Objectives

Discuss challenging biopharmaceutical collaborations and efficient integration of assets; Identify effective strategies for managing complex regulatory submissions in the pharmaceutical industry; Recognize ways to assess risks and develop contingency plans for project timelines and budgets; State how to apply multiple stakeholder management techniques to ensure alignment and informed decision-making across governances.

Chair

Matthew Curin, PharmD

Speaker

Speaker
Andrea Jux

Speakers

Matthew Curin

Sr. Dir, Head of Program Management, Therapeutic Dermatology, Galderma, United States

Matt has been working in the pharmaceutical industry for more than 25 years, spending the first 8 years in clinical manufacturing before moving into project management in 2007. Since then, Matt has provided project, program, and portfolio management leadership in clinical development... Read More →

Andrea Jux

Senior Director, Development Program Management, Genmab US, Inc., United States

Accomplished Leader with 3 decades of experience in the pharmaceutical industry, focusing on strategic initiatives, operational excellence and regulatory compliance. Adept at leading cross-functional teams and forging partnerships to execute complex projects. Passionate about optimizing... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 07: ProjectManagement-StrategicPlanning, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Session

3:45pm EDT

#151: Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication

Monday June 16, 2025 3:45pm - 4:45pm EDT

206

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-549-L04-P; CME 1.00; RN 1.00

This session will include techniques for having robust documentation to deliver clear, confident messages and strategies which improve individual and team performance, confidence and compliance using insights backed by data and real-world examples.

Learning Objectives

Discuss the Impact of Language and how the choice of words and tone can influence performance, collaboration and compliance in the workplace; Recognize practical techniques and strategies for communicating with confidence in various professional scenarios; Describe ways to enhance performance through effective communication.

Chair

Tony Johnson, MS

Speaker

Panelist
Ana Sharma, MPH

Panelist
Anne Marie Inglis, PhD

Speakers

Anne Marie Inglis

Senior Director, Clinical Operations Asset Lead, GSK, United States

Dr. Inglis has over 25+ years of experience in clinical research, spanning all phases of research, specializing in clinical operations. While at Mallinckrodt Pharmaceuticals, she led the initiative to define the Risk Based Quality Management approach within Clinical Development. In... Read More →

Tony Johnson

Senior Director, Clinical Quality, Mallinckrodt Pharmaceuticals, United States

Ana Sharma

Vice President, Global Head of Research and Development Quality Assurance, Abivax, United States

Ana Sharma is an accomplished quality leader with over 20 years of expertise across all GxP areas, successfully bringing more than 30 drugs and medical devices to market. She has worked at large and small pharmaceutical companies and healthcare companies such as Abivax, Takeda, Novartis... Read More →

Monday June 16, 2025 3:45pm - 4:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Session

8:30am EDT

#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates

Tuesday June 17, 2025 8:30am - 9:30am EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-551-L04-P; CME 1.00; RN 1.00

This session will introduce the latest efforts to enhance the quality of safety signal generation from government, industry, and academia (e.g., recommendations, regulatory frameworks, case examples) and will conclude with a panel discussion.

Learning Objectives

Explain the latest recommendations for reporting the results of safety signal generation (transparency, completeness) and relevant case example; Examine case examples to enhance the quality of safety signal generation in industry and academia: task process and methodologies; Discuss perspectives from government, industry, and academia to enhance the quality of safety signal generation.

Chair

Judy Shin, PhD

Speaker

A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and Beyond
Michele Fusaroli, DrMed, PhD

Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD

Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh

Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →

Michele Fusaroli

Uppsala Monitoring Centre, Sweden

Michele Fusaroli, MD, PhD, serves as a Senior Pharmacovigilance Scientist at the Uppsala Monitoring Centre's Research Department. He steered the READUS_PV group, which focused on establishing reporting guidelines for disproportionality analysis. Fusaroli Michele has implemented innovative... Read More →

Wei-I Huang

Director, Division of Drug Safety, Taiwan Drug Relief Foundation, Taiwan

Ms. Wei-I Huang is a clinical pharmacist specializing in pharmacovigilance and regulatory pharmacoepidemiology. Her expertise includes drug safety signal detection, risk assessment, and regulatory compliance. As Director of the Taiwan National ADR Reporting Center, operated by the... Read More →

HYUN JOO JUNG

Department of Drug Safety Information, Korea Institute of Drug Safety & Risk Management, Korea, Republic of

I am currently working as the director of the office of drug safety information of department of drug safety information in Korea Institute of Drug Safety & Risk Management. Based on the Pharmaceutical Affairs Act of Korea, we collect, analyze, assess and management drug safety information... Read More →

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age

Tuesday June 17, 2025 8:30am - 9:30am EDT

206

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-552-L04-P; CME 1.00; RN 1.00

Imagine a future where AI measures patient burden from provided inputs. In this interactive workshop, participants will design input logic for AI using mock data and protocols, then present their rationale to foster collaborative learning.

Learning Objectives

Define and categorize key factors affecting patient burden in clinical trials; Analyze patient-related data to design effective AI inputs; Evaluate and justify the role of human insight in enhancing AI-driven patient burden assessments for patient-centric trial outcomes.

Chair

Mihail Tanev, DMD, PhD

Speaker

Panelist
Karen Correa, PhD

From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age
Mihail Tanev, DMD, PhD

Speakers

Mihail Tanev

Medical Advisor, FindMeCure Ltd, Bulgaria

Dr. Mihail Tanev, DMD, PhD is a health practitioner and scientist with a doctorate in Oral Pathology Science and Photochemistry. Coming from a strong academic foundation in disease biology, diagnostics and clinical research, he brings a uniquely cross-disciplinary perspective to the... Read More →

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Workshop

Level Intermediate
Keyword Artificial Intelligence (AI), Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Patient Experience
Tags Workshop

8:30am EDT

#203: Realizing Value Through Responsible AI in Clinical Development

Tuesday June 17, 2025 8:30am - 9:30am EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-553-L04-P; CME 1.00; RN 1.00

Leveraging expertise from industry, this session will explore how responsible AI frameworks can maximize value in clinical research by ensuring ethical, transparent, and accountable AI use.

Learning Objectives

Recognize a set of responsible principles for AI in drug development; Demonstrate the ability to drive innovation and strategic advantage in AI-driven clinical trials; Propose how organizations can lead with integrity and trust in their AI applications.

Chair

Stephen Pyke, MSc

Speaker

Patient Perspectives on AI in Clinical Development
Alicia Staley, MBA, MS

Regulatory Perspectives on AI in Clinical Development
Tala Fakhouri, PhD, MPH

Industry Perspectives on AI in Clinical Development
Raja Shankar, MS

Speakers

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →

Stephen Pyke

Chief Clinical Data and Digital Officer, Parexel, United Kingdom

Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions... Read More →

Raja Shankar

Vice President, Machine Learning, IQVIA, United Kingdom

As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States

Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

8:30am EDT

#205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem

Tuesday June 17, 2025 8:30am - 9:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-555-L04-P; CME 1.00; RN 1.00

This session will explore the evaluation and implementation of assistive technology for clinical document content creation. The panelists will describe experimental design and adoption of solutions, cross-functional partnerships, and the impact to Medical Writing organizations.

Learning Objectives

Discuss and evaluate the potential benefits and challenges of implementing assistive technology, including both rule-based and AI-based solutions; Recognize the criticality of working with cross-functional teams to assess and implement technologies, ensuring successful adoption and return on investment; Discuss how AI can positively influence Medical Writing organizations.

Chair

Nancy Tam, MS

Speaker

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Matthew Renda, PhD, MS

Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem
Aliza Nathoo

Speakers

Aliza Nathoo

Senior Director, Content Strategy, F. Hoffmann-La Roche Ltd., Canada

Aliza began her career on molecular teams and leading complex regulatory submissions. Over her 20+ years in biopharmaceuticals, she has expanded her focus into automation-assisted content authoring, generation, and management. Today, she leverages her foundation to drive content innovation... Read More →

Matthew Renda

Senior Director Medical Writing Operations, Alexion, Astrazeneca Rare Disease, United States

Matt Renda has 13 years of academic research experience focused on gene therapy and 17 years of pharmaceutical development experience providing regulatory submission management and medical writing leadership to optimize cross-functional processes, implement innovative technologies... Read More →

Nancy Tam

Head of Medical Writing, Pfizer Inc, United States

Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has implemented automated solutions for content creation at several sponsor companies and is working to implement... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

8:30am EDT

#207: Japan Town Hall

Tuesday June 17, 2025 8:30am - 9:30am EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-557-L04-P; CME 1.00; RN 1.00

This session will focus on the attractiveness of developing and obtaining marketing approval of pharmaceutical products in Japan from regulatory and industry perspectives, aiming to get rid of old-fashioned ideas and views about Japan.

Learning Objectives

Discuss outdated misconceptions and “urban legends” about Japan when considering Research and Development (R&D) on new medicines in Japan; Examine the attractiveness of performing R&D in Japan, both from regulatory and industrial perspectives: attractive market, flexibility/predictability, designation for each product characters; Analyze the Roles and Prospects of the PMDA’s Overseas Offices.

Chair

Daisuke Koga, MSc, RPh

Speaker

Panelist
Eri Sekine

Panelist
Sarah Rhee

Panelist
Shinichi Noda, PhD

Speakers

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →

Shinichi Noda

Division Director, Division of Planning and Management, Office of International, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

2024-present Division Director, Division of Planning and Management, Office of International Strategy and Planning, PMDA 2019-2024 Deputy Review Director, Office of Cellular and Tissue-based Products, PMDA 2015-2019 Senior Reviewer, Office of pharmacovigilance II, PMDA 2013-2015 Section... Read More →

Sarah Rhee

Vice President, Head of Global Regulatory Affairs, Alexion Pharmaceuticals, Inc, United States

Eri Sekine

Executive Vice President Data Business, CMIC Co., Ltd, Japan

Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes CDM, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing, Quality Management and Dx Strategy. Eri Sekine has over 30 years' experience in various functions in clinical... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

8:30am EDT

#208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers

Tuesday June 17, 2025 8:30am - 9:30am EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-558-L04-P; CME 1.00; RN 1.00

This session will present on recent work to harmonize RWE guidelines globally. Ongoing efforts in international collaboration on ICH M14 and the ICH reflection paper will be highlighted.

Learning Objectives

Explain recent developments in international guidelines on RWE; Discuss challenges to harmonization efforts in RWE; Recognize how to evaluate gaps in RWE harmonization needs.

Chair

Stephanie Choi, PhD

Speaker

An Overview of Emerging Regulatory Guidance & Frameworks for Developing Fit-for-Purpose Real-World Evidence: Proposed Areas for Harmonization
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH M14: Establishment of an ICH guideline on “General principles on the plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines”
David Moeny, MPH, RPh

Collaborative international efforts on RWD/RWE: What is coming next?
Patrice Verpillat, DrMed, MD, PhD, MPH

Opportunities for regulatory alignment? Data quality assessment and reporting
Nicole Mahoney, PhD

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States

Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

David Moeny

Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States

David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE), Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE),Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

8:30am EDT

#209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge

Tuesday June 17, 2025 8:30am - 9:30am EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-559-L04-P; CME 1.00; RN 1.00

The Platform Technology Designation program reflects longtime practice to leverage prior knowledge to speed development through advanced regulatory science, based on what's already known. But how will this practice and policy continue to evolve?

Learning Objectives

Describe how the FDA, other Health Authorities (HAs), and sponsors have historically leveraged prior knowledge to accelerate innovative product development and review; Examine the FDA’s perspective on applying prior knowledge to enhance the platform technology designation program and other regulatory science advancements or pathways; Discuss how the FDA plans to ensure the consistent application of these policies across review divisions and Centers.

Chair

Alexis Miller, JD

Speaker

Health Authority Perspective
Julia Tierney, JD

Historic Application of Prior Knowledge
Rachel Turow, JD, MPH

Industry Perspective
Danielle Friend Economo, PhD

Speakers

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →

Alexis Miller

Head, Global Regulatory Policy, Merck & Co., Inc., United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →

Julia Tierney

Former Deputy Center Director for Strategy, Policy, and Legislation, CBER, United States

JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

Rachel Turow

Of Counsel, FDA Regulatory, Skadden, United States

A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. Her experience spans cosmetics, dietary supplements, food, over-the-counter and prescription drugs, medical devices and combination and... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#210: MHRA Town Hall

Tuesday June 17, 2025 8:30am - 9:30am EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-560-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.

Learning Objectives

Describe MHRA’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with MHRA regulators.

Chair

Alison Cave, PhD

Speaker

Panelist
James Pound

Panelist
Julian Beach

Panelist
Lawrence Tallon

Speakers

Julian Beach

Interim Executive Director of Healthcare Quality and Access (HQA), MHRA, United Kingdom

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →

James Pound

Group Manager - British Pharmacopoeia & Laboratory Services, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility... Read More →

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency, United Kingdom

Tuesday June 17, 2025 8:30am - 9:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

8:30am EDT

#204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence

Tuesday June 17, 2025 8:30am - 9:30am EDT

143ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-554-L04-P; CME 1.00; RN 1.00

This session will engage an expert panel in a discussion on traceability of RWD. Panelists will describe challenges and discuss potential solutions to maintain and document traceability of RWD used in regulatory submissions.

Learning Objectives

Describe the inherent challenges in maintaining and documenting the traceability of Real-World Data (RWD) for regulatory purposes; Discuss potential solutions, including new and existing technologies, to enhance RWD traceability; Evaluate the strengths and weaknesses of various approaches to RWD traceability in a regulatory context.

Chair

James Browning, MPH

Speaker

Healthcare Organization Research Technology Perspective
Christopher Herrick, MBA

Traceability - Tools & Implementation Perspective
Anand Shroff, MBA, MS

Regulator Perspective
Marie C. Bradley, PhD, MPH, MPharm

Epidemiologist/Observational Researcher Perspective
Nancy Dreyer, PhD, MPH, FISPE

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States

James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Christopher Herrick

VP of Research Systems and Technology, Mass General Brigham (MGB), United States

Christopher Herrick is the Vice President of Research Technology at Mass General Brigham, where he leads the strategic development of data and technology platforms that support clinical research across one of the nation’s largest academic health systems. He co-leads the Hospital... Read More →

Anand Shroff

President, Verantos, United States

Anand Shroff is a co-founder and President of Verantos, a company which specializes in rich and reliable RWD and high-validity RWE using AI. Previously, he was one of the founders of Health Fidelity (acquired by Edifecs/Francisco Partners), which focused on identifying and quantifying... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 03: Data-Tech, Forum

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?

Tuesday June 17, 2025 10:30am - 11:30am EDT

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-562-L04-P; CME 1.00; RN 1.00

The pharmacovigilance (PV) ecosystem is fraught with noise, impeding a single source of truth for effective and timely safety surveillance of Individual Case Safety Reports (ICSRs). However, multi-stakeholder partnerships can synthesize diverse needs and requirements to pilot a modernized future state.

Learning Objectives

Recognize ICSR replication and duplication challenges to the ecosystem; Describe ways to critically appraise a proposed concept for modernizing ICSR management to address challenges, enhance safety analysis, and facilitate a real-time learning healthcare system; Identify the stakeholder perspectives, modern methods and technologies, and change management needed to design and pilot a new ICSR paradigm.

Chair

Mayur Patel, PharmD

Speaker

Panelist
Suranjan De, MBA, MS

Panelist
Andrew Bate, PhD, MA

Panelist
Phil Tregunno

Panelist
Jeremy Jokinen, PhD, MS

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States

Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#216: The Globalization of Risk Management

Tuesday June 17, 2025 10:30am - 11:30am EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-563-L04-P; CME 1.00; RN 1.00

This session will review the key REMS and EU Risk Management guidances issued during 2024. It will review the major strategic and operational impacts of the new guidances and describe practical applications of the new approaches they describe.

Learning Objectives

Discuss the overview and intent of key risk management guidances issued by the FDA and EMA; List the key differences and similarities in the approaches outlined in the guidelines; Identify key areas of activity for organizations to align with the intent of these guidances; Evaluate the key strategic and operational impacts of the guidances on participants' organizations.

Chair

Jamie Wilkins, PharmD

Speaker

Recent EMA Risk Management Initiatives- GVP XVI r3
Priya Bahri, PhD, RPh

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →

Jamie Wilkins

Head, Risk Management Center of Excellence, Pfizer Inc, United States

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

10:30am EDT

#217: Case Studies of Application of AI in Risk-Based Quality Management

Tuesday June 17, 2025 10:30am - 11:30am EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-564-L04-P; CME 1.00; RN 1.00

This session will present multiple case studies illustrating the successful implementation of AI-driven RBQM solutions in real-world clinical trials. Attendees will gain insight into the practical applications of AI technologies.

Learning Objectives

Recognize the key benefits and challenges of applying AI technologies in RBQM; Identify insights into real-world examples of AI's impact on clinical trial risk management; Discuss strategies for integrating AI into existing RBQM frameworks to improve decision-making and compliance; Describe how AI enhances collaboration across clinical trial stakeholders and supports more proactive risk-based strategies.

Chair

Artem Andrianov, PhD, MBA

Speaker

Panel Discussion: AI Teammates in Trials - Elevating Risk Management and Human Insight
Brian Barnes, MA

Novo Nordisk’s Path to Integrated Quality and Risk Management with AI-Powered Study Builder
Bo Maach-Møller, MPharm

Unlocking AI Potential In RBQM: Today and Tomorrow
Cheng Su, PhD

Speakers

Artem Andrianov

CEO, Cyntegrity Germany GmbH, Germany

With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in clinical data quality and biostatistics. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical... Read More →

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States

Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal... Read More →

Bo Maach-Møller

Vice President, Risk Based Quality Management, Novo Nordisk A/S, Denmark

As a Vice President of Clinical Operations and Risk Based Quality Management, Regional Clinical Operations Director, Lean Six Sigma Black Belt, and many other Clinical Operations roles over the years, I bring an extensive and diversified experience in managing people and project initiatives... Read More →

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical, United States

Cheng is the Executive Director of Data Sciences at BioMarin, where he leads RBQM transformation, AI innovation, and statistical support for research and early development. Prior to joining BioMarin, he led the development of centralized statistical monitoring and directed the Research... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

#219: Resilient Leadership: Overcoming Isolation and Adversity

Tuesday June 17, 2025 10:30am - 11:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-566-L04-P; CME 1.00; RN 1.00

In the ever-evolving pharma/biotech landscape, leaders face challenges that test their professional and personal resilience. The past year has seen a significant strain on the industry, marked by the disruption of new technologies (and expectations associated with it), the failure of promising compounds, economic pressures, and layoffs. As leaders, we are often left to shoulder the weight of these challenges, managing not only our own emotional burden but also the morale of our teams and the broader organizational impacts. This presentation, delivered by a panel of seasoned professionals in the regulatory writing space, will explore the often-unspoken loneliness of leadership in times of upheaval. We will share personal insights from our career journeys, addressing the ways in which leadership can feel isolating, especially when navigating industry setbacks. In addition, we will provide practical strategies for coping with these burdens, drawing from experiences in career pivots, reskilling/retooling, and personal resilience. We will discuss ways to maintain emotional well-being, foster collaboration, and lead with transparency, even in the face of industry-wide adversity. Attendees will leave with actionable strategies to support their teams and themselves, and insights into how to continue leading effectively in times of uncertainty.

Learning Objectives

Discuss the unique emotional and professional challenges faced by regulatory writing leaders during periods of significant change; Describe developing strategies for maintaining personal resilience and emotional well-being while leading teams through industry-wide setbacks and economic pressures; Recognize ways to implement actionable techniques for fostering skill development, reskilling, and collaboration to effectively support both individual and team growth during challenging times.

Chair

Robin Whitsell

Speaker

Panelist
Cathy Tyrrell

Panelist
Matthew Robillard, MBA

Speakers

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States

Matthew Robillard is a Senior Director of Strategic Medical Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has progressed... Read More →

Cathy Tyrrell

Head of Medical Writing and Disclosure, CSL Seqirus, United States

Cathy has led medical writing teams and built groups in pharmaceutical companies and CROs of all sizes. Her career started in immunomodulator research that contributed to better lives for rheumatoid arthritis patients. Since then, she has played a part in the successful development... Read More →

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session | 12: ProfDevelopment, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation

Tuesday June 17, 2025 10:30am - 11:30am EDT

202A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-567-L04-P; CME 1.00; RN 1.00

A new community-focused, multi-stakeholder, disease-agnostic framework addressing solutions to sustainably improve clinical trial participation. Learn about, and how to apply, the framework along with a case study of its initial implementation in Atlanta.

Learning Objectives

Discuss an innovative framework for multi-stakeholder, community-focused clinical trial participation developed by patient advocacy and community-based organizations, trial sites, industry sponsors, and communications partners; Recognize its practical applications, real-world experiences, and initial impact through the grassroots pilot, Reflections Atlanta.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Nove Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Ellyn Getz, MPH

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Victoria DiBiaso, BSN, MPH, RN

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Patricia Davidson, MPA

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation
Dawn Rotellini

Speakers

Patricia Davidson

PALADIN Consortium Director, Tufts Center for the Study of Drug Development, United States

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, France

Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →

Ellyn Getz

Director, R&D Partnerships, CSL Behring, United States

Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →

Dawn Rotellini

Chief Operating Officer, National Bleeding Disorder Foundation, United States

Dawn Rotellini has been a leader in the bleeding disorders community for 27 years. As a parent of a son with Hemophilia, she founded the Rocky Mountain Bleeding Disorders Association in Bozeman, Montana, and served as its Executive Director. After moving to Pittsburgh, PA, she served... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

10:30am EDT

#221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities

Tuesday June 17, 2025 10:30am - 11:30am EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-568-L04-P; CME 1.00; RN 1.00

In a rapidly evolving clinical trial landscape, breaking down financial barriers is essential to foster participant enrollment, improve retention, and ensure the success of trials.

Learning Objectives

Identify key findings from DIA’s Participant Compensation Landscape Analysis and discuss their implications to promote diversity and support clinical trial outcomes; Recognize participant-centric strategies to address financial barriers in clinical research, enhancing diversity in trial participation; Discuss collaborative approaches to further understand participant compensation practices.

Chair

Carie Pierce, MS

Speaker

Moderator
Donna Libretti Cooke, JD

Panelist
James Lovett, JD

Contributor-Industry
Karen Correa, PhD

Contributor-Academia
Kenneth Getz, MBA

Speakers

Donna Libretti Cooke

Chief Impact Officer & Owner, ImpactSphere Clinical, LLC, United States

DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC A compassionate pioneer driving clinical trial solutions for a healthier world. Donna is a strategic & collaborative Life Sciences professional with a ‘dive-in’ mindset and an extensive track record... Read More →

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →

James Lovett

CEO, Myonex, United States

James Lovett is Chief Executive Officer and Board Member of Myonex Inc., a leading clinical trial supply company with operations in US, France, Germany and UK and distribution to 80 countries. Myonex partners with pharma and biotech companies, CROs, and other pharma service providers... Read More →

Carie Pierce

Global Head of Growth & Business Development, DIA, United States

Carie serves as Global Head of Growth for DIA. She comes to DIA with over 25 years in the Medical Device, Diagnostic, and Pharmaceutical industry. She has spent much of her career with Terumo Blood and Cell Technologies in various commercial leadership roles, including responsibility... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Bioethics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Bioethics
Tags Forum

10:30am EDT

#223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects

Tuesday June 17, 2025 10:30am - 11:30am EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-570-L04-P; CME 1.00; PDU 1.00 PMI 2166B7YYGZ; RN 1.00

This pilot expanded Project Manager (PM) from R&D to encompass launch activities, enhancing cross-functional collaboration and planning, stakeholder communication and alignment with country organizations. A PM covering the entire value chain drives project success.

Learning Objectives

Assess the impact of end-to-end coverage of projects, including commercialization, on project value; Integrate critical components of launch planning, including R&D, marketing, access, and medical tactics; Develop skills to enhance cross-functional collaboration among R&D and global and local commercial teams to improve project outcomes.

Chair

Andreas Sutter, PhD, MPharm, RPh

Speaker

Industry Perspective
Jo Ann Kerwin

Industry Perspective
Stacy Hurt, MBA, MHA

Speakers

Jo Kerwin

Senior Director Strategic Planning &. Operations, Jo Ann Kerwin, United States

Experienced global pharmaceutical senior director with over 30 years of pharma experience spanning early research, clinical operations, project, program, portfolio management and medical affairs. A solutionner who provides analytical and critical thinking skills to drive innovation... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Andreas Sutter

Senior Program Management Leader, Bayer AG, Germany

Andreas Sutter is a senior program management leader in the pharmaceutical industry, with expertise spanning from early research to product launches. He focuses on implementing R&D and commercialization strategies for oncology, especially radioligand therapies. His experience includes... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Session

10:30am EDT

#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct

Tuesday June 17, 2025 10:30am - 11:30am EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-571-L04-P; CME 1.00; RN 1.00

Effective data management and risk mitigation are crucial for ensuring data quality, safety, and reliability. This session explores strategies to uphold these standards in cutting-edge trials.

Learning Objectives

Outline regulatory requirements for data quality, traceability, and reliability in trials with decentralized elements, adaptive designs, and RWD; Discuss case studies with complex data flows to highlight the importance of understanding data flow, conducting risk conducting risk assessments, and applying effective risk mitigation strategies.

Chair

Cheryl Grandinetti, PharmD

Speaker

Industry Perspectives
Michael Torok, PhD

Health Canada Perspective
Debbi Fox

MHRA Perspective
Jason Wakelin-Smith

Speakers

Debbi Fox

Compliance and Enforcement Specialist, Health Canada, Canada

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Tuesday June 17, 2025 10:30am - 11:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Keyword Clinical Trial Design, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

10:30am EDT

#225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development

Tuesday June 17, 2025 10:30am - 11:30am EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-572-L04-P; CME 1.00; RN 1.00

This session will explore engagement pathways with global regulators to obtain feedback on AI technologies in drug development. It will also identify effective evaluation strategies to support regulatory acceptance of novel methodologies.

Learning Objectives

Identify the appropriate regulatory pathways and mechanisms for engaging with health authorities to discuss AI technologies in drug development applications; Discuss regulatory strategies, use cases, and considerations for AI model development based on context of use; Evaluate lessons learned and experiences from manufacturers, developers and health authorities.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speaker

EMA Perspectives on the Use of AI in the Lifecycle of Medicines
Luis Pinheiro, PharmD, MSc

AI and Machine Learning in Pharmaceutical Manufacturing
Gert Thurau, DrSc, PhD

FDA Perspectives on the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products
Tala Fakhouri, PhD, MPH

Technical and Regulatory Considerations for Streamlining Drug Development with Digital Twins: Sample-size Reduction Case Study
Aaron Smith, PhD

Speakers

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States

Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, artificial intelligence, and advanced therapies. Before joining AbbVie, Ryan served as an international... Read More →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →

Aaron Smith

Founder, Machine Learning Scientist, Unlearn.AI, United States

Aaron is a mathematician with interests in AI, machine learning, and statistics. As a founder of Unlearn.ai, he has focused for the last 8 years on the development of digital twin models and their applications in drug development.

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland

Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

#226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases

Tuesday June 17, 2025 10:30am - 11:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-573-L04-P; CME 1.00; RN 1.00

The US Orphan Drug Act and the European regulatory framework have accelerated orphan medicine development, boosting investments in rare disease treatments. This session will gather key stakeholders to discuss successes a and challenges

Learning Objectives

Discuss the impact of regulatory policies on the rare disease ecosystem; Discuss the challenges and opportunities associated with orphan drug regulations; Examine the role of regulatory frameworks in fostering innovation and access to therapies for rare diseases; Explain the importance of collaboration between regulatory agencies, industry stakeholders, and patient advocacy groups.

Chair

Imran Shah, PhD

Speaker

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases
Anabela Marcal, PharmD

Panelist
Amy Comstock Rick, JD

Panelist
Carolyn Shore, PhD

Panelist
Victoria Gemme, MBA, MS

Speakers

Victoria Gemme

Director, Policy and Regulatory Affairs, National Organization for Rare Disorders, United States

Victoria Gemme is a research associate at the Duke-Margolis Center for Health Policy, where she works on a range of policy topics related to medical product development and regulation. Prior to Duke-Margolis, Victoria worked at the Cystic Fibrosis Foundation where she oversaw a diverse... Read More →

Imran Shah

SVP & Head, Global Regulatory, R&D Quality and Safety (RQS), EMD Serono, United States

Carolyn Shore

Director, National Academies, United States

Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →

Segundo Mariz

European Medicines Agency, Netherlands

Amy Comstock Rick

Director of Strategic Coalitions, Rare Disease Innovation Hub, FDA, United States

https://www.fda.gov/industry/fda-rare-disease-innovation-hub/amy-comstock-rick-jd

Tuesday June 17, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Rare Disease
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease
Tags Session

10:30am EDT

#227: ANVISA Town Hall

Tuesday June 17, 2025 10:30am - 11:30am EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-574-L04-P; CME 1.00; RN 1.00

In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

Learning Objectives

Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator

Chair

Bianca Zimon, LLM

Speaker

Panelist
Daniel Pereira

Panelist
Marcelo Moreira, MS

Panelist
Dandara Braga Santana, MHS

Speakers

Marcelo Moreira

GENERAL MANAGER, ANVISA, Brazil

Pharmacist. At Anvisa, serving as General Manager of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs, and Advanced Therapy Products.

Daniel Pereira

ANVISA, Brazil

Dandara Santana

CMC reviewer, ANVISA, Brazil

Bachelor's degree in Pharmaceutical Sciences with Clinical and Industrial qualification. Master's degree in Health Science. Professional experience as a pharmacist at the Ministry of Health in Brazil. Since 2014, working as a CMC reviewer at the National Health Surveillance Agency... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →

Tuesday June 17, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Regulatory Collaboration, Regulatory Convergence and Harmonization, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Regulatory Collaboration ,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Session

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts

Tuesday June 17, 2025 1:00pm - 1:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements; Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions; Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Speaker

Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Alex Asiimwe

Speakers

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop | 03: Data-Tech, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

207A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-578-L04-P; CME 1.00; RN 1.00

Our industry is still mired in failing to adopt proven technology solutions until it becomes a reg necessity or mainstay of core operations. Industry change agents will present evidence that demonstrates we typically operate with lagging efforts.

Learning Objectives

Identify emergent solutions and innovative business practices that can enhance clinical trial operations; Evaluate the impact of adopting decentralized trials in oncology using the Beat AML Master Trial as a case study; Discuss how risk-taking and cross-sector practices can accelerate clinical trial success and improve patient outcomes.

Chair

Len Rosenberg, PhD, RPh

Speaker

Panelist
Joseph Dustin

Speakers

Joseph Dustin

Founder and Managing Partner, eClinical Consulting, United States

For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up 12 year run with Medidata. He has worked with top Pharmaceutical, Biotech and CRO... Read More →

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States

Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Forum

1:45pm EDT

#241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-579-L04-P; CME 1.00; RN 1.00

This session will review the 2024 revision of the Declaration of Helsinki, one of the foundational codes of clinical research ethics, and the rationale and practical implications of the changes made in the current version.

Learning Objectives

Discuss the history of the Declaration of Helsinki and its relevance and importance for the healthcare industry; Recognize the changes made in the 2024 version and how they will impact the conduct of biopharma clinical trials; Discuss multi-stakeholder efforts that are working towards operationalizing ethical principles in the DOH and where more collaboration and alignment is needed.

Chair

Melissa Heidelberg, MS

Speaker

Speaker
Karla Childers, MS

Speaker
Ann Meeker-O'Connell, MS

Speakers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Melissa Heidelberg

Director, Global Bioethics and Technology Ethics Lead, Takeda, United States

I am a Bioethicist by training with more than 20 years’ experience in industry across various global roles in Research and Development and Pre-competitive Industry Collaborations. I have a passion for evolving and implementing ethical frameworks to address emerging tensions at the... Read More →

Ann Meeker-O'Connell

Director, Office of Clinical Policy, FDA, United States

Ann Meeker-O’Connell is the Director of FDA’s Office of Clinical Policy in the Office of the Commissioner. In this role, she leads an organization that develops and implements cross-cutting policy related to clinical development and research ethics. Ms. Meeker-O’Connell has... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Bioethics, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Bioethics,Student Programming,Global Perspectives
Tags Session

1:45pm EDT

#242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-580-L04-P; CME 1.00; RN 1.00

As the potential of artificial intelligence (AI) is increasingly piquing the interest of researchers, it is critical to discuss how AI works by learning from the data, and how to leverage the results. Choosing the right approach for integrating AI into the research lifecycle can have a massive impact on likelihood of success. As one example, both generalized large language models (LLMs) and purpose build LLMs have their place in the toolkit needed to curate and analyze medical record and other patient data. This presentation will explore best practices/learnings for ensuring the right AI tool for the task, including LLMs tailored to the unique needs of pharmaceutical research; the impact for pharmaceutical research and for patients this can have; and imperatives for ascertaining the reliability and trustworthiness of AI solutions for medical research, as key to promoting adoption and responsible deployment in practice.

Learning Objectives

Identify key factors to consider when selecting AI strategies and methods for use in biomedical settings and pharmaceutical research; Describe the potential impact of AI strategies on research quality and patient outcomes, using real-world use cases and examples; Apply a framework to evaluate the suitability and readiness of AI technologies, such as large language models, for specific research or clinical applications.

Chair

Sarah Lyons, MSc

Speaker

Trust and adoption: ensuring the reliability of AI for Life Sciences applications
Patrick Loerch, PhD

The right AI tool for the task: real world learnings and patient impacts from deploying LLMs in healthcare
Sarah Lyons, MSc

Deploying Large Language Models in Clinical Research: Practical Considerations from Real World Examples
Troy Astorino

Speakers

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom

Troy Astorino

CTO, PicnicHealth, United States

Troy Astorino is the co-founder and Chief Technology Officer of PicnicHealth, where he leads the development of AI for conducting faster, more efficient, and more reliable clinical research. His team at PicnicHealth developed LLMD, the world’s highest-performing AI model for interpreting... Read More →

Patrick Loerch

Senior Vice President, Clinical Data Science, Gilead Sciences, Inc., United States

Patrick Loerch joined Gilead in 2020 as the Senior Vice President of Clinical Data Science where he is responsible for bringing together the data science functions across Development to build an industry-leading, integrated evidence and insights generation function spanning Biostatistics... Read More →

Sarah Lyons

Head of Operations, Applied AI Science, IQVIA, Canada

Sarah Lyons is head of operations for IQVIA’s global Applied AI Science organization, empowering healthcare and life science organizations to unleash the full potential of AI, reliably and responsibly. She leads a team delivering award-winning platforms and deep expertise to help... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

1:45pm EDT

#244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-582-L04-P; CME 1.00; RN 1.00

This session will explore the FDA START program for accelerating rare disease therapies. Three speakers from companies involved in the START pilot and an FDA representative will provide insights.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how the cadence of medical writing and regulatory affairs shifts for those participating in the START program.

Chair

Robin Whitsell

Speaker

Panelist
Wei Liang, PhD

Panelist
Quyen Tran, PharmD

Panelist
Paulette Robinson, PhD, RAC

Panelist
Madiha Khalid, PhD

Panelist
Jhon Cores, PhD

Speakers

Jhon Cores

Associate Director, Medical Writing, Moderna, Inc, United States

Jhon is an Associate Director of Medical Writing at Moderna Inc., where he serves as the Medical Writing lead for various rare disease an oncology programs. He has 10 years of experience in the field working in different sectors, including university startups and contract research... Read More →

Madiha Khalid

Senior Director, Medical Writing, Larimar Therapeutics, United States

Madiha is a pharmaceutical industry professional with a background in fundamental bench research. Her experience as a regulatory medical writer working with small, mid-size, and large pharmaceutical companies over the past 10 years has given her an in-depth understanding of all phases... Read More →

Wei Liang

Pharmacologist, OTAT, CBER, FDA, United States

Dr. Liang is a Pharmacology/Toxicology Reviewer in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She joined OTAT in 2006. Her primary focus is the review of preclinical testing... Read More →

Paulette Robinson

Senior Director, Regulatory Affairs, Neurogene Inc., United States

Paulette Robinson, PhD, RAC is the Senior Director, Regulatory Affairs at Neurogene Inc. Her regulatory affairs experience has focused on gene therapies in rare central nervous system and ophthalmic indications. She continues to lead the global regulatory strategy for the NGN-401... Read More →

Quyen Tran

Science Policy Analyst, OND, CDER, FDA, United States

Dr. Quyen Tran is a Science Policy Analyst on CDER’s Rare Diseases Team. Dr. Tran joined the FDA in 2017 and has worked in the Office of New Drugs and Office of Medical Policy, CDER. She has notable experience in rare disease drug development, policy development and implementation... Read More →

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Keyword Rare Disease
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease
Tags Session

1:45pm EDT

#245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-583-L04-P; CME 1.00; RN 1.00

This session examines the relationship between protocol complexity, participant burden, and enrollment challenges, alongside the development and impact of participant feedback questionnaires. Patient advisors and attendees will interpret results and discuss improvements in trial performance.

Learning Objectives

Discuss patient participation burden based on protocol design characteristics and requirements; Identify design elements driving elevated levels of burden and impacting clinical trial performance; Recognize how to manipulate results into practical improvements for clinical research projects; State the value of participant feedback and compose rationale for inclusion of feedback in future studies; Describe strategies to reduce and address clinical trial and portfolio-wide participation burden.

Chair

Lani Hashimoto

Speaker

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Sabina Kineen

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Patrick Gee, SR, PhD, MS

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, & Signal Interpretation to Drive Impact
Stephanie Manson, PhD

Addressing Participation Burden in Clinical Trials: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA

Speakers

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States

As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Sabina Kineen

Lived Experience Expert, Rare Disease Patient Advocacy, United States

Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →

Stephanie Manson

Founder, Trial By Patient, United States

Dr. Manson is the author of the Study Participant Feedback Questionnaire (SPFQ) which has been implemented across the Transcelerate network to collect quantitative feedback on the patient experience. She is also the founder of Trial By Patient, a structured approach to receiving patient... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Forum

1:45pm EDT

#246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-584-L04-P; CME 1.00; RN 1.00

As of April 2, 2025, President Trump signed 103 Executive Orders in 2025 (EO 14147 to EO 14249) and sweeping government actions have led to widespread change in the health and biomedical research industries. Impacts on precision the effects of many of the Orders are largely unknown and tied up in legislative process. This has created considerable uncertainty for biomedical research and subsequent development of precision medicines and diagnostics. In this session we will review the 2025 Executive Orders, the court decision striking down the LDT Final Rule, and certain organizational changes at FDA that impact precision medicine and research and will delve deeper into the global impacts that are expected as a result.

Learning Objectives

List 2025 Executive Orders affecting personalized medicine and innovation in product and diagnostics development; Summarize impacts of 2025 Executive Orders on health innovation, research, regulations including the LDT final rule and patients; Discuss potential implications of current changes in the environment on global R&D.

Chair

Courtney Granville, PhD, MPH

Speaker

Panelist
Megan Doyle, JD, MPH

Panelist
Lia Ridout

Panelist
Carly McWilliams, MBA

Panelist
Nathan Brown, JD

Speakers

Nathan Brown

Partner, Akin Gump Strauss Hauer & Feld LLP, United States

Nathan Brown leads the FDA practice at Akin LLP. Drawing upon his diverse health care industry and governmental experience, Nathan provides his clients with strategic, practical advice on cutting-edge regulatory, compliance, enforcement, and policy matters. He has worked extensively... Read More →

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, United States

Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →

Courtney Granville

Chief Scientific Officer, GO2 For Lung Cancer, United States

Courtney Granville heads the Research Team at GO2 for Lung Cancer. In this role, she oversees GO2’s community engaged and clinical research efforts, the Lung Cancer Registry, and the LungMATCH program. She identifies areas of unmet clinical research need and develops innovative... Read More →

Carly McWilliams, MBA

Head of Regulatory Policy, Roche Diagnostics, United States

Lia Ridout

Patient Advocate, N/A, United States

Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Session

Level Intermediate
Keyword Diagnostics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Diagnostics
Tags Session

1:45pm EDT

#247: Guerrilla Strategic Delivery

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-585-L04-P; CME 1.00; PDU 1.00 PMI 2166OM1274; RN 1.00

Traditional project management methodologies often burden teams with unnecessary complexity, slowing progress and stifling innovation. Guerilla Strategic Delivery explores bold, adaptive, and pragmatic approaches to project execution that cut through the noise and deliver real results. This session will challenge outdated frameworks, offering fresh strategies that meet teams where they are—maximizing efficiency, flexibility, and impact without the bureaucratic bloat. Whether you're leading a startup, managing cross-functional teams, or driving change within a large organization, you'll leave with actionable insights to streamline delivery and achieve strategic success on your terms.

Learning Objectives

Discuss implementing adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Identify ways to optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; Describe ways to facilitate team empowerment by balancing structure and support with minimal bureaucracy; Apply innovative techniques to accelerate decision-making and improve problem-solving efficiency.

Chair

Sajida Roberson, MBA, MPH

Speaker

Short-Cycle Strategy: Adaptive Execution for High-Impact Delivery
Marina Kobiashvili, MA

Breaking the Waterfall: A Pragmatic Agile Approach in Drug Development Perspective - Applying Agile Principles in a Traditionally Rigid Lifecycle
Sean Ogle

Panelist
Jennifer Trevor, PhD, MS

Speakers

Marina Kobiashvili

Independent Consultant, United States

Sean Ogle

Senior Consultant, SEI Inc., United States

Sajida Roberson

Business Transformation, Independent Consultant, United States

Meet Sajida Roberson, a dynamic consultant blending strategic leadership with hands-on expertise to drive impactful business transformations. With a proven track record in global pharmaceutical companies, Sajida seamlessly transitioned from corporate strategy roles to independent... Read More →

Jennifer Trevor

Director-Global Category Lead- Development, Astellas, United States

Jen Trevor, PhD, combines scientific expertise with business acumen, driving innovation in pharma. With a PhD in Chemistry from the University of Illinois at Chicago, Jen began her career in biosensor research at Argonne National Laboratory and as a Forensic Chemist at the DEA. She... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Session

1:45pm EDT

#248: Embracing ICH E6(R3) with Risk-Based Quality Management

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-586-L04-P; CME 1.00; RN 1.00

Through use cases and maturity models, this session will focus on strategies and barriers to integrating RBQM in clinical trials.

Learning Objectives

Interpret key changes in ICH E6(R3) regarding RBQM and data governance; Implement key principles, components, and change management strategies for RBQM; Assess and benchmark organizational adoption of RBQM components.

Chair

Madeleine Whitehead

Speaker

Navigating the Future of Clinical Trials: Embracing ICH E6(R3) with Risk-Based Quality Management
Nicole Stansbury

New and Expanded Assessment of Risk-Based Quality Manangemnt Adoption: Assessing Implementation Progress and Impactased
Abigail Dirks, MS

Speakers

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States

Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →

Madeleine Whitehead

RBQM CoE - Head, Roche, United Kingdom

Madeleine Whitehead is the Head of Strategic Leads in the RBQM Centre of Excellence at Roche Pharmaceuticals. During her nearly 20 year career in the industry, she has worked in both pharma and CROs as a process and Good Clinical Practice (GCP) specialist. With a robust background... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

1:45pm EDT

#249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-587-L04-P; CME 1.00; RN 1.00

This session will explore the ways in which the data quality criteria within the EMA, FDA and ICH M14 guidelines converge or diverge, and propose some definitive actions for consideration to achieve harmonization of terminology.

Learning Objectives

Examine the current fragmentation in RWD/RWE data quality standards and its impact on research and regulatory decisions; Identify the key stakeholders and their varying data quality criteria within the pharmaceutical landscape; Describe potential strategies for developing a unified data quality framework to enhance consistency and reliability in data-driven research.

Chair

Elena Popa, MPharm

Speaker

Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH

Pursuing Opportunities for Harmonization in Using Real-World Data: ICH Update
Kelly Robinson, MSc

A Comparative Analysis of Data Quality Frameworks
Simon Bennett, MSc

Panelist
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom

As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Elena Popa

Chief of Staff, Global Regulatory Affairs, Bayer, Switzerland

Elena is a pharmacist by training with a master in drug safety & pharmacovigilance. She is the Chief of Staff for Global Regulatory Affairs at Bayer. Elena joined Bayer as a Regulatory Policy & Innovation Lead in 2022, a role which focused on the regulatory use and acceptance of RWD/RWE... Read More →

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

#250: Pediatric Cluster Town Hall

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-588-L04-P; CME 1.00; RN 1.00

Representatives from pediatric cluster health authorities will describe the common deficiencies they see in global pediatric development programs and describe best practices and what to expect for those companies that seek a common commentary.

Learning Objectives

Describe common deficiencies in global pediatric development plans; Explain the process for obtaining a common commentary; Recognize topics that are discussed at monthly pediatric cluster calls.

Chair

Melodi J McNeil, MS, RPh

Speaker

PMDA Perspective
Junko Sato, PhD

EMA Perspective
Corinne de Vries, PhD, MA, MSc

Panelist
Franca Ligas

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD

Speakers

Dionna Green

Director, Office of Pediatric Therapeutics, FDA, United States

Dr. Dionna J. Green is Director of the US Food and Drug Administration Office of Pediatric Therapeutics, a congressionally mandated office whose mission is to assure access for children to innovative, safe, and effective medical products. She leads an organization responsible for... Read More →

Robyn Langham

Chief Medical Adviser, Australia Health Products Regulation Group, Australia

Professor Langham is the Chief Medical Adviser of the Therapeutic Goods Administration, the therapeutic goods regulator in Australia. A nephrologist by training, Prof Langham has spent much of their career as a clinician researcher, in translational studies and drug development.

Franca Ligas

Scientific Officer, Paediatric Medicines Office, European Medicines Agency, Netherlands

Franca Ligas serves as a Scientific Officer at the Paediatric Medicines Office of the European Medicines Agency (EMA), overseeing Paediatric Investigation Plans, particularly in oncology. Since 2021, she has led the Paediatric cluster from the EMA's side. Franca holds a medical degree... Read More →

Melodi McNeil

Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States

Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Pediatrics, Regulator Perspectives, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Pediatrics,Regulator Perspectives,Student Programming,Global Perspectives
Tags Forum

1:45pm EDT

#251: China Town Hall

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-589-L04-P; CME 1.00; RN 1.00

In this forum, speakers from the National Medical Products Administration (NMPA) , academia and industry will present the progress in drug regulation, review China's biopharma innovation in the past decade, and discuss accelerating innovative drug approvals in China. Attendees will have an opportunity to discuss the issues related to drug development with NMPA officials, clinical researcher and industry executive.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the trend in biopharma innovation in the past decade; Discuss the strategies for accelerating innovative drug development and approval in China.

Chair

Ling Su, PhD

Speaker

Brief Introduction from the NMPA
Feng Zhu

The Progress of China's Drug Review and Approval Reform
Jianwu Zhang, PhD

Accelerating the Development and Approval of Innovative Drugs in China: Industry's Perspective
Wei Zhang

The Past Decade of China's Biopharma Innovation
Xiaoyuan Chen, PhD

Speakers

Xiaoyuan Chen

Professor, Tsinghua University, China

Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →

Ling Su

Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China

Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Jianwu Zhang

Division Director, Drug Registration Department, National Medical Products Administration, China

Feng Zhu

Director, Cooperation Department, China Center for Food and Drug International Exchange (CCFDIE), China

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Session

1:45pm EDT

#252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-590-L04-P; CME 1.00; RN 1.00

During this session, speakers will share insights and recent experiences regarding the implementation of Inspection Reliance from both Regulatory Authorities and Industry perspectives, including unilateral reliance and work-sharing.

Learning Objectives

Identify Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Describe Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Discuss the modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections.

Chair

Maria Cristina Mota Pina, MBA

Speaker

Middle East and Africa Perspectives on Inspection Reliance- Panelist
Amira Deia Younes

ANVISA Perspective
Bianca Zimon, LLM

Pathways to Inspection Reliance: A 20 Year Journey
Andrea Kurz, RPh

Speakers

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland

Andrea Kurz is Senior Director, Lead External Advocacy for Europe and Middle East at Roche in Basel, Switzerland. She has +20 years’ experience in the Pharmaceutical Industry holding various positions in Quality & Compliance and Regulatory Affairs. Andrea is a Pharmacist and graduated... Read More →

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates

Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Keyword Regulatory Reliance
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Reliance
Tags Session

1:45pm EDT

#253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-591-L04-P; CME 1.00; RN 1.00

In this session, speakers will share their insight with case studies to demonstrate how the challenges have been addressed and introduce new methods for designing appropriate wining criteria for composite endpoint in small-sized clinical trials.

Learning Objectives

Recognize the pros/cons and challenges in designing clinical trials with composite endpoints; Discuss advanced methods and strategies for analyzing composite endpoints, including the impact of winning criteria and analysis methods via win ratio, win proportion and win scores; Apply different win ratio methods by scenarios and interpret results from real case examples of small-size.

Chair

Xiaoyu Cai, PhD

Speaker

Utilizing Win Ratio Approaches and Two-Stage Enrichment Designs for Small-Sized Clinical Trials
Jialu Wang, PhD

Application of Win Statistics in Non-Malignant Hematology
Wenquan Wang, PhD

Weighted Win Score Ratio – A Generalization of Win-Ratio Approach for Composite Endpoints with Continuous Components
Qian Tang, PhD

Speakers

Xiaoyu Cai

Insmed, Inc., United States

Xiaoyu Cai is an Associate Director, Biostatistics at Insmed, Inc. Prior to joining Insmed, she served for seven years as a Mathematical Statistician at the Center for Drug Evaluation and Research, Office of Biostatistics, within the U.S. Food and Drug Administration. She earned her... Read More →

Qian Tang

University of Iowa, United States

Qian Tang is a Ph.D. candidate in Statistics at the University of Iowa, specializing in machine learning, optimization, and statistical computation. Her research focuses on developing efficient algorithms for analyzing high-dimensional data, with applications in statistical learning... Read More →

Jialu Wang

Statistician, Vertex Pharmaceuticals, United States

Jialu is a senior biostatistician at Vertex Pharmaceuticals. She closely works with health economic and research and market access teams for reimbursements and HTA submissions of multiple therapies. She also works on late Phase 3b/4 studies. Her research interests include adaptive... Read More →

Wenquan Wang

Senior Director, Pfizer, United States

Wenquan got his PhD degree in Biostatistics from the University of Iowa. He was an assistant professor at University of Alabama at Birmingham before joining the pharmaceutical industry. He has over 20 years of experience in applying statistics in translational research and phase I-IV... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Session

1:45pm EDT

#254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development

Tuesday June 17, 2025 1:45pm - 2:45pm EDT

206

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-592-L04-P; CME 1.00; RN 1.00

This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.

Learning Objectives

Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.

Chair

Amber Meriwether, JD, MA

Speaker

Industry Perspective
Elizabeth Iorns, PhD

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec

Speakers

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States

Elizabeth Iorns, Ph.D., is the CEO and co-founder of Science Exchange. Science Exchange accelerates scientific discovery by enabling instant connections to the world’s best R&D facilities through a marketplace of pre-qualified and pre-contracted scientific service providers. Science... Read More →

Amber Meriwether

Corporate Strategy, Astellas Pharma, United States

Amber Meriwether is a global leader with 20+ years in healthcare, driving initiatives that accelerate innovation and deliver measurable impact. As Director of Corporate Strategy at Astellas Pharma, she leads cross-functional teams to develop strategic capabilities and deliver key... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Cecilia Zvosec

Strategy & Insights, ZS, United States

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Session

2:55pm EDT

#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here

Tuesday June 17, 2025 2:55pm - 3:55pm EDT

Exhibit Hall / Zone A

Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session,

Chair

Chaitanya Koduri, DDS, MHS

Speakers

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →

Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

16: Community-Rounds, Session | 09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Tags Session

4:00pm EDT

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-593-L04-P; CME 1.00; RN 1.00

We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).

Learning Objectives

Discuss how to operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures (ST&Fs) in safety reporting; Identify ways to use the PHUSE Safety Analytics Education Library to enhance safety analytics; Describe ways to leverage the PHUSE AE Groupings in Safety (AEGiS) white paper to improve adverse event groupings in safety analysis.

Chair

Greg Ball, PhD

Speaker

PHUSE AE Groupings in Safety (AEGiS) White Paper
Robert (Mac) Gordon, MS

PHUSE Safety Analytics Education Library
William Palo, MS

FDA Medical Queries (FMQs)
Linda Jeng, MD, PhD

Standard Safety Tables and Figures (ST&Fs)
Y. Veronica Pei, MD, MEd, MPH

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States

Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and data visualization for most of his career, including membership in several multi-disciplinary... Read More →

Linda Jeng

Associate Director for Biomedical Informatics, FDA, United States

Dr. Linda Jeng holds an MD and PhD in Cell and Molecular Biology from the University of Pennsylvania. She completed a residency in Pediatrics and Medical Genetics at Rainbow Babies and Children's Hospital and the University Hospitals of Cleveland, followed by a fellowship in Clinical... Read More →

William Palo

Director, Safety Statistics, AbbVie, United States

Bill has an MS in Applied Statistics from the University of Iowa and has been an industry statistician for over 30 years with over half that time dedicated to product safety. He is currently the therapeutic head of safety statistics for the late-stage oncology portfolio at AbbVie... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Advanced Analytics
Tags Session

4:00pm EDT

#262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-594-L04-P; CME 1.00; RN 1.00

This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. This panel will discuss the importance of end-to-end support systems that connect trial management, data collection, and patient engagement. The session will address the challenges sites face in adopting new technologies, from budget constraints to staff resistance, and the challenge of integrating automation into existing workflows.

Learning Objectives

Explain how automation and integration reduce site burden and improve trial efficiency; Identify compliance challenges in implementing automated systems; Discuss best practices for overcoming barriers to technology adoption.

Chair

Denise N Bronner, PhD

Speaker

Strategic Implementation of Automation
Amber Michelle Hill, PhD

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration and Compliance
Cal Collins

Speakers

Denise Bronner

Founder & CEO, Empactful Ventures, United States

Denise N Bronner, Ph.D. has roughly 15 years of organizational thought leadership experience within the global healthcare space and has held various roles in academia, consulting, pharma, and venture capital. During her career, she has specialized in health equity, data-driven global... Read More →

Cal Collins

Chief Technology Officer, OpenClinica, LLC, United States

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has been active... Read More →

Amber Hill

Founder & CEO, R.grid, United Kingdom

Kimberly Tableman

Founder & CEO, Espero, United States

With a robust background in clinical development and a sharp focus on digital health, my journey has led me to found ESPERO, where we're revolutionizing drug development through insight-driven protocol design. At the helm of ESPERO, my team and I are committed to enhancing operational... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

4:00pm EDT

#270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-602-L04-P; CME 1.00; RN 1.00

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?

Learning Objectives

Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance

Chair

Melissa Herman, MSc

Speaker

Industry Perspective
Maria Apostolaros, JD, PharmD, MS, RPh

Industry Perspective
Lesley Maloney, PharmD

Industry Perspective
Elizabeth Rosenkrands-Lange, MPH, MS

Speakers

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark

Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and patient engagement across neurology and neuro-rare development programs.

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States

Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck KGaA, Darmstadt, Germany, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session | 09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
Tags Session

4:00pm EDT

#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

204ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum

Speakers

Stiina Aarum

Senior Scientific Specialist, Scientific Advice, Product Development Scientific, European Medicines Agency, Netherlands

Dr Stiina Aarum (nee Välimäki) graduated as a medical doctor from Karolinska Institute, Stockholm in 2000. Before joining the European Medicines Agency Orphan Office in 2007, she completed her Ph.D. in medical genetics and worked as a hospital doctor at the Karolinska University... Read More →

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States

Adriana Racolta, PhD is an industry professional with 12 years of experience in the field. As a Director of Regulatory Affairs at Pfizer Inc., she spearheads the company's efforts to implement diagnostic regulatory requirements in support of precision medicine development. In this... Read More →

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Forum | 09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

4:00pm EDT

#267: Delivering Effective Business Transformations and How to Apply them to Drug Development

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-599-L04-P; CME 1.00; PDU 1.00 PMI 2166K30VP9; RN 1.00

Significant business transformations can be critical to achieve organizational vision and goals in an evolving landscape. In this session we will discuss how to effectively plan, execute and monitor significant business transformations.

Learning Objectives

Discuss the importance of business transformations in defining future-states and driving organizations forward; Explain how to effectively plan, execute and monitor business transformations; Describe how to apply business transformations to drug development.

Chair

Ashar Choudhry, MBA

Speaker

Delivering Effective Business Transformations and How to Apply them to Drug Development
Jason Eisfelder

Speakers

Ashar Choudhry

Executive Director, Enterprise Program Leadership & Operational Excellence, Bristol Myers Squibb, United States

Ashar Choudhry has over 25 years of experience within the BioPharma industry in leading transformational changes across a variety of major divisions and at the enterprise level. He is highly experienced in strategy development, business operations, operational excellence/process improvement... Read More →

Jason Eisfelder

DSO Practitioner, Bayer, United States

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Session

4:00pm EDT

#268: New Data and Insights on the Vendor Qualification Process in Drug Development

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-600-L04-P; CME 1.00; RN 1.00

Review and panel discussion of the results from a new Tufts Center for the Study of Drug Development (TCSDD) Working Group study assessing the vendor qualification and selection process

Learning Objectives

Discuss the prevailing approaches to vendor qualification in small, mid and large pharma organizations including the level of effort required and time taken; Describe the impact on drug development timelines; Recognize the point of view of clinical service providers from a time and cost standpoint; Identify how pharma companies and CROs are addressing qualification challenges.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Neil McCullough

Panelist
Patty Leuchten

Panelist
Shyard Wong, DrMed

Panelist
Tran V. Huynh

Speakers

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

Tran Huynh

Director, Clinical Vendor Strategy, Fortrea, United States

Patty Leuchten

Founder and CEO, Diligent Pharma, United States

Patricia Leuchten is the Founder and CEO of Diligent Pharma, a quality and compliance organization with tech-enabled service offerings that help mitigate risk in clinical trials. Leuchten has over 30 years of experience as a business owner and entrepreneur in the pharmaceutical industry... Read More →

Neil McCullough

Executive Vice President, Clinical Quality and Compliance, IQVIA, United States

Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →

Shyard Wong

Global Head, Clinical Quality and Continuous Improvement, Sanofi, France

A physician by training who graduated from the National University of Singapore in 1991, Shyard Wong rotated through a series of clinical postings in both the public and private healthcare sectors in Singapore and then undertook a career switch to become a full time healthcare administrator... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
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4:00pm EDT

#269: Pharmacovigilance Inspections Fireside Chat

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

152AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-601-L04-P; CME 1.00; RN 1.00

A rare opportunity to hear inspectors from three global regulators and a European industry association compare and contrast common compliance trends, hot topics, legislative updates, future conduct of inspections, and global collaboration efforts. It is well recognized that pharmacovigilance is a global activity; however, the regulation of pharmacovigilance (PV) still occurs very much at a country-specific level. Regulation is enforced by inspectors in each country which results in organizations being inspected frequently by multiple regulators. Inspectors from three global world-renowned regulatory agencies (US FDA, Health Canada, UK MHRA) will come together in this fireside chat in a rare opportunity to hear inspectors’ perspectives and how they can envision working together to ensure the systems in place are adequately capturing safety issues. The regulator perspective will be complemented by industry views from the European Federation of Pharmaceutical Industries and Associations (EFPIA). Discussions will focus on differences and similarities in inspection styles and requirements across the three regulators, including inspector expectations and conduct of inspections. You will have the opportunity to hear from inspectors about key emerging issues. Common inspection trends will be discussed highlighting areas where inspectors see compliance issues across all three regulators. There will be a chance to hear from the panel discussing the future of inspections, including hot topics such as AI and new initiatives in each of the respective regions . Discussions will also focus on collaboration efforts, such as efforts to reduce burden on industry and looking into the future about upcoming best practices in pharmacovigilance. The audience will have a chance to pose questions to panel members to gain simultaneous insights from regulators and industry.

Learning Objectives

Distinguish commonalities and differences between pharmacovigilance regulations and inspections undertaken by three global regulators and understand their impact on industry; Discuss common trends from inspection deficiencies identified by the three regulators and gain tips on improving compliance; Define areas of future direction for inspections and collaboration efforts in pharmacovigilance inspections globally.

Chair

Sophie Radicke, MSc

Speaker

Industry Perspective
Carrie Scott

FDA Perspective
Namita Kothary, PharmD, RAC

Health Canada Perspective
Stephane Berard, MS

Speakers

Stephane Berard

Interim Supervisor-Health Product Compliance East Unit, Health Canada, Canada

Stéphane is acting supervisor for the Health Product Compliance East Unit at Health Canada since 2022. He joined the organization in 2012 as an inspector and he had been involved in various compliance and enforcement activities for drugs and natural health products. In 2016, he became... Read More →

Namita Kothary

Associate Director, DEPS, OSI, OC, CDER, FDA, United States

Namita Kothary, PharmD, RAC (US) currently serves as Associate Director of Scientific Affairs within FDA-CDER's Office of Scientific Investigations - Division of Enforcement and Postmarketing Safety, where she develops and executes strategies for international collaborations and outreach... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →

Carrie Scott

Head, Global PV Compliance and Policy, Pharmacovigilance and Patient Safety, AbbVie Ltd, Portugal

Responsibility to lead the strategic positioning & direction of Pharmacovigilance (PV) quality & compliance across AbbVie's global PV QMS. Act as an expert in critical assessment & interpretation of PV compliance regulations, and consequential internal PV policy and process determination... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Forum | 01: ClinSafety-PV, Forum

Level Intermediate
Keyword Regulator Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives
Tags Forum

4:00pm EDT

#271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-603-L04-P; CME 1.00; RN 1.00

Global key initiatives towards harmonization, convergence and collaborative efforts in advancing the development and accessibility of advanced therapy medicinal products (ATMPs) will be explored, with a special focus on supporting MICs.

Learning Objectives

Outline global efforts on collaboration and harmonization initiatives for ATMPs; Identify and discuss efforts to build regulatory capacity, provide technical assistance, and facilitate access to ATMPs in middle-income countries (MICs); Discuss strategies for achieving convergence and harmonization for ATMPs.

Chair

Maria Antonieta Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Kowid Ho, PharmD

Panelist
Julia Djonova

Panelist
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

Panelist
Caroline Pothet, PharmD, RPh, RAC

Panelist
Renata Miranda Parca, AHIP

Speakers

Julia Djonova

Head Division ATMP, Swissmedic, Switzerland

Kowid Ho

Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM... Read More →

Yasuhiro Kishioka

Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of regenerative medical products (gene/cell therapy products). Since joining PMDA in 2008, Dr. Kishioka has been involved in various international... Read More →

Dianliang Lei

Scientist of Technology, Standard and Norm, World Health Organization (WHO), Switzerland

Renata Parca

Health regulatory specialist, ANVISA, Brazil

I hold a degree in Biology from the University of Brasília, where I also completed my master’s degree. I work as a health specialist at Anvisa since 2005, in the office of blood, tissues, cells, and advanced therapy medicinal products.

Caroline Pothet

Head of advanced therapies and haemato-oncology, European Medicines Agency, Netherlands

Caroline Pothet is head of the office for advanced therapies and haemato-oncology at the European Medicines Agency. Caroline joined EMA in 2020; prior to this, Caroline worked in the Industry for 20 years in a variety of sectors such as regulatory policy, regulatory science and drug... Read More →

Maria Antonieta Roman

Head Regulatory Policy LaCan, Novartis, Mexico

Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulatory Convergence and Harmonization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulatory Convergence and Harmonization
Tags Session

4:00pm EDT

#272: Towards Instantaneous Regulatory Decisions and Better Predictability

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-604-L04-P; CME 1.00; RN 1.00

An interactive sesion to reimagine regulatory frameworks and streamline product approvals globally. This session will focus on focus on data transparency, collaboration, process optimization and technology to accelerate medicine development and patient access.

Learning Objectives

Recognize the power of data to accelerate submissions; Initiate pilot projects aiming at sharing data, not documents, and lay the groundwork for dynamic reviews; Create better pre-competitive collaborations to share more safety data and endpoints.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Debra Yeskey

Panelist
Len Rosenberg, PhD, RPh

Panelist
Tony Fantana, PhD

Speakers

Tony Fantana

Sr. Dir, Eli Lilly, United States

Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving... Read More →

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States

Debra Yeskey, Pharm.D., is the Head of Regulatory Policy and Intelligence for the Coalition for Epidemic Preparedness Innovations (CEPI). She has been with CEPI since December 2018, and was instrumental in the creation of the Regulatory Affairs Group under COVAX that is co-led by... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#273: Regulatory Cooperation Between US and Japan

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

Salon C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-678-L04-P; CME 1.00; RN 1.00

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Washington, D.C. Office in November, 2024 for one of the purposes of strengthening regulatory cooperation between U.S. and Japan. After the establishment of the Office, direct communication and practical cooperation at D.C. time make possible, and it is also possible to make the foundation of regulatory cooperation. This session will explore the purpose behind the establishment of PMDA’s Washington, D.C. Office and its role in strengthening U.S.-Japan regulatory cooperation. Representatives from PMDA and FDA will share their perspectives on collaborative opportunities, followed by a panel discussion on how this initiative can enhance global regulatory alignment and communication.

Learning Objectives

Analyze the strategic purpose behind the establishment of PMDA’s Washington, DC Office and evaluate its role in enhancing regulatory cooperation between the US and Japan; Engage in a panel discussion to identify and propose opportunities for collaborative initiatives between PMDA and FDA that support global regulatory alignment and improved international communication.

Chair

Naoyuki Yasuda, MSc

Speaker

Panelist
Richard Pazdur, MD

Panelist
Akihiro Ishiguro, PhD

Panelist
Mark Abdoo

Panelist
Yasuhiro Fujiwara, MD, PhD

Speakers

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency, Japan

Yasuhiro Fujiwara

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States

Richard Pazdur

Director, Oncology Center of Excellence, CDER, FDA, United States

Richard Pazdur, MD, is founding director of the FDA Oncology Center of Excellence since 2017. He joined FDA in 1999 as director of the Division of Oncology Drug Products and led consolidation of cancer drug review divisions in 2005. He earned a BS from Northwestern University (1973... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Salon C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Forum

4:00pm EDT

#274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-605-L04-P; CME 1.00; RN 1.00

The pharmaceutical industry faces challenges due to global regulations. Structured data and cloud platforms can facilitate global collaborations. Visualizing the control strategy can enhance understanding of patient benefit-risk.

Learning Objectives

Recognize how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Discuss the concepts of IDMP and PQ/CMC and their roles in product quality discussions; Illustrate how an overall control strategy supports efficient product quality communication.

Chair

Ciby Joseph Abraham, PhD

Speaker

Panelist
Katie Duncan, PhD

Panelist
David Sidney Ross, MBA, MSc, PMP, RAC

Panelist
Vada Perkins, DrSc, MSc

Panelist
Omar Serang

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States

Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

Omar Serang

Chief Cloud Officer, DNAnexus, United States

General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-606-L04-P; CME 1.00; RN 1.00

Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.

Learning Objectives

Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Explain statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.

Chair

Xiang Zhang, PhD

Speaker

Externally Controlled Trials in Oncology: Regulatory Considerations and a Case Example
Arup Sinha, PhD

Panelist
Charles Lee, MBA, MS

An EU Regulatory Perspective on External Controls
Andrew Thomson, PhD, MA, MS

Uncovering the Challenges of Utilizing RWE in Regulatory Decision Making: Barriers, Mitigations and Future Directions
Ran Duan, PhD

Speakers

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →

Arup Sinha

Statistician, OTS, CDER, FDA, United States

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands

Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists to support RWE generation across drug life cycle including clinical development... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Session

4:00pm EDT

#277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

201

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-608-L04-P; CME 1.00; RN 1.00

This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.

Learning Objectives

Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.

Chair

Denyse Baker, RAC

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Transforming Talent: Leveraging Partnerships for Biopharma Success
Dedric Day

Speakers

Denyse Baker

Assoc. Vice President Global Quality Compliance, Eli Lilly and Company, United States

Denyse Baker is Associate Vice President of Global Quality Compliance with Lilly. She has more than 35 years of experience in the pharmaceutical industry including leadership roles with AstraZeneca, US FDA and PDA. Denyse’s expertise includes policy development, external engagement... Read More →

Dedric Day

Senior Director- Strategic Talent Partnerships, Eli Lilly and Company, United States

Dedric Day has worked at Eli Lilly and Company for 22 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing... Read More →

Sheila Mahoney Jewels

Drug Development Multi-Functionalist, LifeSciHub , United States

Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Session

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report

Wednesday June 18, 2025 8:30am - 9:30am EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-609-L04-P; CME 1.00; RN 1.00

The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.

Learning Objectives

Discuss the Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Explain the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Identify strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Claudia Ana Ianos, MD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Carmit Strauss, PharmD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Scott Evans, PhD, MS

Speakers

Scott Evans

Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute of Public Health, United States

Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating... Read More →

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer Inc, United States

Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →

Carmit Strauss

Executive Director, Head of Risk Management and Organ Toxicity, Takeda, United States

Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the Risk Management and Organ Toxicity centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety, Pharmacovigilance and Medical Affairs. Carmit participants... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?

Wednesday June 18, 2025 8:30am - 9:30am EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-611-L04-P; CME 1.00; RN 1.00

Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.

Learning Objectives

Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS; Describe how to prepare and be ready to submit electronically; Discuss reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Industry Perspective: ICH E2B R3 Regional Implementations
Donald Williams

Beyond Borders: Navigating the Complexities of ICH E2B R3 Regional Implementations
Una Kessi

Speakers

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Una Kessi

Product Management Director, Safety and Pharmacovigilance, Oracle Health & Life Sciences, United Kingdom

Una works as a Product Management Director, Safety and Pharmacovigilance, at Oracle Health and Life Sciences. Her main focus is on Regulator Strategy, Safety and PV Regulations, Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also... Read More →

Donald Williams

Global Patient Safety and Pharmacovigilance, Regulatory Reporting, Boehringer Ingelheim Pharmaceuticals, Inc., United States

Donald Williams currently works in the Global Patient Safety & Pharmacovigilance department of Boehringer Ingelheim Pharmaceuticals, Inc. He is a member of the Regulatory Reporting Team, and his responsibilities include overseeing ICSR submission activities and monitoring global regulatory... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities

Wednesday June 18, 2025 8:30am - 9:30am EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-612-L04-P; CME 1.00; RN 1.00

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators

Chair

Jane Myles, MSc

Speaker

Industry Perspective
Shelly Barnes

Industry Perspective
Brittany Niland

Speakers

Shelly Barnes

Global Clinical Innovations Lead, UCB Biosciences, United States

Shelly Barnes is the UCB Global Innovations Lead based in Raleigh, NC, USA. She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Shelly is delivering solutions using novel technologies... Read More →

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and co-leads the Advisory Committee workstream... Read More →

Jane Myles

Program Director, Decentralized Trials and Research Alliance, United States

Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →

Brittany Niland

Senior Director-Clinical Trials Foundation Community Based Research, Eli Lilly and Company, United States

In May of 2016, I began my exciting career at Lilly. I fully embraced the project management role and swiftly advanced to become a subject matter expert in clinical development. As the technical leader, I mentored others and served as the point of contact for my trials, ensuring deliverables... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

8:30am EDT

#306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives

Wednesday June 18, 2025 8:30am - 9:30am EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-614-L04-P; CME 1.00; RN 1.00

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials; Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Identify case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

Chair

Junko Sato, PhD

Speaker

How to Combat Fraud?
Kentaro Ichinose

FDA Perspective
Regina Zopf, MD, MPH

MHRA Perspective
Jason Wakelin-Smith

Speakers

Kentaro Ichinose

Inspector, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Kentaro Ichinose currently serves as a inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA).

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Regina Zopf

Senior Medical Officer, CDER, FDA, United States

Dr. Regina Zopf is a Senior Medical Officer at the FDA with over 11 years of experience in drug evaluation and clinical research oversight. During her FDA tenure she has served in the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) assessing the safety, efficacy... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#307: Regulators and Communication in a Changing World: The ICMRA Role

Wednesday June 18, 2025 8:30am - 9:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-676-L04-P; CME 1.00; RN 1.00

ICMRA played a key role during the COVID-19 pandemic, ensuring sharing of vital information, providing common responses and aligning regulatory practices. A critical lesson learnt was that during a global crisis regulators need to become the main source of trusted information, both for each other and for the general public.

Learning Objectives

Evaluate ICMRA’s role in promoting global regulatory alignment and information sharing during the COVID-19 pandemic; Analyze strategies used by regulators to counter misinformation and disinformation during health emergencies.; Formulate evidence-based communication approaches to build public trust in regulatory authorities.

Chair

Tony Lawler, MD, MBA

Speaker

Panelist
Daniel Pereira

Regulators as Communicators in High-Income Settings
Emer Cooke, MBA, MSc

Findings from the 2025 Edelman Trust Barometer Special Report: Trust and Health
Camille DeSantis

Speakers

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →

Camille DeSantis

Managing Director, US Lead Health Brand Development, Edelman, United States

Camille DeSantis is Managing Director and U.S. Lead of Health Brand Development at Edelman. She returned to Edelman after founding Guard Dog Brand Development and SIGNAVA. A pioneer in archetypal brand strategy and inventor of research methods, she builds successful health brands... Read More →

Tony Lawler

Deputy Secretary, Health Products Regulation Group, Australian Department of Health and Aged Care, Australia

Professor Lawler is the Deputy Secretary, Health Products Regulation Group with the Australian Department of Health and Aged Care. Prior to this he was the Chief Medical Officer and Deputy Secretary Clinical Quality, Regulation and Accreditation with the Tasmanian Department of H... Read More →

Daniel Pereira

ANVISA, Brazil

Wednesday June 18, 2025 8:30am - 9:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

8:30am EDT

#308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

Wednesday June 18, 2025 8:30am - 9:30am EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-615-L04-P; CME 1.00; RN 1.00

This presentation will explore the pivotal role of regulatory affairs consulting in the medical device/IVD industry, focusing on how consultants provide strategic value at every stage of product development and commercialization.

Learning Objectives

Analyze the strategic role of regulatory affairs consulting in the medical device/IVD industry and its impact on product development and commercialization; Evaluate how specialized regulatory consulting helps manufacturers navigate evolving regulatory requirements while fostering innovation and market competitiveness; Apply practical strategies for partnering with regulatory consultants to achieve regulatory compliance and commercial success.

Chair

Michael Ageboh, PhD, RAC

Speaker

Drug Delivery Device Combination Products - Exploring FDA Expectations from Clinical Investigation to Market Approval
Bryce Whited, PhD, MS

Speakers

Michael Ageboh

Senior Manager, MedTech Services, Pharmalex / Cencora, United States

Michael Ageboh is a regulatory affairs professional with extensive experience within the MedTech industry. He has been involved in the end-to-end process of getting new products to market and maintaining products post market launch. He has worked for small, medium and large companies... Read More →

Bryce Whited

Founder and Principal Consultant, WCI Medtech, United States

Bryce Whited, Ph.D. is the Founder and Principal Consultant at WCI MedTech, a consulting firm dedicated to providing medical device and pharma / biologics clients with expert regulatory affairs services for product development, market approval and post-market compliance. Bryce has... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

Wednesday June 18, 2025 8:30am - 9:30am EDT

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-616-L04-P; CME 1.00; RN 1.00

This forum will focus on practical Quality by design (QbD) and risk-based monitoring (RBM) clinical trial implementation strategies based on new case study examples of overcoming persistent adoption challenges, fostering organizational change management, and demonstrating value of implementation.

Learning Objectives

Apply practical QbD-RBM implementation strategies based on case study examples not previously publicly presented; Discuss new initiatives under development that will serve as additional future QbD tools; Identify persistent obstacles to broader QbD and RBM implementation, address their negative impacts, and provide applicable solutions to enable future adoption.

Chair

Gerrit Hamre, MA

Speaker

Existing Adoption Tools for All to Use
Morgan Hanger, MPA

Evidence of the QbD-RBM Continuum in Action
Marion Wolfs, MS

Agency Supporting Mechanisms for Clinical Trial Modernization
Alissa Mun, MS

New Case Study Examples for Others to Build Upon
Sameera Ibrahim

Speakers

Gerrit Hamre

Research Director, Duke-Margolis Institute For Health Policy (DMI), United States

Gerrit Hamre, MA, is a Research Director in Biomedical Regulatory Policy at the Duke Margolis Institute for Health Policy Institute. Gerrit has worked for nearly 20 years in the pharmaceutical industry with a focus on clinical research, regulatory, and commercial roles. Central to... Read More →

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States

Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom

Alissa Mun

Health Scientist Policy Analyst, OMP, CDER, FDA, United States

Alissa Mun is a Health Scientist Policy Analyst in the Division of Clinical Trial Quality of the Office of Medical Policy in CDER/FDA. She provides scientific and technical input for ongoing policy initiatives such as risk-based monitoring, quality by design, and risk management with... Read More →

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands

Wednesday June 18, 2025 8:30am - 9:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

Wednesday June 18, 2025 8:30am - 9:30am EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-617-L04-P; CME 1.00; RN 1.00

National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.

Learning Objectives

Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.

Chair

Amira Deia Younes

Speaker

Panelist
Hamada Sherief

Panelist
Donia Albastaki

Panelist
Sara Torgal, MPharm

Panelist
Maria Cristina Mota Pina, MBA

Speakers

Donia Albastaki

Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Hamada Sherief

Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt

Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating... Read More →

Sara Torgal

Global Regulatory Policy Lead, DIA, Switzerland

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA... Read More →

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates

Wednesday June 18, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Forum

8:30am EDT

#311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance

Wednesday June 18, 2025 8:30am - 9:30am EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-618-L04-P; CME 1.00; RN 1.00

This session will highlight the complexity of regulatory frameworks for PACs drawing from an IFPMA/Clarivate study and case studies. An expert panel from industry and regulatory agencies will discuss solutions and lessons learned on reliance implementation.

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Identify lessions learned from reliance implementation for PACs to facilitate supply of medicinal products.

Chair

Max Wegner, PharmD, RPh

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Marie Valentin, PharmD

Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management (PQKM) Capability
Theresa Mullin, PhD

Bringing Reliance into Action - Our Journey From Pilots to Practice
Susanne Ausborn, PhD

Why is Regulatory Reliance a Necessity and not a Choice? An Illustration Using Industry Survey Results
Andrew Deavin, PhD, MS

Speakers

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →

Andrew Deavin

Senior Director, Regulatory Affairs, GSK, Belgium

Andrew Deavin has spent over 25 years in Regulatory Affairs, after having gained a M.Sc. and Ph.D. in Immunology and working in vaccine research. He has managed regulatory projects in development, registration and life-cycle primarily in vaccines but also in haematology/oncology... Read More →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →

Theresa Mullin

Associate Center Director - CDER, FDA, United States

Marie Valentin

Team Lead, Facilitated Product Introduction, WHO, Switzerland

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international... Read More →

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany

After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges

Wednesday June 18, 2025 8:30am - 9:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-619-L04-P; CME 1.00; RN 1.00

Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.

Learning Objectives

Identify hurdles and solutions to clinical trial recruitment, including early diagnosis and newborn screening; Identify approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Philip (P.J.) Brooks, PhD

Panelist
Anish Bhatnagar, MD

Panelist
Kim Quaintance-Lunn

Panelist
Matthew Klein, MD, MS

Panelist
Annie Kennedy

Panelist
Kerry Jo Lee, MD

Speakers

Anish Bhatnagar

Chief Executive Officer, Soleno Therapeutics Inc, United States

Dr. Bhatnagar, CEO of Soleno since its inception in 2017, brings over 20 years of medical expertise to the biopharmaceutical and medical device industries. His extensive background encompasses the development of biologics, drugs, drug-device combinations, and diagnostic/therapeutic... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Annie Kennedy

Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States

Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →

Matthew Klein

CEO, PTC Theraputics, United States

Dr. Matthew Klein is CEO or PTC Therapeutics, a global biopharmaceutical company that discovers, develops and commercializes innovative therapies for rare disorders. Dr. Klein completed his undergraduate degree at the University of Pennsylvania graduating summa cum laude and Phi Beta... Read More →

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare Disease Cures, FDA, United States

Dr. Kerry Jo Lee is a pediatric gastroenterologist/hepatologist and the Associate Director for Rare Diseases in the Office of New Drugs (OND), CDER. In this role she leads CDER’s Rare Diseases Team and the Accelerating Rare disease Cures (ARC) Program. Dr. Lee joined the FDA in... Read More →

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution, Alexion, United States

Kim Quaintance-Lunn is Vice President, Head of Regulatory Science & Execution, for Alexion Pharmaceuticals; Strategic Advisor to the DIA Board of Directors; and Director at Large and Treasurer for the FDA Alumni Association. At Alexion, Kim is responsible for leading and implementing... Read More →

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

14: DIAmond, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14

Wednesday June 18, 2025 10:30am - 11:30am EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-620-L04-P; CME 1.00; RN 1.00

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speaker

Panelist
Jie Li, PhD

Panelist
Susan A. Oliveria, DrSc, MPH

Panelist
Alice Hsu, MPH

Speakers

William Blumentals

Head of Pharmacoepidemiology, Specialty Care, Sanofi, United States

William has spent over 20 years supporting and leading epidemiology teams in biopharma, including roles in pharmacovigilance and medical affairs. Currently, he co-leads the real-world data access and availability workstream with TransCelerate and is the Head of Pharmacoepidemiology... Read More →

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States

Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →

Jie Li

Associate Director for RWE, OSE, CDER, FDA, United States

Dr. Jie (Jenni) Li is Associate Director for RWE at the Office of Surveillance and Epidemiology (OSE), CDER FDA. She leads office activities relating to RWE, overseeing scientific input into guidance and policy development. An expert in RWE and pharmacoepidemiology, Dr. Li. led major... Read More →

Susan Oliveria

Vice President, Global Head of Epidemiology and Scientific Affairs Peri- and Pos, Thermo Fisher Scientific, United States

Dr. Oliveria's career as a pharmacoepidemiologist spans more than 25 years in academia, industry, and non-profit settings. She is trained as a pharmacoepidemiologist, having received her Doctor of Science from the Harvard School of Public Health. In her current role she leads the... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

10:30am EDT

#315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art

Wednesday June 18, 2025 10:30am - 11:30am EDT

207A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-621-L04-P; CME 1.00; RN 1.00

Signal detection remains central to Pharmacovigilance activities. Better access and use of data, ever improving methods to maximise the utility of data, and better processes and governance to optimise signal detection activities are key focus areas as we continuously strive to do ever earlier and more effective safety signal detection. This session will discuss the current status of signal detection from all these aspects as well as how we anticipate the field evolving moving forwards.

Learning Objectives

Demonstrate and discuss how Generative AI can facilitate the future approach in augmenting PV systems in a trusted, compliant, and transparent manner; Summarize the opportunities and challenges with such an approach.

Chair

Andrew Bate, PhD, MA

Speaker

Industry Perspective
Mariette Boerstoel-Streefland, MD, MBA, MS

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

Mariette Boerstoel Streefland

Senior Vice President, Patient Safety Officer, Bristol-Myers Squibb Company, United States

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Wednesday June 18, 2025 10:30am - 11:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Forum

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Forum

10:30am EDT

#317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa

Wednesday June 18, 2025 10:30am - 11:30am EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-623-L04-P; CME 1.00; RN 1.00

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Kwaku Marfo, PharmD, MBA, MPH

Speaker

Harnessing Partnerships and Collaboration to Sustain the Ecosystem
Chimwemwe Chamdimba

Clinical Trial Conduct In Africa: Current Regulatory Systems and Regulations
Yvonne Adu-Boahen

Unlocking Clinical Research to Drive Access to Innovation
Beno Nyam Yakubu, DVM

Speakers

Yvonne Adu-Boahen

Head of Clinical Trials Department, Food and Drugs Authority, Ghana

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →

Kwaku Marfo

Africa Market Development Specialist, IQVIA, Ghana

Kwaku Marfo currently holds a role of Market Development Specialist for sub-Sahara Africa with IQVIA. Kwaku is a dynamic Life Sciences leader with 18 years of experience in Pharma and Global Health across US, Europe and Africa markets in diverse therapeutic areas such as Hematology... Read More →

Beno Yakubu

Head of Clinical Trial Department, National Agency for Food and Drug Administration, Nigeria

Dr Yakubu background training is Veterinary Medicine, have undergone related trainings on vaccines, epidemiology, Bioethics, and other regulatory activities for over 20 years. has attended many WHO trainings on Vaccines regulatory activities. Dr Yakubu has been involved in the review... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

10:30am EDT

#318: Patient Referral: Is It Hope or Hype?

Wednesday June 18, 2025 10:30am - 11:30am EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-624-L04-P; CME 1.00; RN 1.00

This highlights the challenges of using real-world data (RWD) for patient referral in clinical trials, focusing on issues like data variability, lack of investigator training, and insufficient incentives. It proposes strategic solutions to overcome these barriers.

Learning Objectives

Identify innovative strategies for patient recruitment using RWD referrals that challenge existing practices; Propose new methods for integrating naïve sites into the clinical trial process to expand participation; Evaluate the potential impact of broader patient inclusion on clinical trial outcomes.

Chair

Kim Ribeiro, MS

Speaker

Panelist
Joan Chambers

Panelist
Barbara Isquith Arone, MS

Panelist
Karen Correa, PhD

Panelist
Irfan A. Khan, MD

Speakers

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States

Barbara has worked within late phase research for 25+ years, 20+ with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States

As the Chief Operating Officer for CenterWatch, Joan is responsible for the business operations, financial performance, marketing, and sales of the company along with setting strategic direction. Joan's work experience includes: CHI, Tufts CSDD at Tufts University, Thomson CenterWatch... Read More →

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Irfan Khan

Founder and Chief Executive Officer, Circuit Clinical, United States

Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States

Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

#320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing

Wednesday June 18, 2025 10:30am - 11:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-626-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) and Structured Content Authoring (SCA) tools are here. The challenge of seamlessly integrating these technologies into compliant and efficient workflows is reshaping the regulatory document development process. This session will delve into the balance and interdependence of four pillars (technology, process, people, and organization) to drive the business value of these tools. The interplay of these elements stokes an environment of thriving innovation, leading to enhanced efficiency, quality, and value proposition for the underlying business. AI/SCA have been thoroughly discussed in the regulatory writing process. Now there is focus on evolving technologies, the challenge lies in integrating these advancements into our workflows and processes, or implementing change management processes to allow for their use. Utilizing these tools coupled with organizational and process driven acceleration levers will condense the time to document approval and decrease the number of resources need to produce these documents. Moreover, the concerted and collaborative efforts across various functions, ranging from clinical sciences to biostatistics programming to review and approval pathways, ensures a thorough and compliant documentation process. It is time to focus and clearly define, emphasize, and promote the importance of the human element in the utilization of these tools, the people and the processes, at the heart of transformative authoring. Attendees will gain insights into the strategic integration of the four pillars in medical writing, drawing real-world use cases of these technologies in industry. These strategies, while transformative, do not necessitate a radical shift when applied independently. Instead, their true power lies in their harmonious application, which collectively refines traditional authoring paradigms.

Learning Objectives

Analyze the business value of AI and Structured Content Authoring tools in Regulatory Medical Writing to enhance efficiency and compliance; Evaluate process modifications in document development resulting from technology innovations to optimize workflow; Develop strategies to implement change management and organizational shifts that support technology-driven solutions.

Chair

David Meats, II

Speaker

Industry Perspective
James Best, MBA

Speakers
Louise Lind Skov, PhD

Speakers

James Best

Digital Transformation Lead (Medical Writing), GSK, United Kingdom

Focused on human centered digital transformation - leading strategy, design, end execution. Developer of the pragmatic trust model, a framework informed by psychology and change management models, for trusting and accepting AI within sociotechnical systems.

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States

Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark

Louise is Director and Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

#321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints

Wednesday June 18, 2025 10:30am - 11:30am EDT

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-627-L04-P; CME 1.00; RN 1.00

Multiple stakeholders, including patients, will demonstrate how patient/site collaboration enhances the simultaneous digital health technologies (DHT)/patient journey to produce potential improvements/efficiencies in patient experience, data capture/quality, equitable access, and site/participant burden.

Learning Objectives

Describe the value of patient involvement to improve site engagement and user experience in application of DHTs in clinical research; Discuss key issues with accessibility of patient-reported outcome measurements; Identify how to incorporate patient-defined measurements into potential clinical endpoint development to better align with patient experience.

Chair

Stacy Hurt, MBA, MHA

Speaker

Patient Involvement to Improve Use of eCOA in Clinical Trials
Stacy Hurt, MBA, MHA

Lets Make Sure Accessibility is Considered in ePRO Best Practices: Are We Risking Our Data?
Florence Mowlem, PhD, MSc

Patient-Defined Flare Measurement Development in Conditions with Known Flares
Nell Meosky Luo

Speaker
Alicia Staley, MBA, MS

Speaker
Brian Hunter, MA

Speakers

Brian Hunter

VP / Chief Operating Officer, CNS Healthcare / Sitecentric, United States

In 20 years with CNS Healthcare, I’ve worked as a CRC, Site Administrator, Director of Marketing, Clinical Development Liaison and Director of Contracts & Trial Management. Through these roles, I’ve had the opportunity to interact with patients, physicians and study teams, and... Read More →

Nell Meosky Luo

Chief Executive Officer, Folia Health, United States

Nell Meosky Luo is the Found & CEO of Folia Health, a patient-driven health informatics company where since 2017, she has led a team to develop novel methods for enabling the collection, analysis, and use of home-reported outcomes of patients and caregivers for precision care and... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Florence Mowlem

Chief Scientific Officer, Umotif, United Kingdom

Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of COAs and the use of DHTs in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked... Read More →

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States

Wednesday June 18, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum

Level Intermediate
Keyword Digital Technology
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Digital Technology
Tags Forum

10:30am EDT

#323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development

Wednesday June 18, 2025 10:30am - 11:30am EDT

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-629-L04-P; CME 1.00; RN 1.00

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speaker

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, MD, PhD, MBA

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm

Speakers

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Nobutaka Kobayashi

Deputy Director, Mitsubishi Tanabe Pharma Corporation, Japan

Kobayashi was engaged in medicinal chemistry as a research scientist in the pharmaceutical company for 13 years. After that, he was engaged in medical policy, drug price application, and management planning for 13 years.

Kenichi Nakamura

Chief, Department of International Clinical Development, National Cancer Center Hospital, Japan

Dr. Nakamura is Chief of International Clinical Development at the National Cancer Center Hospital. After earning his MD from Kyoto University in 1999 and completing surgical training, he joined NCC to manage JCOG, Japan’s largest cancer clinical trial group. Since 2015, he has... Read More →

Toshiharu Sano

Associate Vice President, MSD, Japan

Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Forum

Level Intermediate
Keyword Rare Disease, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Global Perspectives
Tags Forum

10:30am EDT

#325: Practical Implementation of MRCTs Based on ICH E17 Guidelines

Wednesday June 18, 2025 10:30am - 11:30am EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-631-L04-P; CME 1.00; RN 1.00

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning a study or evaluating results.

Learning Objectives

Explain how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Chair

Yoshiaki Uyama, PhD, MS, RPh

Speaker

Panelist
Armin Koch, DrSc

Panelist
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka, PhD

Panelist
William Wang, PhD

Speakers

Hideki Hiraoka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Armin Koch

Head, Institute of Biometry, Hannover Medical School, Germany

Dr. Armin Koch, Ph.D., received his diploma in Mathematics and then worked in the Biostatistics Department at the German Cancer Research Center in Heidelberg. From there he moved to the Biostatistics Department at Heidelberg University where he wrote his PhD-thesis (1994). He has... Read More →

Adriane Alves de Oliveira

Health Regulation Expert, ANVISA, Brazil

Health Regulation Expert with 11 years of experience monitoring non-clinical and clinical development of drugs and biological products, with a focus on monoclonal antibodies and vaccines. She is also Good Clinical Practice(GCP) inspector and participated as a representative of Anvisa... Read More →

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →

William Wang

President, Merck & Co, Inc, United States

Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

Wednesday June 18, 2025 10:30am - 11:30am EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-632-L04-P; CME 1.00; RN 1.00

This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.

Learning Objectives

Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.

Chair

Samantha Roberts, PhD

Speaker

Industry Reflection
Rasika Kalamegham, PhD

Industry Reflection
Victoria A. Dohnal, RAC

FDA Update
Meghana Chalasani, MHA

Speakers

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Victoria Dohnal

Director, Global Regulatory Policy and Intelligence, Johnson & Johnson, United States

Victoria Dohnal is currently Director, Regulatory Policy, North America at Johnson and Johnson (J&J) where she is responsible for driving US regulatory policy work related to rare diseases, patient focused drug development, cell and gene therapies, precision medicine, and PDUFA VII... Read More →

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States

Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States

Wednesday June 18, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Forum

10:30am EDT

#322: Navigating the Challenges of Drug Delivery Using a Novel Device

Wednesday June 18, 2025 10:30am - 11:30am EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-628-L04-P; CME 1.00; RN 1.00

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Explain the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Yoshiko Stowell, PhD, MS, PMP, RAC

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC

Speakers

Sarah Fairfield

Associate Director, RA Device and Combination Products, AbbVie, United States

Sarah Fairfield is a dedicated and passionate regulatory professional with extensive expertise in medical devices and combination products. Currently, she serves as the Associate Director of Regulatory Affairs at AbbVie, Inc., where she supports global product development. She also... Read More →

John Lockwood

Sr. Director, Cencora Pharmalex, United States

John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →

Yoshiko Stowell

Vice President Regulatory Affairs, Kenai Therapeutics, United States

Yoshiko Stowell, PhD is VP Regulatory Affairs at Kenai Therapeutics. She has over 20 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 06: PersonalizedMed-ComboProd-Diagnostics, Session

Level Intermediate
Keyword Cell and Gene Therapy
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy
Tags Session

10:30am EDT

#327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval

Wednesday June 18, 2025 10:30am - 11:30am EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-633-L04-P; CME 1.00; RN 1.00

Perceived and real lapses in Manufacturing Quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss issues and opportunities to enhance oversight and communication by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Discuss the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP and submission issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction, application of the Quality Management Maturity model, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker

Speaker
Rosemary Orciari

Speaker
Patrick Saunders

Speakers

Holly Kleinschrodt

Head, Device & Operations Quality, Astellas, United States

Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →

Rosemary Orciari

Senior Director, Reg Intel, Policy and QMS Lead, Pfizer, United States

Rosemary Orciari is the Senior Director of Regulatory Intelligence and Quality Standards at Pfizer, Inc. In this role, she is responsible for enabling quality and compliance excellence to support breakthroughs that change patients' lives. Together with her team, Rosemary actively... Read More →

Patrick Saunders

Senior Director-Quality, Lilly del Caribe, Eli Lilly & Co., United States

Patrick A. Saunders currently serves as the Sr Director - Quality at Lilly del Caribe in Carolina, Puerto Rico. Patrick is a seasoned professional with nearly two decades of experience in the pharmaceutical industry. His expertise spans across both parental and oral solid dosage drug... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health

Wednesday June 18, 2025 10:30am - 11:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-634-L04-P; CME 1.00; RN 1.00

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Chair

Luis Pinheiro, PharmD, MSc

Speaker

Panelist
Timothe Menard, PharmD, MSc

Panelist
Tala Fakhouri, PhD, MPH

Speakers

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Student Programming,Global Perspectives
Tags Session

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment

Wednesday June 18, 2025 11:40am - 12:10pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

In the current political environment where anything related to diversity is at risk, ensuring clinical trials represent the real world is a scientific imperative, not a DEI initiative. The concept of pharmacoequity not only aims to balance the needs

Learning Objectives

Understand the concept of pharmacoequity; Explain how to apply pharmacoequity to ensure representative clinical trial.

Chair

Dyan Bryson

Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop | 02: ClinTrials-Ops, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation

Wednesday June 18, 2025 12:20pm - 12:50pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products; Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development; Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

Chair

Allison Radwick, PhD, RPh

Speakers

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States

Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →

Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Workshop | 15: Content-Hubs, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?

Wednesday June 18, 2025 1:00pm - 1:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Using case examples, the session will be an interactive discussion to share learnings and the impact of the use of drug repurposing from different end users such as industry and academia with input from regulators, patients and HTA representatives.

Learning Objectives

Understand drug repurposing and share lessons learnt so far based on case examples; Identify what could be opportunities using repurposing for rare diseases; Explain what has been done as part of the pilot on repurposing initiated by EMA at the end of 2021.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Can Drug Repurposing benefit drug development in Children & in Paediatric Rare Diseases?
David Sidney Ross, MBA, MSc, PMP, RAC

Speakers

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:45pm EDT

#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-637-L04-P; CME 1.00; RN 1.00

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Discuss the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Recognize how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson, PhD

Panelist
Szczepan Baran

Speakers

Szczepan Baran

Tech4Pets, Chief Barks and Purrs Officer, United States

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States

Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Bioethics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Bioethics
Tags Session

1:45pm EDT

#338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-638-L04-P; CME 1.00; RN 1.00

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Discuss PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Describe the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speaker

Industry Perspective
Sumati Nambiar, DrMed, MPH

Panelist
Teppei KIUCHI, MD, PhD, MPH

Speakers

Edward Ian

Head of Integrated Innovation Service Center, Mediscience Planning Inc., Japan

Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →

Teppei KIUCHI

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Teppei Kiuchi, M.D., MPH, PhD, is an associate executive director in the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In this role, Kiuchi is in charge of the review of regenerative medical products, Bio-CMC, vaccine and blood products. In his career Kiuchi has been... Read More →

Sumati Nambiar

Senior Director, Johnson and Johnson, United States

Dr. Nambiar is board certified in pediatrics and pediatric infectious diseases. She is a Fellow of the American Academy of Pediatrics and has over 20 years of experience in drug development and regulatory science. Currently, she is a Senior Director in the Child Health Innovation... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Cell and Gene Therapy, Pediatrics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy,Pediatrics
Tags Session

1:45pm EDT

#340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

201

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-640-L04-P; CME 1.00; RN 1.00

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Judy Shin, PhD

Speaker

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Speakers

Bonggi Kim

Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of

Jeff Lange

Director of Observational Research in Asia, Amgen, Hong Kong

Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the... Read More →

Min-Jung Lim

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of

Min-Jung Lim is the CEO and Senior Pharmacovigilance Consultant at MediSafe, with over 25 years of experience in clinical research and pharmacovigilance. She previously led drug safety functions as Head of Pharmacovigilance & Post Marketing Studies at GSK Korea. She also serves as... Read More →

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Shinya Watanabe

Reviewer (Epidemiology), Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mr. Shinya Watanabe is an epidemiologist at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. He conducts pharmacoepidemiological studies using medical information databases, such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session | 01: ClinSafety-PV, Session

Level Intermediate
Keyword Global Perspectives, Regulatory Convergence and Harmonization, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulatory Convergence and Harmonization,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

#341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-641-L04-P; CME 1.00; RN 1.00

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speaker

From Data to Action: Driving Inclusive Clinical Trials
Del Smith, PhD, MS

Placing Patients First in the Era of Advanced Tech and AI
Patrick Gee, SR, PhD, MS

Responsible AI and Diversity in Clinical Trials
Nicole Ward, MBA, MS, PMP

Speakers

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States

Katrina Rice

Chief Delivery Officer, Biometrics Services, eClinical Solutions, United States

Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States

Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →

Nicole Ward

Senior Product Manager, Business Insights & Technology, Bristol Myers Squibb, United States

Nicole G. Ward is a customer-centric servant leader with 15+ years of project / program management expertise and solid track record of translating complex business requirements into simple technology solutions spanning across multiple industries (Healthcare, IT, Consumer, Pharmaceutical... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Digital Technology, Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Digital Technology ,Advanced Analytics
Tags Session

1:45pm EDT

#343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-643-L04-P; CME 1.00; PDU 1.00 PMI 2166DQV2DD; RN 1.00

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Speaker

Biotech Perspective
Christine Mears, MA

Rare Disease Industry Perspective
Katie Bloom

Large Pharma Industry Perspective
Rosa Tarng, MA

Speakers

Katie Bloom

Executive Director, Co-Head of PMO, Program Management Office, Ultragenyx, United States

Katie Bloom, Executive Director of Program and Portfolio Management with over 25 years of industry experience. Currently, she co-leads the Program Management Office at Ultragenyx. Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment... Read More →

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States

Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →

Rosa Tarng

Translational Program Management, Takeda, United States

Rosa Tarng is a program management professional with ~20 years of industry experience. Rosa is currently the Head of Oncology Translational Program Management at Takeda where she has also held roles in Cell Therapy Program Operations and Oncology Research Program Management. Prior... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Forum

1:45pm EDT

#344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-644-L04-P; CME 1.00; RN 1.00

This session will outline the risk assessment approaches undertaken by four global regulators, the US FDA, UK MHRA and EMA to identify suitable candidates for inspection and explain the differences in inspection cycles. The session will focus on the risk assessment methodologies undertaken by each regulator, highlighting information sources, risk assessment processes and decision-making factors which help determine define the appropriate type of inspection and frequencies. The session will provide information into the types of inspection which may be undertaken for pharmacovigilance and why a company may be subject to one of these inspection types as well as explain why the same company may be subject to more frequent inspections. The session will include information on new and existing initiatives between regulators to collaborate on inspection risk assessments to share information, improve process, and reduce the inspection burden on industry. Companies can use the information from this session to gain tips to help identify and assess high-risk areas of their own pharmacovigilance systems for quality processes such as auditing.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Chair

Sophie Radicke, MSc

Speaker

EMA Perspective
Peter Twomey, MA, MPharm

US FDA Perspective
Sheilyn Huang, PharmD

Speakers

Sheilyn Huang

Consumer Safety Officer, Pharmacovigilance Compliance Team, FDA, United States

Sheilyn Huang is a licensed pharmacist who currently serves as a Consumer Safety Officer on the Pharmacovigilance Compliance Team in FDA's Center for Drug Evaluation and Research. Over the past 16 years at FDA, she has had the opportunity to work in areas such as drug information... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 01: ClinSafety-PV, Session

Level Intermediate
Keyword Regulator Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives
Tags Session

1:45pm EDT

#345: Africa's Evolving Regulatory Landscape

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-645-L04-P; CME 1.00; RN 1.00

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Janis Bernat, MSc

Speaker

Panelist
Bunmi Femi-Oyekan

Panelist
David Mukanga, PhD, MPH

Panelist
Grace Matimba, MS

Panelist
Chimwemwe Chamdimba

Speakers

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →

Bunmi Femi-Oyekan

Senior Director Accord & Access Regulatory Lead, Pfizer Specialities Ltd, Nigeria

Bunmi Femi-Oyekan is a pharmacist with over 32 years of experience in the pharmaceutical industry, primarily in regulatory, sales, and safety, currently serving as the Regulatory Lead, Accord and Access for Pfizer. She is responsible for development and execution of regulatory strategies... Read More →

Grace Matimba

Chief Regulatory Officer, Medicines Control Authority of Zimbabwe, Zimbabwe

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulator Perspectives, Regulatory Reliance, Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulator Perspectives,Regulatory Reliance,Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

#347: EMA Town Hall

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-647-L04-P; CME 1.00; RN 1.00

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Chair

Ralf Herold, DrMed, MD

Speaker

Panelist
Anabela Marcal, PharmD

Panelist
Corinne de Vries, PhD, MA, MSc

Panelist
Luis Pinheiro, PharmD, MSc

Speakers

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands

Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... Read More →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

1:45pm EDT

#342: Evolving Regulatory Considerations for Medical Affairs Communications

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

151A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-642-L04-P; CME 1.00; RN 1.00

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Discuss and assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Speaker

Evolving Regulatory Considerations for Medical Affairs Communications
Bill Cook

Evolving Regulatory Considerations for Medical Affairs Communications
Lisa Hubbard, RPh, RAC

Speakers

Bill Cook

Senior Global Medical Affairs Leader, AstraZeneca, United States

Torrey Cope

Partner, Sidley Austin LLP, United States

Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been... Read More →

Lisa Hubbard

Principal Consultant, Regulatory Advertising and Promotion, Opus Regulatory, Inc., United States

Lisa Hubbard is a Principal Consultant in Advertising and Promotion at Opus Regulatory, Inc. Her prior roles included Director, Advertising and Promotional Compliance at Alexion/Astra Zeneca and Senior Regulatory and Medical Consultant at One Source Regulatory. Lisa spent 15 years... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 04: MedAffairs-SciComm, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

1:45pm EDT

#339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-639-L04-P; CME 1.00; RN 1.00

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speaker

Industry Perspective
David Sidney Ross, MBA, MSc, PMP, RAC

EMA Perspective
Hilmar Hamann, PhD

Health Canada Perspective
Marcin Boruk, MBA, MSc

Speakers

Marcin Boruk

acting Director, Business Facilitation and Modernization Directorate, Health Can, Health Canada, Canada

Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is an acting Director in the Business Facilitation and Modernization Directorate, Health Canada supporting the branch in projects related to... Read More →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Dr Hilmar Hamann is currently the Head of Information Management at the European Medicines Agency (EMA) where he focuses on improving technological capabilities within the EU Regulatory Medicines Agencies Network to support efficient, all-digital, and data-driven operations. Previously... Read More →

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Global Product Devel, Pfizer Inc, United States

David Isom is Senior Director, Global Regulatory Policy and Intelligence at Pfizer. He leads policy and advocacy for digital modernization of the regulatory ecosystem. Before joining GRPI (2016), David led Pfizer information management, digital, and data services for clinical and... Read More →

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session | 03: Data-Tech, Session

Level Intermediate
Keyword Regulatory Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration
Tags Session

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out

Wednesday June 18, 2025 3:00pm - 3:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation; Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals; Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Speakers

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States

Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.

Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop | 03: Data-Tech, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

4:00pm EDT

#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-652-L04-P; CME 1.00; RN 1.00

This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.

Learning Objectives

Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.

Chair

Daniele Sartori, MPharm

Speaker

Regulatory Perspective
Brett Howard, JD, PhD

From Text to Intelligence: Architecting AI Systems for Drug Labeling and Pharmacovigilance
Fatima Sabar, MSc

AI in Drug Labelling: Toward Harmonized, Globally Aligned Product Information
Daniele Sartori, MPharm

Computerized Labeling Assessment Using AI
Suranjan De, MBA, MS

Speakers

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Fatima Sabar

CEO and Founder, Bluenote AI, United States

Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre, Sweden

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

4:00pm EDT

#357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-653-L04-P; CME 1.00; RN 1.00

This session will be based on a recent effort that examined lung cancer studies to determine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from sponsors, research sites, and academia to discuss challenges and areas of opportunities for re-thinking how to make lung cancer protocols more inclusive, and will include perspectives from the clinical operations, regulatory, research sites, and academia.

Learning Objectives

Identify areas within a study protocol that can adversely exclude marginalized patient populations; Identify organizational challenges that may hinder redesign efforts, and the implications these challenges can have on the clinical operations and regulatory front; Discuss approaches, strategies, and lessons-learned to help simplify protocol design.

Chair

Jennifer Kim, PhD

Speaker

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Ritesh Jain, PhD

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Umit Tapan, MD

Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS

Application of Large Language Models (LLM) to Examine Lung Cancer Protocol Exclusion Criteria
Abigail Dirks, MS

Speakers

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States

Ritesh Jain

Senior Director, EMD Serono, United States

Ritesh Jain is Senior Director and Portfolio Lead in Global Regulatory Affairs Oncology at EMD Serono, Inc. In his role he is accountable for driving global regulatory strategy for several projects in the oncology and immuno-oncology portfolio. Prior to joining EMD Serono, he has... Read More →

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States

I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States

Umit Tapan

Assitant Professor of Medicine, Boston University, United States

Dr. Umit Tapan is an Assistant Professor of Medicine at Chobanian and Avedisian School of Medicine and practicing Thoracic Oncologist at Boston Medical Center. His clinical interests are Non-small cell lung cancer, Small cell lung cancer, Mesothelioma, Immunotherapy, Targeted therapy/Precision... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

4:00pm EDT

#358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-654-L04-P; CME 1.00; RN 1.00

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Identify privacy-preserving approaches for accessing and sharing real-world data (RWD); Discuss use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine policy and regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

Global Privacy and Regulatory Considerations for Synthetic Data
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Real-World Applications of Distributed Data Analytic Solutions in Real-World Data Networks
Darren Toh, DrSc, FISPE

Privacy-Preserving Solutions for RWD Access and Collaboration: A Life Science Industry Perspective on Challenges & Opportunities
Mehmet Burcu, PhD, MS, FISPE

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Darren Toh

Professor, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States

Darren Toh, ScD is DPM Endowed Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. He is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research... Read More →

Echo Wang

Director, Outcome Research, Merck & Co., Inc, United States

Echo Wang is currently a Director, Outcome Research in Merck & Co., Inc. and based in Massachusetts, United States. In her current role, she manages strategic partnerships and drives emerging capabilities that support real-world evidence (RWE) generation. She has led several studies... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

4:00pm EDT

#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao

Speakers

Leo Barella

Chief Technology Officer, Takeda, United States

Jessica Federer

Board Member, Angelini Ventures, United States

Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →

Diogo Rao

Chief Information Officer, Eli Lilly, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Forum

Level Intermediate
Keyword Artificial Intelligence (AI), Student Programming, Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Student Programming,Advanced Analytics
Tags Forum

4:00pm EDT

#360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-656-L04-P; CME 1.00; RN 1.00

Patient experience data (PED) is sought by regulators, payers, and value/health technology assessment (V/HTA) bodies globally and used in different ways. Actively including PED in scientific, regulatory, and V/HTA processes has been a recent feature of regulatory and HTA reform, notably FDA guidance on patient-focused drug development (PFDD) and the EU Joint Clinical Assessment framework. Evolving perspectives on V/HTA have brought attention to the role of PED and there is a need to more systematically integrate PED into payer decision-making. Yet, the PED needs and perspectives of different stakeholders must be better understood for PED to have meaningful impact on product development, evaluation, and related decision-making. Many questions remain. Where do patients believe they have the most impact? What is industry experience gathering and leveraging PED globally? Do government agencies believe their efforts to include patient perspectives are being impactful on evidence they finally review? How can the impact of PED on V/HTA increase and be optimized globally? We will explore options to increase the impact of PED on development, V/HTA, and access decisions through optimal coordination and information sharing, and highlight options and good practices for integrating PED into regulatory, V/HTA, and payer decisions. We will discuss learnings across various opportunities for leveraging PED through policies and processes that affect patient access. Perspectives on PED from patient-group, EMA, payer, and industry panelists will showcase differences and similarities in stakeholder views and evidence needs to inform PFDD, V/HTA, and payer decisions, ultimately impacting patient access. Panelists’ experiences provide a lens on how current processes are working in concert or opposition, and opportunities for meaningful multi-stakeholder collaborations maximize PED impact on access decisions.

Learning Objectives

Discuss patient-group, payer, regulator, and industry perspectives on PED, in general, and regarding how to optimize PED use in decision-making in their respective roles; List the benefits and challenges to integrating PED in regulatory, V/HTA, and payer decision-making, from various stakeholder perspectives; Describe two examples of good practices and recommendations for integrating PED into regulatory, V/HTA, and payer decisions.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

Panelist
Maria Mavris, PhD

Panelist
Maxwell Isaacoff

Panelist
Magdalena Harrington, PhD

Panelist
Anna Hyde, MA

Speakers

Magdalena Harrington

Senior Director, Patient-Centered Outcomes Assessment (PCOA) Team Lead, Pfizer, United States

Magdalena Harrington is a subject matter expert in clinical outcomes assessment (COA) research with over 15 years of experience in delivering health outcomes strategies that demonstrate clinical and economic value of new medicines. She has extensive training in qualitative and quantitative... Read More →

Anna Hyde

Vice President of Advocacy & Access, Arthritis Foundation, United States

Anna Hyde is VP of Advocacy and Access at the Arthritis Foundation, overseeing federal/state legislative programs and grassroots engagement. She works to elevate arthritis as a public health priority, expand access to affordable care, and involve patients in policymaking. Since joining... Read More →

Maxwell Isaacoff

Director, Federal & External Affairs, Elevance Health, Inc, United States

Maria Mavris

Patient Relations, European Medicines Agency, Netherlands

Maria Mavris joined EMA in 2014 as a Patient Liaison in the Public and Stakeholder Engagement department. Her work focuses on engaging patients all along the regulatory lifecycle and supporting them in their involvement as members of EMA’s scientific committees, as representatives... Read More →

Eleanor Perfetto

Independent Consultant, Consultant, United States

Dr. Perfetto is a caregiver and recognized advocate for people with head-trauma-related dementias. She is a current member and past secretary and governance-committee chair for the Brain Injury Association of America’s Board of Directors and past chair of the Concession Legacy Foundation... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Session

4:00pm EDT

#362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-658-L04-P; CME 1.00; RN 1.00

Federally Qualified Health Centers and Community Health Workers play a critical role in reaching underserved populations, often serving as the first point of contact for healthcare in their communities. By partnering with these trusted entities, we can better connect with communities, bridging the gap between clinical research and underrepresented groups to ensure that clinical trials are more inclusive and reflective of the populations they aim to serve. This session will highlight the power of grassroots partnerships in expanding access to clinical research and showcase effective models that can be replicated in other regions.

Learning Objectives

Identify key components of the partnership between Reaching Communities, FQHCs, and CHWs; List ways to leverage the strengths of Federally Qualified Health Centers and Community Health Workers to effectively raise awareness and promote participation in clinical trials among underrepresented populations; Discuss how to foster greater inclusivity and accessibility for historically underserved populations in clinical research.

Chair

Perla Nunes

Speaker

NCCHCA and the FQHCs
Korrey Monroe, MPH

MedNorth Health Center and CHWs
Sharon Renee Brown-Singleton, LPN, MS

Durham Technical Community College and Clinical Research
Sharleen Traynor, PhD, MPH

Speakers

Sharon Brown-Singleton

Chief Strategy Officer, MedNorth Health Center, United States

Sharon Brown-Singleton is currently the Chief Strategy Officer at MedNorth Health Center. She led the implementation of the Community Health Worker program, having experience in writing, developing, and implementing various CHW programs centered around maternal and child health, substance... Read More →

Korrey Monroe

Program Manager, North Carolina Community Health Center Association, United States

Korrey Monroe is the Research Program Manager at the North Carolina Community Health Center Association (NCCHCA). In this role, he collaborates with the department director, Dr. Becca Hayes, to facilitate innovative research to raise awareness and provide resources for underserved... Read More →

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Thought Leader, United States

Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →

Sharleen Traynor

Instructor, Durham Tech, United States

Sharleen Traynor is an epidemiologist and educator with 20 years of public health experience in government and academic settings. In her current role as Director of the Clinical Trials Research Associate program at Durham Technical Community College, Dr. Traynor now focuses on clinical... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Forum

4:00pm EDT

#363: Critical to Quality Assessment Report (formerly termed 'Quality Brief') from Inception to Operationalization: How to Engage Internal Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-659-L04-P; CME 1.00; RN 1.00

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Critical to Quality Assessment Report (CAR) (formerly termed 'Quality Brief'). Sponsors will weigh in on the challenges and opportunities related to the value of the CAR for their internal stakeholders.

Learning Objectives

Recognize the internal value proposition of the Critical to Quality Assessment Report (formerly termed 'Quality Brief') and its application throughout the QMS and beyond; Discuss ways to apply different tactics to persuade and engage internal stakeholders on the value and application of the Critical to Quality Assessment Report.

Chair

Kiernan Trevett, MSc

Speaker

Critical to Quality Assessment Report: Overview and Value Proposition
Kiernan Trevett, MSc

A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Cheryl Grandinetti, PharmD

A Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Jennifer Emerson, PhD, MPH, RN, PMP

A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Mandy Kaur Budwal-Jagait, MSc

Speakers

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group, United States

Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-661-L04-P; CME 1.00; RN 1.00

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Chair

Ralf Herold, DrMed, MD

Speaker

How Industry Is Shaping Public-private Partnerships To Facilitate New Development Pathways For Products
Ginny Beakes-Read, BSN, JD

The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges
Louis Stancato, PhD

Accelerating Translation of Regulatory Science Research – EFPIA’s perspective
Solange Corriol-Rohou, DrMed, MD, PhD

Speakers

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands

Louis Stancato

VP Enabling Technologies, Indiana Biosciences Research Institute, United States

Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulator Perspectives, Regulatory Convergence and Harmonization, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Forum

4:00pm EDT

#366: FDA Rare Disease Town Hall

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-662-L04-P; CME 1.00; RN 1.00

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speaker

Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD

Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD

Speakers

Teresa Buracchio

Director, Office of Neuroscience, OND, CDER, FDA, United States

Teresa Buracchio, MD, is Director of the Office of Neuroscience in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA). She oversees the review of new drug programs for neurologic and psychiatric diseases. Dr. Buracchio joined FDA in 2013. Dr. Buracchio... Read More →

Nikolay Nikolov

Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States

Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist and is currently the Director of the Office of Immunology and Inflammation, CDER. During rheumatology fellowship at NIAMS, NIH, he studied cellular and molecular mechanisms of autoimmunity. Then, at the Sjögren's... Read More →

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Rare Disease, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Student Programming
Tags Forum

4:00pm EDT

#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-663-L04-P; CME 1.00; RN 1.00

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of obesity drug development; Identify the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Speaker

Panelist
Joseph Nadglowski, JR

Panelist
Maria Vassileva, PhD

Panelist
John Sharretts

Panelist
Brad Jordan, PhD

Speakers

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Joseph Nadglowski

President/Chief Executive Officer, Obesity Action Coalition, United States

Joe Nadglowski is President & CEO of the Obesity Action Coalition (OAC) – a nonprofit organization formed in 2005 dedicated to elevating and empowering individuals affected by obesity through education, advocacy and support. A frequent speaker and author, Mr. Nadglowski is especially... Read More →

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Forum

4:00pm EDT

#368: Perspectives on the Adoption of Advanced Manufacturing Technologies

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-664-L04-P; CME 1.00; RN 1.00

Share regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Listen to Industry cases studies showing implementation journeys and interactions with Regulators globally. Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss remaining challenges and priority areas for Industry and Regulators to work collaboratively to promote the adoption of advanced manufacturing technologies.

Learning Objectives

Discuss regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss priority areas for regulatory consideration to promote the adoption of advanced manufacturing technologies.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

Implementation Journey for AI use in Manufacturing (without hallucinating)
Gert Thurau, DrSc, PhD

Implementation Journey of a Digital Twin
Benjamin Stevens, PhD, MPH

mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
Brian Doyle

Speakers

Brian Doyle

Senior Director, Technical Development, Moderna, United States

Brian Doyle has over 15 years of experience in technical and CMC development for vaccines and therapeutics. Since joining Moderna in 2019, Brian has led organizations focused on late-stage and commercial process development and CMC technical writing, with a particular interest at... Read More →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States

Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-666-L04-P; CME 1.00; RN 1.00

Regulatory, industry, and academic organizations discuss modern approaches to clinical drug development by describing novel methods and use cases integrating real-world data and AI to generate real-world evidence, with focus on oncology and rare diseases.

Learning Objectives

Discuss global regulatory guidance and frameworks supporting innovative designs using real-world data as well as approaches to inclusion of artificial intelligence (AI); Describe innovative approaches and methods through examples of applied AI use in drug development; Discuss areas of research interest and promote community collaboration.

Chair

Donna Rivera, PharmD, MSc, FISPE

Speaker

Applying Artificial Intelligence in Drug Development
Sid Jain, MBA

Use of Artificial Intelligence Approaches for Rare Diseases
Christina Mack, PhD, MPH

Speakers

Sid Jain

Senior Vice President, Clinical Development and Data Science, Recursion, United States

Sid Jain is a healthcare innovator reimagining drug discovery and clinical development through data, technology, and biology. As SVP of Clinical Development & Data Science at Recursion, he leads teams integrating AI, real-world data, and clinical expertise to modernize therapy development... Read More →

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Forum

Level Intermediate
Keyword Artificial Intelligence (AI), Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Clinical Trial Design
Tags Forum

4:00pm EDT

#364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

151A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-660-L04-P; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Discuss current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Recognize common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Chair

Robyn Bent, BSN, MS, RN

Speaker

Panelist
Pujita Vaidya, MPH

Panelist
Brett Hauber, PhD, MA

Speakers

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →

Brett Hauber

Patient Preference Evidence Integration Lead, Pfizer Inc, United States

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Forum | 09: Regulatory, Forum

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Forum

4:00pm EDT

#371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

206

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-667-L04-P; CME 1.00; RN 1.00

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Speaker

Beyond Borders: Impact of Economic Shifts on Regulatory Strategies in Obesity Care
Tetyana Fine, MS

Global Strategy Considerations for Biosimilar Approvals
Rosalyn Janine Bailey, MPharm, MS

Artificial Intelligence in Drug Development
Darshini Trivedi, PhD

Speakers

Rosalyn Bailey

Executive Director NA & LATAM Head – Global Regulatory Affairs Solultions, Syneos Health, United States

Rosalyn Bailey, MS, is an experienced Regulatory Affairs leader with over 20 years in the drug development industry. As Executive Director of Global Regulatory Affairs Solutions at Syneos Health, she oversees regulatory teams across the Americas, guiding products through the regulatory... Read More →

Lawrence Fine

Business Consultant, Lawrence Fine, LLC, United States

Extensive experience working with companies of various sizes, including Fortune 500 companies. Deep expertise in Technology, Healthcare, Hospitality and Biotechnology industries across different functions including but not limited to marketing, information technology, and personnel... Read More →

Tetyana Fine

Director, Global Regulatory Affairs, Astrazeneca, United States

Fifteen (15) years of diverse biotechnology and pharmaceutical industry experience, including leadership, regulatory strategy development and execution, chemistry manufacturing and controls (CMC), and program and project management. Effectively direct multinational, cross-functional... Read More →

Darshini Trivedi

Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
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9:00am EDT

#401: Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements

Thursday June 19, 2025 9:00am - 10:00am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-668-L04-P; CME 1.00; RN 1.00

Planning safety reviews for a compound developed for multiple diseases is complex, requiring consistency across studies and analyses. A compound-level Data Monitoring Committee ensures unblinded safety review consistency, while an Aggregate Safety Assessment Plan (ASAP) supports post-study assessments. This presentation explores how an ASAP was implemented across a program to enable ongoing safety profile development as studies complete. It also introduces an interactive R Markdown application for real-time aggregate reviews, aligning with new draft regulatory guidance. This approach provides reviewers with access to program-level and individual study data during development, improving safety oversight. Key topics include the importance of coordination, teamwork, and standards to maintain a reliable safety database. A "year in review" will highlight lessons learned and enhancements made, concluding with an example of the application’s interactive capabilities.

Learning Objectives

Recognize and apply the Aggregate Safety Assessment Planning (ASAP) concept to drug development and aggregate safety analysis; Discuss implementing the ASAP effectively within an organization; Identify and utilize the importance of an interactive application for performing ongoing aggregate safety reviews.

Chair

Robert (Mac) Gordon, MS

Speaker

An Industry Perspective
Lisa A Kammerman, PhD, MS

Overview of the ASAP Process
Greg Ball, PhD

Perspective on the ASAP Process
Y. Veronica Pei, MD, MEd, MPH

Speakers

Greg Ball

Safety Data Scientist, ASAPprocess, United States

Robert (Mac) Gordon

Director, Biostatistics, Johnson & Johnosn Innovative Medicines, United States

Lisa Kammerman

Regulatory Statistics and PRO Consultant, Kammerman Consulting, LLC, United States

Lisa Kammerman, Ph.D. is a former FDA Master Reviewer and industry leader with 30+ years of experience in biostatistics and regulatory strategy. She spent 24 years at the FDA and later held leadership roles at AstraZeneca, bringing deep insight into both sides of drug development... Read More →

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Thursday June 19, 2025 9:00am - 10:00am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

9:00am EDT

#402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders

Thursday June 19, 2025 9:00am - 10:00am EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-669-L04-P; CME 1.00; RN 1.00

A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol decentralized clinical trial (DCT) and outline potential mitigation activities.

Learning Objectives

Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Discuss developing fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speaker

Panelist
Gina Lisette Williamson, BSN, MBA

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Maryrose Petrizzo, MS

Panelist
Terry Katz, MS

Speakers

Paula Horowitz

Program Manager, QA, GCP Software Validation, AbbVie, United States

Paula Horowitz is a Quality, Project and Data Management professional with 25+ years experience in Biopharmaceutical, CRO and academic environments. Currently, at AbbVie, Ms. Horowitz is a Program Manager, Software Validation within the QA organization. She provides QA risk-based... Read More →

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Maryrose Petrizzo

President and Consultant, Clinical Quality Assured,LLC, United States

Maryrose has over 25years of GCP experience in Clinical Quality Assurance and Quality Systems for the pharmaceutical, biologics and medical device industries including: site and process auditing, inspection readiness, due diligence, risk management, acquisition integrations, and clinical... Read More →

Gina Williamson

Associate Director Site solutions, Illingworth, A Syneos Health Company, Spain

A seasoned professional with over 19 years of experience in the Contract Research Organization (CRO) and pharmaceutical industry. Demonstrated expertise in leading and managing clinical trials, with hand on experience from both site and industry perspectives. Proficiency in overseeing... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

9:00am EDT

#403: How AI is Transforming the Area of Data Standards and Access to Source Data

Thursday June 19, 2025 9:00am - 10:00am EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-670-L04-P; CME 1.00; RN 1.00

The use of generative AI (genAI) is already shown to be useful in content generation. The use of genAI to accelerate development and maintainance of data standards and data transformation is rapidly evolving as it will be shown in this session.

Learning Objectives

Describe the current landscape of AI applications for developing, maintaining, and utilizing data standards to accelerate access to source data in electronic health records (EHRs) and registries; Evaluate how AI is currently shaping data standardization and transformation and anticipate its future impact on the landscape.

Chair

Jesper Kjær, MS

Speaker

Industry Feedback to AI in Data Standards
Robert DiCicco, PharmD

OHDSI OMOP AI and open science
Patrick Ryan

CDISC and AI
Chris Decker, MS

HL7 and the AI Train
Charles Jaffe, MD, PhD, FACMI, FACP

Speakers

Chris Decker

President and CEO, United States

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States

Charles Jaffe

Chief Executive Officer, HL7, United States

Dr. Jaffe is the CEO of Health Level 7 International (HL7). He completed his medical training at Johns Hopkins and Duke Universities and post-doctoral training at the National Institutes of Health and the Lombardi Cancer Center. At NIH, he worked in the Laboratory of Clinical Investigation... Read More →

Jesper Kjaer

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →

Patrick Ryan

Vice President Observational Health Data Analytics, Janssen Pharmaceuticals, Inc., United States

Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

9:00am EDT

#404: Embedding and Leveraging AI for Quality and Compliance in Pharma

Thursday June 19, 2025 9:00am - 10:00am EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-671-L04-P; CME 1.00; RN 1.00

This session explores the transformative potential of AI in pharma quality and compliance, sharing use cases, strategies, and regulatory insights. Attendees will learn how AI can transform quality and compliance in pharmaceutical companies.

Learning Objectives

Describe AI use cases in pharmaceutical quality management and compliance processes; Recognize the role, benefits, and risks of using AI in quality management; Discuss strategies for integrating AI technologies into existing pharmaceutical quality and compliance frameworks.

Chair

Hangyu (cedric) Liu, MS

Speaker

AI and the Quality Professional
Michael Pelosi, MA, MBA, MSc

AI in Pharma Quality and Compliance
Roshan D'Souza

Explainable Natural Language Processing: Why you see What you see
Meera Nagaria, MS

Speakers

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche Products Limited, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Hangyu (cedric) Liu

Associate Director, AI/ML, Biogen, United States

Hangyu Liu is currently an Associate Director of Artificial Intelligence Innovation at Biogen. He leads an advanced analytics group with a focus on R&D portfolio and quality analytics. He obtained a Master's degree in Data Science from Brown University. His research interests include... Read More →

Meera Nagaria

Senior Data Scientist, Johnson & Johnson, United States

Michael Pelosi

Director, Quality Analytics, Astellas, United States

Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.

Thursday June 19, 2025 9:00am - 10:00am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

9:00am EDT

#405: EMA - FDA Question Time

Thursday June 19, 2025 9:00am - 10:00am EDT

146BC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-672-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD

Speaker

Advanved Manufacturing
Evdokia Korakianiti, PhD, MSc

Artificial Intelligence
Luis Pinheiro, PharmD, MSc

Advanced Manufacturing
Manuel Osorio, PhD

GCP
Kassa Ayalew, MD, MPH

GCP
Peter Twomey, MA, MPharm

Artificial Intelligence
Tala Fakhouri, PhD, MPH

Speakers

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Manuel Osorio

Senior Scientist for Emerging Technologies, FDA, United States

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming
Tags Forum

9:00am EDT

#406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial

Thursday June 19, 2025 9:00am - 10:00am EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-673-L04-P; CME 1.00; RN 1.00

Alternative methods to a frequentist approach, such as Bayesian, may be superior in certain situations; particularly, when analyzing trial data to support approvals in small populations. Regulators are increasingly considering novel methods.

Learning Objectives

Examine global considerations for leveraging Bayesian approaches in pivotal trials to support marketing authorization; State and debate the situations and circumstances where the Bayesian approach may be the most appropriate method of analysis; Discuss health authority considerations that could facilitate the use of alternative analytical methods beyond the frequentist approach; Identify ways to bridge existing gaps in applying Bayesian methods in clinical research.

Chair

Philip Hougaard, DrSc, PhD

Speaker

FDA perspective
Yun Wang, PhD

EMA Perspective
Andrew Thomson, PhD, MA, MS

Industry Perspective
Scott Berry, PhD

Speakers

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →

Philip Hougaard

Vice President, Biostatistics and Data Science, Lundbeck A/S, Denmark

Vice President in biostatistics at H. Lundbeck A/S, Denmark. He has worked 40 years in the industry. He is Doctor of Science based on frailty models. He is the author of “Analysis of multivariate survival data”. He is external professor at University of Southern Denmark.

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands

Yun Wang

Deputy Division Director, CDER/OTS/OB, FDA, United States

Dr. Yun Wang is the Deputy Division Director for Division of Biometrics II in the Office of Biostatistics at CDER/FDA since March 2021. Before taking her current role, Dr. Wang was a statistical team leader and reviewer supporting anti-diabetic and hematologic products development... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Advanced Analytics
Tags Session

9:00am EDT

#407: Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship

Thursday June 19, 2025 9:00am - 10:00am EDT

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-674-L04-P; CME 1.00; RN 1.00

This session empowers pharmaceutical scientists and researchers with essential business skills, strategies for commercialization, and solutions for industry challenges, enabling a successful transition from lab innovation to entrepreneurial leadership.

Learning Objectives

Identify essential business and entrepreneurial skills to navigate the transition; Discuss the intersection of scientific innovation and business strategy, helping professionals identify and develop viable commercial opportunities from their research; Recognize the unique challenges in the pharmaceutical industry, from regulatory complexities to funding obstacles, and provide strategies for overcoming them.

Chair

Angela Men, MD, PhD

Speaker

Panelist
Bei Ma

Panelist
Matthew Chervenak

Panelist
Shou-Bai Chao

Speakers

Shou-Bai Chao

Chief Operating Officer, CanSino Biologics Inc., China

Matthew Chervenak

Founder & CEO, Allsci, United States

Matthew Chervenak is an entrepreneur and investor advancing science and liberal democracy. He is Founder and CEO of AllSci, an AI platform transforming how researchers explore and share scientific knowledge, and of Legis1, a data and news company supporting lawmakers, advocates, and... Read More →

Bei Ma

Founder and CEO, The Pinea Group, LLC, United States

Angela Men

Chief Executive Officer, The Whiteoak Group, Inc, United States

Thursday June 19, 2025 9:00am - 10:00am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Forum

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Forum

10:30am EDT

#408: FDA Town Hall

Thursday June 19, 2025 10:30am - 12:00pm EDT

146ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-25-675-L04-P; CME 1.50; RN 1.50

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Amy Bertha

Speaker

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Hussein Ezzeldin, PhD

Panelist
Gabriel Innes, DVM, PhD

Panelist
Marie C. Bradley, PhD, MPH, MPharm

Speakers

Amy Bertha

Executive Director, Regulatory Policy and Science, Bayer, United States

Amy Bertha is currently Executive Director, Regulatory Policy and Science at Bayer. Her prior experience includes, regulatory program and project management at FDA Center for Drug Evaluation and Research, regulatory affairs at Pfizer, and research scientist at Hoffman-La Roche. She... Read More →

Marie Bradley

Senior Advisor, Real-World Evidence Analytics, Office of Medical Policy, CDER, FDA, United States

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, CBER, FDA, United States

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Gabriel Innes

Health Science Policy Analyst, OMP, CDER, FDA, United States

Dr. Gabriel Innes is a Health Science Policy Analyst on the Real-World Evidence (RWE) Analytics Team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), FDA. Responsibilities on the RWE Analytics Team include internal consults related to RWD and... Read More →

Thursday June 19, 2025 10:30am - 12:00pm EDT
146ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Global Perspectives, Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Forum

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