DIA 2025 Global Annual Meeting: Full Schedule

11:00am EDT

Is Real-World Evidence Always a Last Resort?

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

Component Type: Forum
Level: Intermediate

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; Discuss how HTA evaluate RWE and current collaborations with regulators.

Chair

Nancy A 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

Speakers

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

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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

11:00am EDT

From Approval to Access: Integrating Patient Insights into Coverage Decisions

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

TBD

Component Type: Session
Level: Intermediate

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

Speaker
Kristi Martin, MA, MPA

Speaker
James D. Chambers, PhD, MPharm, MSc

Panelist
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

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

James D. Chambers, PhD, MPharm, MSc, is an Associate Professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies. His research interests include examining the factors that influence how insurance companies cover and reimburse medical technology... Read More →

Campbell Hutton

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

Campbell Hutton, MSPH, is Senior Director, Regulatory Affairs and is responsible for JDRF’s interactions with regulatory agencies, including the U.S. Food and Drug Administration. In this capacity, she oversees the regulatory affairs team to develop and implement JDRF’s overall... Read More →

Kristi Martin

Director, Camber Collective, United States

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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
Feature Topics Patient Experience,Payers
Tags Session

11:00am EDT

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

TBD

Component Type: Forum
Level: Intermediate

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
Kavita C. Dada, PharmD, RAC

Why do GCP Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
Reza Salehzadeh-Asl

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 of Regulatory Operations, OSI, OC, CDER, FDA, United States

Captain Kavita Dada is the Associate Director of Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. In this role, she leads initiatives and provides expertise... Read More →

Reza Salehzadeh-Asl

National Supervisor Clinical Trial Compliance Program, Health Canada, Canada

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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
Feature Topics Global Perspectives
Tags Forum

11:00am EDT

Accelerating Global Access to Drugs for Chronic Diseases

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

TBD

Component Type: Session
Level: Intermediate

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.

Chair

Carlos Garner, PhD

Speakers

Carlos Garner

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

Executive leader for North American regulatory affairs for Eli Lilly and Company. The organization is responsible for all US and Canadian human drugs and devices regulatory affairs, and global manufacturing regulatory affairs. Organization provides strategic and operational regulatory... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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
Feature Topics Non-CE
Tags Session

11:00am EDT

Project Orbis: Six Years Later

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

TBD

Component Type: Forum
Level: Intermediate

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; Explain how sponsors can benefit from participating in Project Orbis.

Chair

Sema Hashemi, MSc

Speaker

Panelist
Sarah Golding, MD

ANVISA Perspective
Marcelo Moreira, MS

Panelist
Michal Hirsh-Vexberg, PharmD

Panelist
R. Angelo De Claro, MD

Panelist
Dianne Spillman

Panelist
Ulrich Rohr

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, OGPS, OC, 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.

Ulrich Rohr

Unit Head Clinical Review, 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
TBD 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
Feature Topics Regulatory Collaboration ,Global Perspectives
Tags Forum

11:00am EDT

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

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

TBD

Component Type: Forum
Level: Intermediate

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 K Martin, PhD, MS

Speaker

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

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, United States

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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
Feature Topics Payers
Tags Forum

11:00am EDT

Advancing Innovation Through Essential Drug Delivery Outputs

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

TBD

Component Type: Forum
Level: Intermediate

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 (implantable, on-body) and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development (EDDO Focus)
James Bertram, PhD, MS, RAC

Emerging policies driving complex combination product development (How other policies work with EDDO)
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 an Assistant Director with the Regulation, Policy, and Guidance Staff in CDRH/OPEQ. In this capacity, James and his team collaborate across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.

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 a Global Regulatory Policy & Intelligence Director, 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 Stevens is acting Division Director of FDA's Division of Drug Delivery, General Hospital and Human Factors. His division is responsible for regulation of drug delivery and general hospital device premarket submissions and postmarket safety and compliance. The division also provides... 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
TBD 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
Feature Topics Digital Technology
Tags Forum

11:00am EDT

Putting Patients First: 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

TBD

Component Type: Forum
Level: Intermediate

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

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 →

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 →

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD 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
Feature Topics Student Programming
Tags Forum

12:50pm EDT

CH: Regulatory Intelligence to Drive Regulatory Strategy

Monday June 16, 2025 12:50pm - 1:20pm EDT

TBD

Component Type: Workshop
Level: Intermediate

The lifecycle of a Health Authority (HA) advice/feedback from its receipt to how it shapes and drives regulatory strategy will be uncovered with the lens of regulatory intelligence. Discuss the systems, and processes to manage HA advice/feedback

Learning Objectives

Discuss methods, techniques and best practices organizations employ to manage Health Authorities (HA) advice/feedback. Evaluate how HA advice is made searchable to gather internal regulatory precedence and how it informs regulatory strategy. Describe how to build a robust regulatory intelligence framework to manage HA advice/feedback and translate them into actionable insights.

Chair

Meena Naren Muthiah, MPH, MS, RAC

Monday June 16, 2025 12:50pm - 1:20pm EDT
TBD 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

2:15pm EDT

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

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

TBD

Component Type: Forum
Level: Intermediate

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 Myers, JD

Speaker

Academic 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 →

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 19 years and has been active in the DC policy arena for three... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD 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
Feature Topics Rare Disease,Clinical Trial Design,Cell and Gene Therapy
Tags Forum

2:15pm EDT

A Masterclass: Patient Recruitment Campaign Management

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

TBD

Component Type: Session
Level: Intermediate

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
Tom Julian

Case Study Presentation
Kelly Johnston McKee, MS

Speakers

Tom Julian

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

Kelly McKee

Head of Innovative Patient Recruitment, Evinova, An Astrazeneca Company, United States

Kelly McKee is the Head of Innovative Recruitment at Evinova, AstraZeneca’s digital healthcare company, where she is responsible for leading the department in developing and deploying digital and innovative patient recruitment strategies and tactics. Kelly is a proven clinical trial... Read More →

Chris Venezia

Chief Executive Officer, ProofPilot, United States

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

2:15pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Industry Perspective
Kevin Richards

Speakers

Kevin Richards

Head Quality Investigations & Analytics, AstraZeneca, Canada

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
TBD 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
Tags Session

2:15pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

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 Francer, JD, MPA

Speaker

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

Speakers

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 →

Barrett Tenbarge

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

Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD 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
Feature Topics Student Programming
Tags Forum

2:15pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

Regulatory and Industry experts will reflect on progress on global regulatory harmonization of requirements for the development of medicines since the founding of ICH and it’s expanded global footprint following the reforms in 2015.

Learning Objectives

Assess progress in global harmonization of regulatory requirements for the development of medicines since ICH reforms in 2015; Evaluate impact of specific ICH guidelines in global drug development such as E6(R2) Good Clinical Practice, E17 Multi-Regional Clinical Trials and M4Q(R2); Identify opportunities for greater regulatory harmonization to advance global drug development.

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

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 - Strategic Initiatives, 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 →

Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD 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
Feature Topics Regulatory Convergence and Harmonization,Regulator Perspectives,Global Perspectives
Tags Forum

2:15pm EDT

Health Canada Town Hall

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

TBD

Component Type: Session
Level: Intermediate

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

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 →

Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD 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
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Session

2:15pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

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

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

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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

2:15pm EDT

Best Practices for Navigating Divergent Regulatory Feedback

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

TBD

Component Type: Forum
Level: Intermediate

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

FDA Perspective on Best Practices for Navigating Divergent Regulatory Feedback
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 →

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 Affairs, 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 (Global Labeling, US Ad Promo and Regulatory Policy & Intelligence) in 2015. Prior to joining AbbVie, Natalie... Read More →

Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD 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
Feature Topics Student Programming,Regulatory Convergence and Harmonization
Tags Forum

3:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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).

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS

Speakers

Rita Algorri

Senior Manager, Global Regulatory Affairs (CMC), Amgen, United States

Rita Algorri, PhD is a Senior Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging... 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 and Interoperability, AstraZeneca, United Kingdom

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

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

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

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
TBD 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
Feature Topics Rare Disease,Patient Experience
Tags Session

3:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Industry Perspective
Samantha Roberts, PhD

Speakers

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 →

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
TBD 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
Feature Topics Regulatory Convergence and Harmonization,Patient Experience
Tags Session

3:45pm EDT

Ethics in the Era of Precision Medicine and Advancing Technologies

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

TBD

Component Type: Session
Level: Intermediate

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 medcine; Recognize the importance of the inclusion of diverse, representative populations and handling of incidental findings.

Chair

James Wabby, MHS

Speaker

Ethics in the Era of Precision Medicine and Advancing Technologies
James Wabby, MHS

Ethics in the Era of Precision Medicine and Advancing Technologies
Amanda Burkhardt, PhD

Speakers

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States

Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... 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 22 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
TBD 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
Feature Topics Bioethics
Tags Session

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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.

Speaker

Industry Perspective
Robert DiCicco, PharmD

Site Perspective
Ryan Ferguson

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 →

Ryan Ferguson

Acting Director, Cooperative Studies Program, VA Boston Healthcare System, 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
TBD 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
Feature Topics Clinical Trial Design
Tags Session

3:45pm EDT

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

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

TBD

Component Type: Session
Level: Intermediate

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

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

Considerations for Regulatory Collaboration in Chronic Disease
John Sharretts

Industry Perspective
Kevin Bugin, PhD, MS, RAC

Speakers

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 →

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.

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States

Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD 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
Feature Topics Regulatory Collaboration
Tags Session

3:45pm EDT

FDA Accelerated Approval Program: Putting Withdrawals in Context

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

TBD

Component Type: Session
Level: Intermediate

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

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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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 and Director, PQM+, 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
TBD 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
Feature Topics Regulatory Convergence and Harmonization,Student Programming
Tags Session

3:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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.

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

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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
TBD 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
Tags Session

3:45pm EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

Global Head of Quality, Abivax, United States

Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD 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
Feature Topics Student Programming
Tags Session

8:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

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

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

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

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

Departiment of Drug Safty 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
TBD 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
Tags Session

8:30am EDT

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

TBD

Component Type: Workshop
Level: Intermediate

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

Maya Zlatanova

Speakers

Maya Zlatanova

CEO & Co-founder, Findmecure Ltd., Bulgaria

Maya Zlatanova is the CEO and co-founder of FindMeCure (patient navigation platform) and TrialHub (data-intelligence platform for clinical trials). Her team and Maya are on a mission to bring clinical research closer to patients by improving the way we design and conduct clinical... Read More →

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Artificial Intelligence (AI),Patient Experience
Tags Workshop

8:30am EDT

Realizing Value Through Responsible AI in Clinical Development

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

TBD

Component Type: Session
Level: Intermediate

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

Industry perspectives on AI in clinical development
Raja Shankar, MS

Speakers

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

8:30am EDT

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem

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

TBD

Component Type: Session
Level: Intermediate

This session will explore the evaluation and integration of assistive technology for clinical document content creation. The panelists will describe experimental design, cross-functional team formation, and the adoption of tailored solutions.

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; Recognize how to design a strategy for integrating technologies into existing systems and behaviors.

Chair

Ulrike Kochendoerfer, PhD

Speaker

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technolgy Ecosystem
Matthew Renda, PhD, MS

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technolgy Ecosystem
Aliza Nathoo

Speakers

Ulrike Kochendoerfer

Senior Director, Medical Writing, Pfizer Inc, United States

Dr. Ulrike Kochendoerfer has over 20 years of experience in pharmaceutical research. She started her career in pre-clinical research in toxicology and biochemistry, before entering the regulatory medical writing field in 2005. Dr. Kochendoerfer holds a PhD from the University of Bonn/Germany... Read More →

Aliza Nathoo

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

Aliza began her career supporting 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... 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 →

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

8:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, 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 →

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

8:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

Barriers and enablers in international RWE harmonization
Nicole Mahoney, PhD

Comparison of RWE guidelines across regions
Rachele Hendricks-Sturrup, DrSc, MA, MSc

ICH Efforts in International RWE Harmonization
David Moeny, MPH, RPh

Speakers

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 Pharmaceuticals Corporation, 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

Acting 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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE),Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

8:30am EDT

Japan Town Hall

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

TBD

Component Type: Session
Level: Intermediate

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

Speaker
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 →

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

8:30am EDT

MHRA Town Hall

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

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 →

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Global Perspectives
Tags Session

8:30am EDT

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

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

TBD

Component Type: Forum
Level: Intermediate

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

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

Speakers

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

Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

The Globalization of Risk Management

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

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
TBD 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
Feature Topics Global Perspectives
Tags Session

10:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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 A Patel, PharmD

Speakers

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 →

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

10:30am EDT

Case Studies of Application of AI in Risk-Based Quality Management

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

TBD

Component Type: Session
Level: Intermediate

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

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 →

Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

Resilient Leadership: Overcoming Isolation and Adversity

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States

Matthew Robillard is a Senior Director of Regulatory Strategic 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... Read More →

Cathy Tyrrell

Head of Medical Writing and Disclosure, Seqirus, United States

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
TBD 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
Tags Session

10:30am EDT

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

TBD

Component Type: Session
Level: Intermediate

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, Sanofi, 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

Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

10:30am EDT

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

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

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

Donna Libretti Cooke

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

DONNA LIBRETTI COOKE, JD Chief Impact Officer & Owner ImpactSphere Clinical, LLC PROFILE A compassionate pioneer driving clinical trial solutions for a healthier world. (2) Donna Libretti Cooke, JD | LinkedIn BIOGRAPHY Donna is a strategic and collaborative Life Sciences professional... 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
TBD 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
Level Intermediate
format csv
Tags Forum

10:30am EDT

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

TBD

Component Type: Session
Level: Intermediate

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, for 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
TBD 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
Tags Session

10:30am EDT

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

TBD

Component Type: Session
Level: Intermediate

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 to he 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

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
TBD 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
Feature Topics Clinical Trial Design,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

10:30am EDT

ANVISA Town Hall

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

TBD

Component Type: Session
Level: Intermediate

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
TBD 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
Feature Topics Regulator Perspectives,Regulatory Collaboration ,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Session

10:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

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

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

Speakers

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 →

Aaron Smith

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

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, 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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

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

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

Imran Shah

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

Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Rare Disease
Tags Session

11:40am EDT

CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials

Tuesday June 17, 2025 11:40am - 12:10pm EDT

TBD

Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster. Discover how digital protocols are already driving connections and efficiencies at research sites. Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Chair

Denise Meade, MBA

Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD 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

CH: Diversity Action Plans - Listen, Learn, and Execute

Tuesday June 17, 2025 12:20pm - 12:50pm EDT

TBD

Component Type: Workshop
Level: Intermediate

The session will provide an overview of FDA Diversity Action Plans and relevant implications for industry, equipping pharma and biotech professionals with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.

Learning Objectives

Discuss key changes in recent guidance, impact on clinical trials, and trends for FDA Diversity Action Plans; Collect essential knowledge and pragmatic guidance to navigate the evolving regulatory landscape for Diversity Action Plans

Chair

Teresa Oblak, PhD

Tuesday June 17, 2025 12:20pm - 12:50pm EDT
TBD 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

1:00pm EDT

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

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

TBD

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

1. Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements. 2. Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions. 3. Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

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

Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science

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

TBD

Component Type: Session
Level: Intermediate

Risk mitigation (RM) decisions commonly lack conclusive data and reproducibility. This session presents regulatory initiatives, TRIM, the first tool to support RM decision-making, and case studies of evidence-guided RM implementation and evaluation.

Learning Objectives

Summarize new initiatives that support regulatory decision-making on risk mitigation; Explain the use of pharmacoepidemiologic and decision-science approaches in developing an explicit risk mitigation decision tool; Discuss how qualitative and quantitative evidence can support REMS implementation; Compare study design options for formal REMS evaluation.

Chair

Almut G Winterstein, PhD, RPh, FISPE

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

1:45pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

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 →

Joseph Dustin

Founder and Principal, Dauntless Eclinical Strategies, United States

Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... 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
TBD 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
Feature Topics Clinical Trial Design
Tags Forum

1:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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, Office of Clinical Policy and Programs, OC, 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
TBD 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
Feature Topics Bioethics,Student Programming,Global Perspectives
Tags Session

1:45pm EDT

Reliable AI in Biomedical Settings: A Framework for Trust and Innovation in an Evolving Landscape

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

TBD

Component Type: Session
Level: Intermediate

With AI-based technologies used across biomedical settings, this session will share considerations and proven examples on selecting the right AI strategy, assuring AI suitability and reliability, and staying onside of regulatory expectations.

Learning Objectives

Discuss what to consider when selecting AI strategies and methods for use in biomedical settings; Recognize the importance in having a framework for evaluating and determining the suitability and readiness of AI (for example, large language models) for a specific application; Identify necessary inputs and approaches to navigating an evolving regulatory landscape for the application of AI solutions in biomedical settings.

Chair

Sarah Lyons, MSc

Speaker

Not all AI is Equal: Value of Purpose-Tuned Models for High Quality Research
Troy Astorino

Speakers

Troy Astorino

CTO, PicnicHealth, United States

Troy Astorino, co-founder and Chief Technology Officer of PicnicHealth, holds degrees in Aerospace Engineering and Physics from MIT. At PicnicHealth, Troy spearheads the development of technologies transforming unstructured medical records into research datasets. His team has pioneered... 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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

1:45pm EDT

How Medical Writing 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

TBD

Component Type: Session
Level: Intermediate

This session will explore the FDA START program for accelerating rare disease therapies. We will invite companies who participated in the START pilot and a FDA representative.

Learning Objectives

Explain the objectives of the FDA START Program and its role in supporting rare disease development; Discuss how medical writers can support companies applying for and participating in the START program.

Chair

Robin Whitsell

Speaker

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 →

Robin Whitsell

President, Whitsell Innovations, Inc., United States

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Rare Disease
Tags Session

1:45pm EDT

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

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

TBD

Component Type: Forum
Level: Intermediate

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: Primary Causes, Outcomes and Mitigation Strategies and Practices
Kenneth Getz, MBA

Participant Feedback Forum: Active Interpretation of Signals by Patient Advisors and Attendees
Lani Hashimoto

Speakers

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 →

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 →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Patient Experience
Tags Forum

1:45pm EDT

US Executive Orders: Impact on Precision Medicine and Diagnostic Development

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

TBD

Component Type: Session
Level: Intermediate

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

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
TBD 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
Feature Topics Diagnostics
Tags Session

1:45pm EDT

Guerrilla Strategic Delivery

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

TBD

Component Type: Session
Level: Intermediate

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

Implement adaptive strategies to enhance project delivery by prioritizing impact over rigid processes; Optimize workflows by streamlining complexity while ensuring strategic alignment and accountability; 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

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
TBD 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
Tags Session

1:45pm EDT

Embracing ICH E6(R3) with Risk-Based Quality Management

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

TBD

Component Type: Session
Level: Intermediate

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, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... 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
TBD 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
Tags Session

1:45pm EDT

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

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

TBD

Component Type: Session
Level: Intermediate

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

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

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom

As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly... 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, Marketed Health Products Directorate, Health Canada, Canada

Kelly is the Director General of Health Canada’s Marketed Health Products Directorate. She leads a diverse team on a range of health product regulatory activities including surveillance, assessment, and risk management; risk communications; health product advertising; use of real-world... Read More →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

Pediatric Cluster Town Hall

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

TBD

Component Type: Forum
Level: Intermediate

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

FDA Perspective
Dionna J. Green, MD

Australia Perspective
Robyn Langham, MD, PhD

Speakers

Dionna Green

Director, Office of Pediatric Therapeutics, OC, 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 →

Daisuke Koga

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

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.

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 →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Pediatrics,Regulator Perspectives,Student Programming,Global Perspectives
Tags Forum

1:45pm EDT

China Town Hall

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

TBD

Component Type: Session
Level: Intermediate

In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

Learning Objectives

Describe the latest information on the National Medical Products Administration’s activities in drug regulation; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speakers

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 →

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Session

1:45pm EDT

Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency

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

TBD

Component Type: Session
Level: Intermediate

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

Pathways to inspection reliance- a 20 year journey
Andrea Kurz

ANVISA Perspective
Bianca Zimon, LLM

Speakers

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland

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

Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Regulatory Reliance
Tags Session

1:45pm EDT

Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint

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

TBD

Component Type: Session
Level: Intermediate

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.

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

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
TBD 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
Feature Topics Clinical Trial Design
Tags Session

1:45pm EDT

Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development

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

TBD

Component Type: Session
Level: Intermediate

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

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec

Speakers

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States

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
TBD 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
Feature Topics Student Programming
Tags Session

4:00pm EDT

Advancing Premarketing Safety Analytics through FDA and Industry Partnerships

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

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 →

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
TBD 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
Feature Topics Advanced Analytics
Tags Session

4:00pm EDT

Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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 Hill

Overcoming Resistance & Driving Adoption
Kimberly Tableman, MSc

Seamless Data Integration & 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 Executive 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

Kimberly Tableman is Chief Clinical Development Officer (CCDO) at Castor. She has more than 23 years of experience in clinical development and technology. Over the past decade, she has focused on applying digital health technologies to reimagine the patient journey. She was most recently... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
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4:00pm EDT

Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

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
TBD 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
Tags Forum

4:00pm EDT

Delivering Effective Business Transformations and How to Apply them to Drug Development

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Speakers

Ashar Choudhry

Executive Director, Enterprise Operational Excellence, Bristol Myers Squibb, United States

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
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4:00pm EDT

New Data and Insights on the Vendor Qualification Process in Drug Development

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

Panelist
Tran 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

A pharma industry leader and entrepreneur with a focus on driving improvements in clinical trial execution, at scale, through innovative solutions. In 1999, she founded The Avoca Group, whose Avoca Quality Consortium paved the way for Diligent Pharma.

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

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
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4:00pm EDT

Pharmacovigilance Inspections Fireside Chat

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

Health Canada Perspective
Stephane Berard

Speakers

Stephane Berard

Interim Supervisor-Health Product Compliance East Unit, Health Canada, Canada

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
TBD 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
Feature Topics Regulator Perspectives
Tags Forum

4:00pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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 Tony Roman, MPharm

Speaker

Global Efforts to Build Regulatory Capacity and Facilitate Access to ATMPs in Middle-Income Countries
Sarah Adam

Collaborative and Harmonization Initiatives Advancing the Development and Accessibility of Advanced Therapy Medicinal Products
Dianliang Lei

Panelist
Yasuhiro Kishioka, PhD

ANVISA Perspective
Renata Miranda Parca, AHIP

Speakers

Sarah Adam

Associate Director, Regulatory Affairs, IFPMA, Switzerland

Sarah Adam coordinates IFPMA activities in the Regulatory field focussing on policy, regulatory system strengthening and harmonisation. She also leads Regulatory Science Policy for Africa. Prior, Sarah worked for many years, for ICH, supporting the harmonisation of ICH technical Guidelines... Read More →

Yasuhiro Kishioka

Reviewer 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 gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... 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.

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, 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
TBD 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
Feature Topics Regulatory Collaboration ,Regulatory Convergence and Harmonization
Tags Session

4:00pm EDT

Towards Instantaneous Regulatory Decisions and Better Predictability

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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
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

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
Tags Session

4:00pm EDT

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

TBD

Component Type: Session
Level: Intermediate

With several regulatory and ethics authority initiatives to encourage patient input to trial design, how can authorities provide aligned review, guidance and expectations towards these activities and how should sponsors communicate patient engagement?

Learning Objectives

Discuss US (FDA) and EU (EUCTR and country ethics committees) initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from sponsor survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance; Describe emerging markets.

Chair

Melissa Pauline Herman, MSc

Speakers

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 engagement across neurology and neuro-rare development programs.

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
Tags Session

4:00pm EDT

Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Panel
David Sidney Ross, MBA, MSc, PMP, RAC

Panel
Vada A. Perkins, DrSc, MSc

Panel
Brooke Casselberry, MS, RAC

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 →

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Vada A. 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 →

David Ross

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

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
Tags Session

4:00pm EDT

Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Industry Perspective
Ran Duan, PhD

Industry Perspective
Jingyu (Julia) Luan, PhD

Speakers

Ran Duan

Director Biometrics, Vertex Pharmaceuticals, United States

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 →

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 (FORExcellence) at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists that promotes best practices in RWE generation at CSL. His team... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Clinical Trial Design
Tags Session

4:00pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Looking Internally and Externally to Optimize Workforce Development
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
TBD 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
Feature Topics Student Programming
Tags Session

8:30am EDT

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

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 →

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
TBD 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
Tags Session

8:30am EDT

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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
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
TBD 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
Tags Session

8:30am EDT

Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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; Discuss resources to assist teams in navigating regulatory documentation.

Chair

Jane Myles, MSc

Speaker

Regulator Perspective
Timil Patel, MD

Industry Perspective
Shelly Barnes

Speakers

Shelly Barnes

Global Clinical Innovations Lead, UCB, United States

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 →

Timil Patel

Clinical Team Lead (Acting), Division of Oncology 2, FDA, FDA, United States

Timil Patel, M.D., is a medical oncologist who serves as a clinical reviewer on the Gastrointestinal Cancers and Melanoma Team in the Division of Oncology 3 at the U.S. Food and Drug Administration. His research interests include evaluating ways to modernize clinical trials and evidence... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Forum

8:30am EDT

Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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; State 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

MHRA Perspective
Jason Wakelin-Smith

Speakers

Kentaro Ichinose

Inspector, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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 →

Jason Wakelin-Smith

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

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Session

8:30am EDT

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

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

At the Clinical Trials Transformation Initiative (CTTI), Ms. Hanger leads strategic planning and new initiatives. Previously, she was vice president of the online patient research network PatientsLikeMe, where she oversaw programs utilizing patient-generated health data in life sciences... Read More →

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Session

8:30am EDT

Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

Amira Younes

Director, Global Regulatory Policy EEMEA, 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 →

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Feature Topics Global Perspectives
Tags Forum

8:30am EDT

The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

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 →

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Session

8:30am EDT

How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

Lesbeth Caridad Rodriguez, MS

Speaker

ICMRA Pilot, Assessment Summary Report
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 →

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States

Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Session

8:30am EDT

Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges

Wednesday June 18, 2025 8:30am - 9:30am EDT

TBD

Component Type: Session
Level: Intermediate

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.

Speaker

Panelist
Annie Kennedy

Speakers

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 →

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD 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
Tags Session

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

William Blumentals

Head of Pharmacoepidemiology, Special Care, Sanofi, United States

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Tags Forum

10:30am EDT

Trustworthy AI Solutions for Next-Generation Pharmacovigilance

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Forum
Level: Intermediate

Despite advances in AI and Generative AI, its routine use in pharmacovigilance (PV) and high-risk applications is limited. This session will explore what’s needed to enable trusted use, highlighting technical challenges with multistakeholder input.

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

Jens-Ulrich Stegmann, MD, RN

Speakers

Jens Stegmann

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium

Jens-Ulrich Stegmann, MD, RN, is Senior Vice President, Head of Clinical Safety and Pharmacovigilance, and EU QPPV at GSK, Belgium. With an M.D. in nursing from the University of Essen and a Ph.D. in Physiology from Christian-Albrechts University in Kiel, Germany, Jens began his career... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Forum

10:30am EDT

Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

Speakers

Kwaku Marfo

Africa Market Development Specialist, IQVIA, Ghana

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Global Perspectives
Tags Session

10:30am EDT

Patient Referral: Is It Hope or Hype?

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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

Sanghita Bhattacharya, PhD

Speaker

Patient Referral: Is It Hope or Hype?
Joan Chambers

Patient Referral: Is It Hope or Hype?
Barbara Isquith Arone, MS

Patient Referral: Is It Hope or Hype?
Karen Correa, PhD

Patient Referral: Is It Hope or Hype?
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 →

Sanghita Bhattacharya

Director Data Science Global Function, Johnson & Johnson Innovative Medicine, United States

Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →

Joan Chambers

Senior Consultant, Tufts CSDD, 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

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 →

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.

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc

Speakers

Eishita Agarwal

Digital Innovation Manager, Medical Writing, GSK, India

Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into... Read More →

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

Why Patient/Site Collaboration is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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

Vice President of Contracts and Trial Management, CNS Healthcare, United States

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
TBD 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
Feature Topics Digital Technology
Tags Forum

10:30am EDT

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

TBD

Component Type: Forum
Level: Intermediate

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

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, DrMed

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm

Speakers

Akihiro Ishiguro

Deputy Review Director, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Akihiro Ishiguro is the Director of the Review Planning Division, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA). His professional experience includes new drug review and post marketing drug safety. He had the opportunity to join projects to develop... Read More →

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

Director, Department of International Clinical Development, National Cancer Center Hospital, Japan

Dr. Nakamura is the Director of the Department of International Clinical Development at the National Cancer Center Hospital. He completed his degree at Kyoto University in 1999. After spending seven years training as a general surgeon, he joined the National Cancer Center to participate... 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
TBD 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
Feature Topics Rare Disease,Global Perspectives
Tags Forum

10:30am EDT

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

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
TBD 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
Feature Topics Clinical Trial Design
Tags Forum

10:30am EDT

Practical Implementation of MRCTs Based on ICH E17 Guidelines

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka

Panelist
William Wang, PhD

Speakers

Hideki Hiraoka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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
TBD 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
Tags Session

10:30am EDT

Navigating the Challenges of Drug Delivery Using a Novel Device

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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
TBD 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
Feature Topics Cell and Gene Therapy
Tags Session

10:30am EDT

Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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 Directory, Reg Intel, Policy and QMS Lead, Pfizer, United States

Patrick Saunders

Senior Director, Quality, Lilly del Caribe, Eli Lilly & Co., United States

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Tags Session

10:30am EDT

Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health

Wednesday June 18, 2025 10:30am - 11:30am EDT

TBD

Component Type: Session
Level: Intermediate

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.

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD 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
Feature Topics Artificial Intelligence (AI),Student Programming,Global Perspectives
Tags Session

12:20pm EDT

CH: Addressing Key Challenges in Global Biosimilar Development and Regulation

Wednesday June 18, 2025 12:20pm - 12:50pm EDT

TBD

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
TBD 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

1:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

1:45pm EDT

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

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

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

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Sumati Nambiar

Senior Director, Johnson and Johnson, United States

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Cell and Gene Therapy,Pediatrics
Tags Session

1:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh

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

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
TBD 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
Feature Topics Global Perspectives,Regulatory Convergence and Harmonization,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Speakers

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 20 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 →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Artificial Intelligence (AI),Digital Technology ,Advanced Analytics
Tags Session

1:45pm EDT

Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Forum
Level: Intermediate

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
TBD 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
Tags Forum

1:45pm EDT

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

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

Health Canada Perspective
Myriam Salem, MSc

Speakers

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Regulator Perspectives
Tags Session

1:45pm EDT

Africa's Evolving Regulatory Landscape

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Saba Berhane, BSN, MPharm

Speaker

Panelist
David Mukanga, PhD, MPH

Speakers

Saba Berhane

Manager, Regulatory Affairs, IFPMA, Switzerland

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 →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Regulatory Collaboration ,Regulator Perspectives,Regulatory Reliance,Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

EMA Town Hall

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Session
Level: Intermediate

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.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

1:45pm EDT

Evolving Regulatory Considerations for Medical Affairs Communications

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

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 →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD 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
Tags Forum

1:45pm EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Health Canada Perspective
Marcin Boruk, MBA, MSc

Speakers

Marcin Boruk

Manager RMOD, HFPB, 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 a manager in the Information Sciences and Openness Division, Health Canada supporting the branch in projects related to data governance... 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
TBD 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
Feature Topics Regulatory Collaboration
Tags Session

3:00pm EDT

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

TBD

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

Wednesday June 18, 2025 3:00pm - 3:30pm EDT
TBD 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

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Computerized Labeling Assessment Using AI
Suranjan De, MBA, MS

Speakers

Suranjan De

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

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

4:00pm EDT

Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Julieta Argüelles, DrMed

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

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Laura Huggins

Speakers

Julieta Argüelles

Researcher, MD Anderson Cancer Center, United States

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States

Laura Huggins

VP & Head, Global Regulatory Affairs Oncology & CDx, Merck KGaA (EMD Serono), Germany

Laura Huggins has worked in drug development for over 20 years and is currently the VP and Global Head of Regulatory Affairs for Oncology and Companion Diagnostics at Merck KGaA, Darmstadt Germany. Her team is responsible for the regulatory strategy for a broad innovative oncology... 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

Chief Client Officer, Inside Edge Consulting Group, 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 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

4:00pm EDT

Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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
Cindy Hoots

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 →

Cindy Hoots

Chief Digital Officer and Chief Information Officer, AstraZeneca, United States

Diogo Rao

Chief Information Officer, Eli Lilly, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Artificial Intelligence (AI),Student Programming,Advanced Analytics
Tags Forum

4:00pm EDT

Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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 regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

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

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., 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
TBD 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
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

4:00pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

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
TBD 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
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Forum

4:00pm EDT

Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

To guide patient focused drug development, patient input is sought by regulators and Health Technology Assessment (HTAs) in different ways around the world. The session will explore options to increase impact on development through greater coordination and information sharing.

Learning Objectives

Describe different options and processes for patient input into regulatory and HTA advice across key product development milestones; Discuss best practices in maximising the overall impact of patient input on development plans; Identify policy and process changes that would allow continuous improvement and learning across the various set pieces for patient engagement.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

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 the Vice President of Advocacy and Access at the Arthritis Foundation. She oversees both the federal and state legislative programs, in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority, build support for... Read More →

Maxwell Isaacoff

Director, Federal & External Affairs, Elevance Health, Inc, United States

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
TBD 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
Feature Topics Patient Experience
Tags Session

4:00pm EDT

Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Critical to Quality Assessment Report (CAR). 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 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

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 Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Maria Koukounari, MS, 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 →

Cheryl Grandinetti

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

Maria Koukounari

Senior Director Therapeutic Area Quality, BMS, United Kingdom

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
TBD 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
Tags Session

4:00pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

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.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Regulator Perspectives,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Forum

4:00pm EDT

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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
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

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
TBD 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
Feature Topics Student Programming
Tags Forum

4:00pm EDT

FDA Rare Disease Town Hall

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

Speakers

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 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Rare Disease,Student Programming
Tags Forum

4:00pm EDT

Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

Advanced manufacturing (AM) can be a tool to strengthen drug manufacturing and supply chain robustness. Regulatory programs are dedicated to facilitating the adoption and regulation of AM technologies to improve drug development and manufacturing.

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.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Tags Session

4:00pm EDT

Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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.

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 statistical methods for use of hybrid trial designs and examples of AI informed studies for clinical decision making; Discuss areas of current need and promote community collaboration.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Artificial Intelligence (AI),Clinical Trial Design
Tags Forum

4:00pm EDT

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

TBD

Component Type: Forum
Level: Intermediate

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

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 →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Patient Experience
Tags Forum

4:00pm EDT

Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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

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

Senior Director, Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD 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
Feature Topics Student Programming
Tags Session

9:00am EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Industry Perspective on the ASAP Process
Walter Straus, DrMed, MD, MPH, FACP

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

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States

Walter Straus

Vice President, Safety and PV, Moderna, United States

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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
Tags Session

9:00am EDT

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

TBD

Component Type: Forum
Level: Intermediate

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; Develop fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speaker

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
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

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
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 20years 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, acquisition integrations, and clinical vendor management... Read More →

GINA Williamson

Principal Site solutions, Illingworth, A Syneos Health Company, Spain

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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
Tags Forum

9:00am EDT

How AI is Transforming the Area of Data Standards and Access to Source Data

Thursday June 19, 2025 9:00am - 10:00am EDT

TBD

Component Type: Session
Level: Intermediate

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

OHDSI OMOP AI and open science
Patrick Ryan

CDISC and AI
Chris Decker, MS

HL7 and the AI Train
Charles Jaffee

Speakers

Chris Decker

President and CEO, CDISC, 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 →

Charles Jaffee

Chief Executive Officer, HL7, United States

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

9:00am EDT

Embedding and Leveraging AI for Quality and Compliance in Pharma

Thursday June 19, 2025 9:00am - 10:00am EDT

TBD

Component Type: Session
Level: Intermediate

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
TBD 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
Feature Topics Artificial Intelligence (AI)
Tags Session

9:00am EDT

EMA - FDA Question Time

Thursday June 19, 2025 9:00am - 10:00am EDT

TBD

Component Type: Forum
Level: Intermediate

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.

Speakers

Tamei Elliott

Associate Director, Scientific Programs, DIA, United States

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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
Feature Topics Regulator Perspectives,Student Programming
Tags Forum

9:00am EDT

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

TBD

Component Type: Session
Level: Intermediate

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

Speakers

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.

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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
Feature Topics Advanced Analytics
Tags Session

9:00am EDT

Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship

Thursday June 19, 2025 9:00am - 10:00am EDT

TBD

Component Type: Forum
Level: Intermediate

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
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 →

Angela Men

Chief Executive Officer, The Whiteoak Group, Inc, United States

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD 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
Feature Topics Student Programming
Tags Forum

10:30am EDT

FDA Town Hall

Thursday June 19, 2025 10:30am - 12:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

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

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 →

Thursday June 19, 2025 10:30am - 12:00pm EDT
TBD 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
Feature Topics Global Perspectives,Regulator Perspectives,Student Programming
Tags Forum

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