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Monday, June 16
 

8:30am EDT

Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact
Monday June 16, 2025 8:30am - 10:00am EDT
Component Type: Forum

Start your day with a powerful and inspiring session that brings together visionary leaders, groundbreaking science, and real-world patient experiences. DIA President and CEO Marwan Fathallah sets the stage, followed by a moving personal story from Jimi Olaghere, who shares his extraordinary journey from a sickle cell diagnosis to conquering Mt. Kilimanjaro. Dive into the future of innovative treatments with a keynote on Type 1 Diabetes breakthroughs by renowned researcher Douglas Melton. The session concludes with a dynamic multi-stakeholder panel, where top regulators, researchers, and industry leaders explore how global collaboration can accelerate patient-centered innovation and derisk product development.

Learning Objectives

Describe how patient experiences and personal journeys can inform and inspire innovative approaches to drug development and healthcare solutions; Analyze the scientific and regulatory challenges associated with developing innovative treatments for chronic and rare diseases, such as Type 1 Diabetes and Sickle Cell Anemia; Identify collaborative strategies that enable multi-stakeholder partnerships to derisk medical product development and accelerate patient access to innovative therapies.

Chair

Marwan Fathallah, MBA, MSc

Speaker

The Patient Experience
Jimi Olaghere

The Future of Innovative Treatments
Doug Melton, PhD


Speakers
avatar for Marwan Fathallah

Marwan Fathallah

President & Chief Executive Officer, DIA, United States
Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho... Read More →
avatar for Doug Melton

Doug Melton

Distinguished Research Fellow, Vertex, United States
avatar for Jimi Olaghere

Jimi Olaghere

Patient Advocate, United States
Jimi Olaghere is a CasGevy recipient who has developed a keen interest in the advancements of Cell and Gene therapies, since his transformative participation in the groundbreaking clinical trial. He is passionate about the positive impact these therapies can have on patients in need... Read More →
Monday June 16, 2025 8:30am - 10:00am EDT
  00: Plenary, Forum

10:15am EDT

IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
Component Type: Session

We will explore how AI can enhance clinical trials resulting in increased efficiency and precision. Hear from representatives from IQVIA and NVIDIA to 1)Gain insights into how AI will transform workflows in clinical trials, and 2) Explore “what if” scenarios that can help sponsors review different eligibility criteria and parameters to determine what may impact recruitment goals and quantify each option. Join us to discuss how AI will pave the way for more efficient and effective drug development.

Speaker

Speaker
Raja Shankar, MS


Speakers
avatar for Raja Shankar

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 →
Monday June 16, 2025 10:15am - 10:45am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:15am EDT

Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
Component Type: Session

Clinical trials rely on historical data, causing inefficiencies in site selection, patient matching, and execution. To drive change, the industry must apply the scientific method—testing AI-driven approaches to optimize outcomes. Lokavant leads this shift, improving protocol-matching accuracy by 20% and using predictive analytics. CEO Rohit Nambisan shares real-world evidence of AI’s impact on de-risking trials and accelerating enrollment. Learn why pharma leaders now see AI as a necessity.

Speaker

Speaker
Rohit Nambisan


Speakers
avatar for Rohit Nambisan

Rohit Nambisan

CEO & Co-Founder, Lokavant, United States
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:00am EDT

A Regulator's View on the Future Vision for Pharmacovigilance
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Forum
Level: Basic

This session will explore perspectives on the future vision for pharmacovigilance. Examining how advances in technology and science can be leveraged to protect patient safety and will discuss what progress is being made against these ambitions.

Learning Objectives

Evaluate developments in technology being implemented by regulators to advance safety and surveillance of medicinal products; Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Assess opportunities for better ways of working across different stakeholders in pharmacovigilance.

Speakers
avatar for Alison Cave

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 →
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
  01: ClinSafety-PV, Forum

11:00am EDT

Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Basic

Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.

Learning Objectives

Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.

Chair

Tae Hyun Jung, PhD

Speaker

Academic Perspective
Vadim Zipunnikov, PhD

Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD


Speakers
avatar for TAE HYUN

TAE HYUN

Senior Statistical Reviewer, CDER, FDA, United States
Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases... Read More →
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Digital Biomarkers, Verily, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers at Verily, where she leads the research and evidence generation for digital measures and AI/ML capabilities. She oversees the development, validation, and implementation of the technology in internal and external clinical... Read More →
avatar for Tarik Yardibi

Tarik Yardibi

Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Tarik Yardibi is the Director of Sensing and Measurement at Takeda Pharmaceuticals, operating within the Digital Health Sciences department at Takeda R&D. As a digital health and data science technical leader, Tarik has contributed extensively across both medical device and pharmaceutical... Read More →
avatar for Vadim Zipunnikov

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, 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
  02: ClinTrials-Ops, Session

11:00am EDT

Is Real-World Evidence Always a Last Resort?
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
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
avatar for Brian Bradbury

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 →
avatar for Nancy Dreyer

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 →
avatar for Richard Gliklich

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

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
JC

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 →
avatar for James Chambers

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 →
CH

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 →
KM

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

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
avatar for Mandy Budwal-Jagait

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 →
avatar for Kavita Dada

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 →
RS

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

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
CG

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

11:00am EDT

Moving Toward Pragmatism in Clinical Trials
Monday June 16, 2025 11:00am - 12:00pm EDT
TBD
Component Type: Session
Level: Advanced

Pragmatism in clinical trials advances modernization of clinical research. Key stakeholders including experts from the FDA will review advantages and challenges of pragmatism in clinical trials including trials in support of new labeling claims.

Learning Objectives

State the strengths and limitations of pragmatic trials and the reasons for uneven adoption among industry and regulators; Discuss the regulatory framework and FDA initiatives supporting the use of pragmatic elements in clinical trials; Identify how to determine the appropriate context-of-use for successfully deploying pragmatic trials in clinical research.

Chair

Zhanna Jumadilova, MD, MBA

Speaker

Moving Toward Pragmatism in Clinical Trials
Adrian Hernandez, MD, MHS

Moving Toward Pragmatism in Clinical Trials
Jyothis George

Moving Toward Pragmatism in Clinical Trials
Thomas Bognanno


Speakers
TB

Thomas Bognanno

Patient Representative, Alliance Practice, United States
Founder and Partner of Alliance Practice LLC, a firm dedicated to supporting select organizations in the trauma-informed care sector. Before retirement in 2023, Bognanno served as the Chief Executive Officer of Creating Healthier Communities for 17 years. Before that, he served as... Read More →
JG

Jyothis George

Global Medical Vice President, Obesity and Related Conditions, Amgen, United Kingdom
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
ZJ

Zhanna Jumadilova

Clinical Lead, Pfizer Inc, United States
Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs for small molecules and biologics. Her diverse experience... 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

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
avatar for R. Angelo De Claro

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 →
SG

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 →
SH

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 →
MH

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 →
avatar for Melissa Hunt

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 →
MM

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.
UR

Ulrich Rohr

Unit Head Clinical Review, Swissmedic, Switzerland
avatar for Dianne Spillman

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

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
RG

Ryan Gough

Partner, Senior Vice President, Public Affairs, Woodberry Associates and PACH, United States
avatar for Sarah Martin

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 →
JP

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 →
RX

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

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
avatar for James Bertram

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.
SK

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 →
avatar for Chelsea O'Connell

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 →
AS

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 →
avatar for Rumi Young

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

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
avatar for Janis Bernat

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 →
avatar for Peter Hjelmstrom

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 →
avatar for Joseph Kannarkat

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

12:00pm EDT

Student Poster Session I
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH
Component Type: Session

Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
avatar for Xianwen Chen

Xianwen Chen

Student, University of Macau, Macao
Chen Xianwen is currently a PhD candidate in the Institute of Chinese Medical Sciences at the University of Macau. Her research interests include drug regulatory science and drug policy. In 2020–2022 she obtained her Master’s degree at University of Macau, then she worked as an... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
KD

Kimberly Dayato

Full Time Student, Mount St Mary's University, United States
avatar for Tanvi Gupte

Tanvi Gupte

Student, University of Maryland, United States
JH

Jackson Hanf

Student, University of Southern California, United States
avatar for Md Rashedul Islam

Md Rashedul Islam

Undergraduate Research Scholar, Queensborough Community College, United States
Md Rashedul Islam is an undergraduate researcher at Queensborough Community College, City University of New York, majoring in Computer Science & Information Security. As a 2024–2025 CUNY Research Scholars Program scholar, he conducts research in medical & radiation physics, focusing... Read More →
avatar for Nabeela Jahangeer

Nabeela Jahangeer

Student, University of Southern California, United States
avatar for Patricia Jumelle

Patricia Jumelle

Student, University of Southern California, United States
LL

Lauren Le

Student, Butler University, United States
avatar for Jeremiah Lee

Jeremiah Lee

Research Ambassador, University of Southern California, United States
Jeremiah Lee (they/them) is a budding queer health researcher with an emphasis in inclusive clinical practice. As a M.S. student in Clinical Trial Management at USC Mann and Research Ambassador for the SC CTSI Regulatory Science Research Team, they explore how and why clinical trials... Read More →
RM

Ritika Malik

Student, Temple University, United States
TM

Taraneh Mousavi

PhD Student, University of Maryland, Baltimore, United States
SN

SRIVIDYA NARAYANAN

Student, Northeastern University, United States
Srividya Narayanan is a dedicated regulatory affairs professional with a background in dentistry, now specializing in medical devices and AI integration in health systems. She currently works with Culture Care Collective, contributing to an AI-driven platform to enhance community... Read More →
avatar for Ebere Okpara

Ebere Okpara

Research Assitant, University of Illinois Chicago, United States
Ebere Okpara is a PhD Candidate in Pharmacy Systems, Outcomes, and Policy at the University of Illinois Chicago. Her research focuses on real-world evidence generation in chronic diseases, including oncology and respiratory conditions. She also applies mixed methods to evaluate health... Read More →
avatar for Mercy Owusu-Asante

Mercy Owusu-Asante

Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
Mrs Mercy Owusu-Asante is a pharmacist with an MSc in Pharmaceutical Services and Medicines Control obtained from the University of Bradford, UK. In the area of personal professional development, Mercy is pursuing a PhD in Regulatory Science at the University of Herfordshire, UK... Read More →
avatar for Ruonan Peng

Ruonan Peng

Graduate Research Assistant, University of California, Riverside, United States
Ruonan Peng is a Ph.D. candidate in Chemical Engineering at University of California, Riverside, specializing in CRISPR-based diagnostics and microfluidic platforms for infectious disease detection. She previously worked as a Regulatory Affairs Specialist at Ferring Pharmaceuticals... Read More →
avatar for Yen Phan

Yen Phan

Student, University of Oxford, Ireland
Yen Phan has completed an MSc in Medical Statistics at the University of Oxford and is currently pursuing a Doctor of Health Science (DHSc) in Leadership in Clinical Practice and Education at The George Washington University School of Medicine and Health Sciences. She works as a Clinical... Read More →
avatar for Ran Tu

Ran Tu

Phd Student, Georgetown University, United States
My name is Ran Tu, and I am a Ph.D. candidate in Biostatistics at Georgetown University. I got my Bachelor’s degree in Mathematics from Wuhan University and my Master’s degree in Biostatistics from Yale University. Currently, under the mentorship of Professors Ming Tan and Ao... Read More →
avatar for Alice Vanneste

Alice Vanneste

PhD Student, KU Leuven, Belgium
Alice Vanneste is a PhD researcher at the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven. Her PhD research focusses on the systematic implementation of patients' perspectives across the medical drug life cycle. By collecting more patient-based evidence derived... Read More →
avatar for Jenna Wildeman

Jenna Wildeman

PharmD Candidate, University of Washington, United States
Jenna Wildeman is a PharmD candidate at the University of Washington School of Pharmacy with a strong interest in real-world evidence and health outcomes research. Jenna is passionate about improving care through data-driven insights and aspires to contribute to evidence-based policy... Read More →
avatar for Siqian Zheng

Siqian Zheng

Doctor of Biomedical sciences, University of Macau, China
Zheng Siqian obtained her Bachelor of Engineering degree in Pharmaceutical Engineering from the School of Pharmacy at Shandong University. She continued her academic journey and earned a Master of Science in Pharmaceutical Management from the University of Macau, where she was awarded... Read More →
Monday June 16, 2025 12:00pm - 2:00pm EDT
EH Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  17: Posters, Session

12:10pm EDT

CH: Leading Teams Through Organizational Change and Layoffs - Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
TBD
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs. Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions. Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Monday June 16, 2025 12:10pm - 12:40pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

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

12:55pm EDT

PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success
Monday June 16, 2025 12:55pm - 1:25pm EDT
TBD
Component Type: Session

This panel brings together experts from across the research continuum to explore how community-based research models contribute to trial success. Through real-world experiences and case studies, panelists will discuss the operational, medical, and regulatory considerations of integrating community research into clinical trials. Attendees will gain insights into how these approaches work together to improve patient reach, retention, and overall trial efficiency.

Speaker

Speaker
Mark McKenzie, MD

Speaker
Thad Wolfram


Speakers
avatar for Tajuana Barron

Tajuana Barron

Vice President Project Management Global Clinical Trials, PCM Trials, United States
Tajuana Barron is the Vice President of Project Management responsible for project delivery. Ms. Barron joined PCM Trials in 2022 with over 30 years of clinical research experience working for Pharma companies and CROs. Prior to joining PCM Trials, Ms. Barron served as a Senior Director... Read More →
avatar for Mark McKenzie

Mark McKenzie

Chief Medical Officer, EmVenio Research, United States
Mark McKenzie, MD is the Chief Medical Officer responsible for strategies and new initiatives in the clinical and therapeutic areas. He also provides medical and clinical oversight to EmVenio’s team of principal investigators involved in trials at community research sites globally... Read More →
avatar for Thad Wolfram

Thad Wolfram

Chief Strategy Officer, EmVenio Research, United States
With a foundation of more than 20+ years in clinical trials, healthcare, and the pharmaceutical industry, Thad Wolfram brings a wealth of knowledge and experience to EmVenio. As President, he is focused on the growth of hybrid and decentralized trial capabilities and increased clinical... Read More →
Monday June 16, 2025 12:55pm - 1:25pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma
Monday June 16, 2025 12:55pm - 1:55pm EDT
TBD
Component Type: Session

This session will showcase a GenAI-powered platform for Medical and Regulatory Authoring, transforming global pharma operations. Real-world case studies highlight how the platform reduces CSR and protocol preparation time by 50%. Key features include integrated authoring solutions, scalable content reuse, GenAI-driven quality control, and change management strategies. Designed for medical writers, regulatory executives, and digital innovation professionals aiming to streamline processes.

Speaker

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen is a visionary leader at the intersection of computer science and life sciences, boasting over 25 years of pioneering software development experience. As the Founder and CEO of AlphaLife Sciences, she drives innovation in generative AI-powered clinical development solutions... Read More →
Monday June 16, 2025 12:55pm - 1:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:30pm EDT

CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
TBD
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle. Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply. Propose the key requirements to take steps industry-wide to solve "A global problem needs a global solution."

Chair

Ana Sengupta, MBA, MS, RAC

Monday June 16, 2025 1:30pm - 2:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop

1:35pm EDT

Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

Case managers play a crucial role in educating patients about their treatment options, including access to cutting-edge oncology clinical trials. Attendees of this session will learn about success in supporting research enrollment through a collaboration between Cigna Health Plan and Leal Health to guide patients through the process starting with awareness, to receiving a personalized list of precise trial matches, and partnering with a dedicated trial navigator.

Speaker

Speaker
Ria Westergaard, PharmD

Speaker
Anthony Gulotta


Speakers
avatar for Anthony Gulotta

Anthony Gulotta

Head of Sales and Strategic Partnerships, Leal Health, United States
Anthony Gulotta is a tech executive with a track record of launching and scaling AI-driven startups. As the founding sales team member at Leal Health, he leads sales and strategic partnerships across payers, sponsors, and providers. With deep industry connections and a strong belief... Read More →
avatar for Ria Westergaard

Ria Westergaard

Head of Product Strategy and Innovation, Evernorth Clinical Trial and RWE Solutions, United States
Ria Westergaard is an experienced leader with background in clinical research and pharmacy benefit management. At Evernorth, the health services division of The Cigna Group that serves more than 180 million people, Ria's role focuses on designing solutions that use integrated health... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

The drug development landscape is evolving rapidly, characterized by increasing complexity, innovative trial designs, advanced technologies & AI, and the integration of real-world data. Outsourcing models are adapting to these changes, with a growing trend towards hybrid (blending FSO/FSP outsourcing) approaches. We’ll share our comprehensive research findings that examine these shifts, with recommendations for driving innovation and efficiencies while cultivating the workforce of the future.

Speaker

Speaker
Stephen Pyke, MSc

Speaker
Jenny Denney


Speakers
avatar for Jenny Denney

Jenny Denney

EVP, Global Head Parexel FSP, Parexel , United States
avatar for Stephen Pyke

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 →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

Embrace the future of Data Management and TMF management with the power of Agentic AI. These intelligent systems automate processes, including protocol -> CRF/DVP -> eCRF/EC, and document filing -> QC. By leveraging the power of LLM and eClinical platform capabilities, we can experience a new era of clinical operations where AI is not just a function of an eClinical platform, but an integral part of the process, driving smarter, more efficient outcomes.

Speaker

Speaker
Kevin Lu


Speakers
avatar for Kevin Lu

Kevin Lu

CTO, Taimei Technology, United States
Kevin Yiming Lu is Chief Technology Officer at Taimei Technology. Since joined Taimei in 2018, Kevin led the R&D effort of TrialOS, the digital platform of life science, and is responsible for Taimei's global technical strategy. Kevin has extensive experience in database, cloud computing... Read More →
avatar for Shou Yuan

Shou Yuan

Director, Global Solutions, Taimei Technology Inc., United States
Shou leads customer success efforts at Taimei Technology, fostering enduring relationships with CROs and Sponsors to align with their needs. He oversees global customer success and consulting teams, ensuring top-tier service delivery. Shou spearheads strategic planning and product... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

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
avatar for Jeff Allen

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 →
KM

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 →
avatar for Nancy Myers

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

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
TJ

Tom Julian

Assoc. Director Design and Innovation, Gilead Sciences, United States
avatar for Kelly McKee

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 →
CV

Chris Venezia

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

2:15pm EDT

Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Advanced

This session will delve into the historical and ethical context for distinguishing between clinical care and research and how the blurring poses a risk for engagement with patients. Experts in ethics and health literacy will discuss potential pitfall

Learning Objectives

Recognize the ethical and historical context for distinguishing between clinical care and research; Describe the regulatory and ethical challenges that are exposed when sponsors and investigators push patients to clinical research; Discuss how language and health literacy have the potential to impact an individual’s decision to participate in research.

Chair

Karla Childers, MS

Speaker

Bioethics perspective
Lindsay McNair, MD, MPH, MS

Patient and health literacy perspective
Catina O'Leary, PhD

IRB perspective
David Borasky, MPH


Speakers
avatar for David Borasky

David Borasky

Vice President, IRB Compliance, WCG IRB, United States
David A. Borasky serves as Vice President of IRB Compliance for WCG IRB. Mr. Borasky has 20 years of experience in managing IRBs in settings that include global public health organizations, large academic medical centers, and independent IRBs. He has facilitated training activities... Read More →
avatar for Karla Childers

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 →
avatar for Lindsay McNair

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 →
CO

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States
Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... 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
  05: Patient-Impact-Product-Dev, Forum |   02: ClinTrials-Ops, Forum |   04: MedAffairs-SciComm, Forum

2:15pm EDT

Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Basic

Through this session, we will explore the advantages of incorporating AI and digital pathology for drug and biomarker discovery as part of a long-term companion diagnostic (CDx) partnership. We will also explore potential regulatory challenges in this ever-evolving space.

Learning Objectives

Discuss the importance of a complete development lifecycle of drug and companion diagnostic; Describe a complete development lifecycle of a drug and companion diagnostic; Describe potential regulatory challenges facing AI, Digital Pathology, and CDx development.

Chair

Greg Morehouse, MS

Speaker

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Brendan O'Leary

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Mark Stewart, PhD

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Elaine Katrivanos

Panel Discussion: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
Andrew Ciupek, PhD


Speakers
avatar for Andrew Ciupek

Andrew Ciupek

Associate Director, Clinical Research, GO2 for Lung Cancer, United States
Andrew Ciupek, PhD, is Associate Director of Clinical Research at GO2 for Lung Cancer. Originally a translational cancer researcher, Andrew transitioned to patient-advocacy to have increased impact on driving patient-centered research. At GO2, Andrew leads implementation of patient-centric... Read More →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
GM

Greg Morehouse

Senior Manager, RA Device, Combination Products, Abbvie, United States
Greg Morehouse has worked in regulatory affairs for precision medicine, both within in vitro diagnostics and pharmaceutical products, since 2018. Greg's experience with companion diagnostics across the pharmaceutical, medical device, and CRO industries affords him unique insights... Read More →
BO

Brendan O'Leary

Consultant, United States
Brendan O’Leary is Deputy Director of the Digital Health Center of Excellence (DHCoE) at FDA and led the DHCoE as its Acting Director throughout 2022. Over his nearly 14-year tenure with FDA, Mr. O’Leary has built an international reputation as an expert on digital health, medical... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... 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
  06: PersonalizedMed-ComboProd-Diagnostics, Session

2:15pm EDT

Models of Collaborations to Advance Regulatory Science: Lessons Learned
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Advanced

Regulatory science is a rapidly evolving field with emerging technologies. This session explores collaborative models in drug development and highlights lessons-learned and factors for effective collaborations in advancing regulatory science.

Learning Objectives

Discuss models and management of collaborative partnerships to advance novel therapies for patients; Describe strategies to help optimize cross-functional team engagement and multidisciplinary interactions.

Chair

Huong Huynh, PhD

Speaker

Panelist
Liang Zhao, PhD

Panelist
Carla Rodriguez-Watson, PhD, MPH

Panelist
Allison Cuff Shimooka, MBA


Speakers
avatar for Huong Huynh

Huong Huynh

Director of Regulatory Science, Critical Path Institute, United States
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Reagan-Udall Foundation for the FDA, United States
Dr. Carla Rodriguez-Watson is the Scientific Director of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program at the Reagan-Udall Foundation for the FDA. The Foudation’s mission is to advance FDA’s mission to modernize product development, accelerate... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
LZ

Liang Zhao

Director for Global Regulatory Science and Innovation, University of California San Francisco, United States
Dr. Liang Zhao has been serving as Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) in Office of Generic Drugs, CDER since 2015. He initially joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology... 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
  07: ProjectManagement-StrategicPlanning, 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
KR

Kevin Richards

Head Quality Investigations & Analytics, AstraZeneca, Canada
avatar for Michael Torok

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

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
JF

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 →
BT

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

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

Discuss how to 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
MM

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.
avatar for Theresa Mullin

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 →
avatar for Wassim Nashabeh

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 →
avatar for Amanda Roache

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

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
avatar for Alysha Croker

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

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
avatar for Mehmet Burcu

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 →
LL

Laura Lasiter

Regulatory Affairs Director- Digital Health, Astrazeneca, United States
avatar for Shirley Wang

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

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
avatar for Namandjé Bumpus

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 →
avatar for Steve Sibley

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 →
avatar for Natalie Tolli

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

2:15pm EDT

Building a Regulatory Landscape to Support CMC Innovation
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Advanced

Senior leaders from industry and regulatory agencies will discuss the role of cooperation across regulatory bodies to facilitate innovation in the CMC/product quality sector. Senior leaders will discuss how, despite various internal and external pressures, an agile path forward can be found to advance innovative and high quality medicines.

Learning Objectives

Describe initiatives to streamline regulatory assessment/inspection; Recognize how regulatory initiatives can facilitate innovation in CMC; State comparing perspectives from senior leaders regarding regulatory initiatives and regulatory advancements.

Chair

Demetra Macheras, MBA

Speaker

Panelist
Jennifer McCafferty, PhD


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
avatar for Jennifer McCafferty

Jennifer McCafferty

Senior Vice President, Regulatory CMC and Quality Assurance, Merck, United States
Jennifer McCafferty is Senior Vice President, Quality Assurance and Regulatory CMC in Merck Research Laboratories. Jennifer’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory... Read More →
avatar for Theresa Mullin

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 →
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
  10: RegCMC-Product Quality, Session

2:15pm EDT

Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Session
Level: Basic

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc


Speakers
avatar for Ankush Chandna

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States
KL

Kevin Lee

Data Scientist, Clinvia, United States
Kevin Lee is a Data Scientist and Biometrics Leader with 20 years of experience in Big Data, Cloud, Open-Source Programming, Data Sciences and Machine Learning in pharmaceuticals. His leadership and passion for innovation drive continuous advancement in Pharma. Recently focused on... 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
  12: ProfDevelopment, Session

2:15pm EDT

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum
Level: Basic

Data science, AI and LLMs are redefining how we conduct clinical development to be faster, more efficient and more patient-centric. The National Insititute of Health, in partnership with the private sector, is leading the charge in driving change.

Learning Objectives

Describe examples of NIH innovation in tech-enabling clinical development through the application of data science, AI and LLMs; Identify potential opportunities for future public-private partnerships to accelerate tech enablement of clinical development.

Chair

Peter Ronco

Speaker

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Warren A Kibbe, PhD

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Arnaub Chatterjee, MHA, MPA

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
Susan Gregurick


Speakers
avatar for Arnaub Chatterjee

Arnaub Chatterjee

President & GM - Life Sciences, Datavant, United States
Arnaub Chatterjee is Chief Product and Solutions Officer at TriNetX, a health technology platform focused on improving clinical research, evidence generation and safety. He also serves as Senior Advisor at the Carlyle Group where he evaluates investments in the life sciences and healthcare... Read More →
SG

Susan Gregurick

Associate Director, Data Science and Director, NIH ODSS, National Institute of Health, United States
WK

Warren Kibbe

Deputy Director, Data Science and Strategy, National Cancer Institute, United States
Dr. Kibbe is the Northwestern site PI for caBIG™ activities. Dr. Kibbe received his Ph.D. in Chemistry from Caltech, and was a visiting scientist at the Max Plank Institute for Biophysical Chemistry in Göttingen, Germany before joining the faculty at Northwestern.
avatar for Peter Ronco

Peter Ronco

CEO, Emmes, United States
Peter is an accomplished drug developer and innovative senior pharmaceutical executive who advises boards, private equity investors, and leaders across the pharmaceutical and biotech industry. He has extensive global experience across a broad range of therapeutic areas, including... 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
  13: Spotlight, Forum

2:15pm EDT

Ushering in a New Era of Africa Healthcare
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD
Component Type: Forum



Speaker

Panelist
Huwaida Bulhan, MD, MPH

Panelist
Tariro Makadzange, MD, PhD

Panelist
Katherine Van Loon

Panelist
Rebecca A. Vermeulen, RPh

Panelist
David Mukanga, PhD, MPH


Speakers
avatar for Huwaida Bulhan

Huwaida Bulhan

Senior Clinical Research Operations Lead Area Africa, Roche Kenya Limited, Kenya
KV

Katherine Van Loon

Director, Global Cancer Program, UCSF Helen Diller Family Comprehensive Cancer Center, United States
TM

Tariro Makadzange

Executive Director, Founder, Zimbabwe Clinical Research Center, United States
avatar for David Mukanga

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 →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... 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
  13: Spotlight, Forum

3:45pm EDT

Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Basic

An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.

Learning Objectives

Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PhD, MS, RPh, FISPE

Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PhD, MS


Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

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

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
avatar for Saad Shakir

Saad Shakir

Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... 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
  01: ClinSafety-PV, Session

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
avatar for Mehmet Burcu

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 →
avatar for Mehdi Najafzadeh

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 →
EP

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

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); Discuss AI and RWD Dimensions of interoperability.

Chair

David Sidney Ross, MBA, MSc, PMP, RAC

Speaker

Panelist
Mathew Woodwark

Panelist
Dominique Lagrave, PharmD

Panelist
Rita Algorri, PhD, MS


Speakers
avatar for Rita Algorri

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 →
avatar for Dominique Lagrave

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 →
avatar for David Ross

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 →
MW

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

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
avatar for Kristin Hatcher

Kristin Hatcher

Director of Pediatric and Rare Disease/ Alpha One Lived Experience Advocate, Global Liver Institute/Alpha One Patient, United States
avatar for Agathe Le Lay

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 →
BM

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 →
avatar for Patricia Roselle

Patricia Roselle

Head of Patient Stakeholder Engagement, Sanofi, United States
avatar for Martine Zimmermann

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

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
avatar for Samantha Roberts

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 →
avatar for Pujita Vaidya

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

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 medicine; 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
avatar for Amanda Burkhardt

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 →
avatar for James Wabby

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

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
avatar for Robert DiCicco

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 →
RF

Ryan Ferguson

Acting Director, Cooperative Studies Program, VA Boston Healthcare System, United States
avatar for Jason Wakelin-Smith

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

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
avatar for Kevin Bugin

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 →
avatar for R. Angelo De Claro

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 →
avatar for Melissa Hunt

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 →
avatar for Brad Jordan

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.
JS

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

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
avatar for Jeff Allen

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 →
avatar for Kevin Bugin

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 →
avatar for Bridget Doherty

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

3:45pm EDT

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Forum
Level: Basic

Explore the transformative potential of generative AI (genAI) in Regulatory Affairs. This session will share insights and experiences from industry, focusing on education, culture change, and impactful use cases.

Learning Objectives

Recognize the value and potential of generative Artificial Intelligence (genAI) in Regulatory Affairs (RA); Outline how use cases are selected and implemented by Industry in their RA departments; Identify examples of application of genAI in RA; Discuss how to adapt and practice genAI within your own RA organization.

Chair

Paul Bolot, PharmD, MSc

Speaker

Introduction to genAI
Ben Moscovitch

J&J Experience
Joseph William Markmann

BMS experience
Sandra Krogulski, MA

Novartis Experience
David Yao


Speakers
avatar for Paul Bolot

Paul Bolot

Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot works in Regulatory Policy & Science at Bayer. Prior to joining Bayer, he worked as consultant in regulatory affairs at PharmaLex. He is a pharmacist (PharmD) by training and has a master's degree in international drug development and registration. He is based in Basel... Read More →
avatar for Sandra Krogulski

Sandra Krogulski

Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Sandy Krogulski is an experienced and solution-oriented individual with over 10 years of submission and regulatory experience. Sandy joined BMS in 2018, working on global submissions and process evolution. In her current role, Sandy is focusing on digitalization and automation of... Read More →
JM

Joseph Markmann

Principal Data Science Lead, Global Regulatory Affairs, United States
BM

Ben Moscovitch

Public Policy, Amazon Web Services, United States
DY

David Yao

Associate Director, Regulatory Affairs CMC, Novartis, 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, Forum

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
MP

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 →
avatar for Marion Laumonier

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 →
JN

Jude Nwokike

Vice President and Director, PQM+, USP, United States
avatar for Hiiti Sillo

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

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

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
avatar for Matthew Curin

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 →
avatar for Andrea Jux

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

3:45pm EDT

Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Advanced

This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.

Learning Objectives

Describe what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Discuss how prior knowledge may reduce regulatory burden.

Chair

Celeste Frankenfeld Lamm

Speaker

Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon, MS

Overview of ICH Q6
Andrew Chang, PhD

Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche


Speakers
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
SD

Sarah Demmon

Vice President, Eli Lilly, United States
Sarah Demmon, M.S., is Vice President at Eli Lilly and Company. With 28 years in biopharmaceutical development, she specializes in late phase development and commercialization of fusion proteins and monoclonal antibodies. She started as an analytical chemist developing methods for... Read More →
avatar for Celeste Frankenfeld Lamm

Celeste Frankenfeld Lamm

Senior Director, Global Regulatory Affairs – CMC, Merck Sharp & Dohme LLC , United States
Celeste Frankenfeld Lamm, Ph.D., is a seasoned industry professional with 18 years of experience in the field. As a Senior Director of Global Regulatory Affairs – CMC at Merck & Co., she spearheads the company's global CMC policy efforts. In this role, Celeste engages externally... Read More →
WR

Warren Roche

Statistician, Sanofi, Ireland
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
  10: RegCMC-Product Quality, 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
avatar for Anne Marie Inglis

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 →
TJ

Tony Johnson

Senior Director, Clinical Quality, Mallinckrodt Pharmaceuticals, United States
AS

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

3:45pm EDT

AI in Patient Care: Aspirations and Considerations
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD
Component Type: Session
Level: Advanced

We will discuss potential applications of AI in making diagnoses and treatment decisions, the appropriate ethical and regulatory boundaries, and how to progress forward balancing patient benefits against the potential risks.

Learning Objectives

Recognize the potential impact, ethical considerations, and evolving regulations related to the use of artificial intelligence in making diagnoses and treatment decisions; Discuss ways to formulate plans to bring artificial intelligence solutions to market and shape regulations.

Chair

Eli Weinberg, PhD, MS

Speaker

Panelist
Isaac Kohane, MD, PhD

Panelist
Shweta Maniar

Panelist
Subha Madhavan, PhD, FACMI


Speakers
avatar for Isaac Kohane

Isaac Kohane

Chair, Department of Biomedical Informatics, Harvard Medical School, United States
Isaac Kohane, MD, PhD, is the chair of Harvard Medical School’s Department of Biomedical Informatics, whose mission is to develop methods and tools for a new generation of scientists and doctors to move biomedicine rapidly forward with the insight and precision offered by big data... Read More →
avatar for Subha Madhavan

Subha Madhavan

Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States
Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →
avatar for Shweta Maniar

Shweta Maniar

Director, Healthcare and Life Sciences Solutions, Google Cloud, United States
Shweta is the strategy and market leader responsible for Healthcare and Life Sciences. Shweta has quickly risen through the ranks as a well-known innovator, game-changer, and relationship ambassador. With 18+ years’ experience in clinical research, Healthcare and Bio Tech, she has... Read More →
EW

Eli Weinberg

Partner, Bain & Co., United States
Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... 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
  13: Spotlight, Session |   09: Regulatory, Session
 
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  • 01: ClinSafety-PV
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