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Monday, June 15
 

11:00am EDT

#404: Evidence-Based Insights Informing Participant Compensation Strategies
Monday June 15, 2026 11:00am - 12:15pm EDT
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-512-L04-P; CME 1.25; RN 1.25

This session presents findings from a DIA–Tufts CSDD study examining how participant compensation strategies vary across trial phases and therapeutic areas and their impact on recruitment, retention, and enrollment outcomes, with implications for protocol design and trial execution

Learning Objectives

Describe how participant compensation strategies vary by trial phase and therapeutic area; Assess evidence linking compensation practices to recruitment, retention, and enrollment outcomes; Apply study insights to support consistent, ethical, and effective compensation decisions in protocol design and trial execution.

Chair

Kenneth Getz, MBA

Speaker

Panelist
Lindsay McNair, MD, MPH, MS

Panelist
Sabina Kineen

Panelist
Brittany Niland

Panelist
Elizabeth Smith Morris


Speakers
avatar for Kenneth Getz

Kenneth Getz

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

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
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 this 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 →
ES

Elizabeth Smith Morris

Director, Product Management, Patient Engagement, Suvoda, United States
avatar for Brittany Niland

Brittany Niland

Senior Director- Patient Engagement, Recruitment, Diversity & Retention, Eli Lilly and Company, United States
Brittany Niland is Senior Director of Patient Engagement, Recruitment, Diversity & Retention, leading global, patient-centered recruitment and retention strategies across the Oncology portfolio. She focuses on expanding equitable access to clinical trials, accelerating enrollment... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

1:30pm EDT

#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products
Monday June 15, 2026 1:30pm - 2:00pm EDT
Component Type: Workshop
Level: Advanced

Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products

Learning Objectives

Benchmark key drivers for assessing supply- and demand-related risks that may lead to drug shortages. Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products. Apply risk-based decision making to strengthen global supply continuity and regulatory compliance.

Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

2:30pm EDT

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
Monday June 15, 2026 2:30pm - 3:30pm EDT
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P; CME 1.00; RN 1.00

Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI i

Learning Objectives

Identify and summarize regulatory trends specific to AI use in Manufacturing; Distinguish AI use in manufacturing from use in product development.

Chair

Gert Thurau, PHD

Speaker

PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed

Case Study Industry applications of AI
Thomas O'Connor, PHD

FDA regulatory perspectives on AI in Manufacturing
Tina Kiang, PHD


Speakers
avatar for Tina Kiang

Tina Kiang

Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER, FDA, United States
Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has over 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
TO

Thomas O'Connor

Director Process Analytics, GSK, United States
Tom is a director for process analytics at GSK. His team develops models to accelerate process development and increase the robustness of commercial manufacturing. Tom joined GSK from the FDA where he was the deputy director of the Office of Pharmaceutical Quality Research in the... Read More →
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   03: Data-Tech-AI, Session
  • Audience Advanced
  • Area Artificial Intelligence
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA
Monday June 15, 2026 2:30pm - 3:30pm EDT
Component Type: Session
Level: Advanced

China is reshaping global drug development and regulatory strategy. This session equips MNC regulatory leaders with decision framework, actionable strategies, pathway insights, and case studies to optimize China integration and global approvals.

Learning Objectives

Assess China’s evolving regulatory landscape to inform global portfolio strategy; Examine National Medical Products Administration (NMPA) regulatory pathways to optimize timelines and market entry; Apply decision frameworks and practical approaches to integrate China into global programs while balancing global alignment, local requirements, and execution risk.

Chair

Wenny Du, MBA, RAC

Speaker

Global Strategy and Challenges
Todd Paporello, PHARMD, MBA

China Strategy and Solution
Wei Zhang

Panel Discussion
Xiaoyuan Chen, MD

Industry Case Studies
Wenny Du, MBA, RAC


Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
avatar for Wenny Du

Wenny Du

Sr. Director, Global Regulatory Lead, Amgen Inc., United States
Wenny Du, MS, MBA, RAC, serves as Senior Director and Global Regulatory Lead (GRL) for Oncology at Amgen Inc., where she leads global regulatory teams to shape and execute strategies that enable worldwide innovative medicine approvals. With over 25 years of biopharmaceutical industry... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty
Monday June 15, 2026 2:30pm - 3:30pm EDT
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00

Global interest in early intervention for chronic diseases is driving regulatory innovation, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized, patient-focused approaches.

Learning Objectives

Analyze global regulatory and reimbursement challenges associated with decision-making for early treatment of chronic diseases; Assess existing gaps and opportunities within US and EU regulatory and reimbursement frameworks to advance in this area.

Chair

Simon Bennett, MS

Speaker

Regulatory challenges facing the development of treatments for chronic neurological disorders
Steffen Thirstrup, MD, PHD

Panelist
Julian Beach, MBA

Patient Perspective
Mindy Cameron


Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
MC

Mindy Cameron

Patient Advocate, Advocacyworks, United States
Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes
Monday June 15, 2026 4:00pm - 5:00pm EDT
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00

Real-world data that encompass race, ethnicity, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.

Learning Objectives

Describe precision medicine approaches involving clinical phenotype RWD in context with race, ethnicity, ancestry data, that can be instrumental to address unmet patient and health system needs; Discuss how regulators have reacted to precision medicine-based research approaches in context with race, ethnicity, ancestry information, inclusive of research design modifications made along the way.

Chair

Rachele Hendricks-Sturrup, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS


Speakers
avatar for Lysel Brignoli

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France
Lysel Brignoli is an expert in Real-World Evidence and epidemiologic research, with over a decade of experience designing and leading studies that generate insights for healthcare decision-making. Her work focuses on innovative study designs, patient registries, and the integration... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

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

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Session
 
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