DIA 2026 Global Annual Meeting: Full Schedule

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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

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 →

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 →

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 →

Elizabeth Smith Morris

Director, Product Management, Patient Engagement, Suvoda, United States

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

Audience Advanced
Area Patient-Centered Design and Experience, Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Clinical Development & Operations
Feature Topics Patient-Centered Design and Experience,Therapeutic Pathways
Tags 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

115AB

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

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 →

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 →

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 →

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

Audience Advanced
Area Therapeutic Pathways, Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Value & Access,Regulatory
Feature Topics Therapeutic Pathways,Global Alignment in Practice
Tags Session

4:00pm EDT

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

Monday June 15, 2026 4:00pm - 5:00pm EDT

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00

Explore regulatory and manufacturing challenges in cell and gene therapy, including starting material variability, potency testing, comparability, specification, and stability strategies. Gain insights into FDA expectations, ICH initiatives, and collaborative approaches to harmonize definitions and accelerate development while ensuring quality and regulatory clarity across individualized therapies.

Learning Objectives

Identify key regulatory and manufacturing challenges in CGT development, including starting material variability, comparability, stability, setting specifications, and post-approval changes; Discuss FDA and global expectations, harmonization needs, and strategies for individualized therapies to ensure quality and compliance across development phases.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Defining and Controlling Raw and Starting Materials for CGT Manufacturing
Kevin Carrick, PHD

Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
Andrew Chang, PHD

Setting specifications for ATMPs: insights from the ICHQ6 revision
Cecilia Tami, PHD

Stability Considerations for Cell and Gene Products
Akanksha Kaushal, MS

Speakers

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States

Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States

Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... Read More →

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States

Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →

Lesbeth Rodriguez

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

Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States

Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →