DIA 2026 Global Annual Meeting: Full Schedule

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

11:00am EDT

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

Monday June 15, 2026 11:00am - 12:15pm EDT

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P; CME 1.25; RN 1.25

Clinical Operations leaders today are navigating one of the most dynamic periods in recent history. From managing AI-driven transformation to rethinking global outsourcing models and rebuilding teams in a post-layoff landscape, the challenges facing clinical operations executives are unprecedented — and so are the opportunities. This session brings together senior leaders from large, mid-size, and emerging biopharma companies for an unscripted fireside conversation exploring how the role of Clinical Operations has evolved over the past decade and where it’s heading next. Panelists will share candid insights on leading change, balancing innovation with execution, and maintaining resilience in the face of shifting talent models and regulatory expectations.

Learning Objectives

Discuss current trends, pressures, and innovations shaping Clinical Operations directly from industry leaders; Recognize operational strategies using benchmark data through real-world examples of how organizations are adapting their models, technologies, and teams; Identify emerging roles, skill requirements, and leadership priorities within the evolving ClinOps landscape to guide personal career planning and organizational development.

Chair

Joseph Dustin

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Nikki Amaratunge, MA, PMP

Panelist
Rosalie Filing

Panelist
Emily Walker, MBA

Speakers

Joe Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →

Joseph Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Rosalie Filing

Vice President, Clinical Operations, Keenova Therapeutics, United States

Nikki Amaratunge, MA, PMP

Director Clinical Operations, Allergan, United States

Jennifer Sheller

Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc., United States

Jennifer Sheller is Senior Vice President and Head of Global Clinical Trial Operations at Merck, where she leads the global infrastructure responsible for the operational delivery of Merck’s clinical development portfolio. With more than 25 years of experience across pharma, biotech... Read More →

Emily Walker

Vice President, Study Management, Alnylam, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Project Management & Strategic Planning
Tags Session

11:00am EDT

#413: Health Canada Town Hall

Monday June 15, 2026 11:00am - 12:15pm EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25

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

Learning Objectives

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

Chair

Alysha Croker, PHD

Speaker

Panelist
Sophie Sommerer

Speakers

Alysha Croker

Director, Strategic and Horizontal Policy, 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 →

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada

Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Regulatory
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

11:00am EDT

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy

Monday June 15, 2026 11:00am - 12:15pm EDT

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25

This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.

Learning Objectives

Recognize CtQ factors using integrated QbD and RBQM in a collaborative, cross-functional setting; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle; Discuss regulatory expectations and industry best practices for a unified quality strategy; List practical strategies for implementing this approach within organizations.

Chair

Paula Walker, MA

Speaker

Panelist
Mandy Kaur Budwal-Jagait, MSC

Panelist
Paula Walker, MA

Panelist
Sumitra Sachidanandan

Panelist
Cheryl Grandinetti

Speakers

Mandy Budwal-Jagait

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

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

Cheryl Grandinetti

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

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

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore

Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom

Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance/Control & CMC
Feature Topics Cross-Functional Collaboration
Tags Forum

2:30pm EDT

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives

Monday June 15, 2026 2:30pm - 3:30pm EDT

108B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P; CME 1.00; RN 1.00

No one can solve today’s R&D challenges alone. But are industry consortia fit for 2030? We examine the "head, heart, and gut" to re-imagine collaboration and explore what’s needed to accelerate co-creation and innovation.

Learning Objectives

Recognize the value of industry collaborations, analyze emerging trends and future innovation opportunities; Explain how to shift from patient-centric to patient-driven design thinking.

Chair

Sarah Tremethick

Speaker

Industry Collaboration 2030: Head Perspective
Adrian Hernandez, MD, MHS

Industry Collaboration 2030: Head, Heart and Gut Perspectives
Rebecca Vermeulen, RPH

Industry Collaboration 2030: Gut Perspective
Jeff Smith

Speakers

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 →

Jeff Smith

The Curator, Smith and Jones Innovation, United States

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom

A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →

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 15, 2026 2:30pm - 3:30pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Patient Engagement
Feature Topics Global Alignment in Practice,Patient-Centered Design and Experience
Tags Session

2:30pm EDT

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions

Monday June 15, 2026 2:30pm - 3:30pm EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P; CME 1.00; RN 1.00

Explore patient-focused decentralized trials and direct-to-patient shipments, highlighting their impact on recruitment, retention, and trial performance—and how sites adapt operations to deliver these solutions effectively.

Learning Objectives

Evaluate how DCT solutions and direct-to-patient shipments enhance patient access, recruitment, and retention; Identify best practices for sites to operationalize DCT workflows while ensuring quality and compliance.

Chair

Joan Chambers

Speaker

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Kevin Hudziak, MS

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Becky Suzanne Kottschade, MA, PMP

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Joan Chambers

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Jane Myles

Speakers

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States

With 30+ years in the health and life sciences industry, Joan has led senior initiatives across multiple organizations, specializing in team leadership, strategic planning, integrated marketing, communications, and educational programs for B2B and B2C audiences. She is a Senior Independent... Read More →

Kevin Hudziak

Senior Director - Patient Engagement, Clinical Trial Retention, Eli Lilly and Company, United States

Kevin is Senior Director of Clinical Trial Retention on the Patient Engagement team at Lilly. He has extensive experience gathering patient and site feedback, delivering innovation, and impacting DCT capability development and implementation at Lilly. Kevin has a passion for improving... Read More →

Becky Kottschade

Administrator, Clinical Research, Mayo Clinic, United States

Becky Kottschade is an experienced clinical research administrator. Driven by her commitment to developing innovative options for patients she takes pride in providing the best practices for implementing decentralized capabilities possible. As a research administrator her goals are... Read More →

Jane Myles

VP, Programs and Initiatives, Digital Trials and Research Alliance, United States

Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 09: RD-Quality-Compliance, Forum

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Patient Engagement
Feature Topics Patient-Centered Design and Experience
Tags Forum

2:30pm EDT

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

Monday June 15, 2026 2:30pm - 3:30pm EDT

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00

This seminar shows how life sciences teams can align strategy with execution through integrated program plans, AI-enabled planning, and P3M practices to accelerate time to market, foster innovation, and drive organizational transformation.

Learning Objectives

Distinguish how to align strategy with execution by integrating program plans (IPPs) across R&D, Clinical, CMC, Regulatory, and Commercial Leverage AI-enabled planning and P3M practices to enhance visibility, decision-making, and risk management, accelerating time to market; Discuss ways to adapt leadership approaches to drive organizational transformation, innovation, and compliance in an evolving life sciences landscape.

Chair

Christine Mears, MBA, PMP

Speaker

Aligning Strategy with Execution: Leveraging Integrated Program, Project and Portfolio management with AI to advance drug development
Philip M Zack, DVM, PHD

Panelist
Erin Mulrooney, MSC, PMP

Speakers

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States

Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States

Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States

Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 07: RegCMC-Product Quality, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Feature Topics Cross-Functional Collaboration
Tags Session

4:00pm EDT

#446: DIA2026-001: Co-Creating the Patient-Centric Trial Live

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

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-541-L04-P; CME 1.00; RN 1.00

In this interactive forum, attendees will co-create “DIA2026-001” through live polling, exploring how early protocol decisions shapes: patient inclusion, recruitment feasibility, technology strategy, operational complexity. With perspectives from patient advocacy, recruitment and clinical technology experts, the session demonstrates how intentional study design and enabling technologies directly influence recruitment success and long-term retention, critical factors given that most trials struggle to meet enrolment targets.

Learning Objectives

Discuss how to co-create a model protocol while examining how patient and site input influence design decisions and technology choices; Evaluate how early protocol and technology decisions impact recruitment strategy, inclusivity, and operational feasibility; Identify practical approaches to leveraging digital and hybrid delivery models to support patient-centric trial execution.

Chair

Farrell Healion, MSC

Speaker

Panelist
Alexandra Charge

Panelist
Ross Jackson

Speakers

Alexandra Charge

CEO, ISPEP, United Kingdom

A global life sciences executive, specialising in strategic transformation, innovation, and patient-centric approaches in healthcare, medicines development and clinical trial optimisation. As the CEO of the International Society for Patient Engagement Professionals, Alex is an active... Read More →

Farrell Healion

Founder & Managing Director, Optitrial, United Kingdom

Farrell Healion is the Founder and Principal Consultant of OptiTrial, where he partners with sponsors and study teams to deliver smarter, faster, and more connected clinical trials. With over 13 years of experience across sponsor and clinical technology roles, including at AstraZeneca... Read More →

Ross Jackson

Patient Recruitment Specialist, Ross Jackson Consulting, United Kingdom

A patient recruitment consultant who's worked on nearly 200 successful projects. Author of two Amazon best-selling books on patient recruitment, Ross provides advice and oversight to organizations that wish to improve the effectiveness of their patient recruitment activities - sponsors... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Project Management & Strategic Planning
Feature Topics Patient-Centered Design and Experience
Tags Forum

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration

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

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00

This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.

Learning Objectives

Analyze how regulatory harmonization and collaboration accelerate global study start-up; Differentiate key principles of ICH E17, E5, and regional oncology MRCT guidelines; Summarize strategies to navigate regional regulatory differences and enable global studies.

Chair

Angelika Joos, MPHARM

Speaker

ethical aspects of conducting MRCTs from a global perspective
Sarah A. White, MPH

Experience from global conduct of MRCTs
Aloka Chakravarty, PHD

Panelist
Paz Vellanki

PMDA perspective
Yoko Aoi, PHD

Speakers

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States

Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium

Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →

Paz Vellanki

Associate Director, OND, CDER, FDA, United States

Sarah White

Executive Director, MRCT Center, United States

Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Regulatory
Feature Topics Global Alignment in Practice
Tags Forum

4:00pm EDT

#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications

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

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-543-L04-P; CME 1.00; RN 1.00

This session shares insights from a global survey of 12,000+ respondents, highlighting patient comfort levels and receptivity to AI processing their medical information as part of a clinical trial.

Learning Objectives

Discuss patient comfort levels and receptivity to AI processing medical information as part of a clinical trial; Describe strategies to address patient preferences and comfort levels with AI analyzing medical data.

Chair

Annick De Bruin, MBA

Speaker

Panelist
T.J. Sharpe, PMP

Panelist
Shanelle Gabriel, MED

Speakers

Annick De Bruin

Chief Research and Insights Officer, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP), United States

Annick de Bruin is the Chief Research and Insights Officer of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including... Read More →

Shanelle Gabriel

Patient Advocate, N/A, United States

Shanelle Gabriel

Patient Advocate/Speaker/Poet, Building Constellations, LLC, United States

Shanelle Gabriel is an internationally touring poet, speaker, communications consultant, and lupus patient advocate. She has performed globally gracing stages from Carnegie Hall to the Vatican. As a creative strategist, she has crafted poetry on various themes for events and for campaigns... Read More →

Ellyn Getz

Director, R&D Patient Engagement, CSL Behring, United States

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

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States

T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Development & Operations
Feature Topics Patient-Centered Design and Experience
Tags Session

4:00pm EDT

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children

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

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00

This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis.

Learning Objectives

Identify innovative regulatory strategies for pediatric drug development, including the ICH E11A guideline; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.

Chair

Christina Bucci-Rechtweg, MD

Speaker

Panelist
Laura Jawidzik, MD

Panelist
Lauren Krupp, MD

Panelist
Lynne Yao, MD

Speakers

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States

Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States

Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States

Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice
Tags Forum

4:00pm EDT

#455: Japan Town Hall

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

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00

This session explores the benefits of drug development and approval in Japan, highlighting market size, development predictability, and regulatory support, with insights from administrative bodies and the international pharmaceutical industry.

Learning Objectives

Recognize misconceptions about Japan's drug development environment and learn the latest updates; Discuss the benefits of drug development in Japan from regulatory and industry perspectives.

Chair

Daisuke Koga, MS, MSC

Speaker

Panelist
Seiko Usami, PHD

Panelist
Yoshiaki Uyama, PHD, MS, RPH

Speakers

Daisuke Koga

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

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

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Clinical Development & Operations
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

4:00pm EDT

#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P; CME 1.00; RN 1.00

Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trials

Learning Objectives

Examine GCP inspection classification and outcomes across regulatory agencies, highlighting similarities and differences in enforcement; Identify common deficiency patterns and regulatory expectations across regions, emphasizing protocol adherence, recordkeeping, and data integrity; Recognize the impact of inspection observations on regulatory decisions; Discuss industry best practices.

Chair

Jenn Sellers, MD

Speaker

Overview of MHRA's GCP Inspections
Rachel Mead

Speakers

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →

Jenn Sellers

Chief, GCP Assessment Branch, FDA, United States

Dr. Sellers serves as Chief of the Good Clinical Practice (GCP) Assessment Branch in the Office of Scientific Investigations at the U.S. FDA, where she leads the evaluation of GCP compliance and provides regulatory recommendations in support of marketing applications. She is a board-certified... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Session

4:00pm EDT

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?

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

203AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00

This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions

Learning Objectives

Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA, PMDA, MHRA) and discuss recent progress within the EU on this topic; Analyze the key similarities and differences in regulatory recommendations for study design, and describe the rationale for greater alignments across agencies.

Chair

Gracy G Crane, MS

Speaker

Panelist
Motiur Rahman, PHD, MPHARM, MS

Panelist
Denise Umuhire, MBA, MSC

Panelist
Tricia Luhn, PHD, MPH

Speakers

Gracy Crane

Policy Lead, Roche, United Kingdom

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →

Tricia Luhn

RWD Oncology, Genentech, United States

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands

I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Evidence Innovation
Tags Forum

8:00am EDT

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies

Tuesday June 16, 2026 8:00am - 9:00am EDT

114

Component Type: Session
Level: Intermediate

This plenary session will bring together first-hand perspectives from academic and pharmaceutical experts involved in the development of the GLP1 therapies that first achieved regulatory approval for the treatment of obesity. Speakers will reflect on the scientific and clinical journey that enabled these breakthroughs, while examining how innovation in this space continues to evolve. The session will also address the persistent access gap facing patients worldwide and explore how global companies are working closely with regulators to expand access in a sustainable and equitable manner. Key health policy implications will be discussed, setting the stage for subsequent sessions within the new Chronic Disease and Obesity Pathway.

Learning Objectives

Analyze the key scientific and clinical milestones that led to the first regulatory approvals of GLP-1 therapies for obesity using expert perspectives; Assess how innovation in GLP-1 therapies is evolving and consider its impact on future obesity and chronic disease treatment; Examine global access gaps to obesity therapies and identify policy and regulatory strategies to expand equitable and sustainable patient access.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Robert M. Califf, MD

Panelist
Brad Jordan, PHD

Panelist
W. Scott Butsch, MD, MSC

Speakers

W. Scott Butsch

International Medical Vice President - Obesity, Novo Nordisk A/S, Denmark

Robert Califf

Instructor, Medicine, Duke University School of Medicine, United States

Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and... Read More →

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.

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Tuesday June 16, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

00: Plenary, Session | 02: ClinicalTrialOps-Innovation, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Therapeutic Pathways
Level Intermediate
format csv
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

10:15am EDT

#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care

Tuesday June 16, 2026 10:15am - 11:30am EDT

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-556-L04-P; CME 1.25; RN 1.25

Too few sponsors and sites have access to primary care organizations (PCOs). PCOs deliver first-contact, comprehensive, and continuous care to over 100 million people. This session will bring forth easy to use and action oriented PCO tactics.

Learning Objectives

Distinguish between types of primary care organizations (PCOs) & their objectives to increase study participation; Discuss common PCO research barriers to improve collaboration outcomes short and long-term; Outline actionable tactics for study implementation and strategic initiatives.

Chair

Pete Fronte, MBA

Speaker

Panelist
Alpa Patel

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Ruma Bhagat, MPH

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Osa Eisele, MD, MPH

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Rakesh Patel, MD, MBA, FAAFP

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Maggie McGuire Kuhl

Speakers

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States

Osa Eisele

Executive Director, Amgen, United States

Osa Eisele, MD, MPH, is a physician-scientist and global health leader with over 20 years of experience in drug safety, clinical research, and population health. As Head of Representation in Clinical Research (RISE) at Amgen, she advances proportional representation in clinical trials... Read More →

Pete Fronte

Founder and Chief Executive Officer, Altura, United States

Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within primary care organizations and community... Read More →

Maggie McGuire Kuhl

Vice President, Patient Engagement, The Michael J. Fox Foundation For Parkinson's Research, United States

Rakesh Patel

CEO, Neighborhood Healthcare (FQHC), United States

Dr. Rakesh Patel is the Chief Executive Officer (CEO) for Neighborhood Healthcare, Neighborhood Healthcare PACE, and Neighborhood Healthcare Institute of Health. Neighborhood Healthcare is a 501(c)3 nonprofit Federally Qualified Health Center (FQHC) with 30 Health Centers serving... Read More →

Alpa Patel

Senior Vice President, Population Science, American Cancer Society, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Forum

10:15am EDT

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

Tuesday June 16, 2026 10:15am - 11:30am EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P; CME 1.25; RN 1.25

We will share case examples and trends from 24,000 records, analyze ethical challenges involved in paying participants, and discuss how protective policies or administrative practices can result in unjust treatment.

Learning Objectives

Explain the ethical considerations that govern payment to research participants; Evaluate the potential for institutional and administrative policies to inadvertently create unjust treatment of research participants; Apply the Belmont Principles of Beneficence and Justice to real-world cases involving payment to research participants and propose strategies for ethical decision-making.

Chair

Kelly Fitzgerald, PHD

Speaker

Panelist
Karla Childers, MS

Panelist
Wenora Johnson

Panelist
Sam Whitaker

Panelist
Robin Kuprewicz, MA

Speakers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Karla Childers is Vice President, Bioethics, Policy & Partnerships 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 has... Read More →

Kelly FitzGerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States

Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →

Wenora Johnson

Administrative Support & Research/Patient Advocate, United States

Robin Kuprewicz

Clinical Trials Director, Georgetown University, United States

Robin Kuprewicz is the Clinical Trials Director for the Georgetown University Huntington's Disease Care, Education and Research Center. She holds a Masters in Medical Anthropology and has ten years of experience in clinical trials. She has helped Huntington's Disease participants... Read More →

Sam Whitaker

Founder & CEO, Mural Health, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Session

10:15am EDT

#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing

Tuesday June 16, 2026 10:15am - 11:30am EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-558-L04-P; CME 1.25; RN 1.25

Learn how mixed FSP (functional service provider)/FSO (full-service outsourcing) models deliver additional agility to help clinical trial sponsors manage complexity, enhance efficiency, and facilitate the transition from FSO to FSP outsourcing.

Learning Objectives

Identify opportunities where mixed FSP (functional service provider)/FSO (full-service outsourcing) models create additional agility in clinical trial operations; Discuss how mixed FSP/FSO models facilitate the transition from FSO to FSP outsourcing; Assess flexible options to deliver drug development on time and on budget in complex, global trials.

Speaker

Moderator
Andrew Studna

Panelist
Samantha Hadfield

Panelist
Nick Scott

Speakers

Samantha Hadfield

Vice President, Operational Delivery, PPD FSP solutions, Thermo Fisher Scientific, United Kingdom

Nick Scott

Head, Strategic Resourcing and Performance Optimization, Biogen, United States

Andrew Studna

Senior Editor, Applied Clinical Trials, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 01: ClinSafety-PV-RM, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Tags Forum

10:15am EDT

#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development

Tuesday June 16, 2026 10:15am - 11:30am EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-566-L04-P; CME 1.25; RN 1.25

This session covers the importance of data sharing and the new tools that might enable that pooling and integration in order to facilitate progress in personalized medicine and ensure faster access to treatments for the oncology patients who need them the most.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of oncology data pooling efforts and the advancements offered by AI that can allow faster integration; Describe emerging programs and global initiatives designed to facilitate faster oncology drug development; Assess various considerations and strategies that are meaningful to both physicians and patients.

Chair

Alberto Grignolo, PHD

Speaker

Panelist
Beth Meagher, MA

Panelist
Sean Khozin, MD, MPH

Panelist
Stacy Hurt, MBA, MHA

Leveraging Federated AI and Open Data to Transform Oncology Research and Development
Maria Vassileva, PHD

Panelist
Joseph Kannarkat, MD

Speakers

Alberto Grignolo

Editor-in-Chief, DIA Global Forum, United States

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion... Read More →

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States

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

Sean Khozin

CEO, Roundtable on Cancer (CEORT) and Project Data Sphere (PDS), United States

Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine... Read More →

Beth Meagher

Principal, Deloitte Consulting, United States

Beth Meagher is a Deloitte Consulting LLP principal and leader of the Federal Monitor Deloitte Strategy practice. She started and leads Deloitte's Translational Medicine, which bring strategy, informatics, clinical, and research capabilities together on collaborative teams. Beth focuses... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

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

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Therapeutic Pathways, Artificial Intelligence, Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Therapeutic Pathways,Artificial Intelligence,Therapeutic Pathways
Tags Session

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech

Tuesday June 16, 2026 10:15am - 11:30am EDT

103A

Component Type: Session
Level: Intermediate

Many clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.

Learning Objectives

Design and execute a streamlined customer discovery process to validate unmet needs, buying triggers, and budget ownership before finalizing a go-to-market strategy; Translate insights into a sales learning roadmap that tests positioning, pricing, compliance, and objections to reduce commercial risk before raising capital; Align GTM and fundraising with validated demand to present a credible revenue story.

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA

Speakers

Laura Hilty

Principal, HealthX Ventures, United States

Jeff Lee

Board Director, Medstar Health Research Institute, United States

Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States

Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →

Dan Sndyer

The Playbook, United States

Dan Sndyer

The Playbook, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Digital Enablement and Modernization, Cross-Functional Collaboration
Level Intermediate
format csv
Interest Area Data Management & Data Standards,Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway,Digital Enablement and Modernization,Cross-Functional Collaboration
Tags Session

10:15am EDT

#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA

Tuesday June 16, 2026 10:15am - 11:30am EDT

201AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P; CME 1.25; RN 1.25

Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development, outlines the current landscape, explores opportunities and challenges, and assesses strategies to boost efficiency and accelerate therapeutic innovation.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of chronic disease drug development; Describe emerging programs and global initiatives designed to facilitate development of chronic disease drugs; Assess various considerations and strategies to enhance the efficiency of chronic disease drug development.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH

Speakers

Alison Cave

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

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →

Ayaka Kubota

Office of Safty II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

She is a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is involved in the scientific review of pharmaceuticals, primarily focusing on cardiovascular drugs and treatments for Alzheimer’s disease, with an emphasis on clinical evaluation and regulatory... Read More →

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... 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 →

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway, Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Rare Disease & Special Populations,Regulatory
Feature Topics Global Alignment in Practice,Student and Early Career Pathway,Therapeutic Pathways
Tags Session

10:15am EDT

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

Tuesday June 16, 2026 10:15am - 11:30am EDT

203AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-561-L04-P; CME 1.25; RN 1.25

Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.

Learning Objectives

Apply FDA’s CDS guidance criteria to determine whether AI software tool (used to identify patients or risk factors) qualifies as a regulated medical device or exempt CDS; Analyze real-world digital health scenarios using a structured decision tree to support regulatory classification; Evaluate the impact of software classification on drug development strategy, trial design, and regulatory planning

Chair

Michael Mayrosh, PHARMD

Speaker

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Jeppe G. Manuel, MLIS

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Lesley Maloney, PHARMD

Speakers

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States

Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark

Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →

Michael Mayrosh

Associate Director Global Regulatory Policy and Strategy, Eli Lilly and Company, United States

Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Workshop | 02: ClinicalTrialOps-Innovation, Workshop | 08: RegPolicy-Strategy-GlobalCollaboration, Workshop

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Workshop

10:15am EDT

#519: Patient Registries: Basket Trial or Basket Case?

Tuesday June 16, 2026 10:15am - 11:30am EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P; CME 1.25; RN 1.25

Akin to basket trials which study a single treatment for multiple conditions, patient registries enroll people with similar conditions, look for safe and effective treatments and disease management strategies, and are used to guide decision-making by clinicians, regulators and payers. Yet the very nature of real-world evidence requires that patient registries be nimble and opportunistic -- desirable attributes to maintain relevance, but ones that inevitably raise questions about data quality and completeness, transparency, provenance and Fitness for Use. Recent guidance documents from regulators and professional societies hint that real-world data from patient registries may be viewed more favorably than other, less traceable and auditable sources of real-world data. This session will illustrate key attributes of high quality, trustworthy patient registries, the criticisms and barriers they generally face and what they do to bolster trust.

Learning Objectives

Explain the value of RWE on population groups that may not be fully representative of all cases, and who may have some missing data; Explain expectations for quality, transparency and provenance; Describe key values of patient registries and common approaches to bolster trustworthiness.

Chair

Nancy Dreyer, MPH, FISPE

Speaker

How registries are changing with technology and AI, and what that means for quality
Richard Gliklich, MD

Gauging registry quality according to its intended use
Mike D'Ambrosio

Life in the trenches of a patient registry: navigating the reality of RWD
Angela Dobes, MPH

Speakers

Mike D'Ambrosio

Parexel, United States

22 Years Industry experience at top 5 CRO’s including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross functional teams. Currently leads Parexel's Real World Research (RWD/RWE) business franchise - Helping customers build innovative RWD/RWE solutions to... Read More →

Angela Dobes

SVP, IBD Plexus, Crohn's & Colitis Foundation, United States

Angela Dobes is the senior vice president of IBD Plexus, a real-world data platform and biorepository that redefines how researchers study inflammatory bowel disease to advance precision-medicine strategies and cut years off the R&D timeline. She strives to elevate the important role... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness... Read More →

Richard Gliklich

Founder & Director, 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 →

Tuesday June 16, 2026 10:15am - 11:30am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Biostatistics
Feature Topics Evidence Innovation
Tags Forum

1:45pm EDT

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P; CME 1.25; RN 1.25

This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10 companies, FDA, EMA, and many other advisors from patient advocacy organizations across the Americas and Europe.

Learning Objectives

Identify key clinically meaningful endpoints used in GLP-1 trials; Describe current opportunities and challenges in obesity drug development; Explain how the public private partnership led by Drug Information Association is advancing trial endpoint alignment.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Katherin Ruiz

Panelist
Alison Matsui, MPH

Panelist
Brad Jordan, PHD

Panelist
Jingyu (Julia) Luan, PHD

Speakers

Brad Jordan

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

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Alison Matsui

Senior Principal PCOR Scientist, Genentech, A Member of the Roche Group, United States

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

1:45pm EDT

#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P; CME 1.25; RN 1.25

Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials, highlighting conceptual model progress and stakeholder insights for regulatory decisions.

Learning Objectives

Describe recent developments from the DIA study integrating patient experience into immuno-oncology tolerability assessments; Examine findings from literature and KOL interviews; Identify strategies for operationalizing a multidimensional tolerability framework; Recognize multistakeholder perspectives to support trial design, data collection, and benefit–risk evaluation.

Chair

Devin Peipert, PHD

Speaker

Panelist
Efrat Dotan, MD

Panelist
Maria Paula Bautista Acelas, MSC

Panelist
Lia Ridout

Speakers

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States

Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →

Efrat Dotan

Executive Medical Director, Ann B Barshinger Cancer Institute, Lancaster General, Penn Center for Cancer Care Innovation, United States

Devin Peipert

Professor of Health Outcomes Measurement, University of Birmingham, United Kingdom

Prof Peipert holds a 125th Anniversary Chair in the Department of Applied Health Sciences at the University of Birmingham, where he is affiliated with the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation... Read More →

Lia Ridout

Patient Advocate, -, United States

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

Angela Rylands

Global Head of Patient Centred Outcomes, Kyowa Kirin, United Kingdom

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

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

1:45pm EDT

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

108B

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25

This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.

Learning Objectives

Describe how synthetic AI patient personas can augment real patient input to personalize and improve patient trial experience; Identify the data requirements and limitations for building synthetic AI personas.

Chair

Robina Weermeijer

Speaker

Panelist
Jason Binder, MA

Panelist
Himanshu Manchanda, PHD

Panelist
Sabina Kineen

Speakers

Jason Binder

Founder & CEO, Ember, United States

Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany

Robina Weermeijer

Boehringer Ingelheim, Netherlands

Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Basic
Area Artificial Intelligence, Patient-Centered Design and Experience
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Patient Engagement
Feature Topics Artificial Intelligence,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

116

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25

Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope, principles, and current thinking reflected in their respective documents, as well as discuss areas of alignment, divergence, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion, participants will gain insight into how Bayesian methods are being evaluated in practice, including considerations for trial design, external data integration, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.

Learning Objectives

Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods; Compare regulatory perspectives and areas of alignment and divergence across regions; Explain applications of Bayesian approaches in clinical trial design, analysis, and regulatory decision-making; Identify current expectations, implementation challenges, and opportunities for industry engagement in shaping future guidance.

Chair

May F Mo, MBA, MS

Speaker

Panelist
Juan Jose Abellan

Panelist
Andrew Thomson, PHD, MA, MSC

Speakers

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

May Mo

Associate Vice President, Biostatistics, Amgen, United States

May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →

Andrew Thomson

Consultant, Regnitio, Netherlands

Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice
Tags Forum

4:15pm EDT

#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

108A

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P; CME 1.00; RN 1.00

This pilot project aimed to upskill community cancer centers to carry out clinical trials. ACCC and ACRP identified needs and provided self-study and instructor-led training that improved learner knowledge and confidence.

Learning Objectives

Describe the challenges faced by research-naïve and low trial capacity programs at community cancer centers in conducting clinical research; Recognize the role of professional training in preparing community cancer centers to implement clinical trials; Integrate learnings from a training pilot that helped advance foundational knowledge and confidence among clinic healthcare staff.

Chair

David Vulcano Landis, MBA

Speaker

Panelist
Ruma Bhagat, MPH

Panelist
Pete Fronte, MBA

Speakers

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States

Pete Fronte

Founder and Chief Executive Officer, Altura, United States

Susan Landis

CEO, Association of Clinical Research Professionals (ACRP), United States

Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →

David Vulcano Landis

CEO, Association of Clinical Research Professionals (ACRP), United States

David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards and initiatives. He currently serves as the Chief Executive Officer of the Association of Clinical Research Professionals and previously served as the Vice... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Tags Session

4:15pm EDT

#549: Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors, Sites, and Patients

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-583-L04-P; CME 1.00; RN 1.00

This session is intended to show how modern site source and integrated site solutions connect data, people, and processes to create a more efficient, future-ready clinical trial ecosystem.

Learning Objectives

Discuss the evolving role of site source in optimizing trial execution and ensuring data quality, compliance, and efficiency across stakeholders; Identify best practices for implementing digital site solutions including eSource and integrated site technologies that balance standardization with site autonomy; Recognize how site-centered innovations connect data, people, and processes.

Chair

Jonathan Andrus, MS

Speaker

Technology Perspective
Samir Jain

Site Perspective
Aneesh Vaze

CRO and Site Network Perspective
Melissa Gottschlich, MSC

Speakers

Jonathan Andrus

CEO, CRIO, United States

With 30 years of experience, Jonathan specializes in developing eClinical services that integrate data and technology to optimize study execution. At CRIO, he oversees customer success, sales, marketing, finance, compliance, and people programs. An active thought leader, Jonathan... Read More →

Melissa Gottschlich

Senior Director Site Network, Accellacare, United States

Melissa “Missy” Gottschlich is Senior Director, Site Network at ICON, where she leads global strategy and centralized operations for Accellacare, ICON’s proprietary clinical site network. She oversees cross-functional teams spanning technology, finance, quality, project management... Read More →

Samir Jain

Head of EHR and Interoperability Solutions, Medidata, a Dassault Systèmes Company, United States

Samir Jain is the Head of EHR and Interoperability Solutions at Medidata, driving the company's healthcare interoperability strategy. With over 20 years in health tech, he previously built EHRs and led interoperability at Allscripts, developed large-scale Health Information Exchanges... Read More →

Aneesh Vaze

Managing Director, Clinical Research of Philadelphia, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Tags Forum

4:15pm EDT

#559: China Town Hall

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-592-L04-P; CME 1.00; RN 1.00

In this session, speakers from NMPA, Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulatory policy, drug review and approval, and international collaboration.

Learning Objectives

Recognize the latest information on the National Medical Products Administration (NMPA) activities in drug regulation, supporting innovation and international collaboration; Describe the recent update on the progress in drug review, inspection and approvals in China; Discuss the issues on drug regulation with NMPA officials.

Chair

Ling Su, PHD

Speaker

Panelist
Wei Zhang

Panelist
Qinghua Wang, MD

Introduction
Hui Shi

Update on Drug Regulation in China
Huijuan Zhou

Evolution of clinical trial landscape enabling early clinical development
Xiaoyuan Chen, MD

Speakers

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 →

Hui Shi

Director, Development Research Division, China Center for Food and Drug International Exchange, China

Ling Su

Research Fellow, Yeehong Business School, China

Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →

Qinghua Wang

Founder and CEO, Innogen Pharmaceuticals, China

Professor Qinghua Wang has dedicated over 30 years to translational research in metabolic diseases. He began his medical training in Shanghai, followed by graduate studies in Biochemistry in Antwerp. By 2000, he became an Assistant Professor at the University of Toronto’s Department... Read More →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Huijuan Zhou

Exchange Division, China Center for Food and Drug International Exchange, China

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Global Alignment in Practice
Feature Topics Student and Early Career Pathway
Tags Session

10:15am EDT

#604.1: Trial Navigator: Sponsors and Payors Discuss a Collaborative Non-Profit Recruitment Model to Better Connect Patients to Trials

Wednesday June 17, 2026 10:15am - 11:30am EDT

116

Component Type: Forum
Level: Basic

Despite major investment, trial enrollment remains a system failure. Could a collaborative model align sponsors and payors – those who run trials & those with patient populations – via shared infrastructure and trusted human navigators? Help shape it.

Learning Objectives

Diagnose enrollment challenges as a system-level coordination failure; Outline shared values and differentiate value across sponsors, payors, and patients; Identify opportunities to enhance trust and build collaborative infrastructure (core governance, incentives, data); Apply cross-sector and emerging data collaboration lessons to pilot and scale solutions.

Chair

Van Crocker

Speakers

Percy Van Crocker

Founder and President, Agonist Health, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum

Audience Basic
Level Basic
format csv
Tags Forum

10:15am EDT

#604: Counting the Cost: Translating Participant Burden into Fair Compensation

Wednesday June 17, 2026 10:15am - 11:30am EDT

108B

Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-599-L04-P; CME 1.25; RN 1.25

This interactive workshop moves beyond analysis to implementation—translating burden into cost and exploring fair compensation models to advance equity, access, and the participation experience

Learning Objectives

Examine how participant burdens translate into measurable costs and affect recruitment and retention; Apply fairness-based frameworks that align compensation with lived experience; Evaluate ethical, regulatory, and policy considerations to guide implementation models that improve equity and strengthen science through representative participation

Chair

Lani Hashimoto

Speaker

Panelist
Donna Libretti Cooke, JD

Panelist
Bernadette Tosti

Panelist
T.J. Sharpe, PMP

Panelist
Shay Webb

Speakers

Donna Libretti Cooke

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

Donna Libretti Cooke, JD is Chief Impact Officer and Owner of ImpactSphere Clinical, LLC, advising pharma sponsors, CROs, and start-up vendors on participant payment strategy and clinical trial operations. She co-developed the Whole-Person Participant Support™ framework and led... Read More →

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

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

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States

Bernadette Tosti

Partner, BGT Partners LLC, United States

Bernadette Tosti brings nearly 10 years of healthcare marketing, clinical trial recruitment and retention, and digital recruitment technology experience to her role at Quintiles. During her tenure at Quintiles, she has helped develop innovative technology solutions for recruitment... Read More →

Shay Webb

Global Clinical Trials Operation, Emerging Talent Rotation, Merck & Co., Inc., United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Workshop

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Patient Engagement,Value & Access
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Workshop

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

Wednesday June 17, 2026 10:15am - 11:30am EDT

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25

In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.

Learning Objectives

Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials; Identify key factors driving burden in clinical trials; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.

Chair

Abigail Dirks, MS

Speaker

Panelist
Stephanie Christopher, MA

Panelist
Katrina Mateo, PHD, MPH

Speakers

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States

Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →

Abigail Dirks

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

Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States

Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence, Digital Enablement and Modernization
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

Wednesday June 17, 2026 10:15am - 11:30am EDT

102AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25

Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.

Learning Objectives

Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.

Chair

Kevin Bugin, MS, RAC

Speaker

Panelist
Mary Thanh Hai, MD

Panelist
Henry Wei, MD

Panelist
Zhanna Jumadilova, MD, MBA

Speakers

Kevin Bugin

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

Dr. Kevin Bugin is the head of global regulatory policy 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 →

Alison Cave

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

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States

Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →

Zhanna Jumadilova

Clinical Lead, Pfizer, 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. Her diverse experience in both large pharmaceutical... Read More →

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Workshop | 02: ClinicalTrialOps-Innovation, Workshop

Audience Intermediate
Area Global Alignment in Practice, Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice,Evidence Innovation
Tags Workshop

10:15am EDT

#613: FDA Rare Disease Town Hall

Wednesday June 17, 2026 10:15am - 11:30am EDT

201AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-609-L04-P; CME 1.25; RN 1.25

Senior FDA leaders will discuss evolving regulatory trends in rare disease development, including accelerated approval, innovative trial designs, patient engagement, and real-world evidence, followed by open Q&A with attendees.

Learning Objectives

Identify current FDA regulatory trends and scientific approaches shaping rare disease drug development; Apply FDA expectations around accelerated approval, surrogate endpoints, and innovative trial designs; Integrate patient voice and real-world evidence into development strategies to support benefit-risk assessment.

Chair

James Valentine, JD, MHS

Speakers

Vijay Kumar

Acting Director OTP/CBER, FDA, United States

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine advises medical product companies and patient advocacy organizations on regulatory strategy for the development and approval of drugs and biologics, with a focus on rare diseases. He has helped secure FDA approvals, and often works in areas without well-defined regulatory... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Therapeutic Pathways, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Therapeutic Pathways,Student and Early Career Pathway
Tags Session

10:15am EDT

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?

Wednesday June 17, 2026 10:15am - 11:30am EDT

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P; CME 1.25; RN 1.25

Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials.

Learning Objectives

Explain DCT regulations in Japan, the US, and Europe and how to overcome their differences.

Chair

Junko Sato, PHD

Speaker

DCT in Japan
Ruri Matsumoto, RPH

Experiences and expactation to DCT
Rasmus Enggaard, MPHARM, MSC

Speakers

Rasmus Enggaard

Therapy Area Head, CardioRenal/Liver/RareD, Novo Nordisk A/S, United States

Rasmus Enggaard is the Therapy Area Head for CardioRenal, Liver, and Rare Diseases in U.S. Clinical Development & Operations at Novo Nordisk, where he is responsible for execution of a broad and complex clinical trial portfolio. His work focuses on operational excellence, scalable... Read More →

Ruri Matsumoto

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

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Alignment in Practice
Tags Session

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

108B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00

This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.

Learning Objectives

Analyze new benchmarks on the distribution of protocol data across core, standard, and non-core endpoints; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden; Discuss strategies to evaluate protocol data collection, simplify design and lower participation burden.

Chair

Kenneth Getz, MBA

Speaker

New Benchmarks on Clinical Trial Data Collection Practices and their Impact
Kenneth Getz, MBA

Frameworks and Tools Guiding Optimization of Protocol Data Collection
Jackie Cole, MS

Speakers

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States

Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →

Kenneth Getz

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

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Data Management & Data Standards
Tags Session

1:45pm EDT

#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00

Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges.

Learning Objectives

Explain how trial emulation using real-world data can be used to enhance design of future clinical trials; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice; Discuss the challenges of emulating trial endpoints, eligibility criteria, and other design elements.

Chair

Leo Russo, MS

Speaker

Panelist
Jingchuan Serena Guo, MD, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Speakers

Jingchuan Serena Guo

Associate Professor, Purdue University, United States

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States

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

Leo Russo

Advisor, Get Real Institute, United States

I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Tags Forum

1:45pm EDT

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

111AB

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P; CME 1.00; RN 1.00

We’ll review the history, laws, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of pa

Learning Objectives

Describe the history of data sharing and the laws and policies that have informed it; Discuss the ethical considerations for shifting our mindset about data access permissions; Apply a patient-directed mindset to data access to unlock innovation and improve data utility

Chair

Karla Childers, MS

Speaker

Panelist
Mary Gray, PHD

Panelist
Aaron Leibtag

Panelist
Sarah Chamberlin

Speakers

Sarah Chamberlin

Founder and Chief Program Officer, flok, United States

Sarah Chamberlin is Founder & Chief Program Officer of flok Health, a nonprofit advancing care and research for inherited metabolic disorders. She is a leader in patient-directed research and participatory data models, building community-powered data infrastructure that centers patient... Read More →

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Mary Gray

Senior Principal Researcher, Microsoft Research, United States

Mary L. Gray is a Senior Principal Researcher at Microsoft Research and a leading scholar of the social and ethical dimensions of data-driven AI systems. Trained as an anthropologist, her research examines how digital infrastructures shape labor, identity, and human rights. She leads... Read More →

Aaron Leibtag

CEO, Pentavere, Canada

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Ethics, Trust and Responsible Innovation
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation
Tags Forum

4:00pm EDT

#645: Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

108B

Component Type: Session
CE: ACPE 1.00 Application UAN: 0286-0000-26-631-L04-P; CME 1.00; RN 1.00

Speaker

Panelist
Lani Hashimoto

Panelist
Loriana Hernandez-Aldama

Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas
Robina Weermeijer

Panelist
Mitch Herndon, MPH

Speakers

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Loriana Hernandez-Aldama

Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup Media, United States

Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →

Mitch Herndon

Head, Patient Experience & Recruitment, UCB Biosciences, United States

Mitch Herndon leads a global team at UCB in meeting study enrollment and improving the experience of clinical study participants. Mitch has 29 years of experience in partnering with patients including at a pediatric clinic, patient organization, CRO and pharma. He has served in a... Read More →

Robina Weermeijer

Boehringer Ingelheim, Netherlands

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P; CME 1.00; RN 1.00

50,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.

Learning Objectives

Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs; Analyze how operational practices reflected RBQM and QbD principles without labels; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.

Chair

Leslie Sam

Speaker

Panelist
Lisa Collins

Speakers

Lisa Collins

Founder - Head Clinical Operations, Innomas Clinical Research (Africa), Nigeria

Lisa Ursella Collins is Co-Founder and CEO of Innomas Clinical Research and a global clinical operations and program leader. She works at the intersection of clinical execution, quality, and operational risk—translating development strategy into disciplined delivery. Through Innomas... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 09: RD-Quality-Compliance, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Session

4:00pm EDT

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P; CME 1.00; RN 1.00

Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas, consider market implications, and reflect on their roles in getting us there.

Learning Objectives

Evaluate three “big goals" for AI transformation of clinical development (eg, 10xing drugs reaching the market, eliminating human trial participants); Discuss the infrastructure implications of each goal (eg., with more drug candidates advancing, how will the system need to adapt?); Identify necessary, accompanying regulatory changes (eg, how will we meet increased demand for reviews?)

Chair

Morgan Hanger, MPA

Speaker

Panelist
Tala Fakhouri, PHD, MPH

Panelist
Henry Wei, MD

Panelist
Gabriel Westman, MD, PHD, MSC

Speakers

Tala Fakhouri

Vice President, AI & Digital Policy, Real-World Research, Parexel International, United States

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

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States

Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden

GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Development & Operations
Feature Topics Artificial Intelligence
Tags Forum

4:00pm EDT

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P; CME 1.00; RN 1.00

India’s recent regulatory, policy, and digital reforms are accelerating innovation, quality, and global collaboration. This town hall will highlight key updates shaping clinical research, medtech growth, and patient safety, and India’s rising global role.

Learning Objectives

Identify key regulatory, policy, and digital reforms transforming India’s healthcare and innovation ecosystem; Evaluate how updates in clinical trial rules, medical device policy, GMP standards, and data privacy impact global development; Identify opportunities for global collaboration and regulatory convergence enabled by India’s evolving frameworks.

Chair

Vivek Ahuja, MD

Speaker

Panelist
Marc Franklin

Panelist
Shahin Fesharaki

Panelist
Rajeev Singh Raghuvanshi

Speakers

Shahin Fesharaki

Chief Scientific Officer, Lupin, United States

Marc Franklin

CEO - North America, Cipla, United States

Vivek Ahuja, MD

Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India

Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive... Read More →

Rajeev Singh Raghuvanshi

Drug Controller General, Central Drugs Standard Control Organization, India

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 02: ClinicalTrialOps-Innovation, Forum | 07: RegCMC-Product Quality, Forum

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Clinical Development & Operations
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Forum

8:00am EDT

#710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities

Thursday June 18, 2026 8:00am - 9:00am EDT

107AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P; CME 1.00; RN 1.00

Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views, using FDA data to highlight global trends, compliance strategies, and harmonization, with insights on coverage of sites, sponsors, clinical research organizations (CROs), and regions.

Learning Objectives

Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites; Compare inspection approaches among regulators; Evaluate opportunities for harmonization and information sharing; Analyze industry strategies for global inspection readiness and compliance.

Chair

Kassa Ayalew, MD, MPH

Speaker

panelist
Thomas Haag

Panelist
Izumi Oba

Panelist
Jong-Hoon Lee, MD

Speakers

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew serves as the Division Director for the Division of Clinical Compliance Evaluation within the Office of Scientific Investigation at the FDA’s Center for Drug Evaluation and Research. In this role, he oversees the evaluation of the integrity of efficacy and safety... Read More →

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC, United States

Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →

Jong-Hoon Lee

Senior Physician, FDA, United States

Dr. Lee graduated from University of Virginia (BA; Charlottesville, VA) and Virginia Commonwealth University (MD; Richmond, VA), then completed internship at State University of New York at Syracuse (Internal Medicine; Syracuse, NY), residency at George Washington University (Anatomic... Read More →

Izumi Oba

Inspection Deupty Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Thursday June 18, 2026 8:00am - 9:00am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Forum

8:00am EDT

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

Thursday June 18, 2026 8:00am - 9:00am EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00

The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.

Learning Objectives

Identify the nuances while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.

Chair

Satrajit Roychoudhury, PHD

Speaker

Panelist
Xiaofei Wang, PHD

Panelist
Scott Berry, PHD

Panelist
Kannan Natarajan, PHD

Panelist
Pralay Mukhopadhyay, PHD

Speakers

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →

Pralay Mukhopadhyay

Vice President, Medicines Development Leader, Oncology R&D, GSK, United States

Dr. Mukhopadhyay has a proven track record in oncology drug development. He currently works as Vice President, Medicine Development Leader at GlaxoSmithKline. Over the years, he has made significant contributions in the development of several anti-cancer agents in both hematologic... Read More →

Kannan Natarajan

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States

Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides... Read More →

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States

Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →

Xiaofei Wang

Professor, Biostatistics & Bioinformatics, Duke University Medical Center, United States

Xiaofei Wang is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Statistics at the Alliance Statistics and Data Management Center. He received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2003... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Evidence Innovation
Tags Forum

DIA 2026 Global Annual Meeting

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