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Wednesday, June 17
 

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
PV

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

#609: Decision Under Uncertainty
Wednesday June 17, 2026 10:15am - 11:30am EDT
203AB
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-603-L04-P; CME 1.25; PDU 1.25 PMI 2166LODLKY; RN 1.25

In this interactive workshop, participants will participate in an interactive, case-based racing simulation that places participants in a high-pressure “go/no-go” decision before the most important race of the season. This is one of Harvard's case studies most commonly used in business school programs. In this simulation, participants decide whether to race in a high-stakes event, balancing technical risks, financial pressures, and limited data, highlighting decision-making under uncertainty. The exercise addresses key issues in decision-making under uncertainty and bias without awareness under time and stakeholder pressure. Upon conclusion of the exercise, participants report increased awareness of decision drivers, stronger analytical skills, and strategies to mitigate bias.

Learning Objectives

Demonstrate teamwork and communication under time constraints; Identify biases when making decisions under financial pressure; Assess technical, financial, and reputational risks in complex business situations.

Chair

Valerie Huh, PHARMD, MBA

Speaker

Decision under uncertainty
Dave Bezick, RN


Speakers
avatar for Dave Bezick

Dave Bezick

Vice President, Medical Information, Propharma, United States
Dave brings over 17 years of Medical Information Contact Center Management and Operations experience. A licensed Registered Nurse, he began his career as a front-line Medical Information Specialist and has continually advanced into roles of increasing responsibility within the Medical... Read More →
avatar for Valerie Huh

Valerie Huh

Director, Global Innovation and Implementation, Propharma, United States
Valerie Huh has over 21 years of experience in the pharmaceutical, healthcare, and education sectors, with more than 11 years specializing in Contact Center and Medical Information Process Improvement. She holds a Pharm.D and an MBA and is passionate about leveraging advanced technology... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

10:15am EDT

#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability
Wednesday June 17, 2026 10:15am - 11:30am EDT
105AB
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-604-L04-P; CME 1.25; PDU 1.25 PMI 2166GIDLXI; RN 1.25

Link common team dysfunction signals with a practical mapping method to uncover hidden beliefs and routines. Learn small, safe-to-learn experiments and simple indicators to build trust, enable healthy debate, and strengthen accountability.

Learning Objectives

Diagnose how common dysfunction signals relate to hidden beliefs and protective routines in team culture; Apply a step-by-step, unbranded mapping method to translate dynamics like low trust or weak accountability into testable insights; Design small, safe-to-learn experiments with lightweight indicators to build trust, productive debate, commitment, and accountability.

Chair

John Z. Sun, PHD, MBA, PMP

Speaker

Panelist
Jeremy Jokinen, MS

Panelist
Sarah Tremethick

Panelist
John Dobbins, MS

Panelist
Jessie Li


Speakers
avatar for John Dobbins

John Dobbins

Senior Manager, External Engagement, TransCelerate BioPharma Inc., United States
John Dobbins is an experienced change management practitioner and former educator. John is currently a senior manager of external engagement at TransCelerate BioPharma Inc., a collaborative biopharma consortium. In his day-to-day role, John supports TransCelerate's portfolio in its... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President Global Patient Safety, Argenx, United States
Jeremy Jokinen is the Vice President and Head of Global Patient Safety at argenx. He has more than 25 years of experience in the pharmaceutical industry, having held roles at Abbott Laboratories, Johnson & Johnson, AbbVie, and Bristol Myers Squibb. Jeremy has led numerous cross-industry... Read More →
avatar for Jessie Li

Jessie Li

Director of Project Delivery, Fifth Quadrant, United States
Jessie Li is the Director of Project Delivery at Fifth Quadrant, where she leads the design and execution of professional programs that foster collaboration, knowledge exchange, and innovative thinking among professionals and organizations. She brings extensive experience in clinical... Read More →
avatar for John Sun

John Sun

Program Lead, Portfolio, Strategy & Operations, CRM DU, Development, Novartis, United States
John is a Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively volunteered... Read More →
avatar for Sarah Tremethick

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 →
Wednesday June 17, 2026 10:15am - 11:30am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

10:15am EDT

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact
Wednesday June 17, 2026 10:15am - 11:30am EDT
204AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-607-L04-P; CME 1.25; RN 1.25

The FDA Commissioner's National Priority Voucher (CNPV) program represents a novel regulatory mechanism designed to accelerate the development and review of drugs addressing critical public health priorities. This session provides a comprehensive analysis

Learning Objectives

Discuss the fundamental framework and eligibility criteria of the CNPV program; Analyze real implementation challenges and successful strategies; Evaluate the program's impact on expediting critical drug development and public health priorities.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Emel Mashaki Ceyhan

Panelist
Lawrence Eugene Liberti, RAC

Panelist
Kellie Taylor


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
EM

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey
avatar for Elizabeth Lange

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
avatar for Lawrence Liberti

Lawrence Liberti

Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he served as the Executive Director of CIRS. He is the Director of the DK Kim International (USC DRQS) and has been actively involved in promulgating... Read More →
MM

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States
KT

Kellie Taylor

VP, CMC Regulatory Affairs, Regeneron Pharmaceuticals, United States
Wednesday June 17, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

4:00pm EDT

#646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
109AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-633-L04-P; CME 1.00; RN 1.00

Siloed data stifles advancements in AI-powered drug discovery. Federated computing (FC) provides a secure, privacy-preserving, decentralized approach that enables AI-model sharing, fine-tuning and inference - moving AI demos to real-world applications.

Learning Objectives

Define Federated Computing and its related components; Examine traditional data centralization methods with decentralized federated approaches; Identify use cases for Federated AI in drug discovery and development.

Chair

Ittai Dayan, MD, MPH

Speaker

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Jonathan Gilbert

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Nadia Harhen

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Kyle Tretina


Speakers
avatar for Ittai Dayan

Ittai Dayan

CEO, Rhino Federated Computing, United States
Dr. Ittai Dayan is the Co-Founder and CEO of Rhino Federated Computing, a company transforming the way data is used for creating and deploying Artificial Intelligence solutions in regulated industries. A pioneer of bringing privacy preservation technologies into regulated industries... Read More →
JG

Jonathan Gilbert

Senior Director, Ecosystem Growth and Contributor Partnerships, Eli Lilly and Company, United States
NH

Nadia Harhen

General Manager, AI Simulation, SandboxAQ, United States
KT

Kyle Tretina

Product Marketing Lead, NVIDIA, United States
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Forum

4:00pm EDT

#649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
119AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-635-L04-P; CME 1.00; RN 1.00

Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Speakers across patient advocacy, clinical research, and medical ethics examine the social conception of long-term follow-up, its challenges, and practical solutions for sustainable participation and evidence generation.

Learning Objectives

Identify scientific, operational and regulatory factors driving the growing significance of long-term follow-up (LTFU) in gene therapy; Compare stakeholder challenges and solutions in sustaining LTFU participation and data quality for gene therapy programs; Evaluate strategies to strengthen accountability and align incentives to ensure sustained LTFU participation.

Chair

Alen Agaronov, DRSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Dennis Akkaya

Panelist
Carolyn Riley Chapman, PHD


Speakers
avatar for Alen Agaronov

Alen Agaronov

Independent, United States
Alen Agaronov ScD is a social scientist, bioethicist, and business ethicist focusing on new medical technologies and patient advocacy and engagement. He holds a doctoral degree in Social & Behavioral Sciences from the Harvard T.H. Chan School of Public Health and completed postdoctoral... Read More →
avatar for Dennis Akkaya

Dennis Akkaya

Corporate Development, My Tomorrows, United States
avatar for Carolyn Chapman

Carolyn Chapman

Independent Consultant, Freelance, United States
Dr. Chapman is currently an Independent Consultant at the intersections of pharmaceutical development, genetic technologies, policy, ethics, and strategy. Previously, she directed the CGT project at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital (BWH) and... Read More →
avatar for Patricia Furlong

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States
Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Forum

4:00pm EDT

#650: Leading for Growth: Unlocking Individual Potential in Your Team
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: Workshop
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-657-L04-P; CME 1.00; PDU 1.00 PMI 2166FWL0S0; RN 1.00

This workshop equips leaders at all levels with adaptable, evidence-based tools to meet diverse team needs, boost motivation and performance, and strengthen retention through interactive discussions and hands-on activities.

Learning Objectives

Identify and adapt leadership practices to different employee needs, backgrounds, and motivations; Discuss personalized growth opportunities that align with organizational goals; Demonstrate coaching and feedback skills that empower employees to own their growth journey.

Chair

Jennifer Kim, PHD

Speaker

Removing siloes and increasing information transparency in interdependent teams
Tamei Elliott, MS

Which inclusive leadership behavior matters the most for improving employee outcomes?
Elizabeth Lange, MPH, MS


Speakers
avatar for Tamei Elliott

Tamei Elliott

Director, Global Scientific Content, DIA, United States
Tamei Elliott, MS, is the Director of Global Scientific Content at the Drug Information Association (DIA). She leads DIA’s global scientific content strategy, ensuring alignment with regulatory priorities, industry trends, and evolving stakeholder needs across regions. She also... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Behavioral Scientist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on addressing health and work disparities in drug development, examining strategies and interventions that can... Read More →
avatar for Elizabeth Lange

Elizabeth Lange

Executive Director/ Head of Regulatory Scientific Policy, EMD Serono, United States
Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →
avatar for Elizabeth Rosenkrands-Lange

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States
Elizabeth Rosenkrands Lange is an experienced R&D policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency and... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Tags Workshop

4:00pm EDT

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00

Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.

Learning Objectives

Demonstrate the need for a continuous approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development

Chair

Claudia Ana Ianos, MD

Speaker

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD


Speakers
avatar for Megan Aragon

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States
Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer, United States
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →
avatar for Bennett Levitan

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States
Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →
DM

Diana Morgenstern

Head, Real World Evidence and Outcomes Research, Viatris, United States
Diana Morgenstern, MD, FACP is a general internist whose varied career includes depth and breadth in clinical practice, medical education, and strategic approaches to pharmaceutical industry medical affairs, including real world evidence generation to address care gaps. Dr. Morgenstern... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm EDT

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P; CME 1.00; RN 1.00

This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.

Learning Objectives

Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry, focusing on practical applications such as structured authoring of audit reports, Generative AI validation frameworks, and AI-powered chatbots for knowledge management; Discuss the challenges, user experiences, cost efficiency, and compliance considerations involved in integrating AI into regulated environments.

Chair

Oliver Fink, MS

Speaker

Framework for computer system validation of Gen AI
Haleh Valian, PHD

Regulators expecatations and insights into Gen AI
Karen Bleich, MD

Gen AI-powered structured authoring for audit reports
Srilatha Endabetla, MS


Speakers
KB

Karen Bleich

Lead Physician, OMP, CDER, FDA, United States
Dr. Bleich is a Lead Physician in the Division of Clinical Trial Quality and a member of the AI team within the Office of Medical Policy (OMP), CDER, FDA. In these roles, she drives clinical research quality and innovation through the development of medical policy programs and strategic... Read More →
SE

Srilatha Endabetla

Senior Director, Business Intelligence - Global Quality, Bristol Myers Squibb, United States
Srilatha Endabetla is a senior leader driving Business Intelligence and Digital & Data Strategies for Global Quality, with over 30 years of experience in digital transformation, data analytics, and data governance in the pharmaceutical industry. She has spent 23 years at Bristol Myers... Read More →
avatar for Oliver Fink

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim, Germany
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →
Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   03: Data-Tech-AI, Session
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Feature Topics Artificial Intelligence
  • Tags Session
 
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DIA 2026 Global Annual Meeting
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
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  • 05: PersonalizedMed-ComboProd-Diagnostics
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