DIA 2026 Global Annual Meeting: Full Schedule

arrow_back View All Dates

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures

Monday June 15, 2026 8:00am - 10:00am EDT

Component Type: Session
Level: Intermediate

This opening plenary explores how patient driven science, AI enabled discovery, and regulatory innovation can uncover “hidden cures” in the medicines and data we already have. Through a keynote from David Fajgenbaum and a panel on AI in biopharma, the session asks how we can find, trust, and deliver tomorrow’s cures from today’s science.

Learning Objectives

Describe the latent potential of existing medicines and data, and how patient driven science can uncover new uses for known therapies; Explain how AI and advanced analytics can de risk drug discovery and trial design, surfacing overlooked opportunities and improving investment decisions; Identify system level levers: collaboration, regulation, and capital, that can help translate today’s science into tomorrow’s cures more quickly, safely, and equitably.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Lawrence Tallon

Panelist
David Pfeiffer

Panelist
Greg Sarafin

Panelist
Rahul Gupta, MD, MBA, MPH

Panelist
David Fajgenbaum

Panelist
Audrey Greenberg, CPA, MBA

Speakers

David Fajgenbaum

Co-Founder & President of Every Cure, Every Cure, United States

Audrey Greenberg

Mayo Clinic, Venture Partner and Chair, Mayo Ventures, United States

Rahul Gupta

President, GATC Health, United States

Dr. Gupta was appointed President of GATC Health, a tech-bio company advancing drug discovery and development, in February 2025. He previously served as Director of the White House Office of National Drug Control Policy (ONDCP) from 2021 to January 2025—the first physician to lead... Read More →

David Pfeiffer

SVP, Head of ARCAS, Bio-Tech, Acrisure Re, United States

Greg Sarafin

Chief Administrative Officer, Sovereign AI, United States

Greg Sarafin is the Chief Administrative Officer of Sovereign AI where he oversees corporate functions, capital, partnerships, and vendors. Sovereign AI is a vertically integrated, country-first AI infrastructure and platform designed to support governments, regulated industries... Read More →

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

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 →

Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 05: PersonalizedMed-ComboProd-Diagnostics, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Interest Area Health Technology & AI,Biotechnology & Investors
Feature Topics Digital Enablement and Modernization
Tags Session

11:00am EDT

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics

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

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P; CME 1.25; RN 1.25

In this session, we will address the challenges of conducting clinical research in Europe under IVDR and CTR, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.

Learning Objectives

Explain the key principles involved in biomarker-driven approvals; Describe the role of in vitro diagnostics; Identify the types of detailed information required in applications to meet regulatory expectations for biomarker-guided medicinal products.

Chair

Ana Trullas, PHARMD, MSC

Speaker

Building Bridges, Not Silos: Lilly's IVDR-Driven Transformation
Lauren Tobe, JD

tbd. In vitro biomarker tests for patient selection for efficacy
Martin Mengel

Companion Diagnostics and Medicinal Products: A notified Body perspective on Co-development under IVDR
Rolf Thermann, PHD

Combined studies in the EU- overview and considerations for industry
Joshua D Levin, MA

Speakers

Joshua Levin

Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK, United States

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany

Rolf Thermann

Section Manager IVD, Companion Diagnostics lead, TÜV Rheinland, Germany

Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development... Read More →

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands

Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →

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

05: PersonalizedMed-ComboProd-Diagnostics, Session

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

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes

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

116

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00

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

Learning Objectives

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

Chair

Rachele Hendricks-Sturrup, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS

Speakers

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France

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

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States

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

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States

Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →

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

05: PersonalizedMed-ComboProd-Diagnostics, Session | 03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session