DIA 2026 Global Annual Meeting: Full Schedule

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8:00am EDT

#600: From Breakthrough to Life: Engineered T-Cells, Patients, and the Future of Biotech

Wednesday June 17, 2026 8:00am - 9:00am EDT

Component Type: Session
Level: Intermediate

Following a keynote presentation by Bruce Levine on the future of genetically engineered T-cells for human therapeutics, sit down with Bruce and Brad Watts for a fireside chat. Through scientific, policy, and patient lenses, the session will examine what it takes to translate high-risk science into sustainable therapies, and what that implies for regulators, payers, sponsors, and technology partners.

Learning Objectives

Describe how advances in engineered T-cells, including CAR-T, are reshaping expectations for cancer treatment and the broader pipeline; Identify scientific, regulatory, and system conditions needed to translate high-risk engineered innovations into equitable, scalable patient benefit; Discuss how real patient and family experiences inform future strategies for regulators, payers, sponsors, researchers, and technology partners developing next-generation cell therapies.

Chair

Katie Truong

Speaker

Panelist
Bradley Watts

Plenary Presenter
Bruce Levine

Speakers

Bruce Levine

Barabara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine at the University of Pennsylvania, United States

Katie Truong

SVP & Managing Director, DIA Americas and Global Head of Business Operations, DIA, United States

Katie Truong is the Senior Vice President & Managing Director of DIA Americas and the Global Head of Business Operations. In her role, Katie focuses on driving growth, optimizing operations, and enhancing business performance. With experience spanning various industries, including... Read More →

Bradley Watts

Patient/Industry Advocate and Vice President, Business Development Executive, Emily Whitehead Foundation and Conner Strong & Buckelew, United States

Brad Watts is a cancer survivor and CAR-T therapy recipient, Brad is an active advocate with The Emily Whitehead Foundation and Blood Cancer United, and is a member of Act for Hope, which is working to expand patient access by collaborating across the healthcare ecosystem. Drawing... Read More →

Wednesday June 17, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Therapeutic Pathways, Student and Early Career Pathway
Level Intermediate
format csv
Interest Area Clinical Development & Operations,Rare Disease & Special Populations
Feature Topics Biotech-ClinTech-Pathway,Therapeutic Pathways,Student and Early Career Pathway
Tags Session

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

1:45pm EDT

#636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access

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

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-625-L04-P; CME 1.00; RN 1.00

This panel will explore how patient advocacy can shape regulatory strategy, trial design, and access planning for autoimmune cell and gene therapies as they move toward future approvals.

Learning Objectives

Identify how patient advocacy can shape regulatory strategy and access for future autoimmune CGTs; Describe approaches to incorporating patient priorities such as quality of life and treatment burden into trial design; Discuss strategies to ensure equitable and sustainable patient access.

Chair

Samantha Roberts, PHD

Speaker

Perspectives from the Myositis Community
Paula Eichenbrenner, MBA

Patient Perspective
Joy Buie, BSN, PHD, MS, RN

Patient advocacy perspective
Brian Kennedy

FDA perspective
Vijay Kumar

Speakers

Joy Buie

Vice President of Research, Lupus Foundation of America, United States

Dr. Joy Buie is a nurse-scientist and leader advancing patient-centered innovation in autoimmune disease, particularly lupus. She leads strategic research initiatives that integrate real-world and patient experience data into clinical development, regulatory decision-making, and therapeutic... Read More →

Paula Eichenbrenner

Executive Director, The Myositis Association, United States

Brian Kennedy

Executive Director, Global Alliance for Patient Access, United States

Vijay Kumar

Acting Director OTP/CBER, FDA, United States

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States

Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Therapeutic Pathways
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

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 →

Dennis Akkaya

Corporate Development, My Tomorrows, United States

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 →

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