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Wednesday, June 17
 

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
avatar for Bruce Levine

Bruce Levine

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

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 →
avatar for Bradley Watts

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

10:15am EDT

#601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets
Wednesday June 17, 2026 10:15am - 11:30am EDT
Component Type: Session
Level: Advanced

This session takes participants inside the investor’s mind in today’s complex funding environment. Investors and financial leaders will discuss how they evaluate pipelines, platforms, and partnerships, where they look for differentiated deal flow, how valuation frameworks are changing, and what ultimately convinces them to lean in—or pass.

Learning Objectives

Explain how current biotech investors evaluate pipelines, platforms, and partnerships in today’s funding climate; Describe how valuation frameworks, risk appetite, and evidence expectations are evolving across stages and modalities; Identify what ultimately convinces investors to engage, lean in, or pass and how companies can position themselves accordingly.

Chair

Raju Kucherlapati

Speaker

Panelist
Jay Roberts, MBA

Panelist
Sahirzeeshan Ali

Panelist
Mey Boukenna, MD, PHD


Speakers
avatar for Sahirzeeshan Ali

Sahirzeeshan Ali

Founder and General Partner, Modi Ventures, United States
Sahir Ali is the founder of Modi Ventures, a venture capital firm at the forefront of investing in the convergence of biology and technology. With a focus on scientific superintelligence and the engineering of life, he has backed breakthrough companies advancing AI-driven drug discovery... Read More →
MB

Mey Boukenna

Partner, Life Sciences & Healthcare Investments, PagsGroup, United States
Mey Boukenna, M.D., Ph.D., leads Biotechnology and Healthcare Investments at PagsGroup, Steve Pagliuca’s family office. She transitioned to investments after starting her career in medicine and research at the University of Bern, Switzerland. There, she conducted a few years of... Read More →
avatar for Raju Kucherlapati

Raju Kucherlapati

Paul C. Cabot Professor of Genetics and Professor of Medicine, Harvard Medical School, United States
Since 2001 Dr. Kucherlapati is the Paul C. Cabot Professor of Genetics and Professor of Medicine at Harvard Medical School and was the first Scientific Director of the Harvard Medical School-Partners HealthCare Center for Genetics and Genomics (HPCGG). He was a co-founder of several... Read More →
avatar for Jay Roberts

Jay Roberts

Partner, Ventac Partners, United States
Senior strategic executive in the biopharma industry for over 30 yrs. Serving as an Executive Advisor for Life365, a next generation AI platform connecting patients and providers. Also serves as a Partner with Ventac Partners, a global venture catalyst in life sciences and a Venture... Read More →
Wednesday June 17, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

1:45pm EDT

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P; CME 1.00; RN 1.00

Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks.

Learning Objectives

Evaluate current global regulatory frameworks for E&L assessment in complex generic products; Analyze risk-based approaches for leachable impurity control across different jurisdictions; Synthesize harmonization opportunities to streamline product development and regulatory submissions.

Chair

Allison Radwick

Speaker

Panelist
Chaitanya Koduri, DDS, MHS

Panelist
Karthik Balasubramanian, PHD, MS

Panelist
James Wabby, MHS

Panelist
Ji Guo, PHD


Speakers
avatar for Karthik Balasubramanian

Karthik Balasubramanian

Dir Project/Program Management, External Manufacturing, Teva Pharmaceuticals, United States
Dr. Karthik Balasubramanian, Ph.D is Director, Program and Project Management at Teva Pharmaceuticals. He has over 20 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in... Read More →
JG

Ji Guo

Chemist, OPQ, CDER, FDA, United States
Dr. Ji Guo is a chemist in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Office of Pharmaceutical Quality (OPQ) at the FDA's Center for Drug Evaluation and Research (CDER). Her work encompasses scientific review of drug quality issues, policy analysis, and collaboration... Read More →
avatar for Chaitanya Koduri

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

1:45pm EDT

#629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
Component Type: Session
Level: Intermediate

This candid panel looks inside notable biotech breakthroughs to explore what “success” really takes beyond the headlines. Through case studies from leading venture groups and founders, speakers will unpack key decisions, near misses, pivots, and partnership strategies, translating them into practical lessons for emerging companies and their partners.

Learning Objectives

Describe the strategic and operational decisions that shape successful biotech trajectories from idea to inflection point; Analyze real-world case studies to identify patterns in pivots, near misses, financing, and partnership strategies; Translate investor and founder perspectives into practical lessons for emerging companies and their partners.

Chair

Robert Tepper

Speaker

Panelist
Abbie Celniker, PHD

Panelist
Gabriela Apiou, PHD


Speakers
avatar for Gabriela Apiou

Gabriela Apiou

Investigator, Assitant Professor (M), Massachusetts General Hospital, United States
Gabriela Apiou, PhD, is an Assistant Professor of Dermatology at Massachusetts General Hospital (MGH) and Harvard Medical School, the inaugural Endowed MGH Research Institute Chair in Translational Sciences, and Director of the MGH Wellman Center for Photomedicine’s Translational... Read More →
AC

Abbie Celniker

Partner, Third Rock Ventures, United States
avatar for Robert Tepper

Robert Tepper

Co-founder and Partner, Third Rock Ventures, United States
Bob Tepper is a co-founder and Partner of Third Rock Ventures and a distinguished physician-scientist with more than 30 years of experience building and operating leading research and development organizations in the biotech industry. Bob focuses on the formation, development, and... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   18: Lift-Series, Session

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
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
 
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