Program

The Policy Summit brings together policymakers, industry leaders, and science stakeholders to discuss emerging issues in the cell and gene therapy field and explore innovative solutions. You’ll connect with experts in the field in an environment designed for meaningful discussion and collaboration. This dynamic 1.5-day event includes fireside chats with leaders in the field, in-person networking opportunities, expert-led presentations, and audience Q&A. 

Register to join us in Washington, D.C.

Thursday September 25, 2025  

All times are in ET

9 – 9:05 a.m. ET - Policy Summit Opening Remarks 

• Snehal Naik, PhD,  ASGCT Regulatory Affairs Committee Chair   

9:05 – 10:20 a.m. ET - European Value Assessment and Payment Systems for CGTs  

• Francis Pang, Orchard Therapeutics 
  Industry Perspective on European Valuation and Payment Systems 

• Damjan Osredkar, MD, PhD, University Medical Centre Ljubljana 
  Patient Advocate Perspective on European Valuation and Payment Systems 

10:20 – 10:50 am.. ET - Networking Break  

10:50 – 11:50 a.m. ET - Development Pathways for Rare Disease Therapies 

• Helen Heslop, MD, Baylor College of Medicine 
  Exploring Alternative Development Pathways: The Access 4 Kids Approach  

• Moderator: Terence Flotte, MD, UMass Chan Medical School 

11:50 a.m. – 12:35 p.m. ET - Session to be Announced 

12:35 – 1:35 p.m. ET - Lunch 

Session 5 – 1:35 – 2:30 p.m. ET - Addressing CGT Bottlenecks: Focus on Clinical Care 

• Moderator: Susan Matesanz, MD, Children’s Hospital of Philadelphia 

2:30 – 3:00 pm.. ET - Focus on Capitol Hill: Bipartisan Congressional Staff Chat 

• Moderator: Margarita Valdez Martínez, ASGCT 

3 – 3:30 p.m. - Networking Break 

3:30 – 4:15 p.m. ET - Session to be Announced 

4:15 – 5 p.m. ET - Session to be Announced 

5 – 6:30 p.m. ET - Networking Reception 

Friday September 26, 2025 

9– 9:45 a.m. ET - Session to be Announced 

9:45 – 10:30 a.m. ET - Artificial Intelligence for Genetic Medicine Development 

• Moderator: Barrett Tenbarge, JD, Faegre Drinker 

10:30 – 11 a.m. ET - Networking Break 

11 a.m. – 12 p.m. ET - Regulatory Harmonization to Address CMC Challenges 

• Kathleen Francissen, PhD, Genentech 
  The ICH Cell & Gene Therapy Discussion Group: Overview and Updates 

• Sadik Kassim, PhD, Danaher Genomic Medicines  
  Harmonization of CMC Standards for ‘N of 1’ and ‘N of Few’ Patients 

• Bryan Shy, MD, PhD, University of California San Francisco 
  Harmonizing Requirements for Starting Biological Materials 

Check back on this page and subscribe to ASGCT’s The Advocate newsletter for agenda updates as speakers are confirmed.  

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ASGCT is a 501(c)3 tax-exempt organization and does not participate in any political activity, either directly or indirectly, including support for or against campaigns for public office. The participation of speaker(s) who are elected officials, members of their staff, members of the governing administration, and/or former members of these offices (“government officials”), does not indicate support for or against any political party, political party agenda, or candidate for public office. Any government official who is also a speaker at an ASGCT-sponsored event is permitted to discuss topics related exclusively to the mission of the Society and is expressly prohibited from discussing any campaign for public office or other political activity.