Policy Summit

Featured at the Policy Summit: The Future of CGT Manufacturing

Discuss Sept. 18-19 - September 08, 2023

The future of CGT access lies in efficient development and manufacturing—here's how regulatory bodies like the FDA are tackling the relevant challenges. Register today to be part of this and more discussions with top CGT decision makers, Sept. 18-19 (virtually + in-person in Washington, DC)! 

Cell and gene therapies (CGTs) hold immense promise for patients, but their transformative potential can be hindered by the manifold challenges of manufacturing, scaling up, and meeting regulatory requirements. In navigating these realities, regulatory bodies like the FDA are actively engaged in developing manufacturing pathways and programs to standardize processes while recognizing the unique complexities of CGT manufacturing.

The CGT Manufacturing: Policy Realities session at the Policy Summit will highlight current efforts to overcome today’s challenges and help patients realize the full potential of CGTs, including:

  • Key Manufacturing Challenges and Future Pathways
  • FDA's CMC Development & Readiness Program (CDRP)
  • The Advanced Manufacturing Technology (AMT) Designation

Join on Sept. 18, 3-4:30 p.m. ET, virtually or in Washington, DC, to discuss the following: 

  • "Overview of Manufacturing Considerations for CGTs: Key Challenges and Future Pathways" with Kim Benton, PhD, Dark Horse Consulting 

  • "The Advanced Manufacturing Technology Designation: Application and Challenges for CGTs" 
    with Kit Shaw, PhD, Boston Children’s Hospital 

  • "FDA's CMC Development & Readiness Program (CDRP): Background and Goals for the Agency and Industry" with Anne-Virginie Eggiman, PhD, Tessera Therapeutics 

  • "Cell Therapy Manufacturing Challenges" with John Tomtishen, Cellares 

  • Moderator: Katy Spink, PhD, Dark Horse Consulting 

Register for the Policy Summit View Full Agenda


ASGCT's Policy Summit connects you with policy and industry leaders in the field where you'll learn from a variety of stakeholder perspectives and how they inform regulatory, legislative, and payment policies that impact gene and cell therapy development. Join us virtually or in person!

In-person registration will be extremely limited - so register today to secure your spot in Washington, D.C.!


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