Explore Patient-Focused Development at the Policy Summit

At the session Considerations for Patient-focused Development, incorporate patient perspectives and the principles of Patient-focused Drug Development (PFDD) for cell and gene therapies. Discuss the role of patient input in developing novel endpoints for CGTs, patient preference studies in regulatory development and decision-making, and what patient advocates want regulators and product developers to know.

Join this conversation with our panel of experts and patient advocates:

• Anne Rowzee, PhD (FDA CBER Office of Therapeutic Products)
• Mary Booth Dwight (Cystic Fibrosis Foundation)  
• Snehal Naik, PhD (Spark Therapeutics)
• Juan Marcos Gonzalez Sepulveda, PhD (Duke University) 
• Rasika Kalamegham, PhD (Genentech )

For many cell and gene therapy products (CGTs), FDA approval is only the beginning. The post-commercialization space for CGTs has faced reimbursement challenges, site of care disputes, and coverage delays. Catch the session Patient Access to CGTs: Realities on the Ground to uncover the unique considerations for CGTs, learn about the current state of health system readiness for approved products, and contribute to the dialogue on ensuring equitable care.

Join this conversation with our panel of experts and patient advocates:

• Kelly Maynard (Little Hercules Foundation)
• Michael Storey, PharmD (Nationwide Children’s Hospital)
• Beth Halpern, JD (Hogan Lovells)
• John Feore, JD (Institute for Gene Therapy)
• Diane Berry, PhD (Sarepta Therapeutics)

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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