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Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation
Session Chair(s)
Akanksha Kaushal, MS
Director, Science and Regulatory Advocacy
PhRMA, United States
This session will explore scientific and regulatory considerations unique to cell and gene therapies (CGTs), emphasizing the urgent need for harmonization among health authorities globally. Participants will discuss regulatory challenges and examine opportunities for regulatory collaboration, including harmonization efforts led by the ICH Cell and Gene Therapy Discussion Group. The session will also cover recent efforts by regulatory authorities to streamline expectations for CGT manufacturing, showcasing best practices and flexible regulatory strategies that support faster development. Attendees will gain an understanding of current collaborative efforts and policy innovations shaping the future of CGTs worldwide.
Learning Objective : Analyze global regulatory considerations and opportunities posed by current frameworks for cell and gene therapy products to drive innovation and increase patient access to medicines; Discuss work under international organizations, such as ICH, to align regulatory expectations and harmonize technical requirements; Evaluate recent regulatory approaches and best practices designed to streamline CGT manufacturing, and recognize policy initiatives shaping the advancement of CGTs.
Speaker(s)
EMA’s role in Transforming CGT Innovation and Access
Representative Invited
European Medicines Agency, Netherlands
Industry Perspective on Driving Regulatory Alignment: Analyzing Regulatory Challenges and Identifying Needs and Opportunities for Convergence
D. Allen Callaway, MBA, MS
Johnson and Johnson, United States
Associate Director - Global Regulatory Affairs CMC
ICH Harmonization Efforts- The Cell and Gene Therapy Discussion Group
Lesbeth Caridad Rodriguez, MS
Bayer, United States
Director, Regulatory Affairs Policy and Science
FDA Initiatives to Streamline CGT Manufacturing to Accelerate Development
Andrew Byrnes, PHD
FDA, United States
Director, Division of Gene Therapy 1, CBER
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