• June 3-6, 2024
  • San Diego Convention Center, California

Sessions

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Preparing for Platforms: Sponsor and Regulator Perspectives on the Platform Technology Designation (PTD)

Tuesday, June 04, 2024
Breakout Session
Cell and Gene Therapy and Genome Editing
31AB
Section 2503 of the 2022 Food and Drug Omnibus Reform Act (FDORA) outlines the establishment of a designation program for platform technologies, with an associated draft guidance to be published shortly. This program will grant sponsors the right to leverage previously submitted data for an approved product that meets the definition of platform technology and receives the designation. In this session, sponsors across a range of therapeutic modalities (including CGTs, vaccines, and small molecule/biologics) will share their initial reactions to the platform guidance and how they envision the program can best streamline development of innovative platform products. Sponsors will also share what other considerations they hope to see included in the final guidance and during the designation's rollout.
Moderator
Dylan Bechtle, MS
US Regulatory Policy Lead
Johnson & Johnson
Speakers
Snehal Naik, PhD
Head of Regulatory Policy
Spark Therapeutics
Carla Vinals, PhD
Head Regulatory Strategy for Infectious Diseases
Moderna Therapeutics
Rob Berlin, JD
Head US Regulatory Policy
GSK
Anne-Virginie Eggimann
Chief Regulatory Officer
Tessera Therapuetics
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