Gene Therapy: CMC & Regulatory Summit

Cowen’s Gene Therapy Summit is a virtual event focused on the gene therapy clinical development space, with a focus on the current state of the regulatory landscape. Panel topics will include:

  • FDA/CBER’s approach to gene therapy reviews given the ongoing COVID pandemic
  • Current and potentially changing requirements for pivotal clinical datasets
  • The current state of gene therapy CMC standards
  • The role and contribution of patient-focused drug development in gene therapy reviews and access.

Cowen is partnering with the EveryLife Foundation for Rare Diseases, a 501(c)(3) nonprofit, nonpartisan organization dedicated to empowering the rare disease patient community to advocate for impactful, science-driven legislation and policy that advances the equitable development of and access to lifesaving diagnoses, treatments and cures.

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