Meet the Experts Behind the Planning for Accelerated Approval Webinar

Thank you for tuning in to our webinar, Planning for Accelerated Approval: Timing is Everything.

 
Accelerated approval remains an important pathway for therapies addressing serious conditions and unmet medical needs. But evolving FDA expectations mean sponsors must plan earlier and take a coordinated approach across clinical development, regulatory strategy, operations, confirmatory trials, and CMC.
 
Success requires cross-functional alignment and a development strategy that anticipates potential challenges before they become roadblocks.
 

Our experts will guide you toward success. We can help you:

  • Navigate recent changes to the accelerated approval pathway
  • Align clinical and regulatory strategy early
  • Design confirmatory trials ahead of submission
  • Strengthen operational and inspection readiness
  • Integrate CMC considerations into development planning

Meet Our Experts:

seth_depuy

Seth DePuy, Ph.D.

Sr. Director, Regulatory & Product Strategy

Paulla Dennis

Executive Director, Program Strategy, Rare Disease, Pediatrics, Cell and Gene Therapy

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