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The Changing Environment Around Accelerated Approvals and Regulatory Pathways

  • Broadcast in Science
Pharma Talk Radio

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In this session recorded at CMO Summit 2022, panelists share strategy trends and opportunities around accelerated approvals and regulatory designations. Additionally, they discuss:

  • How to approach the FDA based on the different types of meetings
  • How these trends and pathways affect trial design
  • Implications after approval based on the pathway

Speakers:

  • Edith Perez, MD, CMO, Bolt Biotherapeutics
  • Jeffrey Bornstein, MD, CMO, Eledon Pharmaceuticals
  • Amy Blawas, PhD, Principal Consultant, NDA Group

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