The Changing Environment Around Accelerated Approvals and Regulatory Pathways
PharmaTalkRadio
English - October 07, 2022 12:00 - 21 minutes - 19.1 MB - ★★★★ - 16 ratingsScience pharmaceutical biotech clinical trials patient engagement immuno-oncology drug delivery r&d Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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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 meetingsHow these trends and pathways affect trial designImplications after approval based on the pathway
Speakers:
Edith Perez, MD, CMO, Bolt BiotherapeuticsJeffrey Bornstein, MD, CMO, Eledon PharmaceuticalsAmy Blawas, PhD, Principal Consultant, NDA Group