Rare Disease Drug Commercialization With Zevra Therapeutics' Neil McFarlane
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On this week's episode of the Business of Biotech, Neil McFarlane, CEO at Zevra Therapeutics, talks about transitioning to a focused rare disease company through acquisitions, and building out a commercial organization. Neil explains the importance of working with rare disease patient advocacy groups, using AI to analyze electronic health records and claims data to identify and diagnose patients with Niemann-Pick disease type C, and adapting to regulatory inconsistencies around rare disease drug approval frameworks in the U.S. and Europe.
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- 0:00Welcome And What’s Ahead
- 1:05Military Roots And Patient Mission
- 6:22Leading Through Teams And Operations
- 12:17M&A Lessons: Culture And Synergy
- 16:37Why Neil Joined Zevra
- 20:21Filing The Niemann-Picks Type C NDA
- 22:56Why Build The Hub In Boston
- 26:06Acer Therapeutics Deal And Celiprolol
- 29:06Building A Fit For Purpose Commercial Team
- 32:40Advocacy Partnerships And Patient Support
- 38:59Expanded Access And Europe Readiness
- 42:22Using AI To Find Undiagnosed NPC Patients
- 44:18Europe Commercial Options And Label Strategy
- 48:14FDA And EMA Consistency Challenges
- 51:28Near Term Priorities And Pipeline Strategy
- 54:37Closing And Where To Follow