This week on The Genetics Podcast, Patrick is joined by Max Bronstein, CEO of Aviva Strategies. They discuss the shifting regulatory and political landscape shaping biotech, the realities of today’s drug development process, and why new incentives and flexible trial pathways are critical to advancing rare and ultra-rare disease therapies.
Show Notes:
0:00 Intro to The Genetics Podcast
00:59 Welcome to Max
01:51 Regulatory shifts and FDA challenges under the new administration
05:40 Overview of the regulatory process for therapeutic development and the push for patient-centered trials
11:26 Challenges in drug development from regulatory gaps to shifting FDA priorities
15:45 Unprecedented government turnover and its impact on biotech industry stability
18:32 Status and significance of the pediatric priority review voucher program for rare and ultra-rare disease development
22:02 How Congress uses “must-pass bills” to advance or block health policies
25:17 Max’s role in creating Advanced Research Projects Agency for Health (ARPA-H) to drive high-risk innovation
30:02 How ARPA-H is funded
31:21 Adapting science policy to politics
33:35 Breakthroughs in rare disease therapies and the policy frameworks needed to ensure access
37:15 Lessons from the Orphan Drug Act and why new incentives are needed to make ultra-rare disease drug development viable
39:23 The push for flexible rare disease trial pathways and the disconnect between FDA rhetoric and practice
43:26 Closing remarks and a call to connect for patient organizations and rare disease parents
Find out more
Aviva Strategies (https://www.avivastrategies.com/)
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