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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