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On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies. Sean also discusses FDA pathways, incentives, and agency engagement, and offers thoughts on the regulatory outlook for cell and gene therapies.
Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.
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Get in touch with guest and topic suggestions: [email protected]
Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/
Chapters
1. Opening And Guest Introduction (00:00:00)
2. Navy Roots And Lab Beginnings (00:01:03)
3. Early Stem Cell Gene Work Lessons (00:02:05)
4. First Startup Compendia And Exit (00:03:30)
5. Optogenetics And Founding RetroSense (00:06:03)
6. Fundraising In Downturns And Team Building (00:09:19)
7. Designing For Acquisition And The Allergan Deal (00:12:15)
8. Why EmuSoft And Systemic Delivery Goals (00:15:14)
9. Redosing And Avoiding Immunosuppression (00:18:00)
10. How Autologous B Cells Become Biofactories (00:20:18)
11. Manufacturing Timeline And Patient Experience (00:23:00)
12. Choosing MPS I And Platform Criteria (00:24:45)
13. Beyond ERT: Continuous Protein Delivery (00:27:12)
14. Early Clinical Signals And Redose Update (00:29:35)
15. Pipeline Strategy And Platform Leverage (00:32:17)
16. Board Roles, Governance, And Leadership (00:36:05)
17. FDA Trends, Designations, And Pathways (00:39:10)
18. Priority Review Vouchers And Incentives (00:43:05)
19. Pivotal Trial Alignment And What’s Next (00:47:02)
20. Closing Remarks And Where To Subscribe (00:52:01)
284 episodes
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