Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

March 2, 2017 Jim Combs

 

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On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We also cover common ways agency decisions can destroy value if not done properly.

Dr. Tim Franson and Dr. Joe Lamendola recently gave a presentation to a group of private equity and venture capital funds to outline the importance of regulatory strategy for small biopharma companies.

Dr. Tim Franson is YourEncore's Chief Medical Officer and former Worldwide VP of Regulatory Affairs at Eli Lilly & Company.

Dr. Joseph Lamendola is the former head of US Regulatory for Bristol-Myers Squibb and the current leader of YourEncore's biopharma practice.

If you have topics you would like YourEncore to explore on future episodes of The Pharmcast, please email Pharmcast@yourencore.com with feedback or suggestions.

The Pharmcast is now available for download on iTunes, Google Play, and Stitcher. If you like what you hear, share it with your friends and write a review or give us a rating on your podcast store. 

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