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The Pharmcast

YourEncore's Pharmcast is your weekly dose of wisdom from today's top life science minds. YourEncore is a leading provider of proven expertise in the life sciences industry. Focused on highly experienced R&D or technical talent, YourEncore gives clients the people or insights needed to outpace, outthink and outperform. Each week in the Pharmcast, we talk with top industry experts in our network or beyond about hot industry topics, leadership, and the path to success.
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Now displaying: February, 2017
Feb 16, 2017

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new administration has signaled hiring freezes for government agencies, including the FDA.

While many of the policy and leadership changes in 2017 may not appear to make a day-to-day impact on drug developers at first, these changes can in fact have a profound impact. 

To help us understand how 21st Century Cures, PDUFA 6, and leadership changes can affect your development plans, we sit down with Dr. Tim Franson, who is not only YourEncore's Chief Medical Officer, but also Chairman of the Board  for The Critical Path Institute, the Immediate Past-President for the USP, and a key contributor to the last few PDUFAs.

 

 

Feb 10, 2017

This week on the Pharmcast, we talk with Dr. Joseph Lamendola on four New Drug Application (NDA) mistakes to avoid.

Dr. Lamendola is the former VP of U.S. Regulatory Affairs for Bristol-Myers Squibb and Schering-Plough, and now serves as the SVP and leader of YourEncore's Biopharma practice.

Joe has over 20 drug approvals to his name, so we ask Joe to share his life lessons on how to work with the FDA to receive NDA approval and ultimately get life-changing therapies to patients.

Feb 6, 2017

In this week's episode of The Pharmcast, we talk with Dr. Janet Vargo and Minnie Baylor-Henry, J.D. to share 10 mistakes medical device start-ups frequently make during development that ultimately reduce their valuation to potential acquirers.

After evaluating dozens of innovative new medical device products as an executive at Johnson & Johnson, Dr. Vargo has seen firsthand the common mistakes that small companies make. In this session, she will outline regulatory and commercialization pitfalls to avoid that will improve your speed to market, valuation, and interest from large medical devices companies.

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