YourEncore Insights - Life Sciences

State of the Industry: U.S. Regulatory Policy Improvements (Ep. 19 of The Pharmcast)

Posted by Jim Combs on 5/12/17 8:00 AM

 

In this episode of The Pharmcast, we share a recording from our May 5th webinar, State of the Industry: U.S. Regulatory Policy Overview. Parthenon-EY and YourEncore recently conducted a nationwide survey of life sciences experts to query them on recent market trends, uncover their points of view on potential regulations, refine their current business models and gain insights into what discovery efforts might yield better results. With all the rhetoric surrounding the drug industry from political, news and personal channels, we wanted to know what “those who know” think of various ways to improve the system.

We asked 10 simple questions, soliciting input from more than 50 past and present industry executives and Experts from pharmaceutical, consulting and pharmacy backgrounds. What we heard was informative, provocative and in some cases unsurprising — but important to consider. 

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Topics: Regulatory, Pharmcast, policy

Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

Posted by Jim Combs on 2/16/17 8:30 AM

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.

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Topics: Regulatory, FDA, Pharmcast, policy, pdufa