Regulatory R.A.N.T. Highlights PDUFA

July 23, 2015 jim.merritt

Tim-Franson4051

Short for Relevant Assessments, New Trends, YourEncore’s R.A.N.T. offers a refreshingly pragmatic perspective of regulatory policy strategy from people who understand it from the inside out.

With the upcoming PDUFA renewal, 21st Century Cures uncertainty, and a leadership transition at FDA, it is a dynamic and uncertain time in the biopharma industry. The outcomes of these key policy debates, along with others, will impact how industry pursues drug development and works with patients and regulators to improve public health.

To advance the conversation and propose practical ways forward, YourEncore assembled a panel of regulatory experts, including former industry and FDA leaders, to share their best thinking on pressing regulatory policy issues in the biopharma industry.

Meet the Panelists:

Tim Franson, M.D.
Tim Franson, M.D., is the Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and current President of the USP Convention. Dr. Franson was also a key contributor to PDUFA V, particularly as it relates to rare disease incentives, and co-authored the first-ever patient advocacy-initiated guidance for a rare disease submitted to the FDA in 2014.

Joe Lamendola, PH.D.
Joe Lamendola, Ph.D., is the former VP of U.S. Regulatory Sciences for Bristol-Myers Squibb and is responsible for over 20 global approvals across 10+ therapeutic areas. Over a 25+ year career, Joe also led the Regulatory Policy and Intelligence Organization for Bristol-Myers Squibb, which was responsible for assessing and influencing regulatory policies, including PDUFA V and multiple therapeutic guidances.

Peter J. Pitts
Peter J. Pitts is a former FDA Associate Commissioner and key influencer of PDUFA V and its renewal. Peter is an authority on global regulatory issues, founded drugwonks.com, a blog which receives over 100,000 web hits a month, and was named one of the 300 “most powerful people in American healthcare” by Modern Healthcare magazine.

Watch a live-recording of the discussion, or download the full transcript to learn more about how you can prepare for these changes.

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