Regulatory R.A.N.T. – Relevant Assessments, New Trends

3 Possible Monkey Wrenches in Pharmaceutical Development Planning

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YourEncore convened a panel of experts to offer insights about the changing face of biomarkers, pediatric studies and benefit/risk - timely topics if you've read the FDA's recently released 'Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016.'

To prepare for the upcoming guidance season, download this whitepaper, which outlines both the promise and challenges within these 3 areas. 

We trust readers will find this material useful in shaping future development and regulatory strategies.

Our panel includes:

Tim Franson, M.D. (Moderator) – the Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and Immediate Past President of the USP Convention.

Martha BrumfieldPh.D. – the incoming President of the RAPS Board and President and Chief Executive Officer of the Critical Path Institute.

Peter J. Pitts – a YourEncore Executive Partner, former FDA Associate Commissioner, current Chief Regulatory Officer for Adherent Health Strategies and Founder/President of the Center for Medicine in the Public Interest.

Stephen P. Spielberg, M.D., Ph.D. – a YourEncore senior advisor, former FDA Deputy Commissioner for Medical Products & Tobacco, Dean of Dartmouth Medical School, and Editor-in-Chief of the Drug Information Association’s (DIA) journal,Therapeutic Innovation and Regulatory Science.

Don Therasse, MD – a YourEncore Executive Partner, former VP, Global Patient Safety and Global Medical Affairs at Lilly.

Complete this short form to download the white paper.