Regulatory R.A.N.T. - Biomarkers, Pediatrics, Benefit-Risk - Oh my!

February 11, 2016 Peter J. Pitts, Tim Franson M.D.



To protect sustainable innovation, it is vital to look beyond present conditions and develop proactive interventions for anticipated environmental changes. With development times for new biomedical medicines and devices now spanning years (and sometimes over a decade), regular audits (at least yearly) are essential in recognizing and adapting to key "climate changes."

Given the importance of both identifying new trends and their impact on the development and commercialization of every product and process, YourEncore gathered an eclectic entourage of experts with deep experience in regulatory and industry leadership after the recent RAPS meeting in Baltimore. We call these sessions R.A.N.T.s - Relevant Assessments, New Trends.  We turned the panel discussion into a white paper, full of insider insights on the changing face of biomarkers, pediatric studies and benefit-risk, all of which are integral factors in development planning that exist in a state of constant flux.

The discussion is particularly timely if you've read the FDA's recently released 2016 Guidance Agenda.  We trust you will find this material useful in preparing for the upcoming guidance season as well as informing your product/portfolio management and regulatory strategies.

Download the white paper now. 


The YourEncore expert 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 Brumfield, Ph.D. – is the incoming President of the RAPS Board and President and Chief Executive Officer of the Critical Path Institute.

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.

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.

Don Therasse, M.D. – a YourEncore Executive Partner, former VP, Global Patient Safety and Global Medical Affairs at Lilly. He led Lilly’s pharmacovigilance organization and established Lilly’s global medical affairs, benefit-risk assessment and bioethics organizations.

Regulatory RANT white paper cover


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