YourEncore Insights - Life Sciences

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

Posted by Peter J. Pitts, Tim Franson M.D. on 2/11/16 11:44 AM

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. 

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory, Rare Disease, Pharmacovigilance

Social Media & Postmarketing Surveillance - Signal vs. Noise

Posted by Peter J. Pitts, Don Therasse M.D., on 12/16/15 8:30 AM

New technologies that support postmarketing patient communication and safety surveillance can produce a mountain of data.  But are these new tools creating value or just more noise?

YourEncore recently convened a panel of experts to discuss this topic after the 2015 Regulatory Affairs Professional Society (RAPS) Convergence conference in Baltimore, Maryland. To watch the panel discussion, click here.

YourEncore Executive Partners, Peter J. Pitts, former FDA Associate Commissioner, and Dr. Don Therasse, former VP of Global Patient Safety and Global Medical Affairs at Eli Lilly & Co., shed some light on the topic.

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Topics: Pharmaceutical Industry, Regulatory, Pharmacovigilance