Month: June 2017

Mark V. Pic

Biorasi Spotlight: Mark Vieder, RPH, MBA – V.P. of Drug Safety & Pharmacovigilance

For this week’s Biorasi Spotlight, meet Mark Vieder, RPH, MBA, Vice President of Drug Safety and Pharmacovigilance at Biorasi, LLC. 1. How did you get into clinical research? Being a health care professional (HCP) and having practiced for a number of years, I accidentally fell into the research side of …

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The Decision on Timing in the BPCI Act

This week, the path to market for biosimilar developers cleared up just a bit. The Supreme Court made a final decision in the three-year lawsuit between Amgen and Sandoz that sets a precedent regarding the interpretation of some widely-contested language in the BPCI Act. The language in question referred to …

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Emerging Challenges in Global Clinical Studies

Clinical research is going global. This growth translates to sponsors no longer running separate studies in each and every country they are seeking marketing approval; instead they are opting for large, global studies that have percentages of the required subjects in each venue they desire for marketing approval. A major …

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