Rapid Formulation Development and Clinical Testing (RapidFACT) – ExpAediting Development of Optimal Drug Products

RapidFACT™ is a novel, streamlined, data driven approach to screening and optimizing drug products based on human clinical data. The technique has been extensively adopted by Pharmaceutical Development teams from more than 30 pharmaceutical and biotechnology companies worldwide as a key tool to support drug production optimization, with over 50 programs now completed.

RapidFACT has been proven to accelerate program timelines by at least 50 percent, and deliver significant associated cost savings. This has been achieved by the co-location of real-time GMP manufacturing and clinical testing, under Quotient’s Translational Pharmaceutics™ platform, which enables formulation selection to be underpinned by emerging clinical data. Applications have included assessments of solid state forms, solubility enhancement and modified release.

This webinar will describe the applications and benefits of Translational Pharmaceutics and RapidFACT, illustrated by case studies and metrics from industry experts and users of RapidFACT.

Speakers

John McDermott, Director, Drug Product Optimisation, Quotient Clinical.

After gaining a BSc in Analytical Chemistry from the University of Hull, UK, in 2000, John worked in Pharmaceutical analysis with Rhone Poulenc Rorer and Covance, before joining Quotient Clinical, (then Pharmaceutical Profiles) in 2001. After fulfilling roles in the development and validation of radiolabelling methods for solid oral dosage forms, and leading Quotients’ Pharmaceutical Analysis function, John was appointed to his current position, in which he has overall responsibility for RapidFACT™ formulation development and clinical testing, regional absorption, and gamma scintigraphic services.

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Magnus Ronn, Ph.D., Senior Vice President, Chemistry, Manufacturing and Control, Tetraphase Pharmaceuticals

Magnus Ronn, Ph.D.serves as our Senior Vice President, Chemistry, Manufacturing and Control. From October 2009 until January 2014, he served as Vice President, Chemistry, Manufacturing and Control and he served as our Senior Director for Chemistry, Manufacturing and Control from our inception in 2006 until September 2009. From 2001 to 2006, he served as a Scientist at increasing levels of responsibility within Process Chemistry Research & Development at Millennium Pharmaceuticals, Inc. (now a Takeda company), a Pharmaceutical company. Prior to joining Millennium, Dr. Ronn was a scientist at Roche Colorado Corporation (now known as Corden Pharma Colorado, Inc.), a Pharmaceutical manufacturing company. Dr. Ronn received a B.S. in chemistry and a Ph.D. in organic chemistry from the University of Uppsala, Sweden.

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