Regulatory Science

Gordon Arbuthnot

Gordon Arbuthnot

Mr. Gordon Arbuthnot, senior director of CMC, has 35 years of commercial experience in the pharmaceutical industry. His career of more than 32 years at Eli Lilly and Company included CMC work on compounds covering the entire spectrum of drug development, from preclinical research to the successful registration and launch of new pharmaceuticals. After retirement, he consulted on a number of CMC projects and worked for the startup company Marcadia Biotech. Mr. Arbuthnot has published in the CMC discipline, is a registered professional engineer in the state of Indiana, and is an inventor on a number of patents.

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Paul Gesellchen, Ph.D., RAC

Paul Gesellchen, Ph.D., RAC

Dr. Paul Gesellchen is currently an independent consultant in all aspects of non-CM&C regulatory affairs (2006 to 2011).  His most recent full-time job function was as Vice President of Regulatory Affairs at Targanta Therapeutics Corporation (2006 to 2008) where he guided the regulatory strategy for submission of FDA and EMEA marketing applications for a proposed new injectable antibiotic for complicated skin and skin structure infections.

Prior to this period, Dr. Gesellchen worked at Eli Lilly and Company for 29 years (1977 to 2006), spending his final 16 years in the Regulatory Affairs Department and retiring in 2006 as Senior Scientific Director of Regulatory Affairs.  In his regulatory affairs function he was the liaison between Lilly and the FDA for new drug candidates, primarily in the endocrine therapeutic area (growth, diabetes, and osteoporosis).

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