Ed Mitchell, PhD

With over 30 years of drug development, regulatory affairs, and quality assurance experience, Dr. Mitchell brings a broad background of practical experience in the pharmaceutical industry to consulting.  He has worked with small start-up companies such as airPharma, Crititech, and Oread Laboratories as well as large, multi-national, companies that include Sanofi-Aventis and IVAX.  

Dr. Mitchell held a senior position in Industrial Operations Chemistry, Manufacturing, and Controls (CMC) for Sanofi-Aventis, and was VP of Regulatory Affairs for IVAX.  At IVAX Dr. Mitchell was the direct liaison with the FDA for Elmiron®, an Orphan Product, and the first generic version of Albuterol MDI.  As Chief Regulatory Officer (CRO) for Oread he was responsible for regulatory, quality, and environmental oversight for research, development, and manufacturing projects from discovery through clinical candidate stage.  

Dr. Mitchell held a strategic position at PRA International where he was responsible for development strategies for several products.  His regulatory and product development experience includes respiratory/pulmonary, cardiovascular/renal, gastrointestinal, oncology, genitourinary, biologics, medical devices, and dental products.  Dr. Mitchell worked directly with the FDA for the approval and ongoing marketing of Cardizem® (IR, SR, CD, and IV), Carafate®, Pentasa®, Seldane®/Seldane D®, and Ditropan®.  He served as an Expert for FDA review of NDAs in the dental drugs area, and is Chairman of the Board for Global Lipidomics, LLC, a start-up lipidomics company.  

Dr. Mitchell received his bachelor’s degree in Biology and Education from Kansas State University, and his PhD in Pharmacology and Physiology from the University of Missouri in Kansas City.