Strategic and Regulatory Consulting Leadership |
Kevin Keim, PhD
Chief Development Officer
 Dr. Keim brings more than 39 years of research and discovery, clinical research and regulatory experience to INC Research. Most recently, Dr. Keim served as president and CEO and board director of Vela Pharmaceuticals Inc. Prior to Vela Pharmaceuticals Inc., Dr. Keim was president of Quintiles Pacific, Inc., where he provided executive leadership and directive consultative solutions in the global CNS therapeutics market. His formative years in the pharmaceutical industry were spent at Hoffmann-La Roche and Wyeth. Dr. Keim currently sits on the boards of directors of the American Society of Experimental NeuroTherapeutics (ASENT), NeuroMedix, Inc., Clinilabs, Inc., and the Affiliated Research Institute. He received his doctoral degree from New York University and his masters of science degree from Fairleigh Dickinson University. His undergraduate work was done at Delaware Valley College.
Wayne Whittingham
Vice President, Regulatory Affairs and Strategic Drug Development
 Wayne Whittingham leads and is responsible for our Global Regulatory Services. He has more than 20 years of pharmaceutical industry experience, including four years working within the FDA. Mr. Whittingham has 12 years experience in pharma and four years CRO experience, all devoted to the practice of pharmaceutical and device regulations. His regulatory services experience includes pre- and post-approval applications and broad and extensive US and EU experience with experience and expertise submitting applications in Asia and South America. Mr. Whittingham has also acted as representative of ex-US entities with the FDA. Mr. Whittingham has extensive IND and NDA/BLA submission experience as well.
Geoff Fatzinger
Executive Director, Regulatory Affairs and Strategic Product Development, Europe & Asia Pacific
 Mr. Fatzinger brings a comprehensive scientific and legal background to the Global Regulatory Services group, plus extensive experience in global regulatory affairs including product and clinical development in both pharmaceutical and CRO environments, with extensive knowledge in Europe and Asia Pacific. He has expert knowledge in product development, including combination products and medical devices and regulatory study start-up; having successfully managed several global regulatory start-up groups with 98 percent first round approval rates and accelerated first patient in (FPI). His therapeutic experience in cardiovascular, CNS, oncology and women’s health trials is well aligned with the company’s therapeutic focus. Mr. Fatzinger is also a registered member and speaker for regulatory associations including The Organization for Professionals in Regulatory Affairs (TOPRA) and Regulatory Affairs Professionals Society (RAPS) and is a frequent lecturer on international regulatory requirements and legislation issues. In addition, Mr. Fatzinger has extensive strategic and operational experience in regards to CTD, PIP and market authorizations for Europe and Asia Pacific.
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Leadership
Kevin Keim, PhD
Chief Development Officer
Wayne Whittingham
Vice President, Regulatory Affairs and Strategic Development
Geoff Fatzinger
Executive Director, Regulatory Affairs and Strategic Product Development, Europe & Asia Pacific
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