Date: 2015-05-27
Type of information: Nomination
Compound:
Company: Zafgen (USA - MA)
Therapeutic area: Rare diseases - Genetic diseases - Metabolic diseases
Type agreement: nomination
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Disease:
Details: * On May 27, 2015, Zafgen, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, announced the appointments of Nerissa Kreher, M.D., M.S., M.B.A., as Global Head of Medical Affairs, and Kevin P. Malobisky, Ph.D., M.S., R.A.C., as Global Head of Regulatory. Dr. Kreher is a physician and board certified pediatric endocrinologist with deep academic, clinical research and biotechnology industry experience that includes both Medical Affairs and Clinical Development in start-up environments and within large biotechnology companies. She has a proven ability to build and develop Medical Affairs teams. Most recently, Dr. Kreher was the Global Clinical Development Lead, Neonatology, at Shire. Previously, she held several roles at Alexion Pharmaceuticals and Enobia Pharma, where she became the Executive Medical Director, Medical Affairs Franchise Lead, Metabolic Diseases, and was responsible for the global medical affairs metabolic disease program. Prior to that, Dr. Kreher was Medical Director, Medical Affairs, at Genzyme, responsible for U.S. Medical Affairs for Endocrinology. She began her career in the industry as Director of U.S. Medical Affairs, Endocrinology, at EMD Serono. Dr. Kreher is a member of several professional organizations, including the Endocrine Society, and the recipient of a number of awards and honors. She received a B.A. from the University of North Carolina, Chapel Hill; her M.D. from East Carolina University School of Medicine; her M.S. in Clinical Research from Indiana University; and an Executive M.B.A. from Northeastern University. Dr. Malobisky is a seasoned global regulatory affairs professional with 25 years of laboratory, clinical, and regulatory development expertise spanning devices, biologics, and small molecules. He has held leadership roles at the country, region, and global levels, developing and implementing strategies to support both early and late-phase biologic and small molecule compounds across multiple therapeutic areas including obesity and orphan indications, as well as supporting marketed products across North America. Most recently, Dr. Malobisky was a Senior Regulatory Consultant working with the Harte Group. Prior to that, he spent 14 years with Sanofi, where he held positions of increasing seniority in Regulatory Affairs and ultimately served as Associate Vice President, Global Regulatory Affairs, a position comprised of two roles: Regional Head, United States and Canada, and Global Head, Fibrosis & Cardiovascular. In addition, Dr. Malobisky represented Sanofi at PhRMA by serving on the Regulatory Affairs Coordination Committee and leading multiple industry initiatives and pilot programs. Dr. Malobisky is a current member of several professional societies including the Regulatory Affairs Professional Society (RAPS) and the Drug Information Association (DIA), and has extensive experience as an instructor and speaker. He earned his Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy, and his Ph.D. in Organization and Management from Capella University School of Business and Technology.
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