Review Chief, OBP, OPQ, CDER, FDA
Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from...
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Vice President, Global Development, Amgen Inc.
Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he...
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Head, Global Biologics Research and Development, Mylan Pharmaceuticals
Dr Ullanat has significant experience in key senior management positions leading multi-functional teams associated with Biopharmaceutical R&D. Dr Ullanat has significant experience related to Global Biosimilar development especially with respect to EMA and US-FDA and has led regulatory...
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Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.
T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing...
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