ROCHELLE, Va., July 31, 2019 /PRNewswire-PRWeb/ -- NDA Partners Chairman Carl Peck, MD,
Dr. Bates currently serves part-time roles as both Senior Vice President of Regulatory Affairs at Axial Biotherapeutics, Inc., and as Regulatory Affairs Lead at ATAI Life Sciences AG. Prior to joining Axial and ATAI, he served as Vice President of Regulatory Affairs at Depomed, Inc. and on the senior management team of Xenoport, Inc. At XenoPort, he served as Senior Vice President of Regulatory Affairs and Quality Assurance and, prior to that, as Vice President of Regulatory Affairs. During his tenure at XenoPort, he successfully led the company's NDA and sNDA filings and approvals for its Restless Leg Syndrome and Postherpetic Neuralgia drug, Horizant® (gabapentin enacarbil). Prior to XenoPort, Dr. Bates served as the Senior Director and Director of Regulatory Affairs at Pharmacyclics, Inc., where he directed regulatory affairs and coordinated communications with global regulatory agencies. In his early career, he served in regulatory affairs positions at Otsuka America Pharmaceutical, Inc., Genentech, Inc., and Syntex (USA), Inc.
"Dr. Bates' expertise in regulatory affairs encompassing the regulation of drugs, biologics, and live biotherapeutic products and experience working with global regulatory agencies will be valuable to our clients who are developing products in a wide range of therapeutic areas. We are very pleased that he has joined NDA Partners' team of Expert Consultants," said Dr. Peck.
Dr. Bates received his Doctor of Veterinary Medicine from the University of California, Davis and holds a bachelor's degree in human physiology from the University of California, Berkeley.
About NDA Partners NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle@ndapartners.com
SOURCE NDA Partners LLC
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