ROCHELLE, Va., July 25, 2018 /PRNewswire-PRWeb/ --áNDA Partners Chairman Carl Peck, MD,
Dr. Shafer is a former member and chair of the US Food and Drug Administration's (FDA) Anesthetic and Life Support Drugs Advisory Committee and has served as a Special Government Employee on ad hoc FDA advisory committees. He is a former Professor in the Department of Anesthesiology at Columbia University, the former Vice President of Product Development at Pharsight Corporation, and co-founder of Signature Therapeutics. His research focuses on PKPD models, statistical review, identifying unmet medical needs, designing research programs for drug approval, drug and device regulatory strategy, and litigation.
"Dr. Shafer is a highly-regarded anesthesiologist and clinical pharmacology expert. We are very pleased to welcome him to NDA Partners, where his knowledge of intravenous anesthetic drugs will be valuable to our clients, especially those developing therapies for pain management," said Dr. Peck.
Dr. Shafer earned his medical degree from Stanford University and his bachelor's degree from Princeton University. He is the former Editor-in-Chief of Anesthesia & Analgesia, the oldest journal in perioperative medicine, and a former Editor of Clinical Pharmacology & Therapeutics, the Journal of Pharmacokinetics and Biopharmaceutics, and Clinical Pharmacokinetics.
About NDA Partners NDA Partners is a life sciences management consulting firm 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; 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 management of client product development programs.
Contact Earle Martin, Chief Executive Officer Office: 540-738-2550 MartinEarle(at)ndapartners.com
SOURCE NDA Partners, LLC
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