Dr. Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners.
ROCHELLE, VIRGINIA (PRWEB) February 22, 2017
NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant.
In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma.
Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications.
“Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice.
Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. 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 virtual product development teams.
Earle Martin, Chief Executive Officer