NDA Partners Chairman Carl Peck, MD, announced today that Dr. Philip Chaikin, a senior pharmaceutical industry executive with extensive drug development experience in development strategy, regulatory strategy, clinical pharmacology, and clinical study design, has joined the firm as an Expert Consultant. Throughout his 30 year career, Dr. Chaikin interacted with the US Food and Drug Administration (FDA), including the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), European regulatory bodies, and the European Medicines Agency (EMA) and participated in FDA Advisory Committee Meetings in the cardiovascular, anesthesia/critical care, oncology, respiratory, and anti-infectives therapeutic areas. He also secured numerous global drug approvals including the development and launch of the blockbuster drugs: Lovenox®, Taxotere®, and Procardia XL®.
Dr. Chaikin formerly served as Executive Vice President for Drug Development and Head of International Drug Development at Kyowa Pharmaceuticals. Prior to this position, he served as Vice President of Clinical Research and Regulatory Affairs at Acumen Sciences, Vice President of Oncology R&D at Elan Pharmaceuticals, and Senior Vice President of Development at Pharmacologics. In addition, he served as Vice President of Worldwide Clinical Development at Rhone-Poulenc Rorer/Aventis Pharmaceuticals and Vice President of Clinical Development at Hoechst-Roussel Pharmaceuticals. In his early career, Dr. Chaikin served as Director of Clinical Pharmacology at Bristol-Myers Squibb, Senior Associate Medical Director at Pfizer, and Senior Research Scientist, Drug Metabolism and Pharmacokinetics at Ortho Pharmaceuticals.
“We are pleased to welcome Dr. Chaikin to NDA Partners,” said Dr. Carl Peck. “Dr. Chaikin’s expertise in pharmaceutical drug development strategy, regulatory strategy, clinical pharmacology, and experience interacting with FDA, EMA, and other European regulatory agencies will bring significant value to our drug development clients developing therapies in a wide range of therapeutic areas.”
Dr. Chaikin earned a PharmD from the University of Maryland College of Pharmacy, where he also completed a postdoctoral research fellowship in clinical pharmacology. He received his medical degree from New Jersey Medical School and did training in internal medicine at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. He is a fellow of the American College of Clinical Pharmacology and a former member of the society’s Board of Regents.
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 Expert Consultants in NDA Partners include three former FDA Center Directors; 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.
Earle Martin, Chief Executive Officer