Rochelle, Virginia (August 22, 2014) - Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Janet B. Arrowsmith, MD, has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company's clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways,
build companies that are attractive to professional investors, and initiate access to
Dr. Arrowsmith is board-certified in internal medicine and an epidemiologist trained at the federal Centers for Disease Control (CDC). She has extensive experience in pharmaco-epidemiology at the US Food & Drug Administration (FDA) and has served both as a member of the Special Emphasis Panel of the National Institute of Allergy & Infectious Disease (NIAID) and a consultant to the National Institute of Drug Abuse (NIDA).
During her 11 year career at the FDA, Dr. Arrowsmith was selected as Acting Director, Office of Surveillance and Biometrics in CDRH; Medical Review Officer in both the Division of Blood Applications (CBER) and the Division of Anti-viral Drug Products (CDER); and as Deputy Director, Office of AIDS and Special Health Concerns,
Office of the Commissioner.
"Our clients, many of whom are developing new drugs in this area, will benefit greatly from Dr. Arrowsmith's expertise in epidemiology and infectious diseases, and from her senior-level regulatory agency experience in drug review and approval", said Dr. Peck. "We are pleased to welcome her to the NDA Partners team and look forward to her leadership in this area."
Dr. Arrowsmith served as a Commissioned Officer in the US Public Health Service where she achieved the Navy rank of Captain. She has published numerous articles in peer reviewed medical literature, authored or co-authored several book chapters on postmarket surveillance, and spoken before numerous national medical and professional organizations on medical product regulation. Dr. Arrowsmith in an elected fellow of both the American College of Physicians and the American College of Epidemiology.
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 two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 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, 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, General Manager