ROBERT J. MEYER, M.D. JOINS GREENLEAF HEALTH

Greenleaf Health announces that Robert (Bob) Meyer, M.D. has joined the firm as Principal, Drug and Biological Products.

Dr. Meyer and Dr. John Jenkins, Principal, Drug and Biological Products, will serve as co-leads of the firm’s Drug and Biological Products Team, where they will provide strategic guidance and support to drug and biological product companies on the earliest stages of product development through post-approval commitments.

About Dr. Meyer

Dr. Meyer, a pulmonologist and critical care specialist, spent 13 years at the FDA (1994 – 2007), during which he served as the Director for the Office of Drug Evaluation II (ODE II) within the Center for Drug Evaluation and Research (CDER). In this role, Dr. Meyer was responsible for the evaluation of various drug products including pulmonary and allergy; metabolic and endocrine; analgesics; anesthetics; and rheumatologic drugs. Dr. Meyer was involved in several CDER initiatives, amongst them chairing the development of the Pre-Market Risk Assessment guidance. Additionally, he participated with the FDA negotiation team for the reauthorization of the Prescription Drug User Fee Act (PDUFA) III and IV.

Following his FDA service, Dr. Meyer joined Merck & Company (2007 – 2013) where he served as Global Head/VP of Strategy, Policy and Safety at Merck Research Laboratories (MRL). In this role, Dr. Meyer was responsible for all global regulatory strategy and operations, regulatory policy and intelligence, as well as product safety and pharmacovigilance for all Merck products. Dr. Meyer also co-chaired the Late Stage Development committee at MRL. Most recently, Dr. Meyer served as Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia (UVA) School of Medicine. While at Greenleaf, Dr. Meyer will continue to serve as an Associate Professor of Public Health Sciences at UVA.

Externally, Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for the Pharmaceutical Research and Manufacturers of America (PhRMA), and served as a key PhRMA negotiator on PDUFA V. He also served on the third expert panel for the National Heart, Lung and Blood Institute’s National Asthma Education and Prevention Program (NAEPP EPR3), as well as on the Board of Directors for the Reagan-Udall Foundation for the FDA. A Medical Science Trustee for the United States Pharmacopeia (USP) Board of Trustees, Dr. Meyer served on the USP expert panel making recommendations on Medicare Model Guidelines prior to his Board role.

Dr. Meyer began his career as an academic pulmonologist and critical care specialist at the Oregon Health and Science University, where he helped create the medical service in support of the Lung/Heart-Lung Transplantation program. Dr. Meyer graduated from Lehigh University cum laude with a Bachelor of Science and received his medical degree from the University of Connecticut School of Medicine, where he also served as Chief Medical Resident. He has published peer-reviewed articles in numerous journals, including the New England Journal of Medicine, the Journal of Clinical Pharmacology and Therapeutics and the Archives for Internal Medicine.

About the Drug & Biological Products Team

The Drug and Biological Products Team delivers a variety of services, including: monitoring and assessing the regulatory environment for emerging trends, analyzing the impact of agency actions on current developmental programs, and reviewing the competitive landscape for specific therapeutic areas.

Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, as well as post-market requirements, including safety monitoring. The team’s approach, firmly grounded in established principles of public health practices, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts has more than 225 years of combined FDA experience, and as such provides a wealth of regulatory experience that is unmatched.

Greenleaf is guided by experts with a combined total of more than 225 years of FDA experience. Dr. Meyer joins several former FDA officials at Greenleaf, including Patrick Ronan, former FDA Chief of Staff; John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. John Jenkins, former Director of the Office of New Drugs for FDA’s Center for Drug Evaluation and Research (CDER); Dr. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); and Michael Chappell, former Associate Commissioner for Regulatory Affairs. Greenleaf’s blend of former FDA officials and industry experts provide a unique set of capabilities when advising entities regulated by the FDA.

For more information on Dr. Meyer and Greenleaf Health, visit greenleafhealth.com