Three Former FDA Officials Join Greenleaf Health

Greenleaf Health Inc. (Greenleaf), a U.S. Food and Drug Administration (FDA) regulatory consulting firm, has added three former FDA officials to its team of experts. Julia Barrett, M.D., M.P.H., and Chris Leptak, M.D., Ph.D., will join the Drug and Biological Products Team as executive vice president and senior vice president, respectively. Grace McNally will join the Product Quality, Manufacturing, and Compliance Team as senior vice president.
 
Barrett brings more than 28 years of clinical development and regulatory expertise to her role as executive vice president, Drug and Biological Products. She began her career as a clinical reviewer in the FDA’s Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER). Prior to joining Greenleaf, Barrett spent more than 17 years as a senior clinical consultant at Biologics Consulting Group, where she focused on clinical product development and U.S. regulatory submissions. Her product expertise includes cell and gene therapy/regenerative medicine, protein therapeutics, allergy immunotherapy, vaccines, toxins, and microbiome-based products.

Barrett earned her bachelor’s degree in biology from Smith College, an M.D. from Northwestern University, and an M.P.H. from George Washington University (GWU). She trained as a resident in internal medicine at the University of Minnesota and completed a fellowship in general internal medicine at GWU. Learn more about Barrett here.
 
Leptak joins Greenleaf following a distinguished 14-year career at the FDA, where much of his work focused on biomarker and diagnostic device utility in clinical trials and drug development. Most recently, Leptak served as associate director, Regulatory Science, in the Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER). During his FDA tenure, Leptak led multiple programs and initiatives aimed at developing CDER’s approach to regulatory science, including as director of the CDER Biomarker Qualification Program, director of the OND Regulatory Science Program, and acting director of the Office of Drug Evaluation Science.
 
Leptak earned his undergraduate degree from Yale University and his M.D./Ph.D. at the University of California, San Francisco. He completed his residency in emergency medicine at Harvard’s combined Mass General and Brigham program. Learn more about Leptak here.

McNally brings more than 33 years of FDA service to her role as senior vice president, Regulatory Compliance at Greenleaf. Her FDA career is highlighted by multiple leadership positions, including her service as director of the Division of Regulations, Guidance, and Standards within CDER’s Office of Policy for Pharmaceutical Quality; branch chief in the Office of Process and Facilities within CDER’s Office of Pharmaceutical Quality; and compliance officer within CDER’s Office of Compliance. McNally began her career at the FDA as a field investigator in the Philadelphia district and later joined the Denver District, where she specialized in pharmaceutical and medical device inspections.

McNally earned a bachelor of science degree in physics from Boston College. Learn more about McNally here.
 
Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Barrett, Leptak, and McNally join a group of professionals at Greenleaf who previously served as leaders throughout the agency, including: John Taylor, former FDA counselor to the commissioner and principal deputy commissioner; Dr. Daniel Schultz, former director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former director of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former director of CDRH’s 510(k) staff; David Elder, former director of the FDA’s Office of Regional Affairs and Office of Enforcement; and Cynthia Schnedar, former director of CDER’s Office of Compliance.
 
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing solutions to global public health challenges. Greenleaf’s blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.