Wilson joined Greenleaf Health in 2023, following a 19-year career at the FDA that culminated in his leadership of the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER). A neurologist and neuromuscular specialist, Wilson was a clinician and clinical researcher for over a decade prior to his work at the Agency.

Wilson began his regulatory career as a medical officer in CBER, where he served as primary reviewer for Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). He subsequently served two years as a clinical team leader in the Division of Neurology Products within the Center for Drug Evaluation and Research (CDER), with a focus on neuromuscular disorders, bioterrorism, and sleep disorders. Wilson then worked for three years as a regulatory consultant with the Biologics Consulting Group.

Wilson returned to CBER in 2009 as Chief of the Clinical Evaluation Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT), and was later promoted to Director of the Division of Clinical Evaluation and Pharmacology/Toxicology. In 2016, Wilson became Director of the newly formed Office of Tissues and Advanced Therapies (OTAT). OTAT was responsible for the regulation of gene therapies, cellular therapies, genetically-modified cells (e.g., chimeric antigen receptor T cells), tissue-engineered products, plasma protein therapeutics (e.g., immunoglobulins; coagulation factors), selected medical devices, and xenotransplantation. OTAT-regulated products covered a full range of medical indications, including oncology, hematology, neurology, cardiology, endocrinology (e.g., diabetes), pulmonary, nephrology, dermatology, and a variety of surgical indications. Of the thousands of applications in the OTAT portfolio, approximately 50% were for the treatment of rare diseases. OTAT also developed processes and standards for the new Regenerative Medicine Advanced Therapy (RMAT) designation. Wilson retired from the FDA when OTAT was reorganized into the Office of Therapeutic Products (OTP) in 2023. His work at Greenleaf is informed by the experience of overseeing the FDA’s regulation of cellular and gene therapies, along with other advanced technologies, during a transformative period in which the foundation was laid for today’s development and approval processes.

Before joining the FDA in 2000, Wilson was on the faculty of the Department of Neurology of the University of Texas Southwestern (UTSW) Medical School for 13 years. At UTSW, he served as a neuromuscular specialist and was an investigator for clinical trials in neuromuscular disorders, particularly amyotrophic lateral sclerosis (ALS), and in cerebrovascular disease.

Wilson received his bachelor’s degree from the University of South Carolina and his medical degree from the University of Chicago Pritzker School of Medicine. He completed an internal medicine internship at Grady Memorial / Emory University Hospitals, a neurology residency at Parkland Memorial Hospital / University of Texas Southwestern Medical School, and a neuromuscular / neurophysiology fellowship at Tufts University / New England Medical Center. 

Dr. Karen Midthun joined Greenleaf Health following a distinguished 28-year career in public service, of which 22 years were dedicated to the FDA. An infectious disease physician by training, Dr. Midthun served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) from 2009 to 2016.

At Greenleaf, Dr. Midthun serves as Principal, Drug and Biological Products, co-leading the firm’s Drug and Biological Products Team with fellow principals Drs. John Jenkins, Bob Meyer, and Sandra Kweder. Dr. Midthun contributes specialized insight — informed by her regulatory, research, and clinical experience — to the strategic and technical guidance that Greenleaf provides to FDA-regulated entities developing products to prevent or treat infectious diseases, addressing ongoing public health needs for biologics, and advancing the growing field of cell and gene therapies.

During her FDA tenure, Dr. Midthun played a critical role in facilitating policy and technology development in the areas of blood products, vaccines, and cell, tissue, and gene therapies. Under her leadership, the FDA approved several vaccines that have had a significant public health impact, including vaccines for pneumococcal disease, meningococcal disease, and human papilloma virus. Dr. Midthun received praise for her work responding to the 2009 influenza pandemic; developing a framework for the regulation of human cell and tissue products; and, in collaboration with the Center for Drug Evaluation and Research (CDER), developing a policy for the regulation of biosimilar products.

Prior to her role as Center Director, Dr. Midthun served as the Deputy Director of CBER and the Director of the Office of Vaccines Research and Review within CBER. Before joining the FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.

Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology (MIT) and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases (NIAID). She is a fellow of the Infectious Diseases Society of America.

As a Principal of Greenleaf’s Drug and Biologics group, Dr. Robert Meyer contributes a rich knowledge, gained through 30 years of regulatory and academic leadership, of the important issues facing the pharmaceutical sector today. Bob was previously the Director of the Virginia Center for Translational and Regulatory Sciences (VCTRS) at the University of Virginia (UVA) School of Medicine and continues as an Associate Professor of Public Health Sciences at UVA.

At the VCTRS, Bob led the development of a new regulatory science curriculum and served as a faculty expert in drug/biologic regulation, clinical development and study design, and commercial discovery and development, providing insight to support the regulatory success of medical research with transformational potential. Before joining UVA in 2013, Bob headed worldwide regulatory and pharmacovigilance activities at Merck Research Laboratories (MRL), most recently as Vice President, Global Regulatory Strategy, Policy, and Safety. He was also a member of MRL’s Early Stage and Late Stage Development Review Committees and Safety Review Committee. Bob serves currently as a non-executive Director on the Board of Chimerix Inc., and did so for Translate BIO until its acquisition by Sanofi.

Prior to his academic and corporate experience, Bob had a notable career at the U.S. Food and Drug Administration (FDA), including five years (2002-2007) as the Director of the Office of Drug Evaluation II within the Center for Drug Evaluation and Research (CDER), with oversight of pulmonary and allergy, metabolic and endocrine, analgesic and anesthetic, and rheumatologic drug products. The rest of his tenure at the FDA was spent in CDER’s Division of Pulmonary and Allergy Drug Products, which he directed from 1999 to 2002 after positions as a medical reviewer and team leader. He chaired the Pre-Market Risk Assessment guidance development for CDER and participated in several Prescription Drug User Fee Act (PDUFA) negotiations on behalf of both the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA).

During his tenure at Merck, Bob chaired the Regulatory Affairs Coordinating Committee for PhRMA. While at the FDA, he served on the third expert panel for the National Heart, Lung, and Blood Institute’s National Asthma Education and Prevention Program (NAEPP EPR3). Bob also served on the Board of Directors for the Reagan-Udall Foundation and an elected term as a Medical Science Trustee for the United States Pharmacopeia Board (2015-2020). A recognized expert on environmental impacts of medical aerosols, Bob has contributed his expertise to the United Nations Environmental Program (UNEP) Technical Options Committee on Medical Aerosols beginning in 1998.

Bob received his medical degree from the University of Connecticut School of Medicine and completed his residency with the University of Connecticut School of Medicine at the VA Medical Center in Newington, CT, serving as Chief Medical Resident from 1987-88. At the Oregon Health Sciences University in Portland (1991-94), he was an academic pulmonologist and critical care specialist, helping to establish the medical service for the Lung/Heart-Lung Transplantation team. He has also served as a volunteer staff physician in pulmonary medicine at the National Naval Medical Center in Bethesda, MD.