Lisa Bollinger, M.D.
Lisa Bollinger, M.D., is a pharmaceutical regulatory consultant with a passion for delivering medicines to patients. Dr. Bollinger’s major areas of focus include, but are not limited to: Pediatric drug development, rare disease drug development, general medicine drug development (Cardiovascular, immunology, metabolic, nephrology, neurology, bone, pulmonary, dermatology), and pharmacovigilance. Dr. Bollinger also has experience in pediatric oncology, FDA Advisory Committee Meetings, biosimilars, regulatory inspections, and business development (due diligence). As someone who was trained in regulatory affairs at the US Food and Drug Administration, Dr. Bollinger thinks like a regulator and can provide true insights to her clients.
Dr. Bollinger is a pediatrician with 20 years of practice experience who began regulatory work at the US Food and Drug Administration (US FDA) in the Division of Dermatologic and Dental Drug Products. During this time, Dr. Bollinger continued to deliver primary care at Walter Reed Military Medical Center in Bethesda Maryland. Ultimately, she was in senior leadership at the FDA where she led pediatric drug development – establishing policies and then implementing them across both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). After the FDA, Dr. Bollinger spent almost 10 years at Amgen (Regulatory Affairs, Regulatory CMC, Pharmacovigilance), and 3 years at Merck (Regulatory Affairs), working cross functionally to bring important therapies to patients.
In the last year, Dr. Bollinger has provided consultation for over 25 biotech companies in early development across cardiovascular, immunology, metabolic, nephrology, neurology, bone, pulmonary, and dermatology.
With a broad background across both government and private industry, Dr. Bollinger has experience with high level strategy as well as the hands-on work needed for regulatory interactions, and insights that can only come from working across every aspect of drug development.