Project Manager, Booz Allen Hamilton
Dr. Healy has more than 15 years of management consulting experience with Booz Allen Hamilton, focusing on biomedical and biotechnology research, drug development and regulatory science for the Department of Defense (DoD), Food and Drug Administration (FDA), and pharmaceutical/biotechnology industry clients. He is a Project Management Professional (PMP) and has led a variety of program evaluation, policy assessment, and business process improvement projects in the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH). Dr. Healy has a deep knowledge and understanding of FDA’s regulatory review processes and policies for new drugs, biologic products, and medical devices, as well as postmarket safety and surveillance programs and policies such as postmarketing requirements (PMRs) and Risk Evaluation and Mitigation Strategies (REMS). He also has served as a subject matter expert on drug development and regulatory policy in support of pharmaceutical and biotechnology companies, as well as clients in DoD involved in medical product development for military applications. Dr. Healy was the project manager for the Independent Assessment of FDA’s Medical Device Review Program, and is a leader on Booz Allen’s Regulatory Science Team.