Dr. Michael Dudley has over 30 years of experience in antiinfective drug research and development, with experience in the discovery, preclinical and clinical stages in both academia and industry. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor from a new chemical class (vaborbactam) as the combination product Vabomere™ that advanced from discovery to FDA in 2018 approval in < 8 years. He has been the principal investigator for ~ $200 million funding from public-private partnerships (e.g., BARDA) to advance antimicrobial agents in development in the US and Europe.
Prior to his current position, he held positions of increasing responsibilities at small biotech companies Microcide, Diversa, and Mpex Pharmaceuticals. He cofounded Rempex Pharmaceuticals in 2011 as the CSO which was acquired by the Medicines Company in 2013. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted research in infectious disease, including important clinical studies (Phase I-IV) and pioneering work in describing PK-PD approaches and characterization of several classes of antibacterial, antifungal, and antiviral agents.
Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, and at international meetings on infectious diseases. He has served as a consultant on several advisory boards for pharmaceutical industry on antiinfective use and development and as an Editor for Antimicrobial Agents and Chemotherapy. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (Pharm.D.) from the University of California San Francisco (UCSF) in 1980, completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.