Speaker

Dr. Michael N. Dudley, PharmD, FIDSA

President, CEO, and co-Founder

Qpex Biopharma, San Diego, California

Dr. Dudley is currently President, CEO, and co-Founder of Qpex Biopharma in San Diego, CA. Qpex Biopharma now operates as a Shionogi Group Company in antiinfective drug discovery and development following its acquisition in 2023. Since the merger, Qpex has expanded its R&D footprint and moved into a new state-of-the-art research laboratory and expanded the number of research and clinical scientists.

Mike has over 30 years of experience in anti-infective R&D and commercialization, leading a team associated with 4 regulatory approvals for antibiotics during the previous decade, including discovery of vaborbactam that emerged from a new class of boronate beta-lactamase inhibitors. He and his team advanced vaborbactam in combination with meropenem-vaborbactam (Vabomere) from discovery to FDA approval in < 8 years.

In 2018, he co-founded Qpex Biopharma as a spin-out from the Medicines Company and advanced 3 programs to Investigational New Drug status with FDA in the company’s first 3 years. Immediately prior to Qpex, he was Chief Scientific Officer of Rempex Pharmaceuticals/ The Medicines Company and was co-leader of the Infectious Disease Business Unit.

Mike has lead negotiations for multiple public-private partnerships to advance new antibiotics in development, including the US government’s Biomedical Advanced Research and Development Authority (also known as BARDA) and Europe’s Innovative Medicines Initiative for over $190 million to advance the development of antimicrobial agents in the US and Europe.

Mike completed undergraduate work at Pepperdine University, his PharmD and clinical pharmacy residency from the University of California San Francisco (UCSF), and a fellowship in infectious diseases with Drs. Charles Nightingale and Richard Quintiliani at Hartford Hospital. Prior to his career in industry, he held academic appointments between 1983 and 1996 including Professor and Chair at the University of Rhode Island College of Pharmacy, and Brown University School of Medicine where he conducted laboratory and clinical research and practiced what is now considered antibiotic stewardship. He has published over 170 scientific papers/book chapters on the discovery, development, and clinical use of antiinfectives. He has served on the Boards for several companies, scientific bodies, and professional organizations, including co-founding of the Society of Infectious Diseases Pharmacists (SIDP) in 1991 and served as its 2nd President.

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