Michael N. Dudley is President and Chief Executive Officer of Qpex Biopharma, a clinical-stage resistance-focused company based in California, USA which he co-founded in 2018.
He has overseen the development (R&D) and regulatory approval of multiple antimicrobials. Most recently, vaborbactam, a first member of a new class of beta-lactamase inhibitors that progressed from discovery to FDA and EMA approval in less than 8 years as a combination product with meropenem (Vabomere®; Vaborem®). As Chief Scientific Officer and Co-leader of the Infectious Disease Business Unit at The Medicines Company, he was involved in the approval and launch of 3 antibiotic treatments. He led negotiations for multiple public-private R&D partnerships including BARDA and the Innovative Medicines Initiative to advance the development of antimicrobial agents in the USA and Europe. Michael also held academic appointments as Professor and Department Chair at the University of Rhode Island College of Pharmacy as well as Brown University School of Medicine both in the USA. Here, he pioneered research into the pharmacokinetics and pharmacodynamics of antimicrobials. Michael has published extensively on drug discovery of antimicrobials and has also served on expert regulatory and scientific advisory committees.