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IALSN presents "New Antimicrobial Agents for Multi-Drug Resistant Pathogens" by Michael N. Dudley, P


Antimicrobial resistance and its transmission has become a major worldwide threat. The exit of many companies from antiinfective drug discovery and development has resulted in many “bad bugs, no drugs”. This loss of drugs to treat patients and rescue immunocompromised at risk for serious infection impacts all facets of medicine. Public health officials, regulators, and clinicians have recognized this crisis and have moved to create streamlined pathways for new drugs to address these unmet needs. These pathways, along with examples from development will be discussed, as well as a summary of the FDA Antiinfective Drugs Advisory Committee Meeting in early December will be discussed.


Dr. Michael Dudley serves as Head of Health Sciences in the Infectious Disease Global Innovation Group of The Medicines Company. He has over 30 years of experience in the discovery, preclinical and clinical development of antiinfectives. Prior to leading infectious diseases research and development at The Medicines Company, he was a co-founder of Rempex Pharmaceuticals where he served as Chief Scientific Officer. Prior to Rempex, he held positions of increasing responsibilities at Mpex Pharmaceuticals, Diversa Corp and Essential Therapeutics/Microcide Pharmaceuticals. Prior to his career in industry, he held full-time appointments as professor and chairman at the University of Rhode Island College of Pharmacy (URI), and Brown University School of Medicine and was based at Roger Williams Medical Center in Providence, RI. Dr. Dudley has served as a consultant on several government advisory boards, notably CDCs Antimicrobial Resistance Working Group, and was an Editor for Antimicrobial Agents and Chemotherapy. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF) in 1980, completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

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