Michele Yelmene

Michele has over 35 years of hands-on biotech and pharmaceutical industry experience in all aspects of drug development from bench research and clinical trial design through product registration and post-marketing activities. Her breadth of experience includes the submission of over 100 INDs with 18 drugs/biologics achieving domestic and international regulatory marketing approval.

She has designed, conducted, and reported global clinical studies in a wide variety of therapeutic areas, including infectious diseases, metabolic and endocrine disorders, and oncology. She has also implemented and overseen Quality Systems and manufacturing for Phase 1 through the commercial launch of new drugs and biologics in addition to preparing for and hosting inspections by FDA and other regulatory authorities.