Michael Stevens, PharmD is a pharmaceutical executive with over 30 years of experience Clinical, Medical Affairs, and Drug Development. He has broad experience in drug discovery ranging from preclinical through Phase 4 in the therapeutic areas of oncology, virology (HIV/AIDS, hepatitis B, etc.) clinical nutrition, and Gram-positive/Gram-negative antibiotics gained in both Big Pharma (Bristol-Myers Squibb) and small biotechs. As Vice President, Medical Affairs Virology at BMS, Dr. Stevens had direct responsibility for Phase 3b/4 Research, Retrospective Analyses, Clinical Intelligence, Medical Science Associates, and Medical Information for the USA Virology franchise as well as drafting regulatory submissions, medical publications, and corporate communications. In recent years, he has gained experience in lead compound selection, preclinical, and early stage (Phases 1 and 2) development with several small biotech concerns.
In the fight against HIV/AIDS, Michael was a member of 16 protocol committees within the National Institutes of Health’s AIDS Clinical Trials Group (ACTG). In addition to this, Michael also served as an Executive Council member of the Forum for Collaborative HIV Research. The Forum includes representatives from government, industry, patient advocates, health care providers, academia, and foundations. The Executive Committee includes members from each of these groups.
Dr. Stevens’ experience in drug development includes interfacing with both the FDA and the EMA in matters of protocol design and implementation, subject safety, and regulatory submissions. While primarily focusing on virology, he has also gained experience with oncology agents, nutritional products developed for the clinical setting, therapeutic vaccines, and medical devices. Specific products include etoposide/etoposide phosphate (oncology), an additional indication for hydroxyurea (Sickle Cell Anemia), didanoside, stavudine, efavirenz, reyataz, and combination products (HIV/AIDS), baraclude (hepatitis B), and a therapeutic vaccine for HIV/AIDS, as well as novel compounds targeting emerging Gram-negative pathogens including Acinetobacter baumannii. Dr. Stevens has experience in creating and writing clinical protocols, designing and implementing Case Report Forms, analyzing the resultant data, writing Clinical Study reports, producing publications and presentation based upon those results, and incorporating those results into regulatory submissions to both the FDA and EMA.
Dr. Stevens has authored/co-authored more than 50 publications, text book chapters, posters, and abstracts. He obtained both his BSPharm and PharmD degrees from Purdue University.
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