Michael J. Daley Ph.D.
Product lead and development strategies, Post-marketing support, Regulatory & Clinical Affairs, Outsourcing strategies, Drugs/Biologics/Devices, Licensing
Mike’s 27 year career in the biopharmaceutical industry has ranged from working in small emerging to large biopharmaceutical companies. He started his industrial career in drug discovery as Group Leader of Immunology & Microbiology at American Cyanamid (Pfizer) and, advancing two candidates to product development. He joined a JV of DuPont and ConAgra, DCV Biologics LLC, as Director of Clinical, Regulatory and Quality Affairs. Headvanced2 products into clinical development, established an internal QA/QC program, successfully filed 2 GRAS affirmations, as well as serving as primary regulatory liaison to the FDA. He later joined SRA Life Sciences, an emerging CRO, as Director of Program Development helping to establish internal processes and support to expand their marketed services. He joined the Medical Affairs department at Sanofi Pharmaceuticals Inc. (Sanofi), where he served 8 yrs. as Medical Director of Internal Medicine Products that covered orthopedic, rheumatology and physiatry specialty markets, as well as medical oversight of 53 non-promoted drugs, collectively accounting for $80MM in sales.