Founders

Roberta Schneider, MD

 

Roberta “Bobbie” Schneider, MD is a dynamic, results-oriented physician with over 29 years of pharmaceutical industry experience in all aspects of drug development.  Bobbie has worked in large, medium and small pharmaceutical and biotechnology company settings in leadership and operational roles. These include: Restoragen, Daiichi/Sankyo, Takeda America Research and Development Center, Novo Nordisk, Sanofi, and Merck.  She led clinical programs that culminated in major drug approvals and has since added a decade of experience in advising and supporting a wide range of companies as an independent consultant.  Bobbie has evaluated potential development compound selection, IND creation and submission, clinical trial design and implementation (Phase 1-4), NDA preparation and filing, defense of proposed labeling, leading teams at FDA Advisory Committees, marketing material review, product safety (drug and device) and all aspects of medical services.  She has experience with US and foreign-based organizations with multi-national, multi-disciplinary project teams.  Bobbie is excellent in FDA interactions at all levels. She has extensive public speaking experience for all levels of pharmaceutical professionals.