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Carol S. Maskin, M.D. Dr. Carol Maskin is a Cardiologist and a seasoned pharmaceutical executive with 25 years experience developing and implementing clinical and regulatory strategies for new drug and new claims approvals, both Rx and OTC, in a broad range of therapeutic categories. Carol’s consulting practice focuses on Rx drug development in cardiovascular disease, hypertension, diabetes, dyslipidemia and obesity, and on Rx-to-OTC switches. She also evaluates intellectual property for potential licensing or co-development, and she provides advisory support to Venture Groups and to business development teams. Before becoming an independent consultant in 2005, Carol was Vice President and Head of Global Development Projects for Aventis Pharmaceuticals where she led strategy and implementation of all Rx projects, Phase 2b – 4, in all therapeutic categories. A partial list of the major products developed within her teams includes: Lovenox, Lantus, Apidra, Exubera, Actonel, Allegra, Alvesco, Taxotere. Prior to Aventis, Carol was VP and Head of R&D for Bristol-Myers Squibb Worldwide Consumer Medicines where she restructured and globalized R&D, achieved BMS’ first Rx-to-OTC switch, Vagistat-1 (launched as Monistat-1), and led development of Excedrin Migraine, the first FDA approved OTC medicine for treatment of migraine. Therapeutic category responsibility included: analgesics, women's health care, cardiovascular health, skin care, cough/cold, allergy, vitamins. Earlier in her career, Carol was Executive Director of Rx Cardiovascular Development at BMS, responsible for Phase 2 – 3/3b clinical research for heart failure, myocardial infarction, hypertension, and nephropathy, including conduct of large multinational morbidity/mortality outcomes trials. This work led to several "1st in class" indications for Capoten and full development of Monopril and Monopril HCT. Carol also contributed to lifecycle strategy for Pravachol, and to BMS/Sanofi planning for co-development of Plavix and Avapro. Before moving to industry, Carol was a member of the full time academic faculty at the Albert Einstein College of Medicine and then at the University of Chicago Pritzker School of Medicine, Divisions of Cardiology. She was a clinical investigator specializing in heart failure and ischemic heart disease and also served as a consultant to industry on a variety of cardiovascular drug development programs. Carol's research has been published extensively in the medical literature. |
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