Rekha Garg, MD MS joined Sanifit in October 2016 as Senior Vice President Development, Regulatory and Safety of the company’s US subsidiary. Dr. Garg has over 20 years of biopharmaceutical industry experience in various leadership roles including regulatory, safety, risk management, clinical development and across multiple therapeutic areas.
Dr. Garg has led global regulatory strategy along with global filings (BLA, NDA, MA etc.) including Repatha® for lipid lowering and Corlanor® for chronic heart failure and regulatory interactions with global health authorities including the FDA, EMA, TGA CFDA, PMDA and several FDA advisory committees. She also has led the development, implementation and removal of product Risk Evaluation and Mitigation Strategy (REMS) programs as well as clinical development across cardiovascular, renal, oncology and critical care therapeutic areas.
Prior to joining industry, Dr. Garg was responsible for conducting cardiovascular clinical trials at NIH-NHLBI in the Division of Epidemiology & Clinical Applications and as an Epidemic Intelligence Officer at the CDC National Center for Health Statistics. She received her MD Degree at the Medical College of Ohio and completed her post graduate training at University of Maryland School of Medicine where she also received an MS in Epidemiology.