Article | August 20, 2014

Interview With Dinesh Thakur, ISPE Annual Meeting Keynote Speaker And Executive Chairman At Medassure Global Compliance Corporation

Source: ISPE
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Risk Management And Quality Management Systems (Quality Systems)

Dinesh S. Thakur is an expert and accomplished entrepreneur in pharmaceuticals, biomedical product development, drug regulation, and information technology. During his career, he held senior positions at Bristol-Myers Squibb Company, Ranbaxy Laboratories, and Infosys Technologies. Most recently, he co-founded and was the Chief Executive Officer of Sciformix Corporation, a scientific processing outsourcing organization that delivers services in the areas of drug safety, biometrics, medical and regulatory writing, and clinical operations. From 2003 to 2005, Thakur was the Director and Global Head, Research Information and Portfolio Management at Ranbaxy Laboratories, India’s largest generic drug manufacturer. He was responsible for managing research and development information for generic drug development, manufacturing, and commercial operations. In addition, he implemented automated systems to capture research and development data for global regulatory submissions, compliance, and manufacturing. While at Ranbaxy, Thakur discovered that the company was falsifying drug data and violating current good manufacturing practices and good laboratory practices. He resigned in 2005 after reporting the fraud to company management, and worked with authorities for eight years to unravel the complicated trail of falsified records and dangerous manufacturing practices. In May 2013, Ranbaxy pleaded guilty to multiple criminal felonies and agreed to pay $500 million to resolve criminal and civil allegations of falsified drug data and systemic manufacturing violations resulting in substandard and unapproved drugs. The groundbreaking settlement is the largest of its kind against a generic drug manufacturer. Thakur received a Bachelor’s degree in technology from Osmania University, an MS in chemical engineering from University of New Hampshire, and graduate training from Syracuse University.

This Article is published with permission from the International Society of Pharmaceutical Engineering (ISPE), and Pharmaceutical Engineering Magazine