Mukesh Kumar

Dr. Kumar is the Senior Vice President, Regulatory Affairs for Vivacelle Bio. Prior to his election to the Board of Directors of Vivacelle Bio and to his appointment to serve as Vivacelle Bio's Senior Vice President for Regulatory Affairs, Dr. Kumar provided services to Vivacelle Bio as the independent consultant with respect to regulatory affairs and in his capacity with a third-party FDA clinical and regulatory affairs company. Under Dr. Kumar's leadership, Vivacelle Bio received its first clearance to proceed with its clinical trial of VBI-1 primarily designed to treat the hypovolemia caused by blood loss. Dr. Kumar is an inventor and a former NIH Staff Scientist. His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU and India. He has conducted GCP, GLP, GMP, and GACP audit in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance-related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar has a Ph.D. in Biochemistry and in addition to his work at the NIH, he has also worked as a research scientist at the Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA. Dr. Kumar is also CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies.