Dr. Munish Mehra is a senior biopharmaceutical executive and researcher who currently serves as the Managing Director at Quantum BioPharma and Global Drug Development Experts, and as the President of the not-for-profit Global Alliance of Indian Biomedical Professionals.
During a career spanning over twenty five years, he has designed, conducted, and reported on Phase I through IV clinical trials across multiple therapeutic areas, helping to grow two contract research organizations (CROs) into global players, one of which was the first CRO to go public in 1991. More recently, he led clinical research operations at a mid-size CRO where he expanded operations globally and created an offshore Biometrics center. He is currently a sought after consultant for helping develop new CNS, cardiovascular, dermatology and respiratory drugs, and the use of Item Response Theory with Rasch analysis for creating more sensitive and clinically meaningful endpoints.
Dr. Mehra has helped several sponsors ensure studies are designed optimally and executed efficiently. His work across Europe, China and India, has enabled him to focus on assisting companies to accelerate drug development with global strategies for rapid enrollment, optimized clinical data management and statistical methods. He developed a unique method and system for remote electronic monitoring and mentoring of computer assisted performance support for the conduct of clinical trials, for which he received US Patent No 6871195.
Dr. Mehra has previously presented at (Drug Information Association) DIA meetings in India and the U.S., and Regulatory Affairs Professional Society (RAPS), Biotechnology Industry Organization (BIO), ExL Pharma, and IDEAS Exchange conferences around the world. From 2007 to 2011 he chaired the DIA’s Good Clinical Practice (GCP) Special Interest Area Community (SIAC) and currently serves on their Core Committee. In 2011 he was asked to chair the DIA’s annual meeting in India and he currently serves on the Program Committee for the DIA’s U.S. annual meeting.
Dr. Mehra holds a PhD in Biostatistics and a Masters in Computer Science from the University of Kentucky, as well as a Masters in Mathematics from the Indian Institute of Technology. His inspiration for clinical research is his great-grand father, Dr. Sir RN Chopra, one of history’s leading pharmacologists who was once the physician to George VI and is widely considered the father of modern drug development in India. Dr. Mehra resides in North Potomac, Maryland with his family.