Ashok Srivastava , DM, PhD, MBA
Chief Scientific Officer, Executive Vice President, Clinical Operations and Medical Affairs
Dr. Srivastava has more than 10 years of experience in clinical drug development. In his current position, he has complete responsibility for Diverse Lynx’s global strategic planning, therapeutic divisions, medical monitoring, data management, biostatistics, specialized pharmaceutical services, and regulatory affairs. He has extensive experience in drug development of all phases including evaluation of biomarkers. Dr. Srivastava is trained in clinical research and medicine from All India Institute of Medical Sciences, India, Czechoslovak Academy of Sciences, Czechoslovakia, University of Nagasaki School of Medicine, Japan, and pharmaceutical business from Rutgers University, USA. He has conducted numerous phase 1, 2, and 3 registration trials along with phase 3b, 4, observational and registry trials of Oncology therapeutic. He has contributed to INDs and NDAs of oncology therapeutics and supportive care. Dr. Srivastava has worked and trained in renowned medical and pharmaceutical institutions, such as Walter Reed Army Institute of Research, Daiichi Pharmaceutical, Pharmacia/Pfizer, Dianippon Pharmaceutical, and Sopherion therapeutics. Prior to joining Diverse Lynx, he was Executive Director of Clinical Operations Oncology at Cytogen. Dr. Srivastava is a seasoned professional and has led international drug development programs in European Countries, India, Japan and USA. He has published 45 papers in national and international medical journals, more than 70 abstracts and 2 patents. His major area of expertise in drug development is Oncology and CNS therapeutics. Dr. Srivastava is recipient of numerous international prestigious awards and recognitions from UNESCO/United Nations, MONBUSHO Japan, Department of Army, Walter Reed Army Institute of Research, Washington DC. He is a member of prestigious organizations; ASCO, ASTRO, and AACR.
Myron B. Peterson , MD, PhD
Medical Director
Dr. Peterson has broad experience in Medical Affairs. He served on faculties at Harvard Medical School, Duke University, and Tufts School of Medicine. In addition, he was the Division Chief of Pediatric Critical Care Services at Tufts Medical Center. He has conducted pre-clinical and clinical trials in acute lung injury, cardiac and liver transplantation, septic shock, trauma, and reperfusion injury. He has extensive experience in critical care transport and integrated emergency medical systems. He received his medical degree from University of Colorado, magna cum laude, and was an intern and resident at Children’s Hospital Boston. He completed his fellowship training at Children’s Hospital Boston in Pulmonary Medicine, Massachusetts General Hospital in Anesthesia, and Peter Bent Brigham Hospital in Cardiovascular Medicine. Dr. Peterson has extensive experience in the clinical management of many disease states, and drug development expertise across many therapeutic areas including central nervous system, cardiovascular and pulmonary diseases, and oncology.
Joseph S. Barone , MD
Vice President Pharmacovigilance
Dr. Baron oversees pharmacovigilance and global safety strategic planning. Dr. Baron has over a twenty-seven years of experience in clinical research programs to provide new drug registrations, revision of labeling claims for established products, pharmacovigilance compliance and issues analysis teams for top-tier biopharmaceutical firms, and the strategic medical advisory function to senior corporate management including marketing and sales. He has developed proven capabilities as a quality-focused, issues-oriented, rapid-turnaround senior consultant to the executives of major biopharmaceutical companies looking to expand their organizational and functional competencies in the areas of global pharmacovigilance compliance and in drug-associated risk management planning and execution. Dr. Barone is expert in managing drug safety monitoring and evaluation processes for drugs and biological products in the pre-authorization and post-marketing phases of development. Dr. Barone’s experience includes seven years in clinical R&D including registration management and authorship roles at American Cyanamid Co. (now part of Wyeth), over seven years in Phase IV Medical Development and post-marketing Medical Services at Pfizer Inc., two years at Bayer Corp. where he managed the QTc interval prolongation characterization effort for moxifloxacin for German and US registration programs, six years at Daiichi Pharmaceutical where he led both Global Pharmacovigilance and Medical Services, nearly one year at Solvay Pharma where he served as VP, Drug Safety and Surveillance and over one year at Schering-Plough where he mentored and led groups of physicians, epidemiologists and signaling specialists as Director, Global Pharmacovigilance in aggregate post-marketing and pre-authorization data analysis and report, e.g., PSUR, QSR, ASR and RMP, authorship. He interacted with FDA and international regulatory agencies and delivered authoritative presentations on the topics of drug-associated QTc interval prolongation and strategies in promotional materials. Barone, M.D. is a Board-certified general Internist with a sub-specialty in Endocrine and Metabolic disorders.
Richard Trout , PhD
Lead Consultant in Biostatistics
Dr. Trout is Professor Emeritus from Rutgers – The State University of New Jersey. He was a member of the faculty of the Department of Statistics of Rutgers University for 29 years. During this period he has worked on a large number of drug and device projects, in a wide variety of therapeutic areas, sponsored by over 75 pharmaceutical companies. Dr. Trout has contributed to many NDA and PMA submissions in different therapeutic areas. He has worked in all phases of drug development including design of clinical trials, development of statistical analysis plans, data analysis and statistical summary of clinical studies, and representation of the sponsor at FDA meetings. He has represented the pharmaceutical industry at fourteen FDA sponsored advisory panel review meetings. Dr. Trout received his Bachelors of Science degree in mathematics from Lafayette College and his MS and Ph.D. degrees in Applied and Mathematical Statistics from Rutgers University.
|