FDA Approval Expert Witnesses in Delaware

This expert is a board certified internal medicine doctor who has been working as an attending physician in a nursing home for over 30 years. He has extensive experience in dealing with patients who are at higher risk for falls.

This expert holds a doctorate degree in toxicology and has been a practicing toxicologist for over 40 years. Board certified by the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, he had published over 35 scientific articles and is a former president of the Mid-Atlantic chapter of the Society of Toxicology. He spent over 30 years as a Director of Toxicology for two major pharmaceutical companies and currently serves as an independent toxicology consultant.

This highly qualified Associate Professor earned a masters in Public Health in Epidemiology from the highly regarded Bloomberg School of Public Health. He is board certified in Internal Medicine. He has won many honors throughput his career including the Bruce Squires Award for the Best Research Paper. He is a member of numerous professional societies including the International Society of Pharmacoepidemiology. He serves as a reviewer for more than 50 peer-reviewed medical journals and has published 107 peer-reviewed journal articles. His expertise are highly sought after and he is frequently invited to lecture as a guest speaker both nationally and internationally. He is currently clinically active at a major university affiliated hospital in addition to his academic position.

This highly qualified expert has years of experience in assessing, developing and executing regulatory strategies. He is board certified in internal medicine and endocrinology and has been practicing for 34+ years. He received his PhD degree from Washington University and completed his residency training at Yale-New Haven Hospital. He is a fellow of the American College of Physicians and a member of multiple other professional societies, including the Endocrine Society and the American Diabetes Association, which honored him with its "Outstanding Service Award" in 1991. He has published 16+ peer-reviewed journal articles and lectures nationwide. He is the former executive director of global regulatory strategy, policy and safety at Merck Research Laboratories and the former chief of the diabetes program branch at the National Institute of Health. He is also a former consultant in the division of metabolism and endocrine drug products at the FDA. Currently, he is the owner of an individual pharmaceutical/regulatory consulting company in Pennsylvania.

This expert is board certified psychiatrist and addiction specialist, and also is certified by the American Board of Disability Analysts. He is an expert in handling capital, personal injury, loss mitigation, malpractice and negligence cases that involve the use of abused substances (especially, opiates, alcohol, hallucinogens, and stimulants), prescribed pharmacological agents, and in the general field of psychiatric and brain disease. This expert also is a leading neuroscientist and neuropsychopharmacologist. He can provide expert testimony on the effects of different brain states and function, in both health and disease, and their potential association with with legal culpability and liability. He currently serves as the Chairman of the Department of Psychiatry at a leading university in the USA, and has over 12 years experience as Chairman in Psychiatry Departments in the USA. His research focus is in the neuropsychopharmacology of addiction, addiction and pain, pain treatment, impact of genetics on human behavior, the basic, molecular, and the brain imaging sciences related to the functioning of the brain in health, disease and addiction. In recognition of his academic, scholarly and professional achievement, he is a Fellow of the Collegium Internationale Neuro-psychopharmacologicum and a Distinguished Fellow of the American Psychiatric Association. He is the recipient of numerous professional and scientific awards, including the Jack Mendelson Award at the NIH, which is awarded to individuals who have made distinguished contributions to our understanding of the science of addiction. He has an h-index of 46, and 11829 citations of his published work.

This Pharmaceutical Business Executive has a proven history of strategic marketing experience and increasing sales growth at Eisai, Roche, and Pfizer, among other firms. He previously served as Director of Marketing, the Head of Primary Care and Speciality Marketing, and the Head of Commercial Operations in the Americas at Eisai. He now serves as a consultant and mentor at the C-suite and Board Level to growing pharmaceutical and biotech firms.

This accomplished senior finance executive has more than 30 years of experience within the global pharmaceuticals, healthcare, pharmacy benefits management and manufacturing industries. Most recently, he held the title of Vice President of Finance, Gross Margin Planning and Strategic Pricing with Express Scripts from April 2013 to March 2016. In this role, he managed the finances, strategic planning, business development, competitive intelligence and pricing for over $100 billion in annual revenue and associated gross margins across all business units. The expert previously held positions as a Market Group CFO & the Senior Vice President of the Employer & Key Accounts Group, the Vice President of Client Analysis & Account Management Planning, and the Vice President of Pricing & Underwriting. He has extensive experience overseeing negotiations and pricing for renewals and new sales. The expert earned his B.A. in Accounting & Business Administration and an M.B.A. in Finance from Rutgers University. He is currently an independent consultant.

This accomplished expert received his BA in Biology from the State University of New York at Buffalo and his DO at the New York College of Osteopathic Medicine. He completed his fellowship in Pediatric Anesthesia at the Children's Hospital of Philadelphia, is board certified in Pediatrics, Anesthesiology, and Pediatric Anesthesiology, and is certified in Advanced Cardiac Life Support and Pediatric Advanced Life Support. He is an active member in the International Anesthesia Research Society and the Medical Director of the Malignant Hyperthermia Association of the United States, and the Medical Director of the Institute for Safe Medication Practices. This expert is also currently a member of the FDA's Anesthesia and Analgesia Drug Advisory Committee. His research focuses on medication safety, malignant hyperthermia, and many different aspects of pediatric anesthesia safety. Formerly, he was the Chief of Pediatric Anesthesia at the University of Rochester, and an attending Anesthesiologist at Strong Memorial Hospital. Currently, he is a professor of Pediatrics and Professor of Anesthesiology & Critical Care and Pediatrics at a prestigious university, as well as an attending anesthesiologist at a children's hospital in Pennsylvania.

This expert has served the Drug Enforcement Administration for 21 years before entering the private sector. He gained a BA in law enforcement administration from Youngstown State University and was a state trooper for the Maryland State Police for 7 years before joining the DEA. At the DEA, he investigated international and domestic crime organizations, seizing millions of dollars in drug-related assets. This expert has been decorated numerous times and has been honored by the Attorney General for his service.

This qualified expert has nearly a decade of board-certified experience in his field. He earned his undergraduate degree in premedical education from the Adamjee Government Science College and his MD from the Dow Medical College in Pakistan. He then worked as an administrator, medical officer, and house staff general surgeon in the Civil Hospital of Karachi. He then completed a residency in internal medicine at the University of Texas Medical Branch, Galveston before going on to complete a prestigious fellowship in hematology and oncology from Albert Einstein College/Montefiore Medical Center. This expert is triple board certified in internal medicine, hematology, and medical oncology. He is very active in his field as a member of multiple professional societies including the Society for Immunotherapy of Cancer, the European Society for Medical Oncology, the American Association of Cancer Research, the American Society of Hematology, and the American Society of Clinical Oncology. In addition, this expert has published over 40 peer-reviewed articles. Formerly, this expert served as a physician in hematology and oncology at the Greater Washington Oncology Associates and was the director of clinical oncology at Medimmune/AstraZeneca. He also was a clinical instructor for internal medicine residents at Prince George Hospital. Currently, this expert is a clinical program lead for a biotechnology company and he is an independent practicing physician in hematology and oncology.