FDA Approval Expert Witnesses in West Virginia

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 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 highly qualified expert earned her BS and MS from The Ohio State University. She has been in the health informatics field for over three decades and has extensive experience with clinical informatics and pharmacy operations. Formerly, she was Associate Director of The Department of Pharmacy at Ohio State and also served as Practice Manager for Allscripts (an EMR database). Currently, she is an Independent Healthcare Consultant in the Ohio area.

This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the average consumer will understand, integration of behavior modification and design, working with medical teams to provide documentation required for FDA approval process, and developing health professional’s tools for patient counseling to ensure that the patient education materials are used correctly. She also has expertise in working with medical device companies and packaging companies to ensure that it will be easy for patients to understand the “how to use” instructions and use the products correctly. She received her BSP degree and completed her residency training in hospital pharmacy at the University of Saskatchewan before receiving her Pharm.D. degree from the University of Cincinnati. She is a founding member of the American College of Clinical Pharmacy, a former member of the Board of Directors and Chairperson of the Business Council at the National Council on Patient Information and Education, and is active in many professional and consumer organizations, including the American Association of Colleges of Pharmacy and the Alliance for Safe Online Pharmacies. She has published 150+ peer-reviewed journal articles on patient education and adherence and serves as a reviewer for the American Pharmacists Association. She is the author of 23 books on how to use medications safety for health professionals and consumers. She has appeared on many radio and television shows to help consumers learn how to take their medications correctly. She is also the former director of clinical affairs at the American Pharmacists Association, which honored her with its Foundation Pinnacle Award for her outstanding leadership. Additionally, she is the former coordinator of the ambulatory patient pharmacy at Sunnybrook Medical Center and a former associate professor of clinical pharmacy at the University of Toronto. Currently, she is the CEO of a major patient education company that develops information to help patients understand how to manage their medications, medical devices and therapies correctly, consults with pharmaceutical companies on how to promote patient understanding and patient safety, develops multi-component patient education programs requiring FDA approval, and develops patient education programs for world-wide clinical trials to increase patient adherence so that the approved FDA dosage is more accurate and thus safer.

This clinical development and regulatory expert has an M.S and Ph.D. in Pharmacology & Toxicology from West Virginia University. A member of the American Society of Clinical Pharmacology & Therapeutics, he has extensive product development experience in the pharmaceutical field. The expert spent his early career in clinical research roles, including a position as the Director of Clinical Research Operations for Univax Biologics. He has since founded/run a biotech development business and acts as both a Professor and Consultant in his field.

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.

This highly-qualified expert has nearly 45 years of experience in pharmacology. He specializes in pediatric clinical pharmacology, toxicology, and clinical pharmacy, as well as adverse drug reactions, drug-drug-food interactions, pharmacokinetics-pharmacodynamics, and pharmacogenomics. He earned both his BS in pharmacy and his PharmD from the University of Cincinnati. He also completed an internship in community pharmacy at Winston Place Pharmacy, an internship in hospital pharmacy at Holmes Hospital, and a residency in pediatric clinical pharmacy and clinical pharmacology at Children's Hospital Medical Center. This expert is board certified in applied pharmacology by the American Board of Clinical Pharmacology. He is active in his field as a member of the American Society of Hospital Pharmacists and the American College of Clinical Pharmacology. He has formerly served as the co-director of pediatric clinical pharmacology and toxicology at Rainbow Babies and Children's Hospital and the director of the clinical research center at Akron Children's Hospital. Additionally, he has held a variety of teaching positions, including as a tenured professor of pediatrics in the division of pediatric pharmacology and critical care at Case Western Reserve University and as a professor of pediatrics at Northeast Ohio Medical University. Currently, this expert is a professor emeritus of pediatrics at an Ohio university.