FDA Approval Expert Witnesses

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 qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

This certified compounding pharmacist has received his training from a top pharmacy program and holds clinical and academic positions in his field at both pharmacy and medical schools. He has given invited lectures on compounding pharmacy, and has authored major publications on the topic. Furthermore, he has been in practice since 1977 and has owned a compounding-only pharmacy since 2003. He serves on the North Carolina Board of Pharmacy and the USP Compounding Expert Committee for the 2010-2015 cycle. Memberships include the American Society for Pharmacy Law and the National Associations of Boards of Pharmacy.

This expert isProfessor and Head of the Department of Health Outcomes Research and Policy at a major university school of pharmacy. He holds a bachelors degree in pharmacy from the University of Wisconsin, and a PhD in Social, Administrative, and Clinical Pharmacy from the University of Minnesota. Prior to joining Auburn University he was Associate Professor of Pharmaceutical Outcomes and Policy in the Eshelman School of Pharmacy at the University of North Carolina. This expert’s research focuses population-level assessment of the benefits and risks of drug treatments. His work has been funded by numerous organizations, including the National Institutes of Health, the Agency for Healthcare Research and Quality, the Foundation for the National Institutes of Health, the National Pharmaceutical Council, and the U.S. Food and Drug Administration. He has worked extensively in the area of comparative effectiveness research and drug safety, and teaches classes related to this work.

This board-certified and fellowship-trained expert has over 20 years of experience in neurology with extensive clinical research experience, contributing to over 55 different clinical studies. He has involved in various committees for the University of Nevada School of Medicine. He currently serves as Associate Professor of Neurology and Medical Director for an ALS and muscular dystrophy clinic.

This expert has over 25 years of experience in analytical chemistry including pharmaceutical development. With a Ph.D. from the prestigious Massachusetts Institute of Technology, he has published in analytical and physical chemistry. His previous positions include various lead positions of research and development as well as analytical testing. He currently serves as a Senior Vice President of an analytical services firm.

This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised Product Monographs in consultation with medical and marketing departments, reviewed labeling and promotional material to ensure compliance, and conducted product label audits. He is a member and former Director of the Canadian Association of Professional Regulatory Affairs and also holds membership in the Regulatory Affairs Professional Society. Currently, this expert is the Principal of his own regulatory affairs consulting firm, providing regulatory expertise and services in the pharmaceutical, biotech, and medical device industries.

This board-certified and fellowship-trained expert has over 40 years of experience working as a clinician and researcher of post-traumatic stress disorder. Listed in "The Best Doctors" in America, he is a Distinguished Lifetime Fellow of the American Psychiatric Association and the past president of the International Society of Traumatic Stress Studies. He has over 300 publications including 27 books and monographs. He currently serves as Professor of Psychiatry and Professor of Pharmacology and Toxicology at a major university medical center. He also serves as Senior Advisor at the Department of Veterans Affairs, National Center for Posttraumatic Stress Disorder

This highly qualified expert currently serves as Associate Professor of Ophthalmology and Co-Director of Vitreo-Retina Service at a major medical university. He received a B.A. in Biochemistry from New York University and a M.D. from Johns Hopkins University. He also finished fellowships in Vitreo-Retinal Service and Ocular Immunology and Uveitis Service at Johns Hopkins Hospital and Harvard Medical School, respectively. A member of both the American Academy of Ophthalmology and the American Society of Retinal Specialists, he has published several publications and textbooks on the treatment of uveitis and retinal conditions including retinal detachment. He is very involved in research and serves as a consultant to various companies including Allergan Pharmaceuticals and Lux Biosciences.

This highly qualified Professor of Pharmaceutical Sciences received a bachelors in Pharmacy and a PharmD in Clinical Pharmacy. He is a member of numerous highly regarded professional organizations including the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology. He is an innovator with 10 patents registered in his name. He is widely published in Pharmaceutical literature with over 350 articles. In addition to his academic role he currently serves as CEO of three Pharmaceutical companies.

This fellowship-trained doctor received his medical doctorate from the University of Massachusetts School of Medicine. He completed a fellowship in Clinical Pediatric Hematology-Oncology at the prestigious University of Chicago Medical center. He is currently an assistant professor in the department of pediatrics hematology/oncology at a, where he frequently lectures on topics such as vascular abnormalities of the newborn.

This highly qualified expert is a nationally renown authority in toxicology. He received his Ph.D. in pharmacology from the University of Kansas Medical Center. He has served as Toxicology Program Director in the Department of Environmental Health at the University of Washington, then as Associate Chairman of the Department, as Associate Dean for Research in the School of Public Health, and Associate Vice Provost for Research. He is currently Dean and Vice Provost of the Graduate School at the University of Washington. This expert continues his academic appointment as Professor Environmental and Occupational Health Sciences, and Public Health Genetics. He has served as the founding director of the Center for Ecogenetics & Environmental Health, an NIEHS Core Center of Excellence. Nationally, he has served on the Board of Directors and as Treasurer of the American Board of Toxicology, and as President of the Society of Toxicology. He has also served on the Board of Environmental Studies and Toxicology, National Academy of Sciences /National Resource Council, as a member of the Board of Directors and Vice-President of the Toxicology Education Foundation, and on the Board of Trustees of the Academy of Toxicological Sciences. He is an Elected Fellow of the American Association for the Advancement of Science and the Academy of Toxicological Sciences. This expert was elected to the Institute of Medicine of the National Academy of Sciences, and to the Washington State Academy of Sciences. He has published over 150 scientific articles and book chapters in the field of toxicology and risk assessment. He is the sole author of a widely used Law Review article titled on scientific judgment and toxic torts.

This expert began his career as a medical consultant to the emergency room drug treatment and referral program. He’s been practicing for over 40 years and focuses on internal medicine, consulting in clinical pharmacology, and quality assurance medicine. He is currently involved in many aspects of pharmacology, and holds many positions on boards and committees related to drug abuse, prevention, and treatment. He has been a special government employee consultant for the US Department of Health and Human Services, Public Health Service Food and Drug Administration, and Center for Drug Evaluation. He has numerous patents, trademarks, fellowships, grants, and publication and presentations.

This highly qualified Professor of Pharmacology received a bachelor's degree from the University of Illinois and went on to receive a doctorate in Pharmacy from the University of Michigan. He is board certified in Clinical Pharmacology and Nutrition. He is a Fellow of both the American College of Clinical Pharmacology and the American College of Nutrition. he has won many awards throughout his career including the American Society of Pharmacy Law honor for legal writing. He has published over 300 journal articles and book chapters and currently serves as a reviewingeditor of the American Journal of Therapeutics. He is frequently invited to lecture as a guest speaker both nationally and internationally. This expert is a former assistant director of pharmacy at Cook County Hospital, and is currently an associate professor of pharmacology at a major medical college.

This expert has ~17 years of experience as a pharmacist, with the most recent five years serving as a pharmacy director specializing in clinical pharmacy (inpatient acute care), clinical information systems, safe medical practice, quality improvement, and project management. Earlier in his career, he spent approximately 5 years as a pharmacist in a retail setting. This expert has advised and lead projects and teams on a number of start-up initiatives in the healthcare and information systems marketplace. He has also consulted on five major projects for the County of San Diego, Health, and Human Services Agency.

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug Applications, Drug Product Surveys, and Research Projects. Currently, this expert is an independent consultant in which he assists pharmaceutical firms in technical, regulatory, and management areas to ensure their clients' products hit the market in a timely manner. He assists attorneys as an Expert Witness/Subject Matter Expert in Pharmaceutical cases.

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 expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in front of the U.S. Senate as a healthcare policy expert, FDA expert and Pharmacology expert. He has authored or co-authored over 50 publications, papers, articles, reviews, clinical protocols and reports in many related areas including FDA law, drug pricing, healthcare policy, healthcare insurance, drug development and drug patent law.

This expert is a licensed pharmacist and associate professor of clinical pharmacy at a top university pharmacy school. She earned her PharmD at the University of the Pacific and belongs to a number of prestigious societies in the pharmacy space, including the American Association of Colleges of Pharmacy and the American Society of Health System Pharmacists. She has served in various pharmaceutical positions throughout her career and has authored more than 20 publications in the field.