FDA Approval Expert Witnesses

This qualified expert of Addiction Psychiatry completed his undergrad and MD in Canada at the McGill University. He completed his post-doc Residency and Fellowship in Psychiatry and Pharmacology in Canada at the University of Toronto. He is Board Certified in the US in Psychiatry & Neurology and in Addiction Psychiatry. He is a member of multiple Addiction Psychiatry Medical Associations and has published 200+ Publications on Addiction Psychiatry Research. He is currently a Professor of Psychiatry at a Top Medical University, the Director of a Top University's Addiction Center, and is the Chief Psychiatrist and Associate Medical Director at a Top University Hospital.

This highly qualified expert has been conducting academic studies in toxicology for 30+ years. He completed his postdoctoral and fellowship training at Rochester University. He is a fellow at the American Association for the Advancement of the Sciences and a member of numerous professional associations, including the Academy of Toxicological Sciences, where he serves in the board of directors. He is also the past president of the International Neurotoxicology Association. He has authored approximately 300 peer-reviewed manuscripts and chapters in the area of neurotoxicology and serves on the editorial board of several journals. He is the former director of clinical pharmacology and toxicology at Vanderbilt and the former director of the NIEHS Molecular Toxicology Center. Currently, he is a professor and chair of molecular pharmacology at a major university in New York.

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 highly qualified expert has years of experience in using animal models to study diabetes. He received his PhD degree from Ohio State University and completed his fellowship training in physiology and biophysics at the University of Illinois. He has published 98+ peer-reviewed journal articles and serves as a reviewer for 26+ renowned medical journals. He has been listed in "Who's Who in America" for science and engineering and lectures nationwide. Currently, he is a professor of pharmaceutical science and research and the director of pharmacology and toxicology at a major university. He is also the director of the Center for Diagnostic Nanosystems and the associate director of the Cell Differentiation and Development Center at the same institution. Additionally, he is the biological sciences laboratory supervisor at another major university.

This highly qualified expert earned her PharmD from Midwestern University College of Pharmacy Glendale. She continued her post graduate education with a residency in Acute Care Pharmacy Practice and a residency in Geriatrics. She is a member of the American Society of Consultant Pharmacists and a Member of the Arizona Pharmacy Association. This expert has been the recipient of distinguished honors and awards such as AzPA Geriatric Care Academy Service Award. She has published 10 peer-reviewed journal articles. She is a former Visiting Instructor from Midwestern University College of Pharmacy Glendale. She currently serves as current Adjunct Faculty from a major university and a Long Term Care Clinical Consultant Pharmacist from a private consulting group.

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.

Medication Information Specialist with over 30 years of pharmaceutical experience in the areas of mental health comorbities, chronic pain management, psychiatric pharmacotherapy, pharmacoepidemiology, substance abuse, therapeutic medication monitoring, pharmaceutical marketing, illicit drug usage, adverse drug reactions, medication interactions, dietary and herbal supplements.

This highly qualified psychiatric pharmacology expert received a BS in Bacteriology from the Univeristy of California Los Angeles (UCLA) and earned his doctor of pharmacy (Pharm.D.) at the University of Southern California (USC). He had a National Institute of Mental Health (NMH) training fellowship in Psychiatric Pharmacy at the University of Nebraska Medical Center in Omaha, and was recruited to join the faculty of the highly-ranked The University of Texas at Austin College of Pharmacy. He is Board Certified in Psychiatric Pharmacy (BCPP) by the Board of Pharmaceutical Specialties. He serves on the Board of Directors for the College of Psychiatric and Neurologic Pharmacists Foundation and is a founding member of the College of Psychiatric and Neurologic Pharmacists (CPNP). During his 37 years career, this expert has provided clinical care and education in a variety of settings and treatment roles. He teaches didactic and experiential courses for Pharm.D. students and graduate courses for MS and PhD post-Pharm.D. students. He authored and successfully discussed with members of the Texas Legislature the creation of a clinical research unit at San Antonio State Hospital (SASH) that was funded by the Texas Legislature and jointly governed by the UT Austin College of Pharmacy, UT Health Science Center San Antonio Department of Psychiatry and SASH. This expert continues to publish scholarly articles and is regularly invited to do scholarly and lay presentations around the country on a variety of pharmacy and mental health related topics. He was the Senior Founding Editor for a major mental health publication. He edited Psychopharmacology Update newsletter from 1998-2002, and edited two editions of a compendium based upon this newsletter, Psychopharmacology Desktop Reference, published by Manisses Communications Group in 1999 and 2002. He has received several awards reflecting his accomplishments as a clinician, teacher, and researcher.

This highly qualified expert earned his BS from George Fox University and PhD from University of California- Los Angeles. He completed a postdoctoral fellowship at The Scripps Research Institute. He is actively involved in research and education; to date he has 60+ original peer reviewed articles/ abstracts. Currently, he is an Assistant Professor of Pharmacology at a major university affiliated medical center. He has been trained in the study of drug discovery and taught on Molecular Pharmacology, Drug Discovery, Molecular Signaling/Transduction for the past few years at two medical schools. His research work includes collaborations with discovery teams to design new drug strategies, synthesize novel drugs, evaluate them in cell culture models, then evaluate their efficacy, side effect profiles, pharmacokinetics, and toxicology in animal models, all with the goal of developing new drugs for human treatment. Most of his research and drug development work is centered on developing new opioid and cannabinoid drugs for chronic pain, cancer treatment, and similar diseases.

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 expert has over 20 years of expertise in the pharmaceutical industry. He holds a Bachelor's degree in Business Management from Georgia Tech and an MBA in Marketing from California Coast University. He has hands on experience in Sales & Marketing, Managed Markets, Distribution, Operations, & Business Development. He has designed & implemented national commercial programs for a variety of drugs.

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 expert is a well respected and established Professor of Law specializing in ethics of the healthcare industry. He has testified before Congress and state legislatures and served on government commissions and advisory boards, including the Food and Drug Administration. He has provided training on conflicts of interest related to pharmaceutical good governance for various nations under the aegis of the World Health Organization. He has participated in meetings of the National Academy of Sciences, Institute of Medicine and worked for the World Health Organization. He has extensive experience in the fields of health law and policy, pharmaceutical policy, biomedical law, medical ethics, and more.

This highly qualified and board certified psychiatrist has been practice for 33+ years. He earned his BS at the Massachusetts Institute of Technology and MD at Emory University. He completed residency training in psychiatry at Massachusetts General Hospital. This expert is a member of several professional organizations including the American Psychiatric Association and American Academy of Psychiatry and the Law. Currently, he is a clinical instructor at a university affiliated hospital. His clinical and forensic expertise includes assessment of complex diagnoses, treatment of depression, bipolar disorder, ADHD, and anxiety disorders. His expertise also includes dosing, side effects, drug interactions, and toxicity of psychotropic agents.

This expert in EMR and Hospital Billing systems has worked as a certified Epic consultant with various healthcare providers for the past 7 years. He is currently certified in 10 Epic applications ranging from hospital billing to CDM and ASAP. He has previously held positions as a Senior Epic Consultant at multiple hospitals, as an Epic Instructional Designer, and as an Epic Revenue Cycle Report Writer. He is currently a Senior Epic Hospital Billing Consultant at a large university cancer center in Texas.

This well-credentialed expert earned his B.S. in Pharmacy from Columbia University, an M.S. in Pharmacy from the University of Iowa, and a Ph.D. in Pharmaceutical Chemistry from the University of Iowa. He has extensive experience in cosmetics development, including positions at Johnson & Johnson, Avon Products, and DeLaire Inc. From 1993 until 2001, the expert was the Senior Director of Research and Development for Gryphon Development / Bath & Body Works Inc. / Victoria Secret Beauty. In this position, he developed formulations for treatment products, cleansing products, and OTC drugs. The expert currently runs his own independent cosmetics development consultancy, through which he has worked with firms including Bath and Body Works, Unilever Latin America, Morning Glory Products, and many others.

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 specializes in epidemiology, biostatistics and pharmacy. He is an alumnus of the UIC College of Pharmacy where he completed his PharmD before pursuing his MPH in Biostatistics and Epidemiology at New York University and a PhD in Epidemiology at the University of Washington. He completed additional training in cancer epidemiology and prevention as a postdoctoral fellow at the Fred Hutchinson Cancer Research Center in Seattle. His primary research interests are related to the influences of commonly used medications and comorbidity on cancer risk and outcomes among cancer survivors.

This expert earned his BS from Brown University and his MD from Brown University's Alpert Medical School; following this he went on to complete a family medicine residency at the Memorial Hospital of Rhode Island. He is active in his field as a member of professional organizations such as the American Academy of Family Physicians and the Society of Teachers of Family Medicine. His expertise are highlighted by his over 60 peer-reviewed publications and the 5+ book chapters he authored. He currently serves as an Adjunct Clinical Associate Professor of Pharmacy at a state university; he also holds several positions at a major medical school in New England including Assistant Dean of Medical Education and Associate Professor of Medical Science and Family Medicine.

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.