FDA Approval Expert Witnesses in Connecticut

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 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 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 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 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 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 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 extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.

This expert has over 35 years of experience in the field of psychopharmacology. He earned his BS from Massachusetts Institute of Technology and his MD from Emory University School of Medicine. He completed an internship in general surgery at Boston University Affiliated Hospitals and a residency in psychiatry at Massachusetts General Hospital. He is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Academy of Psychiatry and Law. He previously served as a staff psychiatrist for Harvard Vanguard Medical Associates, as a clinical supervisor for Lane Health Center at Northeastern University and as a psychopharmacology consultant for the University of Massachusetts. This expert is currently a psychiatrist at a private practice, a staff psychiatrist at a hospital in Massachusetts and a clinical instructor of psychiatry at an Ivy League university.

This highly-qualified expert has extensive experience with pharmaceutical formulation development, as well as transdermal, topical, and controlled release drug delivery. He earned his BS in pharmaceutical science from Sandar Patel University before earning his MS and PhD in pharmaceutical science from Long Island University. This expert is active in his field as a member of the American Association of Pharmaceutical Scientists and holds a patent related to transdermal drug delivery. He formerly held roles in formulation development at Lincoln Pharmaceutical, Torrent Pharmaceuticals, and Apex Pharmaceuticals, and served as an assistant research scientist at Transdermal Research Pharm Laboratories. This expert is currently a principal scientist at a pharmaceutical laboratory in New York.

This highly-qualified expert has 14 years of experience in the field of biopharmaceutical development, having earned her BS in biology from the University of North Carolina and her PhD in genetics from the University of California at San Francisco. Her work focuses on drug development with a particular focus on gene and cell therapies, including those with the following elements: AAV, Adenovirus, CRISPR, Zfn, Endonuclease, CAR-T, mRNA, LNP, Lentivirus, HSPC. She has worked in positions such as principal consultant for Halloran Consulting Group, the founder and CEO of Tremont Therapeutics, the senior director of Shire PLC, and the executive director of CRISPR Therapeutics. She is also involved in research in her field as an author of several scientific articles. This expert currently works as the principal at a drug development consulting company in Massachusetts.

This highly-qualified expert in chemistry and pharmaceuticals has 20 years of experience in his field. He has experience with analytical chemistry analysis, formulation chemistry, and FDA regulation, and his work has involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug formulation, stability studies and the management of CROs. He earned his BA in chemistry from Rhode Island College before earning his PhD in chemistry from Brown University. He formerly served as a scientist at Eikos Inc and as the principal scientist and project coordinator at Paratek Pharmaceuticals. He then worked as a consultant in pharmaceutical development for H-3 Biomedicine and Cemotics. Currently, this expert is a professor of chemistry at a college and a pharmaceutical advisor at a consultancy in Rhode Island.

This highly-qualified expert has over 30 years of experience in pharmacology. He earned his BS in pharmacy from Albany College of Pharmacy before earning his PhD from Shenandoah University. He is a board-certified pharmacotherapy specialist and a licensed pharmacist. He also holds a certification in pediatric advanced life support. He is active in his field as an author of several scientific articles and as a member of several organizations, including the American Society of Health-System Pharmacists and the Pediatric Pharmacy Advocacy Group. He has formerly served as a pharmacist for Brooks Pharmacy, the Medical University of South Carolina, Mary Imogene Bassett Hospital, and Griffin Hospital. He also served as the director of pharmacy for Option Care (Infucor), a clinical pharmacy specialist at Yale-New Haven Hospital, and the director of pharmacy at Upstate University Hospital. Currently, this expert is the executive director of pharmacy services at a university-affiliated hospital in New York.