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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.
Endowed Professor, A Pharmacy School in AL
Doctor of Philosophy (PhD), University of Minnesota
Auburn,
Alabama
This highly qualified expert has years of experience in the field of neuropharmacology. He received his PhD degree from the University of California, Santa Barbara, and completed his fellowship training at Harvard University. He is a member of various professional associations, including the American Society of Pharmacology and Experimental Therapeutics and the American Chemical Society. He has published 250+ peer reviewed journal articles and has 51+ US issued patents that focus particularly on neurological studies. He also serves as the editor-in-chief for ACS Chemical Neuroscience, lectures both nationally and internationally and has received multiple honors for his outstanding work, including the John J. Abel award in pharmacology. He is the former co-director of the Synthesis Facility at the Vanderbilt Institute of Chemical Biology and the former senior organic chemist at Eli Lilly & Co. Currently, he is a professor of pharmacology and chemistry at a major university, where he is also the director of medicinal chemistry and DMPK at the Center for Neuroscience Drug Discovery. Additionally, he is the director of drug discovery at a major science institute in Tennessee.
Director, Major Science Institute
Doctor of Philosophy (PhD), University of California Santa Barbara
Tennessee
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.
Professor, A prestigious TN medical school
Doctor of Medicine (MD), McGill University
Nashville,
Tennessee
This expert is currently an adviser to the biopharmaceutical industry on matters involving business development, licensing, and strategic partnership. He has also held numerous board positions and currently serves on the board of directors for a clinical stage pharmaceutical company. In addition, he is an Adjunct Professor of Law at a University California. Most recently, he served as the Executive Vice President and General Counsel at Acucela, a development stage company that specializes in identifying and developing novel ophthalmic therapeutics. Previously, he was the Corporate Vice President of Corporate Development and Assistant General Counsel for Allergan Inc. The expert earned his BS of Pharmacy and Doctor of Pharmacy degrees from the State University of New York at Buffalo and a J.D. degree from the University of Southern California Law Center. He holds a certificate in alternative dispute resolution from the Straus Institute of Dispute Resolution of the Pepperdine University School of Law.
Member of the Board of Directors, A Clinical Stage Pharmaceutical Company
Certificate (Cert), Pepperdine University School of Law
Franklin,
Tennessee
This expert has 15 years of experience in clinical pharmacotherapy. He received his PharmD from Campbell University School of Pharmacy and completed his residency in pharmacy practice at Wake Forest University's Baptist Medical Center. He is board certified as a pharmacotherapy specialist. He began his career as a decentralized clinical pharmacist at Wake Forest University before accepting a position as an assistant professor of clinical pharmacy practice and the anticoagulation clinic director at Auburn University. He then went on to be an assistant professor, and eventually associate professor, of clinical pharmacy practice at East Tennessee State University. This expert is heavily involved in pharmacological research, having authored several peer-reviewed articles and presenting on numerous posters at various pharmacy conferences. He currently serves as the vice chair of pharmacy practice and professor of clinical pharmacy practice at a pharmacy program at a Tennessee medical school.
Professor, A Pharmacy Program in TN
Doctor of Pharmacy (PharmD), Campbell University
Tennessee
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What Can a FDA Approval Expert Witness Opine On?
Preclinical Testing
Assess safety and efficacy in labs.
Investigational New Drug Application
Submit data for human trial approval.
Phase 1 Clinical Trials
Test drug on a small group of subjects.
Phase 2 Clinical Trials
Evaluate effectiveness in larger patient groups.
Phase 3 Clinical Trials
Confirm effectiveness through extensive testing.
New Drug Application Submission
Request approval for market release.
FAQs for Fda Approval Expert Witnesses
What is a fda approval expert witness?
An FDA approval expert witness is a specialist who explains FDA rules and drug or device approval processes in legal cases. They assist by reviewing records, offering opinions, and testifying to clarify FDA compliance issues.
What types of cases may benefit from the insights of an FDA Approval expert witness?
An FDA approval expert witness supports drug, device, biologic, clinical trial, labeling, marketing, compliance, and product liability cases involving FDA regulatory standards.
How can an FDA Approval expert witness evaluate regulatory compliance timelines?
An FDA approval expert witness evaluates regulatory compliance timelines by comparing documented development, submission, and review milestones against FDA guidance and statutory deadlines.
What qualifications should an FDA Approval expert witness possess for complex litigation?
An FDA approval expert witness should have advanced scientific or medical training, regulatory experience, and a proven track record with FDA approval processes and complex litigation.
How does an FDA Approval expert witness assess adequacy of premarket submissions?
An FDA approval expert witness assesses adequacy of premarket submissions by comparing study design, data quality, and labeling to current FDA regulations, guidance, and review standards.
What is Expert Institute’s process for selecting fda approval expert witnesses?
Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.