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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.
Associate Professor of Pharmacology, Major Medical College
Master of Science (MS), Rush University
Illinois
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 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.
Affiliate Investigator, A Cancer Research Center in IL
Doctor of Philosophy (PhD), University of Washington
Chicago,
Illinois
This highly qualified pharmacology expert obtained his BS in biology from Rockhurst University and his PharmD at the University of Missouri-Kansas City School of Pharmacy. He completed his residency in Pharmacy at Duke University and is certified as a pharmacist, in pharmacotherapy, and medication therapy. This expert is a member of the North American Drug Diversion Investigators, the American Association of Colleges of Pharmacy, and the American Society of Heal-System Pharmacists. He has authored 15+ publications and is currently the founder and CEO of a nutritional supplements laboratory in the midwest. He also serves as a PRN pharmacist at a medical center in Kansas City, an adjunct faculty member at a dentistry school in the mid-west, and a clinical associate professor of pharmacy practice at a midwest university.
Clinical Associate Professor, A Midwest University
Doctor of Pharmacy (PharmD), University of Missouri Kansas City School of Pharmacy
Overland Park,
Kansas
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
This highly qualified expert has 25 years of experience in pharmacotherapy. He earned both his BS in pharmacy and his PharmD from the University of Missouri. He then completed a clinical pharmacy residency at Truman Medical Center. He is board-certified in pharmacotherapy and a certified geriatric pharmacist. He is active in his field as a member of organizations such as the American Association of Colleges of Pharmacy and the American Society of Consultant Pharmacists. He is also highly involved in pharmacological research, having authored numerous journal articles. His former positions include director of the New Mexico Geriatric Education Center, director of the Center for Pharmaceutical Care for the Elderly at the University of Houston, and director of the Institute for Geriatric Pharmacy at the University of Oklahoma Health Sciences Center. Currently, this expert serves as professor emeritus at a pharmacy college in Oklahoma, as well as the managing partner of a consultancy in Oklahoma.
Managing Partner, A Consultancy in OK
Doctor of Pharmacy (PharmD), University of Missouri
Guthrie,
Oklahoma
This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.
Consultant, A private consultancy for FDA regulated businesses in IL
Bachelor of Arts (BA), California State University
East Alton,
Illinois
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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.