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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 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.
Assistant Professor, A Top University Pharmacy School
Master of Business Administration (MBA), University of Colorado Denver
Aurora,
Colorado
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.
Director, A top public research university in TX
Doctor of Pharmacy (PharmD), University of Southern California
San Antonio,
Texas
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.
Lead Advisor, CVS Health
Doctor of Chiropractic (DC), Texas Chiropractic College
Houston,
Texas
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 highly qualified pharmacist has extensive experience in her field. She is a board certified critical care pharmacist and received her AAS in chemistry, then her BA in chemistry from the University of Washington, and her Pharm.D from the University of Washington School of Pharmacy. This expert is a licensed pharmacist in TX and WA and is certified by the Washington State Pharmacy Association in immunizations, and in basic life support and pediatric advanced life support. Formerly, she has served as a pharmacist at Kelley-Ross Pharmacy and the MultiCare Good Samaritan Hospital. Additionally, this expert has held the role of clinical pharmacist at Woodland Heights Hospital. Currently, she is a clinical pharmacist at a TX hospital.
Clinical Pharmacist, A hospital in TX
Doctor of Pharmacy (PharmD), University of Washington School of Pharmacy
Texas
This expert is a well qualified and experienced pharmacy director. He completed his BS in pharmacy at Massachusetts College of Pharmacy and his DPM at New York College of Podiatric Medicine. He also completed a residency in podiatric orthopedics at the Boston VA Medical Center. He is board certified in podiatry and pharmacy. He is active in the field as a member of the American College of Healthcare Executives and the American Society of Hospital Pharmacy among others. He previously served as the pharmacy director for Hubbard Regional Hospital, Forest Park Medical Center, and North Central Surgical Center. He also was a staff pharmacist for Baylor University, Baylor Scott & White, and was a clinical emergency pharmacist for pediatrics at the Children’s Medical Center of Dallas. He currently is the pharmacy director for a medical center in Texas.
Pharmacist, A pharmacy in ME
Doctor of Podiatric Medicine (DPM), New York College of Podiatric Medicine
Ellsworth,
Texas
This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.
Medical Content Writer, A medical consulting firm
Doctor of Pharmacy (PharmD), University of Wyoming
Colorado
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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.