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This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the average consumer will understand, integration of behavior modification and design, working with medical teams to provide documentation required for FDA approval process, and developing health professional’s tools for patient counseling to ensure that the patient education materials are used correctly. She also has expertise in working with medical device companies and packaging companies to ensure that it will be easy for patients to understand the “how to use†instructions and use the products correctly. She received her BSP degree and completed her residency training in hospital pharmacy at the University of Saskatchewan before receiving her Pharm.D. degree from the University of Cincinnati. She is a founding member of the American College of Clinical Pharmacy, a former member of the Board of Directors and Chairperson of the Business Council at the National Council on Patient Information and Education, and is active in many professional and consumer organizations, including the American Association of Colleges of Pharmacy and the Alliance for Safe Online Pharmacies. She has published 150+ peer-reviewed journal articles on patient education and adherence and serves as a reviewer for the American Pharmacists Association. She is the author of 23 books on how to use medications safety for health professionals and consumers. She has appeared on many radio and television shows to help consumers learn how to take their medications correctly. She is also the former director of clinical affairs at the American Pharmacists Association, which honored her with its Foundation Pinnacle Award for her outstanding leadership. Additionally, she is the former coordinator of the ambulatory patient pharmacy at Sunnybrook Medical Center and a former associate professor of clinical pharmacy at the University of Toronto. Currently, she is the CEO of a major patient education company that develops information to help patients understand how to manage their medications, medical devices and therapies correctly, consults with pharmaceutical companies on how to promote patient understanding and patient safety, develops multi-component patient education programs requiring FDA approval, and develops patient education programs for world-wide clinical trials to increase patient adherence so that the approved FDA dosage is more accurate and thus safer.
CEO, Major Patient Education Company
Doctor of Pharmacy (PharmD), University of Cincinnati
Mclean,
Virginia
This expert is a board certified internal medicine doctor who has been working as an attending physician in a nursing home for over 30 years. He has extensive experience in dealing with patients who are at higher risk for falls.
Attending Physician, 2 Major Geriatric Health Care Groups
Doctor of Medicine (MD), Northwestern University Medical School
Maryland
This certified compounding pharmacist has received his training from a top pharmacy program and holds clinical and academic positions in his field at both pharmacy and medical schools. He has given invited lectures on compounding pharmacy, and has authored major publications on the topic. Furthermore, he has been in practice since 1977 and has owned a compounding-only pharmacy since 2003. He serves on the North Carolina Board of Pharmacy and the USP Compounding Expert Committee for the 2010-2015 cycle. Memberships include the American Society for Pharmacy Law and the National Associations of Boards of Pharmacy.
Clinical Associate Professor, A major pharmacy college
Master of Science (MS), University of North Carolina, Chapel Hill
Hickory,
North Carolina
This highly qualified Associate Professor earned a masters in Public Health in Epidemiology from the highly regarded Bloomberg School of Public Health. He is board certified in Internal Medicine. He has won many honors throughput his career including the Bruce Squires Award for the Best Research Paper. He is a member of numerous professional societies including the International Society of Pharmacoepidemiology. He serves as a reviewer for more than 50 peer-reviewed medical journals and has published 107 peer-reviewed journal articles. His expertise are highly sought after and he is frequently invited to lecture as a guest speaker both nationally and internationally. He is currently clinically active at a major university affiliated hospital in addition to his academic position.
Clinician-Investigator, A University in MA
Doctor of Medicine (MD), Patna Medical College
Worcester,
Maryland
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 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.
Laboratory Supervisor, Major University
Doctor of Philosophy (PhD), Ohio State University
Huntington,
West Virginia
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.
Professor of Psychiatry and Pharmacology, A Prominent East Coast Medical School
Doctor of Philosophy (PhD), University of Glasgow
Miami,
Maryland
This expert has over 15 years experience in academia as it relates to Pharmacology. He has been accredited with the discovery of the RGS protein family, leading to 4 issued patents and numerous publications. In 2004 he was awarded the John Abel Award as an Outstanding American Pharmacologist under 40, from the American Society for Pharmacology & Experimental Therapeutics (ASPET). He is currently not only a Professor of Pharmacology, but also the Chair of the department and Director of the MD/PhD Scholars program at a University in West Virginia.
Professor, An Osteopathic Medicine College in TX
Doctor of Philosophy (PhD), University of Toronto
Fort Worth,
West Virginia
This highly qualified expert earned his undergraduate pharmacy degree from West Virginia University. He is certified by The American Pharmacist Association in Medication Therapy Management and Immunization. He is active in his field as a member of numerous medical organizations including The American Society of Health Systems Pharmacists. He has published multiple papers in his field and delivered over 20 invited lectures and presentations. He has served in numerous managerial roles at pharmacies across the West Virginia Area. Currently, he is Chair and Assistant Professor of Pharmacy Practice at a university in West Virginia.
Chair, WV based university
Bachelor of Science (BS), West Virginia University
Ripley,
West Virginia
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 over 15 years of experience as a pharmacist dealing with issues like medication safety, medication errors, and medication policy. She earned her PharmD from the University of North Carolina before completing a drug information specialty residency at Thomas Jefferson University Hospital. This expert is a licensed pharmacist in North Carolina and is certified by the American Heart Association in basic life support. She is active in her field as a member of the American Society of Health-System Pharmacists, a researcher on several pharmacy research studies, an author of multiple pharmacy publications, and a speaker at several industry conferences throughout her career. She has formerly served as a clinical instructor at the University of the Sciences in Philadelphia, a clinical pharmacist in the ambulatory setting at the Duke Outpatient Clinic, and a clinical pharmacist in medication safety at Duke University Medical Center. This expert currently serves as a clinical pharmacist for drug information at a university-affiliated medical center and as the preceptor for the drug information rotation at two North Carolina universities.
Clinical Pharmacist, Drug Information, A University-Affiliated Medical Center in NC
Doctor of Pharmacy (PharmD), University of North Carolina
Durham,
North Carolina
This qualified expert has nearly a decade of board-certified experience in his field. He earned his undergraduate degree in premedical education from the Adamjee Government Science College and his MD from the Dow Medical College in Pakistan. He then worked as an administrator, medical officer, and house staff general surgeon in the Civil Hospital of Karachi. He then completed a residency in internal medicine at the University of Texas Medical Branch, Galveston before going on to complete a prestigious fellowship in hematology and oncology from Albert Einstein College/Montefiore Medical Center. This expert is triple board certified in internal medicine, hematology, and medical oncology. He is very active in his field as a member of multiple professional societies including the Society for Immunotherapy of Cancer, the European Society for Medical Oncology, the American Association of Cancer Research, the American Society of Hematology, and the American Society of Clinical Oncology. In addition, this expert has published over 40 peer-reviewed articles. Formerly, this expert served as a physician in hematology and oncology at the Greater Washington Oncology Associates and was the director of clinical oncology at Medimmune/AstraZeneca. He also was a clinical instructor for internal medicine residents at Prince George Hospital. Currently, this expert is a clinical program lead for a biotechnology company and he is an independent practicing physician in hematology and oncology.
Practicing Physician, An independent practice in MD
Doctor of Medicine (MD), Dow Medical College- Pakistan
Chevy Chase,
Maryland
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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.