FDA Approval Expert Witnesses in Kentucky

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.

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.

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.

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.

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.

This highly qualified expert earned her BS and MS from The Ohio State University. She has been in the health informatics field for over three decades and has extensive experience with clinical informatics and pharmacy operations. Formerly, she was Associate Director of The Department of Pharmacy at Ohio State and also served as Practice Manager for Allscripts (an EMR database). Currently, she is an Independent Healthcare Consultant in the Ohio area.

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.

This clinical development and regulatory expert has an M.S and Ph.D. in Pharmacology & Toxicology from West Virginia University. A member of the American Society of Clinical Pharmacology & Therapeutics, he has extensive product development experience in the pharmaceutical field. The expert spent his early career in clinical research roles, including a position as the Director of Clinical Research Operations for Univax Biologics. He has since founded/run a biotech development business and acts as both a Professor and Consultant in his field.

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.

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.

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.

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.

This highly-qualified expert has 15 years of experience in pharmacology. He received his AA in chemistry and pre-pharmacy from Santa Fe College before earning his PharmD from the University of Florida. He subsequently completed a residency in primary care with an emphasis on infectious diseases and HIV at the Bay Pines VA Healthcare System. This expert is currently board-certified in infectious diseases pharmacy and is certified in antimicrobial stewardship pharmacy, core clinical research training, and HIV pharmacy. He is active in his field as a fellow of the Infectious Diseases Society of America and a member of several associations, including the American College of Clinical Pharmacy and Society of Infectious Disease Pharmacists. He is also involved in research, having authored multiple peer-reviewed articles, spoken at numerous pharmacy conferences, and served on the IRB for various hospitals and universities. His former positions include director of the antimicrobial stewardship program at Bay Pines VA Healthcare System, associate professor of infectious diseases at Presbyterian College, and associate professor of biomedical sciences at Virginia College of Osteopathic Medicine. Currently, this expert serves as a clinical pharmacist at an infectious disease clinic in Indiana, as well as adjunct faculty of pharmacotherapy and translational research at a pharmacy school in Florida.

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.

This highly-qualified expert has nearly 45 years of experience in pharmacology. He specializes in pediatric clinical pharmacology, toxicology, and clinical pharmacy, as well as adverse drug reactions, drug-drug-food interactions, pharmacokinetics-pharmacodynamics, and pharmacogenomics. He earned both his BS in pharmacy and his PharmD from the University of Cincinnati. He also completed an internship in community pharmacy at Winston Place Pharmacy, an internship in hospital pharmacy at Holmes Hospital, and a residency in pediatric clinical pharmacy and clinical pharmacology at Children's Hospital Medical Center. This expert is board certified in applied pharmacology by the American Board of Clinical Pharmacology. He is active in his field as a member of the American Society of Hospital Pharmacists and the American College of Clinical Pharmacology. He has formerly served as the co-director of pediatric clinical pharmacology and toxicology at Rainbow Babies and Children's Hospital and the director of the clinical research center at Akron Children's Hospital. Additionally, he has held a variety of teaching positions, including as a tenured professor of pediatrics in the division of pediatric pharmacology and critical care at Case Western Reserve University and as a professor of pediatrics at Northeast Ohio Medical University. Currently, this expert is a professor emeritus of pediatrics at an Ohio university.