FDA Approval Expert Witnesses

E-702886

Colorado

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....

E-702455

Ohio

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...

E-570667

New York

This highly-qualified expert has over 30 years of experience in pharmacology. He earned his BS in pharmacy from Albany College of Pharmacy before earning his PhD from Shenandoah University. He is a board-certified pharmacotherapy specialist and a licensed pharmacist. He also holds a certification in pediatric advanced life support. He is active in his field as an author of several scientific...

E-000369

Maryland

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.

E-001445

Pennsylvania

This expert holds a doctorate degree in toxicology and has been a practicing toxicologist for over 40 years. Board certified by the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, he had published over 35 scientific articles and is a former president of the Mid-Atlantic chapter of the Society of Toxicology. He spent over 30 years as a Director of Toxicology for...

E-004870

New York

This qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

E-005982

North Carolina

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...

E-007175

Alabama

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...

E-007502

Nevada

This board-certified and fellowship-trained expert has over 20 years of experience in neurology with extensive clinical research experience, contributing to over 55 different clinical studies. He has involved in various committees for the University of Nevada School of Medicine. He currently serves as Associate Professor of Neurology and Medical Director for an ALS and muscular dystrophy clinic.

E-007665

This expert has over 25 years of experience in analytical chemistry including pharmaceutical development. With a Ph.D. from the prestigious Massachusetts Institute of Technology, he has published in analytical and physical chemistry. His previous positions include various lead positions of research and development as well as analytical testing. He currently serves as a Senior Vice President of an...

E-007728

New York

This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to...

E-008237

Connecticut

This highly qualified expert currently serves as Associate Professor of Ophthalmology and Co-Director of Vitreo-Retina Service at a major medical university. He received a B.A. in Biochemistry from New York University and a M.D. from Johns Hopkins University. He also finished fellowships in Vitreo-Retinal Service and Ocular Immunology and Uveitis Service at Johns Hopkins Hospital and Harvard...

E-008734

New York

This highly qualified Professor of Pharmaceutical Sciences received a bachelors in Pharmacy and a PharmD in Clinical Pharmacy. He is a member of numerous highly regarded professional organizations including the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology. He is an innovator with 10 patents registered in his name. He is widely published in...

E-002872

New York

This expert began his career as a medical consultant to the emergency room drug treatment and referral program. He’s been practicing for over 40 years and focuses on internal medicine, consulting in clinical pharmacology, and quality assurance medicine. He is currently involved in many aspects of pharmacology, and holds many positions on boards and committees related to drug abuse, prevention,...

E-008844

Illinois

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...

E-000203

California

This expert has ~17 years of experience as a pharmacist, with the most recent five years serving as a pharmacy director specializing in clinical pharmacy (inpatient acute care), clinical information systems, safe medical practice, quality improvement, and project management. Earlier in his career, he spent approximately 5 years as a pharmacist in a retail setting. This expert has advised and lead...

E-007167

Georgia

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Massachusetts

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods...

E-014463

Colorado

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...

E-024774

Pennsylvania

This highly qualified expert has years of experience in assessing, developing and executing regulatory strategies. He is board certified in internal medicine and endocrinology and has been practicing for 34+ years. He received his PhD degree from Washington University and completed his residency training at Yale-New Haven Hospital. He is a fellow of the American College of Physicians and a member...

E-033508

Arizona

This highly qualified expert earned her PharmD from Midwestern University College of Pharmacy Glendale. She continued her post graduate education with a residency in Acute Care Pharmacy Practice and a residency in Geriatrics. She is a member of the American Society of Consultant Pharmacists and a Member of the Arizona Pharmacy Association. This expert has been the recipient of distinguished...