Drug Expert Witnesses in Pennsylvania

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last three years at FDA he spearheaded the agency's integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the FDA's point-person in managing the intersection of imports and FDA's new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA's import programs; wrote the initial statement of work and acted as program manager over the FDA's new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA's agency-wide Risk-based Import Strategic Plan designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S. As CEO of a FDA consulting firm and Founder of an affiliated law firm, he currently represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. He focuses his practice on FDA matters, including but not limited to: matters relating to FDA inspections, FDA criminal, regulatory and administrative enforcement actions for medical devices, drugs, cosmetics, alcohol, tobacco, dietary supplements, and foods.

This biomedical engineer specializes in materials science and biomechanics. He earned his B.S. and Ph.D. from New Jersey Institute of Technology, where he also served as a Postdoctoral Research Scientist overseeing the development and execution of experiments measuring neuronal activity after traumatic brain injuries. The expert is now an Adjunct Professor in Biomedical Engineering departments at two New Jersey higher education institutions.

This accomplished senior finance executive has more than 30 years of experience within the global pharmaceuticals, healthcare, pharmacy benefits management and manufacturing industries. Most recently, he held the title of Vice President of Finance, Gross Margin Planning and Strategic Pricing with Express Scripts from April 2013 to March 2016. In this role, he managed the finances, strategic planning, business development, competitive intelligence and pricing for over $100 billion in annual revenue and associated gross margins across all business units. The expert previously held positions as a Market Group CFO & the Senior Vice President of the Employer & Key Accounts Group, the Vice President of Client Analysis & Account Management Planning, and the Vice President of Pricing & Underwriting. He has extensive experience overseeing negotiations and pricing for renewals and new sales. The expert earned his B.A. in Accounting & Business Administration and an M.B.A. in Finance from Rutgers University. He is currently an independent consultant.

This expert has been practicing toxicology for over 40 years. She holds a Master of Science in Clinical Chemistry as well as a Ph.D. in Toxicology, and an honorary doctoral degree in Medicine and Surgery from the Faculty of Medicine, University of Helsinki. She serves on the World Anti-Doping Agency's Prohibited List Committee, the National Commission on Forensic Sciences, the Organization of Scientific Area Committee on Toxicology, Transportation Research Board Committee on Alcohol and Other Drugs, and the National Safety Council's Alcohol, Drugs and Impairment Division Executive Board. She was a President of the International Association of Forensic Toxicologists, she is also a former President of the Society of Forensic Toxicologist and past Chair of the Toxicology Section of the American Academy of Forensic Sciences. She has published over 445 peer-reviewed articles and has presented more than 500 abstracts at national and international meetings, and she sits on the Editorial Board of multiple toxicological and chemical journals. She recently retired as Chief of Chemistry and Drug Metabolism, National Institute on Drug Abuse, National Institutes of Health. She serves as an Adjunct Professor at a major medical university. She consults with the US Department of Transportation, NMS Labs, and other diagnostic companies around the world. The journal Clinical Chemistry identified her as an inspiring mind.

This well-credentialed expert earned his B.S. in Pharmacy from Columbia University, an M.S. in Pharmacy from the University of Iowa, and a Ph.D. in Pharmaceutical Chemistry from the University of Iowa. He has extensive experience in cosmetics development, including positions at Johnson & Johnson, Avon Products, and DeLaire Inc. From 1993 until 2001, the expert was the Senior Director of Research and Development for Gryphon Development / Bath & Body Works Inc. / Victoria Secret Beauty. In this position, he developed formulations for treatment products, cleansing products, and OTC drugs. The expert currently runs his own independent cosmetics development consultancy, through which he has worked with firms including Bath and Body Works, Unilever Latin America, Morning Glory Products, and many others.

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 expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.

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 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.

This expert is an internationally recognized human resources expert and is a trained Ohio Drug Free Workplace trainer. She earned a JD from Taft Law School and a MBA from York College of Pennsylvania. She is well published on human resources issues, specifically relating to employment practices. She has served as the HR Vice President or Director for a number of large, for-profit and non-profit corporations and is currently the head of Human Resources for a major psychiatric institution.

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 Pharmaceutical literature with over 350 articles. In addition to his academic role he currently serves as CEO of three Pharmaceutical companies.

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, and treatment. He has been a special government employee consultant for the US Department of Health and Human Services, Public Health Service Food and Drug Administration, and Center for Drug Evaluation. He has numerous patents, trademarks, fellowships, grants, and publication and presentations.

This highly qualified expert has been conducting academic studies in toxicology for 30+ years. He completed his postdoctoral and fellowship training at Rochester University. He is a fellow at the American Association for the Advancement of the Sciences and a member of numerous professional associations, including the Academy of Toxicological Sciences, where he serves in the board of directors. He is also the past president of the International Neurotoxicology Association. He has authored approximately 300 peer-reviewed manuscripts and chapters in the area of neurotoxicology and serves on the editorial board of several journals. He is the former director of clinical pharmacology and toxicology at Vanderbilt and the former director of the NIEHS Molecular Toxicology Center. Currently, he is a professor and chair of molecular pharmacology at a major university in New York.

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 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.

This expert is Board of Governors Professor in the Institute for Health, Health Care Policy and Aging Research and the School of Social Work for a leading NJ University. At the Institute, he directs the Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes, whose programs include the AHRQ-funded Center for Education and Research on Mental Health Therapeutics. He also is Chair of the Institute's Division on Aging and Associate Institute Director for Health Services Research. His work, which has resulted in more than 250 publications, includes many widely cited books and research articles on old-age policy and services for the elderly; on the use and outcomes of psychotropic medications and other mental health treatments; on HIV/AIDS care; and on numerous other health care and social policy topics. His work on gerontological policy and inequality has been particularly influential nationally, as the cumulative advantage model of aging which he originally proposed in the 1980s and has developed in a line of subsequent work has contributed to understanding of late-life inequalities and the way in which initial advantages such as educational attainment; social structures; health and economic events over the lifecourse; and public policies interact to shape late-life outcomes. He has also been an important contributor to research on long-term care and mental health among the elderly. His work on mental health services has contributed importantly to understanding problems of healthcare access, quality and disparities in large usual care populations, particularly those served by Medicare and Medicaid. Much of his recent work has focused on prescription drug use in society where he has pioneered important studies on treatment use, safety, and effectiveness, including current work on comparative effectiveness of treatments funded by the FDA and the Agency for Healthcare Research and Quality. In 2009, his contributions to scholarship on health services and outcomes were recognized by his appointment as Board of Governors Professor of Health Services Research at a leading NJ University with the university's Board of Governors citing his "major theoretical, methodological, and research contributions in the fields of aging, HIV care, and behavioral health; his highly influential and social policy scholarship; the impressive rigor of his cross-disciplinary research contributions that have shaped thinking, both in the U.S. and abroad, on issues confronting some of the most vulnerable groups in our society" and for his "numerous and enormously influential books, journal articles, reports, and other publications . and his outstanding contributions to improving decision-making in public policy as evidenced by his frequent invitations to testify before and advise Congress and other policymakers."

This qualified expert earned her DO at the New York College of Osteopathic Medicine. She is Board Certified by the American Board of Emergency Medicine. This expert is a member of prestigious societies and associations such as the American Academy of Emergency Medicine, the American College of Emergency Physicians and the Society of Academic Emergency Medicine. She has published 3 peer-reviewed journal articles as well as 3 poster presentations at national meetings. She is currently an Attending Physician at major urgent care center and Emergency Department of a major medical center.

This extremely qualified neurologist with over 20 years of experience, hundreds of publications and abstracts, author of multiple books is a leading pioneer in his field. He completed his medical education in Tunisia and then completed his residency in neurology at Temple university, where he was appointed chief resident during his third and fourth year in training. He is a member of multiple societies and a reviewer of numerous medical journals. His clinical, academic and research experience makes this candidate extremely well rounded to handle any neurology case. He currently works as an attending physician and researcher at a highly ranked university affiliated medical center.