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Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of…
Medical Practice Consulting, Physician Contracting, Medical Billing
I have extensive background in evaluation of physician-physician, physician-hospital and third-party-payor contracts. I have assisted physicians and hospital administrators in evaluating and negotiating contracts, resulting in agreements having an equal exchange of value for service. I have an acute awareness…
Biostatistics, Epidemiology, Methodology, Mental Health, Police Procedures, Drug Safety, Malpractice
As a Professor of Statistics, Epidemiology, Public Health and Psychiatry for the last 30 years he has taught, applied and consulted on all of these methods. First trained as public health physician, he did his graduate work (MS and PhD)…
Psychiatry Bio-Psychiatry Neuropsychopharmacology
Expert, MD, is a Board certified Psychiatrist on staff at Pennsylvania Hospital and The University of Pennsylvania in private practice. His special interests include depression, anxiety, panic, sleep disorders, cognitive enhancement, addiction, ADHD, and the use of atypical neuroleptics in…
Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Biomedical Engineering, Biomechanics, Industrial Hygiene, Toxicology, Epidemiology, Occupational Health
Expert is a physician, attorney, industrial hygienist, and biomedical engineer licensed to practice medicine and law in Michigan and Illinois. He is a graduate of Kalamazoo College, Wayne State University School of Medicine and Law School as well as Harvard…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Nursing, Medical Literature, Healthcare
Expert started her career as a medical/surgical and hematology/oncology nurse working at Children's Hospital. She received her master's degree in (clinical nurse specialist and nurse practitioner) pediatrics from the University of Delaware. Expert went on to take a position at…