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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…
Antitrust, Banking, Damages, Demography, Discrimination, Finance; IP Surveys, Statistics, Economics
Expert and his firm are responsible for all Quality Control on all litigation support activities for the Department of Justice. With an office of 15 professionals in the Washington DC metro area, they sample and evaluate the work of multiple…
Medicine, Especially Pathology (Laboratory Medicine), Women\’s Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has practical knowledge of what is…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Cardiovascular Disease, Hypertension, Arrhythmiad, Congestive Heart Failure, Internal Med, Lipids
Expert is an expert in solo cardiology and internal medicine. He has his own practice with 25 years experience in clinical, pharmacologic, medical legal consulting. Ten years experience in medical clinical trials. He is an active expert for consulting, medical…
Environmental Molecular Microbiology, Ecology, Bacteriology, Waterborne Pathogens, E. coli
Expert earned his Ph.D. degree in Veterinary Microbiology (Bacteriology) and substantial years of postdoctoral experience in Environmental health and Toxicology. This makes him more multitask and diverse research in both fields. His experience with mastitis causing bacterial pathogens such as…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…