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Immunopathology, Renal Pathology, Environmental Pathology
Expert is board certified in internal medicine and pathology with subspecialties in anatomic pathology and clinical pathology. After receiving his M.D. from New York University School of Medicine in 1961, he completed his internship and resident training in general medicine…
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)…
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…
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…
Pharmaceutical & Life Science Research and Manufacturing, New Drug Discovery, Therapeutic Strategy
By using standard analytical tools of cellular and molecular biology he has elucidated the molecular mode of action of an anti-diabetic candidate BMOV on the key components of insulin signaling cascades like IR Kinase (IRK) and IRS complexes including gross…
CAUSATION EXPERT IN FORENSIC PATHOLOGY, FORENSIC TOXICOLOGY AND INTERNAL MEDICINE
Experienced expert witness in personal injury, malpractice and wrongful death cases, Autopsy pathology, slide and record review. Expert is and an Independent Medical Examiner. Internal Medicine, Forensic Pathology and Toxicology. Board Certified in Anatomic and Clinical Pathology. Expert is board…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air pollutants,…