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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…
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…
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…
Physiology, Neuroscience, Epilepsy, Neurophysiology, Seizure, EEG, Neurology, Evoked Potentials, EEG
Expert is the director of Clinical Neurophysiology and the Comprehensive Epilepsy Center at a major regional hospital. He has clinical expertise in epilepsy, electroencephalography, clinical neurophysiology, and general neurology. Expert has extensive experience in basic science, translational, and clinical research.…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…
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…
General Hematology/Oncology, Utilization/ Peer-Review, Medico-Legal, Program Develop/Administration
As an academic physician who has extensive experience in research, clinical medicine and administration, he is able to advise on various facets of anticancer drug development and therapy and cytotoxic drug therapy. As an academic physician who has extensive experience…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…
Neuropharmacology, Aging, Brain Injury, Memory Impairments, Imaging, Neurodegenerative Disorders
Expert has worked on several projects involving Alzheimer's disease (AD). In particular, he has used genetically engineered mouse models to test ideas and answer questions related to how biological memory might be affected by AD pathophysiology. In addition, he has…