Drug and Vaccine Adverse Effects, Standard of Care, Hepatitis
ID: 726908
New Jersey, USA
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Expert is board certified in internal medicine with a focus on biomedical clinical research. He received his PhD in immunology and medical genetics from the Department of Microbiology at UCLA in 1977. He also received his MD from UCLA in 1980 and completed his residency in Internal Medicine at the USAF Medical Center in 1983. He has been a practicing internalist for over 25 years.
His expertise include specific areas of medication and vaccine adverse effects and clinical research. His current and past work as Director include providing general medicine coverage and services, hospital coverage, and medical practices at various hospitals. He has worked and currently still works for various pharmaceutical industries serving as director, president and vice president, and clinical research consultant of various clinical research departments, research regulatory services, and Medical research and clinical data management.
His professional clinical research experiences include being an clinical research consultant, Senior Vice President of a Clinical Research and Regulatory Affairs, Vice President Clinical Researcher of a immunomedics industry, Director of Medical Research, Regulatory Affairs and Clinical Data Management and Clinical Research of antibacterial issues for various pharmaceutical industries.
His clinical research has been focused on specific topics such as biotechnology and other technological partners, regulation and IRB approvals of clinical protocols and industrial protocols immunomedics and antibacterial research, blood research and laboratory research. Other experience in this area include writing and currently conducting three IRB-approved investigator-initiated clinical protocols and one industry protocols. He has also worked for the United States Air Force in a clinical research laboratory as a research associate.
His expertise in this area include investigating the pelvic hematoma in relationship to anticoagulation, hemoglobin solution on the clearance of intravascular lipid by the reticuloendothelial system, hemorrhagic shock, antibody response to transfusion, bacteria removal from blood, blood components and antibacterial membrane efficiency, artificial cells and organs, transfusion, vaccines and topics involving gastroenterology, endocrinology and other internal medicine areas.
His FDA experiences include analyzing and evaluating annual reports and protocol presentations to CBER, CDER, NIH and NCI. He has also been involved in outside inspections of IND’s and NDA’s for corporate partners, preparation of PMAs and 510K for in-vitro diagnostic devices, preparation of MAA and PLAs for radioimmunodiagnostic agents and ASI as well as INDs.
He has also presented to the FDA research on Lymerix adverse effects, regulations of OTC, herbal remedies and prescription drugs, adverse effects of SSRI drugs and anti-infective drugs. His publications include original papers on cyanide poisoning, arthritis drugs, drug-induced liver disease, drug toxicity and its effects and drug-induced suicidal ideation to name a few.
