Expert Details

Expert in Drug and Vaccine Adverse Effects, Standard of Care, Hepatitis

Expert 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.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Stamford, Connecticut - Philadelphia, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1980 Degree: MD Subject: Medicine Institution: UCLA School of Medicine
Year: 1977 Degree: PhD Subject: Microbiology and Immunology Institution: UCLA Department Microbiology, Immunology and Medical Genetics

Work History

Years Employer Title Department Responsibilities
Years: 1989 to 1991 Employer: Hoffman LaRoche Title: Associate Director Department: Antibacterials Responsibilities:

Government Experience

Years Agency Role Description
Years: 1976 to 1985 Agency: United states Air Force Role: Various Description: Expert did his internship, residency and served on the USAF as a medical specialist and physician for over ten years.
Years: to Present Agency: FDA Role: Various Description: Expert has provided various annual reports and protocol presentations for the FDA and its various divisions.

Career Accomplishments

Associations / Societies
He is a member of the Academy of Pharmaceutical Physicians and Investigators and the Medical Association of the State of Alabama and a fellow member of the American College of Physicians.
Licenses / Certifications
He is licensed to practice in the states of Alabama and Mississippi. He is also certified by the National Board of Medical Examiner and is a certified Diplomate of the American Board of Internal Medicine. He also has a DEA, BLS and ACLS certification.
Professional Appointments
He serves as a member of the editorial board for 3 national and international medical and scientific journals. His academic and institutional appointments include Clincal Assistant Professor at the Division of General Internal Medicine and visiting research associate. Other professional appointments include director of various medical clinics, president, Senior Vice President, Vice President, Director of Clinical Research and Associate Director of Clinical Research for various pharmaceutical and biotechnological industries.
Medical / Professional
Expert did his internship and residency in internal medicine at the USAF medical center.
Publications and Patents Summary
He has 3 patents, 29 peer review journal publications and 8 non-peer review journal publications in the field of biomedical and biotechnology clinical research.

Additional Experience

Expert Witness Experience
Over 110 depositions and 10 trial appearances.
Marketing Experience
He has 3 patents that involve genetic expression vectors and products.
Other Relevant Experience
Expert has provided service for annual reports and protocol presentations, outside inspections for corporate partners, preparations in-vitro diagnostic devices, radioimmunodiagnostic agents and other protocol preparations for various divisions within the FDA.

Fields of Expertise

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