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Enzyme/Protein/Antibody Stabilization, Biosensor Development & Shelf-life, DNA Stability & Testing
He has to deal with evaluating new business ideas on a daily basis either via his new business or via his enzyme business. A number of new stabilization systems have been incorporated into new product lines as a result of…
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…
Nutrition: Animal & Human; Mineral Bioavailability, Support to Nutritional Claims
His doctoral thesis pertained to the study of fatty acid synthesising enzymes in the different subcellular fractions of rabbit during the development of atherosclerosis and the effect of estrogens on them. The postdoctoral work at Rice University was on the…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…
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…
Molecular Oncology, Cervical Cancer, Breast Cancer, Immunohistochemistry, Diagnostics, and Pathology
Expert trained as a classical molecular biologist using viral model systems to examine regulation of gene expression and DNA replication in bacterial and animal viruses. His post-doctoral work focused upon regulation and malignant transformation caused by human papovaviruses and adenoviruses.…
Assay Development/Molecular Biology
The expert's private consulting and research company was established to provide innovative solutions to technical problems for researchers in academia and industry. Its charter is to develop strategies and protocols that streamline scientific research in the most time/cost effective ways.…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…