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Japanese Technology, Patents, Risk Management, Due Diligence, Fraud, Investigations
It can be as simple as applying the wrong concentration of herbicide, pesticide or fertilizer to agricultural machinery related accidents. Drift of chemicals from treated areas to neighbouring areas which damage people or crops is another example. Although some define…
Executive Management, Finance, Nanotechnology, Polymers, Thin films, Display Devices, RFID
Most of Expert's career has been involved in advanced materials product innovation. He has 24 patents issued in this area and many more pending. Successful products have been released in electronics, energy conservation, post-harvest food preservation, golf clubs, animal neutraceuticals,…
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…
Intellectual Property Law, Patent Law; Industries: Biotech, Pharmaceutical, Life Sciences
Expert's Ph.D. thesis research concerned the plasma proteins, especially fetuin. He completed postdoctoral research fellowships at Harvard Medical School / NIH (Alzheimer’s disease, tau gene, genomic cloning), Johnson & Johnson (skin diseases, homeobox transcription factors), and Memorial Sloan-Kettering Cancer Center…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Mass Spectrometry, HPLC/MS, Ion Trap MS, LC/MS/MS in Environmental, Food, Proteomic, and Pharmaceutical Analysis
Expert has been hired by law firms as an expert witness in the area of analytical chemistry. He has worked with 15 law firms in his career, with some of the cases going over multiple years. This experience includes: •…