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Expert in Stem cells, ischemia, stroke, cryopreservation, bioengineering, wound healing, inflammation, blood, vascular biology, cancer immunology
Expert is currently a consultant specializing in scientific and biotechnological writing and review. Previously Expert had a leading role in the development of new blood-derived products for wound healing in a startup company. Expert is using her previous experience in…
Expert in Licensing, Biopharma, Pharma, Medical Devices, Chemistry, Agreements, Business Development
Expert has more than 25 years of expertise in transactional and regulatory counseling, acquisition, licensing, due diligence, dispute resolution, opinions, and appeals for the development and commercialization of health care, pharmaceutical, biotechnology, chemical, computer and electronics technologies. With more than…
Expert in 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…
Expert in 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…
Expert in Executive Management, Finance, Nanotechnology, Polymers, Thin films, Display devices, RFID
Most of Expert's career has been involved in advanced materials product innivation. He has 24 patents issued in this area and many more pending. Successful products have been released in the electronics, energy conservation, post harvest food preservation, golf clubs,…
Expert in 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…
Expert in 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…
Expert in 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,…
Expert in 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: •…