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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…
Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Materials Science: Diamond Thin Film, Metallurgy, Coating Materials; Microwave and CVD Process
Technology transfer of skills, knowledge, technologies, processes, methods of manufacturing, samples of manufacturing and facilities among governments or universities and other institutions to ensure that scientific and technological developments are accessible to a wider range of users who can then…
Healthcare IT Sales, Hospital Quality and Risk Management Software, and Healthcare Reform Software
Expert's specific experience with implantable devices comes from selling Orthopedic implants, in particular, total joints like hips and knees, and trauma devices in the Operating Room. Other products include Osteobiologics like pig skin for soft tissue repair. He facilitated over…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
Mechanical Design: Automated Machinery, Rotating, Assembly, Gears, Machinability, Safety, Medical Eq
He designed many assembly machines in various industries, including biomedical, and semiconductor. Used all forms of electro-mechanical componentry. He has a patent for a unique mechanism. He has designed automated machines for 20 years, for all forms of industries, using…
Commercial and Product Development for Industrial, Medical and Electronics Markets
Expert has thirty years experience in business development of specialty chemicals, adhesives, materials, coatings, foams, films and conductive polymers in specific markets of automotive, aerospace/defense, construction, electronics, food, industrial, medical and transportation. He has identified new niche markets for specialty…