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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…
Antitrust, Banking, Damages, Demography, Discrimination, Finance; IP Surveys, Statistics, Economics
Expert and his firm are responsible for all Quality Control on all litigation support activities for the Department of Justice. With an office of 15 professionals in the Washington DC metro area, they sample and evaluate the work of multiple…
Patent & Copyright Infringement, Depositions & Testify, Cell Phone Tracking, GPS, Cell Tower Records
Expert has consulted for law firms in California in connection with helping them write claims that provide the best patent coverage. He helps them in avoiding infringement by devising different technical approaches and novel ways to patent ideas and designs.…
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…
Surface Science, Polymers, Textiles, Testing Materials, Plastics, Physical Chemistry, Pharmaceutical
Expert worked for three years as the Director of RD&E for the chemical products division of Waters Inc. In addition to the direction of the research in chromatographic media he was co-inventor of 7 patents for water-wettable extraction media and…
Software Disputes, Internet Technology, Telecommunications, Patent Litigation
He has managed the development of application software for multiple industries including Telecommunications, Publishing, Utilities, Banking / Financial, Healthcare, and Manufacturing. Expert for Software Dispute litigation includes: -CBSI v. Sempra Energy (Telecom software dispute) -Scient v. PointServer (eCommerce softwrae dispute)…
Technology Commercialization Assessment, Strategies, and Product Roadmaps
Ms. Expert has over 20 years technical computer consulting to enterprise IT organizations. Ms. Expert's special expertise in research and technology validation reduces risk of investments by providing un-biased assessments of a technology's commercial potential. Most recently, she has worked…
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…
Patent analysis, claim charting, prior art search. Broad EE subject matter expertise, including digital video and wireless.
High-Definition Television Expert is a pioneer in the field of digital high definition television and display, with 20+ years of experience. Expertise spans product development, R&D, subjective/objective test, IP, specifications, and more. Expert has 33 patents in the field of…
Polymeric Materials, Flooring, Innovation Management, Ideation, Intellectual Property, Expert Witness
Expert spent 34 years in new product development at Armstrong World Industries. He was technical leader/project manager on specific projects and successful developments of new flooring products. He has experience with "Stage/Gate" processes. He held multiple positions in developing flooring…