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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…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
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…
Physician Assistant Practice, Medical Malpractice & Standard of Care, All Clinical Specialties
Expert is a Physician Assistant expert, records reviewer and witness for all cases involving physician assistants; 24 years clinical practice experience in family medicine, emergency medicine, occupational health, urgent care, internal medicine; Former Professor/Chair and Program Director of Physician Assistant…
Polymer Processing and Product Development (Films, Fibers, Nanofibers, Nanocomposites)
PROCESS/STRUCTURE/PROPERTY RELATIONSHIPS Expert has extensive experience and recognized accomplishments in process/structure/property relationships in polymers, especially processes involving polymer orientation and crystallization. Polymers in which he has primary experience include polyesters (PET, PEN, PBT, PTT, PLA), polyamides (PA6, PA66), and polyolefins…
Refining and Petrochemical Processes, Including Safety and Energy Conservation Audits
Expert has over 32 years' experience in Engineering Management at senior level in Process Engineering, Technology, Operations and Project Management, Licensing, Acquisitions, Alliances and Business Development. Provided proven leadership and vision with broader perspectives and able to manage multiple tasks…
Marketing, Advertising and Marketing Customs and Practices: Deceptive Marketing; Retail, Unfair Business Practices; Deceptive Advertising; Unfair Advertising; Unfair Competition; and IP and Trademarks
Expert is a Senior Marketing, Business and Advertising expert, since 2002. Marketing, and Advertising problem solver, since 1971; Business Strategies; he has been a Marketing Consultant, Expert Witness, and Senior Lecturer/Presenter for over two decades. He is deposition-tested and has…
Electrical Engineering, specializing in Fire Investigation, Product Liability, Code Compliance and Associated Matters
Expert has performed forensic investigation of over 200 fires. He has also performed investigations associated with product liability cases. He has also testified in federal and state court on several occasions. Expert has performed consulting engineering concerning industrial personal injury…
Identity and Image (Corporate Identity and Public Image) and Motivation
MTV, Hollywood's David Foster and Brian Wilson, Taiwan Trade, 300th Anniversary of the founding of St Petersburg, Russia, RosAtom, plasma waste management, bio-remediation fertilizers and carbon fiber production in the EEU, Expert has successfully designed and redesigned organizational entities domestically…
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…