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Legal, Business, Professional, Organizational, and Non-profit Ethics and Compliance; Harassment
Expert is the president of an ethics training and consulting firm based in Alexandria, Virginia. A graduate of Harvard and Georgetown University Law Center, he is a member of the D.C and Massachusetts bar associations. He has taught legal ethics…
Information Technology and Cyberlaws, Intellectual Property and Commercial Laws Practice
Expert has successfully advised clients on conducting business online and ensuring all legal compliances have been made. She has suggested better models of doing business through e-commerce and assisted in developing new e-marketing tools and models for a web business.…
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…
Research Joint Ventures, Research Consortia, etc.
Expert has worked for more than 20 years on business development from research and consultancy perspectives, and as a director of new businesses seeking to expand from start-up stage. He was the private sector representative on New Zealand Trade and…
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…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…
Medical/Surgical Device Design, Management, Marketing, Regulatory
Expert is a results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical…
Computers, Software, Hard Disk, Bus, Internet, Firmware, Input/Output, Technology Management
Expert is a technical leader in the computer, software and hard disk industry with over thirty years experience; his Ph.D. in Computer Science is from Stanford University. He is an inventor on seven patents and has authored several published technical…
Plastic and Coating Stabilization; Controlled Degradation Analysis and Design; Analytical Services
Expert's knowledge in the area of amorphous and crystalline polymers is based on 36 years in the field, having worked with all commercially available amorphous, crystalline, and semicrystalline resins. His knowledge includes physical properties and stabilization at many levels and…
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…