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Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Materials & Surface Science, Corrosion, Surface Treatments, Adhesive Bonding, Electrochemistry
Expert over 30 years of experience in basic and applied research and development involving surfaces and interfaces related to adhesion and corrosion. Particular areas of interest include surface treatments, especially those improving the durability or corrosion resistance of materials, and…
Business Licensing & Franchising, Retail Operations, Supermarket Distribution, Food Service Industry
His industry and academic experience extends over 30 years and covers all aspects of licensing/franchising, food processing and supermarket retailing: operating franchisee/licensing systems; establishing, owning and managing franchise operations; owning and managing food processing operations; marketing through food wholesalers and…
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…
Biomedical Engineering, Biomechanics, Industrial Hygiene, Toxicology, Epidemiology, Occupational Health
Expert is a physician, attorney, industrial hygienist, and biomedical engineer licensed to practice medicine and law in Michigan and Illinois. He is a graduate of Kalamazoo College, Wayne State University School of Medicine and Law School as well as Harvard…
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…
Emergency Medical Services, Dispatch, Emergency Preparedness, Disaster Response
LP, EMSI, CHS-III Expert has 34 years of experience providing services, management consulting and education and training in public safety and emergency management. He has received extensive education in Emergency Services and Public Policy (fire, police and emergency medical services)…
Advertising, Branding, Trademarks, Publicity Rights, Media, and Advertising Industry Customs and Practice
Expert is one of America’s most respected marketing-communication professionals. His consulting firm provides advice and counsel to advertisers and advertising agencies both in the U.S. and abroad engaged in marketing consumer goods and services. In addition, he has been retained…
Forensic Economic Consulting, Economic Damages; W/D, Medical Malpractice, P/I, EEO
For more than thirty years Expert has been a Forensic Economic Consultant, assisting attorneys in the evaluation of economic damages in a wide variety of issues, including medical malpractice, wrongful death, personal injury, wrongful termination, business loss, employment discrimination, and…