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Pharmaceutical Imaging, Biological, Physical and Analytical Research, Pharma Commercial Viability
He served as the CEO, President of two public companies, one private company and also as the Chairman of the Board of a Not-for-Profit. His experiences include: managing research, clinical studies, finance, managing personnel, legal issues, patent issues, restructuring companies,…
Hand Injuries, Hand Tool Design, Ergonomic Issues, Work Related Injuries in Dental/Medical
Expert is a certified associate ergonomist. Expert is founder and owner of a nationally based ergonomic consulting firm. Expert's background in ergonomics has allowed her to utilize her skills in preventing work related accidents and in assisting with the development…
Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property
Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…
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…
Strategic Procurement: Negotiation, Supplier Management, Overseas Purchasing, and Leadership
Expert is an experienced procurement professional with over 20 years in the high tech industry. He works with functional groups in a global basis to convey procurement strategy and deploy best practices that always result in significant savings to company…
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…
Parasitology, Immunology, Agricultural Systems
He has many years research experience in understanding and mitigating the impact of a range of agricultural pests such as parasitic worms and ticks. He has carried out numerous small and large animal drug efficacy and residue trials which have…
Electronic Enclosure Product Development Including Mechanical, Electrical, and Industrial Design
Expert has applied his mechanical engineering background to provide innovative mechanically sound solutions to difficult engineering problems. He understands the need to design for manufacturability (DFM) and design for assembly (DFA) and implements cost effective designs into each project. He…
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…