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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…
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…
Human Factors: Human Error and Accident Reduction, Performance and Safety into Complex Systems, etc.
Involved in accident analysis from the point of view of human error as a causal or contributory factor in the accident. Led the investigation for the Nuclear Regulatory Commission into the extent to which human error and training played a…
Telepresence and Effective Visual Collaboration, Personal and Organizational Productivity
Expert S. Expert (HSL) is a productivity-focused technologist and consultant with specialties in Telepresence and Visual Collaboration and Organizational and Personal Productivity. He is the founder and President of the Employer, an independent consultancy covering telepresence and effective visual collaboration…
Biometrics, Facial Recognition, Fingerprint Recognition, Iris Recognition, International Technology Transfers, and IT Engineering
Expert scope of experience in business spans new small business entrepreneurship, management positions for small private business with $20M-40M revenue, key leadership positions in small publicly traded companies ( over $100M revenue) and very large corporate with over $38 Billion…
Software Architecture for Web Services and Multimedia Processing
Lead developer of a distributed transcoding solution that works in a hybrid cluster and is a complete solution for volume multi-screen content preparation. Video codec development: head of international mjpeg2000 video codec team. Codec is multi-threaded, multi-platform, assembly-optimized, runs on…
Economic and Financial Analysis, Business Valuation, Economic Damages
Ph.D. and M.B.A. in finance University of Chicago Graduate School of Business. Developed Doctoral research advanced the work of three economics Nobel Laureates. Taught corporate finance in leading graduate business schools. Manager of economic analysis for the largest Federal Contract…
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…
Oculoplastics and Neuro-ophthalmology
Primary expertise in neuro-ophthalmology, orbital disease and surgery and oculoplastics. Board-certified in neuro-ophthalmology and oculoplastics. Research expertise and legal consulting in the above areas as well. Currently running a private practice.