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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…
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…
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…
Business Opportunities, Buyer/Seller Issues and Litigation, Real Estate Disputes
Expert has over 35 years experience in owning and operating his own businesses and working in corporate environments from sales and manufacturing production to sales of financial services. Expert has been involved with every aspect of business including: Sourcing, Fabrication,…
Insurance Agency Valuation and Common Practices, Producer Agreements and Compensation Programs
For over 25 years Expert has assisted insurance agency owners resolve internal management and ownership disputes in an equitable manner, avoiding sale or dissolution unless no other resolution can be achieved. Expert is a member of the arbitration panel of…
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…
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…
Many Trades: Windows Software, Photography, CAD, Stirling Engines, Electric Guitar Hardware
Applications have ranged from medical data acquisition and processing (statistics, graphs) to image processing to real-time data acquisition and analysis to whole-house power controllers to Stirling engine simulations to web site monitoring and data acquisition to system utilities to duplicate…
Scientific Data Analysis, Simulations, UML, Database, Java, C++
Expert is a high-level Object Oriented Architect specializing in n-tier interface design, development, and security; transferring his knowledge to the client after prototype completion. Primary emphasis has been on complex web-based design and implementation of large-scale databases, including transactions, security,…