Find an Expert
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 Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
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…
Plant Cell Cultures, Somatic Embryogenesis of Angiosperms and Gymnosperms, Lab Scale-up, and Automation
Expert has over 30 years of experience in plant tissue culture. He has developed a number of tissue culture systems based on direct or indirect somatic embryogenesis and organogenesis. These systems were designed to be easy to use, to be…
Structural Engineering; Construction, Failure Investigation of Building Structures
Over 20 years of professional experience in many aspects of structural design in a fast-track environment including reinforced concrete, steel, masonry, timber, aluminum structures, and their foundations, both shallow type and deep foundation systems. This work includes foundation for pre-engineered…
Agronomy, Regulated (GMO) & Regulated Crop/Seed Production, Management, USA, International shipments
Expert's experience in agricultural development includes introduction of center pivot irrigation for irrigated corn to western Nebraska in the early 1970's when the area had previously been considered only as a dry land wheat production land. He also worked in…
Renewable Energy, Biofuels, Microelectronics, Semiconductor Packaging, Water Technologies, Agronomy
Expert has over 12 years of experience in Mergers & Acquisitions, representing both buyers and sellers. He has completed several deals and negotiated terms to maximize value. He has worked with clients to assimilate acquisitions regarding culture, economies of scale,…
Agriculture, Horticulture, Loss Management
A successful twenty eight year career in agricultural chemicals involving retail management, field sales and product development roles. Industry experience with commercial, technical, research and practical hands on experience in a wide range of horticultural and agricultural crops has provided…
Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…