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BioPharmaceutical Commercialization
New product planning, business development, and marketing professional with transactional, launch, and expert witness experience. Expertise in new product commercialization, licensing, valuations, deal structure, strategic brand planning, long range forecasting, pricing & reimbursement, HEOR strategies, payor communications, tactical program implementation,…
Biological Systems Engineering
- Biological systems engineer, marine biologist, ecologist, environmental scientist, and biotechnologist with commercial operations and research experience leading, designing, developing, executing, and managing projects. - Innovative applied scientist and engineer with a multitude of skills, a patent portfolio, over 20…
Pet and Vet Industry; Specializing In Pharmaceutical, Food, Treat and Nutraceutical Formulation
Forward-looking, entrepreneurial CEO and Managing Director with stellar, 20+ year record of achievement. Sets core business strategies that deliver major professional and customer demand in competitive markets. Spurs organizational growth and excellence by proactively developing staff; nurturing and fostering strengths…
Sterile Processing Technology
Expert’s formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization of…
Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Protein aggregation, characterization, purification
Expert leads a team of exceptionally talented downstream scientists to develop scalable downstream processes for viral vectors for use in Gene, Cell and Oncolytic therapies and for Vaccine production and for therapeutics proteins and antibodies. Keywords: Process development, DSP, Downstream…
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…
Plant Pathology
Expert was trained as a mycologist, but her career steered her into the discipline of plant pathology. Throughout the 50+ agriculture research projects that Expert has conducted, she has accrued vast experience on the cultivation of a number of crops…