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Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Infectious Diseases, Infection Control, Epidemiology, Public Health, and Pediatrics
Expert R. Expert was an author on the Centers for Disease Control and Prevention (CDC) Guideline for Prevention of Transmission of M. tuberculosis in Healthcare Settings and the WHO Guideline for Prevention of M. tuberculosis Transmission in Healthcare Settings in…
Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development
Expert has worked in the biotechnology industry for more than 30 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, Agraquest, and GenoSpectra. He has led product…
Pharmaceutical Product Development, Drug & Medical Device Safety, Regulatory Affairs
Expert is active in U.K. General Practice with wide therapeutic area knowledge and practical patient prescribing. He has a good understanding of the U.K. health system, formulary adoption, N.I.C.E., and reimbursement. Expert has 15 years of experience in the design,…
Environmental Compliance, Pollution Prevention, Health and Safety, and Fire Loss and Prevention
Expert has extensive practical knowledge and experience in the field of pollution prevention technologies. He has performed numerous pollution prevention audits internationally resulting in millions of dollars in waste minimization, energy and feedstock material savings for clients. He has worked…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Genomics
Expert worked with a team that cloned and expressed the enzyme T4 endonuclease VII for commercial distribution. He developed the basic assay of enzyme activity that was used in optimization and quality control of the enzyme. He is an author…
Regulation of Gene Expression
Expert has more than 14 years of international experience as a researcher in the areas of endocrinology, biochemistry, molecular biology and genetics. He earned his Ph.D. from the University of Nijmegen working on the regulation of gene expression of Proopiomelanocortin…
Clinical Chemistry, Laboratory Diagnostics, Immunoassay Development, Therapeutic Drug Monitoring
Expert has extensive experience in the field of clinical chemistry and clinical diagnostics. Development of analytical methods for trace analytes in biological fluids, especially in the field of clinical diagnostics, has been Expert's main job responsibility and success over the…
Non-Profit Quality Improvement
Expert has developed and implemented quality improvement plans in large and small non-profit social service organizations. He has organized and facilitated quality assurance activities including peer record reviews, incident and accident reporting, grievance procedures, and more. He has consulted with…