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Electronic and Mechanical Design of Consumer and Healthcare Products for Asian Manufacture
Expert has a biomedical engineering degree from MIT (option of electrical engineering). He was instrumental in the development of an acoustic-based diagnostic instrument for the detection of otitis media (fluid in the ear due to ear infection). The product was…
Arthritis and Collagen Research
Expert A. Expert has expertise in and has established many animal models of disease at multiple institutions. These include models of human rheumatoid arthritis (RA) such as collagen-induced and adjuvant-induced arthritis in rodents. In addition, he has experience in models…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…
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…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Business Strategy for Diagnostic Companies
Expert R. Expert has an over 25-year career of international management in the industrial marketplace. Expert has held line responsibility for the creation, implementation, and re-direction of many businesses. These experiences include successes with venture capital backed start-ups, publicly-traded companies,…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Immunoreagents, Clinical Reagents, Surfactant Science
Expert developed, created and adapted immunoassays for flagship auto analyzers. Using a variety of surfactants, he engineered reagents, controls and calibrators for immunoassays of thyroids (T3, FT3, T4 and FT4), reproductive hormones (FSH, LH, hCG and prolactin), anemia (B12 and…
Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert L. Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease). He developed an asthma clinical guidance system, developed three biofeedback systems particularly for asthma. He also developed…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…