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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…
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…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
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…
Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
Anesthesiology, Physiology
ExpertPaul Expert is an Associate Professor and Director of Research in the Department of Anesthesiology at the Employer. He has a joint appointment in physiology and is a core facultly member in the biomedical engineering institute. Prior to this, Expert…
Statistical Analysis, Market Research, Clinical Trials,Marketing Mix Models,Pharmaceuticals,DOE
CLINICAL TRIAL: Expert has over 20 years experience in the statistical design and analysis of clinical trials of health care products. His experience includes working with both pharmaceutical and over-the-counter products. His recent analytical work has included preparing clinical trial…
Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…