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Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several…
Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology
Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical problem solving. Expert has expertise in the fields of…
Combustion, Air Pollution Control, and Utility and Industrial Boilers, Air Heaters, Dryers, Furnaces, Thermal Oxidizers
He has developed combustion modifications for reducing emissions of CO, unburned hydrocarbons, NOx and SO2, and specified and designed post-combustion systems for the control of NOx, SO2, HCl, and PM. These systems have been both prototype and commercial. He can…
DNA Technology, PCR, Human Identification, Diagnostics, R&D, Technical Support, Management
He has worked with many different applications within the molecular biology field and been very successful in both academic and corporate environments. He worked as a field technical systems specialist for Roche Diagnostics for over 6 years and has expertise…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert (, pronounced "Berr-oo-in") has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run general molecular biology groups primarily…
Food Safety & Food Microbiology
Expert' current research interests include rapid detection of foodborne pathogens; factors controlling growth and survival of microorganisms in foods; and beneficial uses of microorganisms. Expert has authored more than 170 peer-reviewed articles. He has supervised the thesis research of 19…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Immunology, Vaccine Research
Expert is an internationally recognized expert in mucosal immunology. He has published more than 70 papers and reviews in several prestigious scientific journals. He is best known for experimentally establishing (with continuing research) the concept of a common mucosal immunologic…
Medical Diagnostic Tests
MEDICAL DIAGNOSTIC TEST FORMULATING; ORGANIC SOLVENT; SEMISYNTHETIC POLYMER. Expert has spent 21 years engaged in adapting analytical techniques to the quantitative analysis of medically significant substances. This has involved combining pH buffers, enzymes, chromogens, and stabilizers to make a marketable…