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Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
Diving Accident Investigation
Bob notes that corrosion is a major problem that affects many industries. Bob has spent over forty years studying and solving corrosion problems in the construction, aerospace, defense, petroleum, utility and related industries. He was also the technical editor of…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Organic and Medicinal Chemistry
Expert has expertise and broad knowledge in Synthetic Organic Chemistry of various classes of compounds coupled with experiences and adept characterizing compounds using various NMR techniques 1-D and 2-D (COSY, HMBC, TOCSY, ROESY) diverse analytic techniques for compounds purification, use…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
Food, Confectionery and Pharmafoods Technology
Expert has over 35 years of industrial experience in product development, quality systems, food regulatory, allergen management, contract manufacturing, packaging, product labeling, educational training, food safety and food security. He began his career in food consulting while in graduate school,…
Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Chemistry, Crystallography, Crystalline Solids, Polymorphism, Hydrates and Pharmaceuticals
Expert has extensive experience in research on crystalline molecular solids, X-ray and neutron crystallography, coordination chemistry and supramolecular chemistry (RSC Meldola Medal; Bob Hay Lectureship; Corday-Morgan Prize). His research involved organic solid state chemistry, crystallography, polymorphism, solid form and cocrystals.…