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Polymer Chemistry and Organic Chemistry
Expert has over 35 years' career experience in industry. Throughout his career, he was involved almost exclusively with polymer chemistry, spanning a wide range of experiences conducting fundamental research and within various businesses. He has demonstrated the ability to lead…
Intellectual Property (Patent, Trademark, Copyright), Breach of Contract, & Royalty Audit Financial Damage Calculations
Economic Damages Expert Witness, Royalty Audit, Fraud, & Forensics Expert is experienced as an economic damages expert in State, Federal and USITC matters. In additional to economic damages and lost profits, Expert serves as an expert related to royalty audits…
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…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Research; Infectious Disease, Pharmaceutical/Supply Chain, Biontech, Bioinformatics, Clinical Trial Design, Consumer Behavior, and Marketing
Expert currently serves as the Director for Strategic Health Information, coordinating all research-related activities in infectious diseases (TB, HIV, malaria, Hepatitis), chronic diseases like diabetes, cancer. He also collaborates with foreign partners in the design of the clinical trial protocol,…
Immunology and Vaccinology
He has over 25 years of experience designing vaccines and vaccine adjuvants and delivery systems, and measuring innate (DC, NK) and adaptive (B and T cell) responses. He has conducted pre-clinical protective efficacy and immunogenicity studies in mice, guinea pigs,…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Tumor Immunology and Immunotherapy
Expert is an MD with broad clinical and laboratory experience. He has a strong background in human immunology, particularly in cancer immunology and immunotherapy. He is also highly experienced in cancer cell biology, including handling of clinical specimens and generation…
Avocado Fruit Production, Orchard Management and Botany, Nursery Management and Clonal Propagation Procedures
Expert experience in horticulture research includes 10 years of research on avocado (Persea americana) including rootstock selection and evaluation, pruning techniques, post harvest fruit evaluation, and simulated shipping. He serves as Commercial Horticulturist for one of the world's largest avocado…