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X-Ray Diffraction Analyst and Expert Witness in Counterfeit Pharmaceuticals, Determination of Polymorph Types, Structural and Failure Analysis, Metal Processing MethodsX-ray diffraction analysis for characterization of inorganic and organic materials.Development of X-ray diffraction techniques and equipment.Patent law, expert witness and technology related to X-ray diffraction, counterfeit pharmaceuticals, determination of polymorph types and failure analysis.Materials synthesis for ceramics and metals.Determination of polymorph types in pharmaceuticals.Development of methods for detecting counterfeit pharmaceuticals.Polymorph stabili...
Experienced Ph.D. Medicinal Chemist Specializing in Enzyme Inhibitor and ChemistryOrganic Chemist and Medicinal Chemist with laboratory for experiments and custom organic synthesis.Intellectual property and patent expert.Patent infringement and patent validation expert.Medicinal Chemist with extensive drug discovery and lead optimization accomplishments in the pharmaceutical industry.Strong academic organic chemistry experience.Discovered novel, potent heterocyclic and peptide mimetic enzyme inhibitors and receptor antagonists with good permeability and bioavailability properties.Good working knowledge of biochemistry and pharmacology.Stro...
Pharmaceutical exicpients and fine chemical marketing and technical expert.Over 20 years' experience working in specialty chemicals, biotechnology, food and consulting with broad experience in project management, new business development, intellectual property commercialization and licensing, strategic planning, marketing research, business analysis and merger and acquisition. International experience working with French business leaders in the major industrial sectors while living in France. Specific expertise in:Pharmaceutical ExcipientsRare Earth/Gallium MarketsSilicate MarketNew Business/New Venture EvaluationMarket Research & Strate...
Functional properties of IgA. Development of oral vaccine delivery technologies. Effectiveness of host-parasite relationships. Mechanisms of adherence and pathogenisis. Development of oral drug delivery systems. Development of biodegradable nanoparticles, tumor targeting agents, transdermal drug delivery systems, and oral nanolattices for protein drugs.Functional properties of IgA.Development of oral vaccine delivery technologies.Effectiveness of host-parasite relationships.Mechanisms of adherence and pathogenisis.Transport of macromolecules across the intestinal epithelium.Receptor mediated endocytosis.Isolation, purification and refoldi...
Experienced medicinal chemist with proven record of delivering quality API clinical candidates for atherosclerosis, infectious disease, allergy respiratory, inflammation, and cardiovascular therapies.Experienced medicinal chemist. Delivered 17 active pharmaceutical compounds into development with the most advanced currently in Phase 2 trials.Served 6 years on clinical development teams and co - chaired the HIV protease development team.Sustained record of delivering quality API clinical candidates for atherosclerosis, infectious disease, allergy respiratory, inflammation, and cardiovascular therapies.8 years of pharmaceutical discovery ma...
National Pharmaceutical Science Specialist: Drug Pricing, Validation, Stability, Identification, Pharmaceutical Chemistry, and NDA filing, (GLP/GMP/cGMP)Pharmaceutical pricing.Pharmaceutical business development and sales.Pharmaceutical business strategy and decision making: Economic data analysis, tree analysis, probability of success calculations, resource and capacity requirements, drug pricing strategies, scenario presentations and critical path analysis.Pharmaceutical chemistry.Analytical method development and validation for drug stability, impurities, assay, release, content, uniformity, cleaning validation and identification.
Consultant for API Synthesis and Development and New Business Development in the Pharmaceutical IndustryResearch, development and manufacturing of active pharmaceutical ingredients (API).Operation of contract manufacturing organizations (CMO) serving the pharmaceutical industry.Start up of new business in the global pharmaceutical, biotech and healthcare industries.Experienced with pharmaceutical compliance issues related to health, safety, environment and quality regulations.Senior management positions with record of business unit revenue growth rates of 30% - 75% while controlling the cost base.Driver of continuous improvement, major cha...
Pharmaceutical R & D consultant specializing in strategic and operational planning, safety assessment, toxicity study protocols and re-engineering.Pharmaceutical research and development methodology.Pharmaceutical research and development portfolio strategy and management.Drug development modeling, scenarios and matrices for decision support.Re-engineering and R&D core business systems; R&D budget and resource forecasting.Pharmacoeconomics, health outcomes and disease management.New Chemical Entities (NCE) drug development.Phase I to Phase IV drug pre-clinical and clinical safety assessments.Pharmaceutical IND, NDA and ANDA registrations....
Protein Chemistry Consultant Specializing in Protein Purification, Characterization, Analysis, Research and Protein DevelopmentDeveloped novel procedures for purification of proteins from recombinant sources including: bacteria, yeast, mammalian cells and viral expression systems.Purified recombinant proteins containing affinity tags such as six-histidine and glutathione transferase; published new procedure for purification of c-myc tagged proteins by immuno-affinity chromatography.Large-scale production of native proteins from animal tissue and blood products.Developed two commercial products for clinical diagnostics market.Isolated and...
Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.