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...

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....

Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Biomedical Sciences PhD Consultant specializing in Gene Therapy, Virology, ProteomicsVirologyOncologyDNA repair and recombinationDNA replicationProtein-DNA interactionsProtein-protein interactionsProteomicsQuantitative-Polymerase Chain Reaction, (PCR)Allele specific-PCRAntibody production-generationImmunofluorescenceImmunoblotingCell biologyCancer biologyMolecular biologyYeast geneticsGene therapyRecombinasesSite directed gene modifications.Cloning, protein expression and protein purification.Trained in various techniques routinely used in biochemistry.Ind...

Drug Stability, Pharmaceutical Impurities, and Control Strategies ExpertChemical, physical, and environmental stability and degradation.Preformulation, formulation design and stability.Analytical and impurity (including mutagenic impurity) control strategies, including structure elucidation, characterization, predictive technologies and risk assessment.Photostability, photochemistry and photostabilization.Regulatory issues and authoring, primarily chemistry, manufacturing and controls section.Expert Witness ExperiencePatent case in Europe, regarding differences in stability between prasugrel and clopidogrel, and testified as Expert Witnes...