Pharmaceutical Dosage Form Process Engineer: Spray Congealing, Spray Drying, Fluid Bed Coating and Fluid Bed GranulationPharmaceutical process and product development.Design and development of unusual and novel pharmaceutical processes and dosage forms.Extensive experience from initial process development to commercialization.Process evaluation - process design, develop, scale-up, robustness, troubleshooting.Mass Transport and unit operations.Extensive experience in unit operations in pharmaceutical processing development to commercialization:GranulationCompressionExtrusion (melt extrusion and continuous granulation)Spray congealingSpray...

Medicinal chemist and Pharmaceutical Technology Consultant with Expertise in Drug Research, Drug Formulation, Drug Analysis, Drug Synthesis and Purification, In-Vitro, In-Vivo (Efficacy and Pharmacokinetics) and Dosing RoutsDiscovery and development of novel human therapeutics for: Anti-infective, anti-inflammatory and neurodegenerative diseases.Development of antibacterial clinical candidates, and the discovery of five preclinical candidates for Multiple Sclerosis, Arthritis and Spinal Muscular Atrophy.Drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formul...

Water Soluble Polymer Excipents Consultant for Pharmaceutical Dosage FormsFormulation and process development, scale-up, technology transfer and production troubleshooting of pharmaceutical oral solid dosage forms.Extensive experience as a supplier of water soluble polymers to the pharmaceutical industry.Excipient business development and technical service.Expert on water soluble cellulose ethers, wet granulation for sustained release and related drug formulations.Use of water soluble polymers in granulation, film coating and sustained release matrix formulation.Regulatory compliance work on pharmaceutical companies operating under a conse...

Licensed Pharmacist Skilled with Patent Litigation and Pharmaceutical Product Development Projects, Including Regulatory IssuesExpert Witness for pharmaceutical patent litigation.Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.Author of regulatory (IND/NDA/CTD) CMC sections and support documents.Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.Pharmaceutical method development preformulation and pilo...

Ph.D. Pharmaceutical-Nutraceutical Formulator and Consultant for Industrial Pharma and Nutraceutical, Tablets, Capsules, Health Foods, Soft Drinks, Diary, Snacks, Nuts and Seeds, Gums in Food Products, Pectins,Nutraceutical and pharmaceutical formulation and manufacturing.Formulating hemp Cannabidiol (CBD) products.Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.Formulation and manufacturing of food, nutraceutical, and pharmaceutical...

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.

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.

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...