Consultant for Oral Drug Delivery Dosage Forms with Controlled Release and Sustained ReleaseOral solid dosage form formulation and process development.Drug delivery technology for controlled release dosage forms (osmotic, matrix and multiparticulates) and enhancing the oral bioavailability of poorly soluble compounds.Controlled release and sustained release drug dosage forms.Spray dried and hot melt extruded dispersions.Development and application of drug delivery technology.Extensive experience in formulation and process development for controlled and sustained release formulations and poorly soluble compounds for oral delivery.Osmotic sy...

Strategic CMC development and planning of ophthalmic, respiratory, and nasal products. Formulation development of ophthalmic, respiratory, nasal, and dermatological productsStrategic CMC development and planning of ophthalmic, respiratory, and nasal products.Formulation development of ophthalmic, respiratory, nasal, and dermatological products.Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.CMC regulatory writer: Pharmaceutical development and stability reports; CMC...

Regulatory Affairs Consultant Specializing in Chemistry, Manufacturing and Controls (CMC) and Regulatory Strategy for Quality Module 2 and Module 3 of the ICH Common Technical DossierCMC Specialties in Pharmaceutical and Biopharmaceutical IndustriesCMC regulatory strategy, critical review and assessment, related to the content of the drug substance, Active Pharmaceutical Ingredient (API) and drug product quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality of the Common Technical Document (CTD) for regulatory Submissions).Interpretation and application of CMC regulatory regulations and guidances for Investigationa...

Medicinal Chemistry Consultant, Experienced Expert Witness, and Patent Agent Specializing in Drug Discovery, Drug Design, Intellectual Property Rights, Patent Application and ProsecutionTechnical ExpertiseMedicinal chemistryDrug discovery and developmentHit to lead optimizationStructure based drug designFragment based drug designMolecular modelingBiological TargetsVoltage gates ion channelsLigand gated ion channelsG protein-coupled receptorsKinasesTyrosine phosphatasesMetalloproteasesDisease StatesCardiovascular diseaseOncologyChronic pain and inflammationNeurodegenerative diseaseOsteoporosisArthritisIntellectual Property ExpertiseRegister...

Small Molecule Drug Development and Manufacturing Expert with Extensive Biotechnology ExperienceSummaryDrug development from proof-of-concept to commercialization in early to mid stage biotech and large pharmaceutical companies.Extensive background in biotechnology and small molecule development, manufacturing, quality, analytical, regulatory, outsourcing, project management and business development. ServicesMarketed products: Biotech Products: Remicade (infliximab), Simponi (golimumab), Retavase (reteplase), Eprex (epoetin), ReoPro. Small Molecule: Patanol, Azopt and Volfenol%uFFFF.Development drugs: Large molecules: AntiIL5, AntiTNF,...

Biomedical Engineering Expert Specializing in Bone Implants, Dental Biomaterials, and Stem Cell SeparationsSetting up research labs for residency programs.Bone implant design and testing.Dental biomaterials development and testing.Stem cell separations and testing.Bone cement based drug delivery.Undisclosed Medical Center, Director, Orthopedic Bioengineering, Lab., 2007 - PresentWork with surgeons and residents (different specialties) to develop research projects.IRB and IACUC application process.Develop bioskills cadaver laboratory s...

PhD in Immunology focusing on pre-clinical research and clinical translation. Small Pharmaceutical Business Development and FDA-IND FilingMolecular aspects of neuro-oncology.Extensive tumor immunology and neuro-oncology laboratory experience.Developmental use of clinical samples for molecular and immunological studies.Small animal stereotactic surgery, tumor modeling and drug delivery techniques.Clinical research translational development.FDA interaction, IND writing and development.Patent development.Grant development.Small business (pharmaceutical spin-off) development and management.

Drug Discovery and Specialty in Small Molecules, Radiopharmaceuticals, Pre and Post IND PharmaceuticalsDeep understanding of pharmaceutical and biotech industries acquired over 33 years.Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.Pre- and post-IND drug development experience, including translational medicine.Technology platform enhancement and innovation (in-house and in-licensed).Significant business development and strategic planning experience.Exten...

Senior Pharmaceutical Professional Specializing in Global Business Development in the Healthcare Industry Focused on: Medical Devices, Drug Development, Regulatory Affairs, Quality, cGMP, FDA, Pharmaceutical and Clinical ResearchSenior Pharmaceutical Executive concentrating in medical devices, and the pharmaceutical research industries.Global pharmaceutical business development.Regulatory affairs, quality control, clinical research industries and operations.Submission preparation: IND, CTD, ANDA, NDA and MAA.Clinical research including protocol and medical writing.Strategic planning and business analysis.New pharmaceutical development and...

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...