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MD with expertise in neurosciences and brain imaging, with extensive experience in medicine, clinical research and analysis including GCP regulations and specializing in clinical neurology, radiology and pathologyA practicing Medical Doctor with 10 years of experience in neurosciences, five years in nuclear medicine, and one year in molecular biology and pathology.Assessments of brain trauma patients, disability cases, for the insurance industry.Extensive experience in data analysis of PET, SPECT MRI, fMRI, and EEG with source localization.Extensive experience in medicine, clinical research and analysis including GCP regulations, specializ...
Clinical Research and Medical Affairs Expert Physician (MD) Specializing in Global Drug and Biologics Development Clinical Expertise; Approval of Multiple Drugs in Small Molecules and Biologics.Clinical research and medical affairs physician (MD) specializing in global drug and biologics development, approval of small molecules drugs and biologics.Commercial development, including Clinical Development Plans (CDPs) due diligence, business cases, and marketing support and protocols for Phase I-IV as well as post-marketing studies.Respected authority and resource working with key opinion leaders in a diverse range of pharmaceutical and medi...
Medical Device Design and Product Development Expert Specializing in Class III and Class IIb Devices (Coronary and Peripheral Bare Metal Nitinol, SS, Cobalt Chromium and Drug Eluting Stents and Balloons, Scoring Balloon Catheters, Vascular Grafts, Hemodialyzers)Medical device design, product development and commercialization experience of 21 years with a record of building and leading high performance product development teams, developing and commercializing new products, and driving increased revenues and profitability.Successful track record in large (Medtronic, Baxter) and start-up (AVE, AngioScore, NanoVasc) corporations.Research, prod...
Over 30 Years of Experience in Pharmaceutical Research and Development.
Expert Support in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs and Clinical Research at Major Pharmaceutical CompaniesOver 30 years' experience in pharmaceutical research and development.Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drugWorldwide clinical research at major pharmaceutical companies.Educator: Pharmacology and toxicology to medical, dental and p...
Innate and Adaptive Immunity, Inflammation, In Vitro and In vivo models. Biochemistry, Protein Modification, Signal Transduction, Gene RegulationBiochemistry, protein chemistry, and protein modification.Immunology, toll receptors, vaccines and vaccine adjuvants.In vitro and in vivo models of disease.Forecasting and determining future needs in pharmaceutical and biomedical industries.Research for development of 3M TLR agonists, created new opportunities as vaccine adjuvants and cancer therapies.In vitro and in vivo immune response and oncology models to demonstrate efficacy.Widely acknowledged for innovation and creativity to identify pharm...
Extensive Knowledge of Neurological and Psychiatric Disorders expert specializing in preclinical basic and applied CNS drug discovery researchPreclinical CNS research: Preclinical basic and applied CNS drug discovery research in the international pharmaceutical industry.A Neuropharmacologist and an accomplished drug hunter, with in-depth knowledge and broad expertise at the world's largest drug company.In-vitro neuropharmacology identifying new compounds in drug development and establishing new assay enhancements.Extensive preclinical evaluations for the advancement of drug candidates.Extensive knowledge of neurological and psychiatric di...
Consultant in, and Drug Delivery for Oral, Topical, Rectal, Vaginal and Parenteral Products Covering all Stages of Development from Preformulation through to Technical Transfer into Commercial Production, and Expert Witness.Pharmaceutical formulation scienceDrug deliveryPharmaceutical excipientsPharmaceutical quality by designPharmaceutical preformulationScale-upTechnical transferSolid oral dosage formsLiquid dosage formsSemisolid dosage formsPoorly soluble drugsChemistry, manufacturing and controls documentationChemistry, manufacturing and controls project managementTrainingExpert Witness ExperiencePatent infringement, controlled release...
Pharmacist Specializing in Asia/ India Specific Regulatory Requirements - Marketing Authorization, Clinical Trial Permission in Biologicals and Other Market Research; Pilot Plant and Pharmaceutical AnalysisDiverse experience in pharmaceutical regulatory affairs at national and international levels.Current pharmaceutical regulations in India with major regulatory authorities.Acquired training in international forums by (WHO), World Health Organization and USFDA.Working at apex drug regulatory body in India.Inspection of clinical trials.Sourcing pharmaceutical Information.
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.
National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...