Clinical and Legal Nurse Expert Specializing in all Aspects of Medical Device Product Development and Regulatory StrategyProduct development expert in recognition of clinical problems that can generate important medical device solutions that meet or exceed sales expectation.Clinical Research Director for large Maternal Infant Care (MIC) Medical Device Business.Expert in developing claims and regulatory strategy for product development.Patient safety and clinical risk assessment process for MIC portfolio.Risk assessment activities during product development.Planned and directed pre and post-market research projects with more than 60 studies...

Life Sciences Consultant Specializing in Intellectual Property, Marketing, Business Development, R&D, Product Development, Product Evaluation, Manufacturing, and International Sales (Biotechnology and Pharmaceutical Industries)Over 20 years of Life Sciences experience in academia, government and biotechnology and pharmaceutical industries.Scientific discovery, development and marketing knowledge for pharmaceuticals and diagnostic equipment medical devices.Development of novel high-throughput screening products for crystallography, genomic, and proteomic technologies.Development of automated and miniaturized biologic testing kits for nuclei...

Academic Clinical Research and Drug and Biologics Development Experience with Overall Program Development, Individual Trial Design, Execution and Reporting.More than 35 years of both academic clinical research and drug and biologics development experience.Directing overall program development, and individual trial design, execution and reporting.Primary direction of complete drug development programs from IND to NDA that resulted in FDA approval.Complete management and oversight of Chemistry, Manufacturing and Controls (CMC) activities, and nonclinical trials.Complete clinical development activities including clinical trial design protocol...

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...

Synthetic and Medicinal Chemistry Consultant Specializing in the Integration of All Aspects of Drug Discovery; Chemistry, Biology, Patent Protection, Pre-Clinical Development; IND Filing, Support of Phase I & II Clinical TrialsSynthetic and medicinal chemistry.The integration of all aspects of drug discovery, from early-stage research in chemistry and biology, through patent protection, pre-clinical development, CMC, IND-filing and support of Phase I and II clinical trials.Indication areas of experience: Inflammation, cancer, neurological and neurodegenerative diseases, age-related macular degeneration, and diabetic retinopathy.18 years o...

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...