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Pulmonary Hypertension Drugs, Nitric Oxide and Nitric Oxide Delivery Systems
Seasoned Executive with a unique combination of scientific and business expertise in the pharmaceutical industry. Over 18 years of drug development experience (i.v, subcutaneous, inhaled and oral products), 15+ years in Pulmonary Hypertension, including 10 years in years at a…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Formulation Development
Expert has over 20 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms and parenterals dosage forms with leading companies as TTK, Parke-Davis, Strides, Banner Pharma…
Medical Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Drug Delivery, Nutrigenomics/Epigenetics, Molecular Cancer Biology, Mouse Models, Cell Based Assays
Expert completed her PhD in molecular nutrition and cancer biology in the University of Texas at Austin.Throughout her graduate training, she showed initiative and creativity in launching original research projects and her doctoral dissertation was funded by the NIH (F31)…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Improving the Value of Technology Investments, Management of IT and Application in Business
Expert. Expert has a successful track record helping clients to develop and improve the management and application of technology within their businesses; bridging the Business/Technology divide by deploying eclectic, hybridised commercial & technology skills and experience. Expert is fully capable…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…