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BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Biostatistics, Statistics, Programming, and Epidemiology
This expert is a Harvard PhD graduate and currently Associate Professor of Biostatistics at a U.S. university, where her position is tenured. Her biostatistical and statistical research and teaching includes applications Immunology and Infectious Diseases; Pathology; Epidemiology; Anesthesiology, Perioperative, and…
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…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Biochemistry, Drug Development, Antibiotics, Proteins, Medicines, Pathogens, and Pharmaceuticals
Expert serves on the faculty of a University, Department of Chemistry and Chemical Biology. He previously held a senior scientist and lecturer position at ETH Zurich, Switzerland. His interests are at the interface of chemistry and biology, where he is…
Infectious Diseases in Humans and Animals; Vaccines; Vaccinology; Biologicals; and Drug Development
Expert has over 28 years experience in infectious diseases research with a specialty in vaccine development for human and veterinary medicine. He completed 4 year combined residency in Comparative Pathology and NIH post-doctoral Fellowship at the Armed Forces Institute of…
Bioscience, Pharma, Biotechnology, Research, Publications, Funding
Expert (President, Employer) is professor and an established researcher with international reputation in cardiovascular disease and diabetes. He is recipient of academic awards from Canadian Diabetes Association, the Province of Ontario, Canadian Institutes of Health Research and Heart & Stroke…
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…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.
•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…