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IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Pharmaceuticals and Biotechnology
Expert is a clinical psychologist by training with over 9 years of experience in Health Economics and Outcomes Research. His area of focus is Clinical Outcomes Assessment, including Patient Reported Outcomes. Expert helps sponsors define and implement a COA strategy…
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…
Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy operations, finance,…
Medicine and Healthcare
Expert is a physician informaticist who uses evidence-based medicine to develop clinical protocols. His experience ranges from developing process/procedures and relationships to mentoring and coaching. He has amassed more than a decade of understanding the pharmaceutical and medical industry and…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Value-Based Healthcare, Payment Integrity, Analytics and Informatics, and Payer-Provider Collaboration
Expert has implemented a wide variety of value-based care models at more than 600 hospitals and health plans. He is recognized as an expert in Population Health, Bundled Payments for Care Improvement (BPCI), Comprehensive Care for Joint Replacement (CJR), MACRA,…
Research; Infectious Disease, Pharmaceutical/Supply Chain, Biontech, Bioinformatics, Clinical Trial Design, Consumer Behavior, and Marketing
Expert currently serves as the Director for Strategic Health Information, coordinating all research-related activities in infectious diseases (TB, HIV, malaria, Hepatitis), chronic diseases like diabetes, cancer. He also collaborates with foreign partners in the design of the clinical trial protocol,…
Healthcare Practice, Senior Healthcare Management, and Health IT
Expert has over 25 years' experience as a medical practitioner, 18 of which have taken place at the consultant level. He has significant experience studying and working with other professions, healthcare environments and countries. He has developed a keen understanding…
Healthcare and Healthcare Strategy: Advanced Analytics, Process Optimization and Operations, Business Intelligence, Product Development, Sales and Marketing
Expert has 7+ years' experience as a senior executive or consultant in the health care field with deep knowledge across a range of products, functions, and solution providers. These include: Products: Medicare, Medicaid, Commercial (national, middle market, small group), Individual,…