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soy products utilization, nutritional product formulation, probiotics and prebiotics, nutritional clinical study designs
An accomplished and global clinical and nutritional leader with over 25 years of progressive experience in the botanicals, nutritional vitamins, prebiotics/probiotics, multinational healthcare, and consumer products industry sectors. Demonstrated leadership in partnering with internal technical and cross-functional operating teams in…
Emergency Medicine, Air Medical Transport, Emergency Medical Services and Emergency Medical Devices
Expert has been in health care since 1985. He has an extensive background in EMS, emergency medicine and air medical transport as a clinician, educator, author, and leader. Expert has worked at a leading academic medical center and interact regularly…
Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
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…
Formulation Liquids, Soft Gelatin, Two-piece Hard Capsules, and Process Development in Pharma
Expert has developed Soft Gelatin Capsules containing non-aqueous solution, suspension and self-emulsifying formulations for a variety of new chemical entities (NCE), prescription, highly insoluble compounds and OTC drugs. This experience included conducting solubility studies with hydrophilic/lipophilic excipients, as well as…
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…