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Biomaterials, Intraocular Lens Implants, DNA Analysis
Expert has completed doctoral studies in developing a novel polymer for intraocular lens implants. During this study she has designed several new experimental methods to detect polymer biocompatibility and toxicity to ocular and other cell types. Expert also has extensive…
Behavioural and Molecular Genetics, Circadian Biology, Neurodegeneration, Statistics
Expert's main line of research is in behavioural neurogenetics, particularly circadian rhythms, and Huntington's disease. He uses transgenic animal models (Drosophila, mice) and the main thrust is in understanding the molecular basis of these phenotypes. The circadian work is aimed…
Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Non-Invasive Cardiology, New Anti-Coagulation, Hypertension, Atrial Fibrillation, CAD, Lipids, Heart failure, atherosclerotic heart disease
Expert has been an investigator for several DOACs anti-coagulants (RELY and AVERROES) for atrial fibrillation. He has also been and investigator on Coronary Artery Disease and unstable angina in the TIMI studies. He is in clinical practice, with strong clinical…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…