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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,…
Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years’ work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation,…
Biopharmaceutical Sciences
Expert is a skilled, highly motivated, dedicated, and result oriented scientist with vast experience & knowledge in bioprocess development & manufacturing of biopharmaceuticals. He is an analytical SME for bioassays, Immunoassays, Electrophoresis, HPLC, PCR and Cell Culture. Expert is an…
Translational Medicine and Biomarker Research in Cancer Drug Discovery
Expert is a Scientist with 8+ years of extensive hands-on experience and deep understanding of cancer biology with focus on chromatin, RNA, epigenetics and gene expression regulation. She is a leader of multiple projects with interdisciplinary collaborators, driving conceptualization, execution,…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Molecular Genetics and High-Complexity Diagnostics
Expert has been working in Molecular Genetics for over 20 years and has extensive Research and Clinical experience. He hold a clinical license in Molecular Pathology in the state of Florida. His goal is to make healthcare advance through the…
Biotechnology
Expert is an independent consultant in the biotechnology field. She assists firms in bringing their technology to commercialization by working on early innovation, product development strategy, technical feasibility, and building work plans. In her previous role at Zymergen, Inc., she…
Naturopathic Medicine and Certified Nutrition, Focus on Utilizing Integrative Medicine to Treat Chronic Disease
Expert is a naturopathic physician, certified nutrition specialist (CNS), co-owner and medical director of and integrative medicinal specialty center. Expert is the Director of Product Development, Scientific and Clinical Education, and Scientific Advisor for a research group as well. Expert…
Bioanalytics, Chemistry
As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…