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Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
Nutrients Absorption Through GI Tract-Interactions of Natural Products of Bioactive Foods on Genomes
Expert has done extensive work on mechanism of NSAIDs action in small intestine absorption and permeability both in human and animal models. His noninvasive technique has been published in peer reviewed journals and he is an expert in performing analyses…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Drug Delivery, Nutrigenomics/Epigenetics, Molecular Cancer Biology, Mouse Models, Cell Based Assays
Expert completed her PhD in molecular nutrition and cancer biology in the University of Texas at Austin.Throughout her graduate training, she showed initiative and creativity in launching original research projects and her doctoral dissertation was funded by the NIH (F31)…
Genomics and Biomarkers
Expert is a solutions-oriented business development and scientific professional with broad experience in the development of genomics and proteomics tools and the applications of these tools in research and drug discovery. Expert has a BA in Biology from Clark University.…
Internal Medicine, Hospital Medicine, Utilization Review, CMS Compliance, Faculty, Telemedicine
Expert is board-certified in Internal Medicine by the American Board of Internal Medicine. He has been practicing as a hospitalist (inpatient internal medicine) since finishing his residency training in 2007. He has worked in major, tertiary-care, referral hospitals and in…
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: •…
Targeted Therapies for Human Tumours
Expert's group has been working from many years on new treatments for mesothelioma. These new treatments are called "translational therapies" because are directly translated from preclinical research applied to thoracic malignancies.
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…