Biotech consultant assisting companies with business development strategies, technology licensing, start-up formations, assay design and development and marketing strategies.
Areas of expertise: - Biomarker discovery for personalized medicine strategies - Diagnostic test development (design control process, LDT, IVD) and integration with pharmaceutical drug development
- Companion diagnostic regulatory strategy - NAT and serological diagnostic test commercialization strategy - Infectious diseases, oncology, immunology, hematological and rheumatological diseases - Phosphoflow®: intracellular signaing analysis of primary cells by flow cytometry for biomarker services, diagnostic preparation and substances and diagnostic techniques
- Quality system design and implementation - Clinical sample handling logistics
- IT/IS platform approaches to data management - Intellectual property management - Project management, operations and efficiency streamlining - Reagent sourcing and vendor relationships - Strategic marketing, competive intelligence analysis, - Licensing strategies, negotiations, and contract mangement Previous work included: Developed viral NAT and serological diagnostic products, including reagent sourcing and implementation of quality strategy. Developed the phosphoflow® technology including antibody production, conjugate chemistry and QC validation platforms for reagent development.Developed novel assays for viral infection assays, NK cell killing, HIV detection, phospho-epitope monitoring, signal network detection, glycosylation modification detection, receptor dimerization assessment and nuclear localization. Provided expertise in phosphoflow® cytometry for drug screening, pharmacodynamic monitoring, target validation and clinical immune monitoring programs for industry and academia. Consulted on multiplexed assay systems for functional assessment in highly immunophenotyped cells.Provided expertise on clinical sample handling, cryopreservation techniques, and automated flow cytometry. Advised on small molecule screening programs that included FLT3 inhibitors, LFA-1 antagonists and various kinase inhibitors. Clients included both pharma and biotech companies.
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