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Recent Projects
  • IP, market, and regulatory analysis for large Japanese company concerning a diagnostic medical device for a novel multivariant genomic platform.  Analysis includes selection of initial test analytes.
  • IP evaluation for a Fortune 100 company related to ex-vivo leukemia therapy.
  • Working with Medical Director of nation-wide clinical reference lab for multivariant proteomic cancer application.
  • Collaboration with genome center on a microbial ecology project.
  • Assisted and educated a physician inventor regarding the product specifications, value proposition, regulatory, and business plan development for an endoscopic device.
  • Assisted early stage biotechnology with a genetic epidemiology case control associative study with 12, 000 subjects.  Project involved clinical trial management, data management, and statistical oversight.
  • Clinical trials monitoring and support of a biologic for a major pharmaceutical company.
  • Prepared 510(k) application for a diagnostic product.
  • Market Validation and Feasibility for the commercialization of a potentially disruptive mutagenesis technology.
  • Market survey, assessment and strategy development including analyte identification for rapid point of care diagnostic in emergency medicine and OB/GYN.
 
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