- 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.
|