PhD molecular biologist with 20 years of experience in molecular diagnostics and >20 publications in oncology, clinical and translational research. Direct experience managing all phases of molecular diagnostic product development, from feasibility research to FDA approval (PMA and BLA) and post-launch support.
- R&D lead for the team that developed the PROGENSA PCA3 Assay, the first molecular urine test for prostate cancer detection: launched in Europe 2006, FDA-approved February 2012
- Helped establish and staff the Operations Technical Support function at Gen-Probe, including product support and process development.
- Key member of the team that developed and launched the PROCLEIX HIV-1 / HCV Assay, the first nucleic acid amplification test for blood screening.
EVENTS & ACTIVITIES (Speaking, Spoken, and Authored)