Bio
I take pride in the fact that that over my career, I have worked with many talented colleagues on novel and groundbreaking medical treatments and devices which have been impactful to the lives of patients. Having extensive work experience in both Diagnostics and Pharma/Biotech companies, I have in-depth and firsthand appreciation for what it takes to develop and commercialize products cost effectively, in a highly regulated environment which is constantly evolving.
I have developed stand alone Diagnostics, Companion Diagnostics (CDx) and Complementary Diagnostics Medical Devices (assays) for a wide range of indications including Cardiovascular, Women’s Health, Neuroscience, Inflammation & Immunology, Infectious and Rare Diseases.
I have in-depth knowledge of global IVD regulations and industry guidelines. I am experienced in submissions to regulatory authorities of major markets including: US: FDA (510K, PMA, HDE) and CMS (CLIA/CAP), EU: IVDD/ IVDR, Japan: MHW/PMDA and China: SFDA.
I have contributed to the design of over 20 clinical studies and am experienced in operationalizing studies for patient selection through diagnostics assays for Gene Therapy and am considered a Subject Mater Expert (SME) in Anti-AAV CDx assays.
Over my career, I have successfully led the development of over 10 IVD assays and managed the external development of 5 Companion Diagnostics and 1 Complementary Diagnostics. 8 of the IVD assays have been commercialized globally.
I am skilled in development and implementation of IP strategies, evaluation of new technologies and am accustomed to publishing, presenting at scientific seminars and communicating at a wide range of levels.
Core Competencies
- Technical Leadership of Complex and Novel IVD Programs
- Strong Strategic and Analytical Skills
- Evaluation of New Technologies
- Strategic Planning and Execution
- External Collaboration
- Budget Forecasting and Management
- Biomarker Discovery/Verification
- CDx/Dx Development and Commercialization
- Regulatory Submissions
