Yager, Thomas D.

Summary of Experience:

Dr. Yager has more than twenty years of experience in design, development and validation of molecular diagnostic assays for hereditary disease mutations, infectious diseases, multiple-analyte assays, pharmacogenomics and companion diagnostic assays.

He has managerial and strategic level consulting experience with several startup companies, and has done 510k and PMA submissions to the FDA for class II and class III medical devices.

His academic and healthcare affiliations have included University of Oregon, Weizmann Institute, Kings College London, Hospital for Sick Children (Toronto), and cross-appointment to the department of Molecular/Medical Genetics, University of Toronto.

Mentoring Services Provided:

“I can provide both strategic and ‘nuts and bolts’ tactical advice on all aspects of molecular diagnostics assay development. This can include design control, calibrators and controls, performance and validation studies for analytical and clinical validation and bridging studies. I also can assist with design, testing and validation of algorithms and software for data analysis and diagnostic decisions; comprehensive risk analysis and mitigation for design workflow, process and software risk.”