Yan Li

Leading and managing a group of talented CDx strategy leads (PhD and MD) accountable for overarching CDx strategies to accelerate global clinical development of innovative precision medicines in oncology (solid and heme), immunology, and neuroscience Driving innovation of NextGen CDx for clinical biomarkers to enable seamless transition from exploratory biomarker discovery to personalized clinical decision making to maximize therapeutic benefits for patients

Led development and implementation of global diagnostic strategies to expedite global clinical development and commercialization of innovative precision medicines across several key therapeutic areas including oncology, immunology and neuroscience. Received 2023 Discovery Research Impact Award for innovative CDx Strategy in Precision Medicine.

Innovated and drove biomarker & companion diagnostics strategies to accelerate clinical development and commercialization in oncology precision medicine - Bayer's first approved CDx for Vitrakvi in pan tumor indication globally; Originated novel biomarker testing strategy for next generation TRK inhibitor, guided implementation, attained FTD grant from FDA within 15 days; Received R&D Reward for the creative solution to overcome the complexity of simultaneous drug and CDx approval leading to the Marketing Authorization of Vitrakvi in Japan.

Led development of a novel clinical platform for comprehensive biomarker identification and molecular testing to predict response and bring personalized healthcare to patients - in collaboration with our diagnostic partner, Foundation Medicine Inc. Served as a technical lead in Genentech/Foundation Medicine collaboration to develop a novel NGS test - blood tumor mutational burden (bTMB) for personalized cancer immunotherapy Collaborated with clinical manufacturing to develop a sequencing strategy for Personalized Cancer Vaccines (PCV)

Led cross functional teams to develop and validate next generation sequencing (NGS) assay for the successful launch of the first ever FDA approved liquid biopsy companion diagnostic (CDx) test for Genentech and AstraZeneca drugs

Received the first world-wide Roche Molecular Diagnostics (RMD) Innovation Award in 2011 for my contribution to the development and launch of several FDA approved tissue based oncology companion diagnostic tests to enable personalized medicine for cancer patients