Skip to content

The Future Use of Complex Biomarkers

The Future Use of Complex Biomarkers

Friends of Cancer Research (Friends) convened its first virtual symposium on Tuesday, July 14, 2020. The symposium, The Future Use of Complex Biomarkers, convened renowned speakers from several health care sectors, who discussed the current role of biomarker testing in cancer drug discovery and treatment, and explored the future of complex biomarker development. The Tumor Mutational Burden (TMB) Harmonization Project led by Friends was also discussed as a potential framework for future harmonization initiatives for complex biomarkers. This project set out to standardize the way TMB was calculated to ensure consistency of testing results in a clinical setting. The panelists during the symposium emphasized why this approach was necessary, and how this could impact the future of cancer treatment.

The event began with an introductory video that gave a quick overview to TMB. This laid the backdrop to a fireside chat discussing the importance of harmonizing complex biomarkers, such as TMB. The fireside chat was comprised of FDA’s Richard Pazdur, Johns Hopkins’ Elizabeth Jaffee, and Merck’s Eric Rubin. Through their conversation, the panelists discussed the use of TMB as a predictive biomarker for patient response to checkpoint inhibitors in a tissue-agnostic indication. They discussed how this use of TMB was redefining how diseases are classified and treated, requiring people to start thinking outside of the box to improve patient outcomes. They also emphasized the importance of bringing together various stakeholders in pharma, biotech, academia, patient advocates, and regulatory agencies to properly define how to study this new complex biomarker. Looking forward, they emphasized how efforts like the TMB Harmonization Project demonstrate how the FDA is not forgetting its commitment to cancer patients. They wanted to make sure that even in the age of COVID-19, cancer patients are getting the innovation, treatments, and drugs that they need.

“The patients are not here to serve the clinical trial, clinical trials are here to serve patients.” – Richard Pazdur

Following the fireside chat was a live panel discussion, featuring FDA’s Steven Lemery, Caris Life Science’s Jamie Holloway, Foundation Medicine’s  Brian Alexander, and Memorial Sloan Kettering’s Matthew Hellman. The panel was moderated by The Pink Sheet’s Sarah Karlin-Smith. The discussion furthered many of the points brought up in the fireside chat, and also included a Q&A session. Topics covered included the benefits of harmonization to companies and ultimately to patients, how biomarkers like TMB have fundamentally changed how oncology is practiced, and potential future directions with biomarkers. The panelists talked about the implications of the use of complex biomarkers in drug development and discussed the need for harmonizing additional biomarkers like HRD early.

The symposium concluded with closing remarks by Friends’ CEO Jeff Allen and a look forward to the July 23rd follow-up virtual meeting. This meeting will provide the latest results of the TMB Harmonization Project. To learn more about the July 23rd event, visit


Conference FDA News Research