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Category: News

ctMoniTR Step 1 Results: Do Changes in ctDNA reflect response to treatment?

Click HERE for the August 25th Q&A Recap   On Tuesday, August 11, 2020, Friends of Cancer Research (Friends) presented the results of Step 1 of the ctDNA for Monitoring Treatment Response (ctMoniTR) project. Step 1 involved convening clinical and academic leaders, government, industry, and leading advocates to align on a methodology to analyze ctDNA (circulating tumor…

TMB Results: The Future Use of Complex Biomarkers

On Thursday, July 23, 2020, Friends of Cancer Research (Friends) hosted the second in a two-part virtual meeting series, TMB Results: The Future Use of Complex Biomarkers, that focused on the harmonization of tumor mutational burden (TMB). The event covered the results from the TMB Harmonization Project and how the project’s efforts will impact the future use of…

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…

A Closer Look into Phase 1 of the TMB Harmonization Project

The overall goal of the Friends of Cancer Research (Friends) Tumor Mutational Burden (TMB) Harmonization Project  was to ensure consistency across values from different TMB tests for cancer treatment. This article provides information about Phase I of the TMB Harmonization Project and how Friends worked to address the issue of TMB standardization. On March 26, 2020, the paper “Establishing…

Real-world Applications of TMB

The previous posts of this blog series have addressed the why and how of the Tumor Mutational Burden (TMB) Harmonization Project. What has not yet been addressed are the results of the project impact patient care. Phase III of the project sought to address the clinical validation of TMB as a predictive biomarker to help distinguish which patients would likely benefit from…

Understanding the Role of PRO Collection in Curative Therapies

On June 22, 2020, Friends of Cancer Research (Friends) published a paper, “Use of Patient‑Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies” in Therapeutic Innovation & Regulatory Science (TIRS) , a scientific journal of the Drug Information Association. In May 2018, the Centers for Medicare & Medicaid Services…

How we approached the harmonization of TMB

In the first post of this series, we covered why Friends of Cancer Research (Friends) decided to create the Tumor Mutational Burden (TMB) Harmonization Project. Due to a previous lack of understanding of the different ways to measure TMB and apply it as a biomarker for treatment determination, harmonizing definitions of TMB was critical in giving patients…

Why We Decided to Harmonize TMB

The TMB Harmonization Project is a collaborative initiative led by Friends of Cancer Research (Friends), whose goal is to better apply tumor mutational burden (TMB) for cancer treatment by standardizing the way it is measured. TMB measures the quantity of mutations found in a tumor and can serve as a useful biomarker that can predict how well a patient…

Jeff Allen Testifies on MODERN Labeling Act at House Energy & Commerce Subcommittee on Health Hearing

At a House Energy and Commerce Subcommittee on Health hearing titled, “Improving Safety and Transparency in America’s Food and Drugs,” Friends President and CEO, Jeff Allen, testified on the importance of updating medical product labels and the impact on patient safety and care. The hearing considered a series of bills addressing various issues related to the FDA,…

The Future Use of Real-World Evidence

  Significant progress has been made in data collection efforts to support use of real-world evidence (RWE) in regulatory settings; however challenges remain, chiefly with combining, organizing, and analyzing data from various information sources. On July 10th, Friends of Cancer Research (Friends) hosted a meeting to present data from a pilot project assessing the use…