Natalie Kim | August 28, 2020
In the first post of the Real-World Evidence (RWE) blog series, we discussed Pilot Project 1.0 , and the collaborative effort to build consensus around the role of RWE in oncology. In this post, we will explore Pilot Project 2.0: Establishing the Utility of Real-World Endpoints, a key element about RWE that requires further investigation…
Learn MoreNatalie Kim | August 26, 2020
This is the first of a five-part blog series on Real-World Evidence leading up to the September 21st RWE meeting . The series will highlight how Friends of Cancer Research (Friends) is working with various stakeholders to identify key elements about real-world evidence (RWE) that require further investigation for use in drug development and contribute to consensus…
Learn MoreEric Hua | August 21, 2020
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…
Learn MoreNatalie Kim | July 29, 2020
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…
Learn MoreEric Hua | July 24, 2020
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…
Learn MoreNatalie Kim | July 16, 2020
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…
Learn MoreEric Hua | July 8, 2020
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…
Learn MoreNatalie Kim | July 6, 2020
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…
Learn MoreEric Hua | July 1, 2020
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…
Learn MoreEric Hua | June 24, 2020
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…
Learn MoreNovember 3, 2021
August 19, 2021
