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…
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…
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 DNA)…
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…
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…
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…
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,…
At a Senate briefing hosted by Friends of Cancer Research (Friends), a panel comprised of leading stakeholders convened to discuss changes in cancer care and criticisms of the U.S. Food and Drug Administration’s (FDA) expedited approval programs. As recent advancements to discover and develop targeted therapies, immunomodulating agents, and cell-based therapies provide new and potentially…
The Friends of Cancer Research (Friends) Annual Meeting 2019 began with welcoming remarks by Ellen Sigal, Chairperson & Founder of Friends, and Jeff Allen, President & CEO of Friends. In her remarks, Sigal emphasized the time and effort spent by working group members on putting together collaborative whitepapers meant to reach a level of consensus…
On Monday, October 7, 2019, Friends of Cancer Research (Friends) and Prevision Policy hosted the fifth annual BioPharma Congress. This year’s event focused on gene therapies, approval standards, new payment models, drug pricing, and the future of the U.S. Food & Drug Administration (FDA). Featured speakers included Assistant to the President and Director of the Domestic Policy…
