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Natalie 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…
Read 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…
Read 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…
Read 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…
Read 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…
Read MoreFebruary 4, 2020
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,…
Read MoreJanuary 7, 2020
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…
Read MoreNovember 20, 2019
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…
Read MoreOctober 21, 2019
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…
Read MorePeter L. Saltonstall and Jeff Allen | October 10, 2019
On October 1, the first-ever Rare Cancer Day, an awareness day highlighting the challenges people living with rare cancers face and emphasizing the importance of early diagnosis, was marked by thousands nationwide. Cancer is not a singular disease but, rather, many diseases, of which several are rare. One in 5 people living with cancer in…
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