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Engaging Innovation

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July 1, 2020

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...
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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...

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...

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...

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...

Senate Briefing - Turning the Tables: Innovator Meets Regulator

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...

Friends Of Cancer Research Annual Meeting 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...

BioPharma Congress V

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...
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