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…
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…
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…
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,…
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…
Skip to main content Options for the administrative overlayIf you have problems accessing administrative pages on this site, disable the overlay on your profile page.Dismiss this message. Edit Blogs TMB Harmonization Working Group Fall MeetingClose overlayPrimary tabsVIEW EDIT(ACTIVE TAB) REVISIONS NODEQUEUE You are hereHome » TMB Harmonization Working Group Fall Meeting » TMB Harmonization Working…
Molecular diagnostics are central to the delivery of personalized cancer care. Without these important tools, physicians would not be able to select the appropriate patients for targeted therapy, negating the advantages conferred by recent advances in genomics. In the past fifteen years, there has been an explosion of new technologies to interrogate the genes and…
In his first speech to Congress last February, President Trump revived a common misconception about drug regulation. The president’s comments reflect a perennial critique of the FDA, that the agency’s drug regulations impede timely access to new medicines. A few years ago, Friends of Cancer Research (Friends) explored whether these claims were true about cancer…
From L-R: Dr. Gregory Reaman, Pr. Gilles Vassal, Mr. Raymond Rodriguez-Torres Oncology is a widely studied and researched field, and the advancements in scientific and clinical understanding of pediatric oncology provides an opportunity to better inform pediatric drug development. For a long time, there was an idea that children are “tiny adults” and…
In 2012, the Breakthrough Therapy Designation was signed into law. Four years later, Friends of Cancer Research (Friends) continues to steward the program that the organization developed by working closely with FDA and other stakeholders to ensure the program is as efficient and effective as possible. As part of this stewardship, Friends hosted a Senate briefing…
