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…
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…
“Real-World Evidence is already here.” – Ned Sharpless, Acting FDA Commissioner On September 18, 2019, Friends of Cancer Research (Friends) and Alexandria Real Estate Equities, Inc. hosted a meeting to present data from the Real-World Evidence (RWE) Pilot 2.0, building on the Friends RWE Pilot 1.0. The meeting focused on the opportunities and challenges associated…
Friends of Cancer Research (Friends) convened a roundtable meeting on February 6, 2019, to identify key challenges and next steps to further characterize how real-world evidence (RWE) can fill evidence gaps about the performance of approved agents used in the real-world setting, including in populations that may not have been included in initial clinical trials.…
“Patients are waiting. These therapies are potentially curative. They’re important for the field.” – Ellen Sigal On May 17, 2019, Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) held a public meeting on “Designing the Future of Cell Therapies” to explore forward-looking opportunities in the cell therapy field. The meeting…
On Wednesday, November 14, 2018, Friends of Cancer Research (Friends) and Prevision Policy hosted the fourth annual BioPharma Congress. This year’s event focused on drug pricing, approval standards, patient input, and the future of the U.S. Food & Drug Administration (FDA). Featured speakers included HHS Deputy Secretary Eric Hargan and CMS Administrator Seema Verma. The…
