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Engaging Innovation

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October 10, 2019

Despite criticism, FDA is doing what is right by rare cancer patients

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...
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No Results With Current Filter Choices

8th Blueprint for Breakthrough: Validating Real-World Endpoints for an Evolving Regulatory Landscape

  "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...

Real-World Evidence Roundtable

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...

Designing the Future of Cell Therapies

“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...

The FDA’s Budget: How Government Funds Safety and Efficacy

The U.S. Food and Drug Administration (FDA) fulfills its mission to protect and advance the public health by overseeing the development and approval of new medical products and ensuring that they are safe and effective for American consumers. When taking into consideration the full range of products the FDA oversees,...

The Future Use of Real-World Evidence

  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...

TMB Harmonization Working Group Meeting

On May 10, 2018, Friends of Cancer Research (Friends) convened stakeholders across all health sectors to assess current methods of measuring tumor mutational burden (TMB) and develop a consensus approach to the standardization of this biomarker. This roundtable built on a workshop hosted by Friends in the Fall of 2017,...

Safeguarding the Public Health: Enhancing Information About Prescription Drugs

Friends of Cancer Research Congressional BriefingSafeguarding the Public Health: Enhancing Information About Prescription Drugs Patients and their caregivers need access to high quality information about the prescription drugs they use. While many sources of information exist, none can deliver as strong assurances of reliability and scientific rigor as FDA-approved product labels....
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