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…
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, including not just medical products,…
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 and…
Friends of Cancer Research Congressional Briefing Safeguarding 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. Labels are the…
Robust drug development for pediatric cancers is critical to ensuring appropriate access to life-saving drugs and promoting innovation. As such, the FDA Reauthorization Act (FDARA) of 2017 included a provision requiring sponsors to investigate new molecularly targeted cancer drugs and biologics that are determined to be substantially relevant to the growth or progression of pediatric…
November 14, 2017 Disruption In Biopharma The Ritz-Carlton, Washington D.C. 1150 22nd Street, NW On Tuesday, November 14, 2017, Friends of Cancer Research (Friends) and Prevision Policy hosted the third annual BioPharma Congress. This year’s event focused on disruption in biopharma and featured speakers such as former FDA Commissioner Dr. Mark McClellan and former Senate…
