Friends of Cancer Research (Friends) had an eventful year of new projects launched, data insights shared at public meetings and in publications, and partnerships formed. For the final 2024 edition of the advocate newsletter, we’re sharing three advocate’s perspectives on our Annual Meeting topics and reflecting on progress made this year. We look forward to…
On December 5, Friends of Cancer Research (Friends) hosted a public webinar, “Friends Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates,” to provide advocates with an overview of discussions from the 2024 Annual Meeting, outline the path forward, and facilitate a dialogue with the goal of capturing the community’s voice and promoting broader educational access to patient/advocacy groups.
In 2023, the U.S. Food and Drug Administration (FDA) established the Digital Health Advisory Committee (DHAC) to consider topics related to the use of digital tools in drug development. On November 20 and 21st, 2024 the committee convened for the first time to discuss total product lifecycle (TPLC) considerations for generative artificial intelligence (GenAI) enabled medical devices. The establishment of the DHAC and this meeting come in response to growing interest and use of these technologies in healthcare and signal a recognition of the unique regulatory challenges presented by GenAI- and AI-enabled devices.
Friends’ recent research on homologous recombination deficiency (HRD) involved a comparative analysis of 20 independent HRD assays, assessing both an In Silico (n=348; TCGA database) and a Clinical dataset (n=90; nucleic acids from freshly extracted archival ovarian cancer tumor samples). The assays measured a variety of outputs to define DNA damage repair dysfunction and identify patients with high-grade serous ovarian carcinoma (HGSOC) who had HRD. This is important because patients with HRD may benefit from DNA damage repair inhibitor treatments like Poly ADP-ribose Polymerase Inhibitors (PARPi).
Friends of Cancer Research (Friends) held our 2024 Annual Meeting on November 12th in Washington, D.C. The meeting was a culmination of the collaborative efforts of scientists, clinicians, advocates, and policymakers to develop innovative solutions to challenges in oncology drug development. The meeting featured two keynote conversations with the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf and Director of the National Cancer Institute (NCI) Kimryn Rathmell, and panels discussing three topics: interim OS evaluations, pragmatic trials in the post-marketing setting, and incorporating ctDNA in prospectively designed trials.
Welcome to Friends’ third Quarterly Advocacy Newsletter of 2024. In Q3, Friends published several peer-reviewed manuscripts with insights on enhancing representation in clinical trials, use of RWD to assess response to treatment, and opportunities for pragmatic elements to be incorporated in clinical trials supporting regulatory decisions. We’re excited to share details on these publications and…
Chevron deference was established by the 1984 Supreme Court of the United States (SCOTUS) case of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., which related to EPA’s ability to regulate air quality under the Clean Air Act. The decision mandated that federal courts defer to federal agency’s reasonable interpretation of ambiguous statutes…
Friends of Cancer Research (Friends) is pleased to announce the publication of our new perspective on the significance of pragmatic clinical trials (PCTs) in ESMO Real World Data and Digital Oncology. PCTs evaluate the effectiveness of interventions in settings that more closely resemble real-world care, aiming to produce evidence directly applicable to clinical practice. Recognizing…
Testimony for the hearing noted the recent authorities provided through the Food and Drug Omnibus Reform Act of 2022 (FDORA) designed to enhance the accelerated approval program and ensure timely generation of confirmatory evidence.
Welcome to Friends’ second Quarterly Advocacy Newsletter of 2024. In Q2, Friends co-hosted a public meeting about cell therapies with the Parker Institute for Cancer Immunotherapy, published several peer-reviewed manuscripts, and launched a webpage for patients and advocates, including a section about our Advisory Advocates. We’re so excited to share these and other happenings at…
