Blog: Engaging Innovation

Bhaavna Yalavarthi and Grace Collins | February 6, 2025

Data-Driven Insights | 20 Years of FDA Leadership in Novel Cancer Drug Approvals

In 2011, Friends published a study in Health Affairs that challenged the prevailing narrative of the time, which suggested that the U.S. Food and Drug Administration (FDA) was slower and less efficient than other regulatory authorities, such as the European Medicines Agency (EMA). This study provided evidence to the contrary, demonstrating that the FDA approved…

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February 5, 2025

Meeting Recap | Advancing the Future of Diagnostics and Regulatory Innovations

On February 4th, Friends of Cancer Research (Friends) hosted a public meeting, “Advancing the Future of Diagnostics and Regulatory Innovations,” emphasizing the dual objectives of ensuring patient safety while fostering an environment conducive to innovation—a balance that is becoming increasingly critical in an era marked by rapid technological advancements. https://youtube.com/watch?v=wFHolEBYx48%3Fsi%3DCk6uqqepK_R4KsxA Key Takeaways & Helpful Resources…

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January 13, 2025

Project Pulse | Insights from the Digital PATH Project: HER2 Biomarker Variability Across Artificial Intelligence Models | SABCS

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).

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December 9, 2024

Meeting Recap | Friends Annual Meeting 2024 Recap: Sharing Next Steps and Opportunities with Advocates

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.

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December 3, 2024

Stakeholder Connect | Insights from First Meeting of the Digital Health Advisory Committee

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.

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November 25, 2024

Project Pulse | Analysis of 20 Independently Performed Assays to Measure Homologous Recombination Deficiency (HRD) in Ovarian Cancer: Findings From the Friends’ HRD Harmonization Project

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).

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November 14, 2024

Meeting Recap | Friends of Cancer Research Annual Meeting 2024

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.

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September 30, 2024

Stakeholder Connect | Insights from the September 26, 2024 Meeting of the Oncology Drugs Advisory Committee

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...

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Ryan M. Hohman, JD, VP of Public Affairs, Friends of Cancer Research | September 5, 2024

Stakeholder Connect | Supreme Court Decisions and Their Impact on the FDA and Patients’ Lives: The Overruling of Chevron

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...

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August 30, 2024

Project Pulse | Bridging research and practice: enhancing regulatory decisions with pragmatic clinical trials in oncology

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…

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