FDA Archives - Friends of Cancer Research

Insights from the July 25, 2024 Meeting of the Oncology Drug Advisory Committee

| July 26, 2024

Emerging data from clinical trials evaluating the use of immune checkpoint inhibitors (ICI) as part of adjuvant, neoadjuvant, and perioperative regimens indicate improved outcomes for patients with resectable non-small cell lung cancer (NSCLC), including early data suggesting a survival benefit. Perioperative treatment encompasses the entire period surrounding surgery, with neoadjuvant therapy administered before surgery and…

Congressional Hearing Focuses on Key Issues Facing FDA and the Future of Cancer Research

| June 11, 2024

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.

Digital PATH Project looks to the future of oncology

| March 19, 2024

Digital and computational pathology platforms have the potential to provide more precise and novel diagnostic insights to inform treatment decision making and, ultimately, improve patient outcomes. Friends of Cancer Research (Friends) is leading a new research partnership, the Digital and Computational Pathology Tool Harmonization (Digital PATH) Project, to support robust development of digital and computational pathology platforms for use in oncology drug development.

Critical Findings from Friends HRD Harmonization Project

| March 12, 2024

Homologous Recombination Deficiency (HRD) is a complex biomarker that can help identify patients likely to respond to certain therapies. Friends of Cancer Research’s (Friends) HRD Harmonization Project Harmonization Project is a unique research partnership to find alignment among different assays that measure HRD, to support its use as a biomarker in clinical research and care, and to serve as a foundational…

Watch Now: Friends of Cancer Research Annual Meeting 2023

| November 21, 2023

On November 14, 2023, Friends of Cancer Research hosted our 16th Annual Meeting in Washington, D.C. Discussions at the meeting were the culmination of three working groups led by the organization over the past year, which collaboratively proposed solutions for three key challenges in oncology drug development: dose-finding in early phase trials, incorporating pragmatic elements in clinical trials, and using data from academic-led studies for regulatory decision-making.

Watch Now: Future in Focus: Digital Pathology in Oncology Drug Development

| October 3, 2023

On September 26th, Friends of Cancer Research hosted, “Future in Focus: Digital Pathology in Oncology Drug Development,” a virtual public meeting to discuss the opportunities, challenges, and promises of digital and computational pathology in oncology drug development.

Watch Now: Supporting the Use of RWD in Oncology Drug Development

| September 21, 2023

On September 11, 2023 Friends of Cancer Research hosted a public meeting, “Supporting the Use of RWD in Oncology Drug Development”, in Washington, DC. The meeting included a presentation of findings from the Friends Real-world Response (rw-Response) Pilot and two panel discussions focused on the regulatory implications for use of RWD and RWE in oncology drug development.

Watch Now: Establishing Evidence – New Advancements Using ctDNA

| July 20, 2023

On July 11, 2023, Friends of Cancer Research hosted, “Establishing Evidence: New Advancements Using ctDNA”, a public meeting in Washington DC. The meeting included data readouts for two initiatives: 1) the Baseline circulating tumor DNA (ctDNA) Project and 2) the ctMoniTR Step 2 Module 1 data.

Watch Now: The Next Generation of Cellular Therapies – A Blueprint to Accelerate Development

| June 1, 2023

On Monday, May 22, Friends of Cancer Research (Friends) hosted a hybrid public meeting titled “The Next Generation of Cellular Therapies: A Blueprint to Accelerate Development.” This meeting built on Friends’ previous work on Cell & Gene Therapies and was the second of two meetings in 2023 to explore next steps in the field.

Watch Now: The Next Generation of Cellular Therapies – Opportunities to Accelerate Development

| March 9, 2023

On Wednesday, March 8, Friends of Cancer Research (Friends) hosted a virtual meeting titled “The Next Generation of Cellular Therapies: Opportunities to Accelerate Development.” This meeting sets the stage for a meeting on May 22 in Washington DC by providing context around the current state of the science and progress in cell therapy development. These…

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