Current Policy Priorities
Policy Portfolio
At Friends of Cancer Research (Friends), we foster collaboration among leaders from federal health and regulatory agencies, academia, the private sector, and patient advocacy groups to identify and address critical issues in development of new oncology drugs.
We use unique scientific research partnerships to solve current challenges in oncology drug development. The evidence and proposals generated from these efforts inform our legislative and regulatory policy priorities.
Legislative Priorities
Friends works to modernize regulatory frameworks and advance policies that enable efficient development of safe and effective therapies. Our priorities focus on strengthening the scientific and regulatory infrastructure needed to support innovation, improve clinical trial efficiency, and accelerate patient access to new treatments.
Advancing Qualification of Drug Development Tools
Biomarkers, early endpoints, and other drug development tools can improve trial efficiency and support earlier evaluation of therapeutic benefit. However, it is essential for regulatory pathways to become more predictable and scalable to support modern drug development. Friends supports policies that strengthen qualification pathways, improve regulatory clarity, and enable broader use of scientifically validated tools across development programs.
Enabling Responsible Use of Artificial Intelligence
Artificial intelligence (AI) has the potential to enhance clinical trial design, endpoint assessment, and evidence generation. Clear regulatory pathways and validation standards are needed to ensure these tools can be used reliably and responsibly. Friends supports policies that advance validation frameworks, including reference datasets, and enable consistent oversight of AI-enabled tools that have potential to improve drug development.
Supporting Efficient Development of Cell and Gene Therapies
Cell and gene therapies offer transformative potential but often require flexible development approaches due to small patient populations and novel mechanisms. Friends supports policies that enable scientifically appropriate development pathways for cell and gene therapies while maintaining rigorous standards for safety and effectiveness.
Regulatory Policy Priorities
Friends works to advance regulatory science and policy to support the efficient development of safe and effective therapies. Our priorities focus on strengthening evidentiary frameworks, clinical trial methodologies, and data frameworks to enable innovation and accelerate patient access to new treatments.
Our regulatory policy priorities include: Advancing Drug Development, Inclusive Clinical Research, Diagnostic Harmonization and Development, and Innovative Trial Designs.
To explore our work and impact across these areas visit our policy priorities.
Advancing Drug Development
Friends works to ensure oncology clinical trials designs are patient-centered and employ streamlined methods to generate rapid evidence supporting safe and effective therapies.
Inclusive Clinical Research
Friends supports inclusive and representative clinical trials through intentional trial design, proactive planning, and innovative patient-centered approaches. Our work has identified several opportunities for advancing cancer research and care.
Diagnostic Harmonization and Development
Friends promotes alignment across diagnostic tests by generating evidence to understand variability in test performance, ensuring that different testing methods are accurate and consistent for patients.
Innovative Trial Designs
Friends identifies opportunities for flexible and innovative approaches to evidence generation to streamline research, development, and regulatory decision-making, enabling broader and earlier patient access to innovative therapies.
Recent Public Comments
Friends actively monitors the regulatory landscape and submits public comments informed by our ongoing and past initiatives to help shape policy focused on accelerating drug approvals, modernizing Dx, and improving trial methodologies. Our recent comments include advocating for AI benchmarks in care, patient-centered dose optimization, and regulatory improvements for liquid biopsies.
- Friends Public Comment on FDA Draft Guidance: Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development Guidance for Industry
- Friends Public Comment on FDA Draft Guidance: Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects
- ASCO-Friends Joint Public Comment on Series of FDA Draft Guidance Documents: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Performance Status; and Laboratory Values
- ASCO-Friends Joint Public Comment on FDA Draft Guidance: Cancer Clinical Trial Eligibility Criteria: Approach to Available Therapy in Non-Curative Settings
- Friends Public Comment on FDA Proposed Rule: Medical Devices; Laboratory Developed Tests
- Friends Public Comment on CMS National Coverage Analysis for NGS for Medicare Beneficiaries with Advanced Cancer
- Friends Public Comment on FDA Draft Guidance: Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product
- Friends Public Comment on FDA Draft Guidance: Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Guidance for Industry
To access all of Friends public comments, click here.
To learn more about Friends of Cancer Research’s legislative priorities, current policy initiatives, or opportunities for engagement, please contact our team at publicaffairs@focr.org or 202-944-6700.