2026 White Paper | Modernizing The FDA Biomarker Qualification Program Strengthening Regulatory Clarity And Broadening Biomarker Use In Drug Development View PDF
2026 Poster | ISPOR 2026 | External Control Arm Feasibility Across External Data Sources in Oncology: Methodological and Regulatory Science Considerations View PDF
2026 Public Comment | Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause View PDF
2026 White Paper | Leveraging AI-Enabled Tumor Assessment Tools on Radiological Images to Evaluate Treatment Effect and Support Clinical Trial Endpoints in Solid Tumors Read more
2026 Public Comment | Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product View PDF
2026 Peer Review | Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images Read more
2025 Peer Review | Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery Read more
2025 White Paper | Seamless Clinical Trial Designs in Rare Cancers Leveraging Operational and Adaptive Strategies to Accelerate Drug Development View PDF
