The first white paper, “Modernizing Expedited Development Programs” focused on expediting the development of drugs at the pre-clinical and clinical stages.

Each year, the Friends of Cancer Research (Friends) Annual Meeting addresses critical issues in the development of new oncology drugs and features experts proposing unique approaches toward current challenges in drug development. On Day 1 of the 2020 Friends Annual Meeting, panelists will discuss FDA’s expedited development programs and discuss proposals outlined in the white paper “Modernizing Expedited Development Programs.”

September 21st was the first day of the Friends of Cancer Research (Friends) virtual meeting on real-world evidence (RWE). Day 1 covered findings from the RWE Pilot 2.0 Project, exploring the outcomes of patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy versus chemotherapy, as well as related RWE projects from partner institutions across the country and abroad.

This is the final post in the Real-World Evidence (RWE) blog series where we will discuss the Friends of Cancer Research (Friends) whitepaper titled: “Recommendations for Use of Real-world Evidence in Oncology: Lessons Learned from the Friends of Cancer Research Real-world Evidence Framework. ”

This is the fourth installment in our Real-World Evidence (RWE) blog series where we highlight key findings and implications from the RWE pilot projects. You may view previous posts here, here, and here.

In our previous blog posts we discussed Pilot 1.0 and Pilot 2.0 of the Real-World Evidence (RWE) Project. The goal of the RWE pilots is to create better characterization for the role real-world endpoints could play in evaluating drug effectiveness.

In the first post of the Real-World Evidence (RWE) blog series, we discussed Pilot Project 1.0 , and the collaborative effort to build consensus around the role of RWE in oncology. In this post, we will explore Pilot Project 2.0: Establishing the Utility of Real-World Endpoints, a key element about RWE that requires further investigation for drug development.

This is the first of a five-part blog series on Real-World Evidence leading up to the September 21st RWE meeting . The series will highlight how Friends of Cancer Research (Friends) is working with various stakeholders to identify key elements about real-world evidence (RWE) that require further investigation for use in drug development and contribute to consensus toward the potential use of RWE in the regulatory setting. 

Click HERE for the August 25th Q&A Recap

On Thursday, July 23, 2020, Friends of Cancer Research (Friends) hosted the second in a two-part virtual meeting series, TMB Results: The Future Use of Complex Biomarkers, that focused on the harmonization of tumor mutational burden (TMB). The event covered the results from the TMB Harmonization Project and how the project’s efforts will impact the future use of complex biomarkers, such as TMB.