On November 13, 2020, Friends of Cancer Research (Friends) held the first of two virtual sessions of the Friends Annual Meeting. Day 1 covered Modernizing Expedited Development Programs, which focused on the current framework of FDA expedited development pathways and proposed ways to improve on the existing system. The meeting opened with a keynote address…
The first white paper, “Modernizing Expedited Development Programs” focused on expediting the development of drugs at the pre-clinical and clinical stages. On Day 2 of the 2020 Friends of Cancer Research (Friends) Annual Meeting, panelists will examine the second whitepaper, “Optimizing the Use of Accelerated Approval.” This white paper examines opportunities to optimize accelerated approval…
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…
Day 2 of the Friends of Cancer Research (Friends) meeting on real-world evidence (RWE) turned the focus from Day 1 to the regulatory and policy implications of real-world evidence. The hour-long meeting was comprised of two parts: a keynote conversation featuring Amy Abernethy, Deputy Commissioner of the FDA and a leader in the agency on…
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…
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 this post, we will review the Internal Consistency project, which investigated use of the RWE framework to select a clinical trial…
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 this blog, we will review two collaborations that formed between Friends of Cancer Research…
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…
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…
Click HERE for the August 25th Q&A Recap On Tuesday, August 11, 2020, Friends of Cancer Research (Friends) presented the results of Step 1 of the ctDNA for Monitoring Treatment Response (ctMoniTR) project. Step 1 involved convening clinical and academic leaders, government, industry, and leading advocates to align on a methodology to analyze ctDNA (circulating tumor…
