Eric Hua | November 23, 2020
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…
Learn MoreNatalie Kim | November 15, 2020
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…
Learn MoreNatalie Kim | November 10, 2020
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…
Learn MoreEric Hua | October 1, 2020
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…
Learn MoreEric Hua | October 1, 2020
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…
Learn MoreNatalie Kim | September 16, 2020
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. ” The whitepaper, informed by the pilot projects we reviewed in…
Learn MoreNatalie Kim | September 9, 2020
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…
Learn MoreNatalie Kim | September 2, 2020
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…
Learn MoreNatalie Kim | August 28, 2020
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…
Learn MoreNatalie Kim | August 26, 2020
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…
Learn MoreNovember 3, 2021
August 19, 2021
