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Category: FDA

Watch Now: Expediting Drug Development – Use of ctDNA as an Early Endpoint

On Wednesday, July 20, Friends of Cancer Research (Friends) hosted a meeting entitled “Expediting Drug Development: Use of ctDNA as an Early Endpoint.” Welcoming everyone, Jeff Allen, President & CEO of Friends, provided updates regarding Friends’ ctDNA for Monitoring Treatment Response (ctMoniTR) project , a unique collaboration exploring whether changes in ctDNA levels can indicate clinical…

rw-Response Pilot Moves Forward with Meeting During ASCO

During the American Society of Clinical Oncology (ASCO) Annual Meeting in June, Friends of Cancer Research (Friends) convened rw-Response Pilot participants to discuss initial findings. This pilot expands on Friends’ previous real-world evidence (RWE) work focused on answering the question: “What real-world endpoints can be evaluated and compared across multiple data sources using a common…

Watch Now: A Path for Early Detection 

On March 29th, Friends of Cancer Research (Friends) convened a virtual meeting to discuss the use of multi-cancer early detection (MCED) screening tests, a promising technology that may support earlier detection of cancers. Dr. Ellen Sigal, Friends’ chair and founder, opened the meeting by highlighting the potential for MCED screening tests to shift the trajectory…

Watch Now: Supporting Development of Diagnostic Tests for Unmet Needs

On Tuesday, February 22, 2022, Friends of Cancer Research (Friends) hosted a live virtual event that brought together leading voices from various health sectors to discuss key considerations for developing diagnostics tests for rare populations of patients, including those with rare diseases and rare biomarkers. The meeting covered topics surrounding the findings from a recent…

Friends Annual Meeting 2021 Day 2: Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization Meeting Summary  

On Wednesday, November 10th, Friends of Cancer Research hosted the second day of its 2021 Annual Meeting as a virtual event focused on improving patient outcomes through dose optimization. The first panel discussed the recent white paper on dose optimization and the second panel was a conversation between regulators at the FDA Oncology Center of…

Friends Annual Meeting 2021 Day 1: Charting the Path for ctDNA as an Early Endpoint Meeting Summary

On November 9th, Friends of Cancer Research (Friends) held the first of two virtual sessions for their 2021 Annual Meeting, celebrating Friends’ 25th anniversary. The focus of Day 1 was the use of circulating tumor DNA (ctDNA) as an early endpoint. The session opened with a few words of welcome from Friends President and CEO,…

Dose Optimization in Oncology

Each year, the Friends of Cancer Research (Friends) Annual Meeting addresses critical issues in oncology drug development and features experts proposing unique approaches to overcoming current challenges. On Day 2 of the Friends Annual Meeting 2021, panelists will focus on the pressing need for improved dose-finding studies in oncology drug development and discuss proposals to…

Watch Now: “Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation” 

On Monday, September 20th, 2021, Friends of Cancer Research (Friends) hosted a virtual event that brought together industry experts, the U.S. FDA, and patient advocates to discuss improving the Breakthrough Therapy designation (BTD) program. The panelists outlined opportunities to enhance the existing expedited drug development programs, including specific recommendations for the BTD, as outlined in…

Beyond Breakthrough: Key Challenges Between FDA and Sponsors

This is the second of two blog posts highlighting Friends’ upcoming September 20th event discussing the Breakthrough Therapy designation (BTD). This post will focus on the key challenges between the FDA and drug sponsors that we have identified in our work. Read the first here. The regulatory review process for drugs is a resource intensive…

Beyond Breakthrough: Use of Innovative Drug Pathways at FDA

This is the first of two blog posts highlighting Friends’ upcoming September 20th event discussing the Breakthrough Therapy designation (BTD). In this post, we will summarize the recent history of this innovative drug approval pathway and also address potential areas of improvement. BTD is a process that expedites the development and review of drugs intended…