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Category: FDA

Friends’ Project Pulse | 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…

Meeting Recap | 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…

Stakeholder Connect | 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…

Stakeholder Connect | 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…

Meeting Recap | 21st Century Cures 2.0 Listening Session: Harnessing the Power of Collaboration

On July 29th, 2021, Friends of Cancer Research (Friends) hosted a virtual meeting revolving around the recently released 21st Century Cures 2.0 discussion draft. It featured a discussion panel of Representative Diana DeGette (D-CO), Representative Fred Upton (R-MI), Dr. Ned Sharpless, Director of the National Cancer Institute, and Dr. Richard Pazdur, Director of the Oncology…

Friends’ Project Pulse | How Will Expanding Eligibility Criteria Impact Clinical Trial Study Design?

Creating a New Cancer Research Paradigm by Broadening Eligibility Criteria The American Society of Clinical Oncology (ASCO, a professional society for cancer clinicians and researchers) and Friends of Cancer Research (Friends, a cancer advocacy organization focused on advancing science, policy, and regulation) have been collaborating to promote broader, more inclusive cancer clinical trial eligibility criteria…

Meeting Recap | Discussion on Eligibility Criteria and the Impact on Access to Clinical Trials

On Friday, April 9, ASCO and Friends of Cancer Research (Friends) co-hosted a live virtual event, which brought together experts from across the healthcare sector to discuss the recent release of the new ASCO-Friends recommendations for modernizing eligibility criteria to improve patient access and representation in cancer clinical trials. ASCO-Friends recommendations address five specific areas:…

Meeting Recap | Shaping the Future of Emerging Immunotherapies and Cell Therapies

On February 11, 2021, Friends of Cancer Research (Friends) hosted a virtual meeting highlighting and discussing the progress, challenges, and future of immunotherapies and cell therapies. Ellen Sigal, Chairperson & Founder of Friends, gave opening remarks and introduced keynote speaker Ned Sharpless, Director of the National Cancer Institute (NCI). Sharpless spoke about the progress made…

Meeting Recap | Friends Annual Meeting — Day 2: Optimizing the Use of Accelerated Approval Meeting Summary

The second of two sessions for the Friends of Cancer Research (Friends) Annual Meeting was held on November 19th. Day 2 featured a shift from Modernizing Expedited Development Pathways to a focus on Optimizing the Use of Accelerated Approval.  Following a few words of welcome from Friends President and CEO, Jeff Allen, a fireside chat between…

Meeting Recap | Friends Annual Meeting — Day 1 : Modernizing Expedited Development Programs Meeting Summary

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…