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…
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…
Since 1992, Accelerated Approval has facilitated earlier patient access to promising therapies that treat serious and life-threatening illnesses. While a traditional approval is often based on a therapy’s ability to demonstrate meaningful impact upon a clinical endpoint (e.g. overall survival), Accelerated Approval is granted based upon demonstration of an effect on a surrogate or intermediate endpoint…
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:…
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…
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…
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…
