Grace Collins and Eric Hua | September 14, 2021
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…
Learn MoreMax Chan | September 2, 2021
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…
Learn MoreLauren Grunley | August 19, 2021
A few weeks ago, a news story about a new drug caught my attention. The drug was described as the first potential treatment for Alzheimer’s disease in some 20 years. To be clear, I don’t have a medical background, no direct experience with people suffering from Alzheimer’s, and typically wouldn’t really notice such a story. …
Learn MoreMax Chan | August 4, 2021
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…
Learn MoreJuly 7, 2021
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…
Learn MoreMay 21, 2021
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…
Learn MoreGrace Collins | April 23, 2021
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…
Learn MoreApril 14, 2021
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:…
Learn MoreGrace Collins | February 17, 2021
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…
Learn MoreEric Hua | November 23, 2020
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…
Learn MoreNovember 3, 2021
August 19, 2021
