Blog: Engaging Innovation

Max Chan | September 29, 2021

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…

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Grace Collins and Eric Hua | September 14, 2021

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…

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Max Chan | September 2, 2021

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…

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Lauren Grunley | August 19, 2021

What science, informed hope, and the FDA, gave my mother

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. …

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Max Chan | August 4, 2021

Watch Now: 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…

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July 7, 2021

How Will Expanded Eligibility Criteria Impact Clinical Trial 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…

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May 21, 2021

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…

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Grace Collins | April 23, 2021

Data Driven Insights – Accelerated Approval

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…

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April 14, 2021

Watch Now: 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:…

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Grace Collins | February 17, 2021

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…

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