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Category: Data Driven

Watch Now: The Next Generation of Cellular Therapies – A Blueprint to Accelerate Development

https://www.youtube.com/watch?v=W2GVgcg8h2E&t=0s On Monday, May 22, Friends of Cancer Research (Friends) hosted a hybrid public meeting titled “The Next Generation of Cellular Therapies: A Blueprint to Accelerate Development.” This meeting built on Friends’ previous work on Cell & Gene Therapies and was the second of two meetings in 2023 to explore next steps in the field.…

Watch Now: The Next Generation of Cellular Therapies – Opportunities to Accelerate Development

On Wednesday, March 8, Friends of Cancer Research (Friends) hosted a virtual meeting titled “The Next Generation of Cellular Therapies: Opportunities to Accelerate Development.” This meeting sets the stage for a meeting on May 22 in Washington DC by providing context around the current state of the science and progress in cell therapy development. These…

Watch Now: Friends of Cancer Research Annual Meeting 2022

On Thursday, November 17, Friends of Cancer Research (Friends) was proud to host our 15th Annual Meeting to address critical issues in the development of new oncology drugs. After our last two Annual Meetings were hosted virtually, we welcomed attendees back safely in-person and virtually. The entire event can be viewed here and a summary…

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…

Optimizing Dosing in Oncology Drug Development Q & A

  Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization Virtual Event Questions and Answers   Friends of Cancer Research (Friends) continues to be committed to improving clinical trial design and drug development to support patients. In September 2021, Friends hosted an event called Beyond Breakthrough: Optimizing the Breakthrough Therapy Designation that highlighted ongoing…

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…

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…

Designing the Future of Cell Therapies

“Patients are waiting. These therapies are potentially curative. They’re important for the field.” – Ellen Sigal On May 17, 2019, Friends of Cancer Research (Friends) and the Parker Institute for Cancer Immunotherapy (PICI) held a public meeting on “Designing the Future of Cell Therapies” to explore forward-looking opportunities in the cell therapy field. The meeting…

Data Driven: How Oncologists Perceive FDA-Approved Drug Labeling Compared to Other Major Prescribing Resources

Physicians rely on a variety of sources of information to provide high-quality care to patients. In oncology, some of the most prominent resources that inform provider decision-making are the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) clinical practice guidelines; drug compendia; electronic point-of-care decision support tools, such as UpToDate;…