By: Jeff Allen, President & CEO

What is your organization’s mission? 
Friends of Cancer Research (Friends) is a nonprofit organization that brings together patients, advocates, researchers, regulators, and industry to accelerate the development of better treatments for people with cancer. Our work focuses on identifying challenges in cancer research and drug development, building consensus around practical solutions, and generating the evidence needed to inform regulatory policy and improve how new therapies are developed and evaluated. 

Tell us about the communities you serve. 
Patients with cancer are at the center of our work. We focus on improving the research and regulatory systems that shape how quickly promising treatments can be studied, evaluated, and made available to patients. 

Many of the challenges we address cannot be solved by any one stakeholder, and our work also depends on close collaboration across the broader cancer community. We regularly convene patient advocates, FDA and other government agencies, academic researchers, clinicians, biopharmaceutical and diagnostics companies, and other organizations involved in cancer research and care.  

What are your organization’s main programs or issue areas you focus on? 
We focus on regulatory science and policy issues that can make cancer research and drug development more efficient, informative, and patient-centered. 

Our work spans a range of areas, including improving clinical trial design and participation, developing better measures of treatment benefit, strengthening the use of biomarkers and alternative sources of data and evidence, and addressing scientific and regulatory challenges associated with emerging technologies and new therapeutic approaches. 

Much of our work begins by bringing stakeholders together around a specific challenge, developing practical recommendations, and conducting research or collaborative analyses that can help move those recommendations into practice. 

How does your work relate to the National Health Council’s mission and the work of our members? 
Friends and the National Health Council share a commitment to ensuring that the needs and perspectives of patients are reflected in health policy and medical innovation. 

Our work is particularly focused on the research and regulatory policies that shape how new therapies are developed and evaluated. Patient organizations bring an essential perspective to those discussions, including what outcomes matter most to patients, where clinical trials create unnecessary barriers, and how regulatory approaches can evolve without compromising the quality of evidence needed to make treatment decisions. 

We are excited to join the National Health Council and to learn from and collaborate with its members across disease areas. Many of the challenges facing cancer drug development, such as improving clinical trials, incorporating patient experience, evaluating new technologies, and creating more efficient development pathways, extend well beyond oncology. 

Is there an accomplishment your organization is most proud of? 
One accomplishment we are especially proud of is Friends’ role in helping develop the concept that became FDA’s Breakthrough Therapy Designation, which was established by Congress in 2012. The designation created a pathway for more intensive FDA engagement and expedited development of therapies showing substantial improvement over available treatment options. Treatments that have received a Breakthrough Therapy Designation have since been shown to be developed years faster than those without the designation, demonstrating the value of the program in helping promising new treatments reach patients sooner.   

We are proud not only of the designation itself, but of what it represents about how Friends’ works. We bring stakeholders together to identify challenges, develop practical solutions, and build the evidence and consensus needed to move those solutions into policy and practice. That same model continues to guide our work today across issues ranging from clinical trial modernization and dose optimization to biomarkers, new endpoints, and emerging technologies. 

What are you most looking forward to in your work this year? 
I am particularly excited about work that connects advances in regulatory science with the policies and programs needed to put that science into practice. 

One example is our ongoing work evaluating circulating tumor DNA as a potential novel endpoint in cancer clinical trials. Better endpoints could allow us to learn more about whether a treatment benefits patients earlier in development but moving from a promising biomarker to something that can reliably inform regulatory decisions requires strong evidence and clear standards. 

We are also advancing work on FDA’s Biomarker Qualification Program to help make pathways for qualifying biomarkers and other drug development tools more predictable and useful. Qualification can help move tools beyond use in individual development programs and support broader adoption across the research community. 

At the same time, the upcoming Prescription Drug User Fee Act (PDUFA) reauthorization provides an opportunity to think more broadly about how FDA’s programs, processes, and capabilities can continue to evolve alongside the science. For us, these efforts are connected: generating better evidence, creating clearer pathways for using it, and ensuring FDA has the programs and capabilities needed to support innovation while maintaining rigorous standards. 

Friends of Cancer Research is a new member of the National Health Council. For more information on NHC membership, please email membership@nhcouncil.org.