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 Center of Excellence at the U.S. Food and Drug Administration (FDA). The panelists discussed a variety of topics related to the discussion draft, including how clinical trials can be improved, the importance of the FDA’s accelerated approval program, the proposed Advanced Research Projects Agency for Health (ARPA-H), and increased global coordination around cancer research.
The live event was broadcast through YouTube and is available to watch now.
Ellen Sigal, Chair and Founder of Friends, welcomed and thanked the participants for their efforts in prioritizing funding for medical research and innovation, helping patients get access to the treatments they need. She also heralded the success of the original 21st Century Cures Act while noting that there was still much more work to be done.
The listening session panel began with Rep. DeGette and Rep. Upton discussing their previous work with the 21st Century Cures Act, detailing successes since the legislation’s passage, and where they are looking to go from here. They went over some important aspects of the new discussion draft, which includes efforts to increase clinical trial diversity and expanding the use of Real-World Evidence (RWE).
Rep. Upton asked the panel how important ARPA-H is for drug innovation and how it can fit into the new Cures bill. Dr. Sharpless said that though there are areas where the NCI is very successful, such as funding foundational science, there have been challenges when trying to work collaboratively with industry and arranging individual contracting authorities for those projects. He added that these are challenges that can slow down the drug development process, and having an agency like ARPA-H could help encourage quicker collaboration between researchers, government, and drug manufacturers.
Dr. Pazdur also discussed the FDA accelerated approval pathway, giving an overview of the program’s success in enhancing the drug development process for both patients and industry. He said that though there is room for improvement, accelerated approval is responsible for many successful oncology treatments now helping thousands of cancer patients. Dr. Sharpless agreed with Dr. Pazdur, saying that accelerated approval is “super important for cancer patients.”
Jeff Allen, President and CEO of Friends, closed out the event by thanking the panel for their work to advance the Cures 2.0 initiative. He said that he hopes that this will lead to further discussion and “will help propel the Cures 2.0 process forward”
Read more about what Friends is doing with Real-World Evidence and Clinical Trial Eligibility Criteria.
