Section 10409 of the Patient Protection and Affordability Care Act (P.L. 111-148)
For cancers in adults, the biotechnology and pharmaceutical industries assume responsibility for developing and testing new anti-cancer drugs based on biological discoveries about how cancer works. For childhood cancers, there is no sector or system responsible for bringing exciting new laboratory findings into medicines for children. This is in large part because children with cancer comprise a small patient population that provides little in the way of financial incentive for product developers. As knowledge about the underlying biology of cancer has mushroomed in the past 10 years, it has become clear that steps must be taken to bring new insights about molecular pathways of cancer into a new generation of more effective, safer treatments. What is routinely referred to as the "Valley of Death," the chasm between research focused on the discovery and research to develop new anti-cancer therapies, is a chasm that requires a fresh approach in order to bring medicines to patients where there is no commercial interest.
A new funding mechanism, the Cures Acceleration Network (CAN) was recently authorized as part of the Patient Protection and Affordability Care Act (PPACA) to address this very issue. CAN offers a mechanism that could directly facilitate the pace of new therapy development for childhood cancers. CAN establishes a new office in the NIH Directorate to make grants to help facilitate the process of turning new discoveries into new therapies. A board of 24 members from research, FDA, venture capital, patient advocacy groups and others will help coordinate NIH research funded activity with FDA mechanisms of drug approval. Through the CAN funding mechanism, national experts will be able to lend their expertise in a systematic way to solving the complex preclinical development necessary to bridge the "Valley of Death" in drug development for childhood cancers.
The Children's Cause for Cancer Advocacy supports $500 million in appropriations for Fiscal Year 2011 that the PPACA authorizes for the Cures Acceleration Network, joining cancer and other small disease groups. We urge Congress to meet its stated commitment to improved quality of care for patients through health care reform by fully funding this provision that promises to accelerate access to safer, more effective therapies, particularly those for which the commercial market remains inadequate.