CAN is part of a much larger system engaged in or supporting the development of new cures. Throughout the workshop, participants referred to this system as an “ecosystem” in which each part is shaped by, and dependent on, other parts. Even though CAN is currently small, it can influence this much larger system if it is both catalytic and strategic. And if it is successful, it can be expected to grow.
The penultimate session of the workshop featured presentations and panel discussions among participants from a variety of organizations commenting on the role of CAN within the drug development ecosystem. The session was chaired by Margaret Anderson, FasterCures, who also moderated the first panel, which explored regulatory science priorities that are important for drug development. Myrl Weinberg, President, National Health Council, moderated the second panel, which considered the role of CAN in advancing cross-sector and other collaborative translational science activities. This chapter provides an integrated summary of the presentations and panel discussions, organizing the remarks by sector to offer a multifaceted perspective on CAN’s role in the drug development ecosystem and future.
FDA Regulatory Science
CAN’s authorizing legislation provides that one of its functions is to “facilitate review in the Food and Drug Administration for the high need cures funded by CAN” (see Appendix B). CAN is well positioned to support such collaboration, said Jesse Goodman, Chief Scientist, FDA. It could, as an explicit part of its work, address gaps in regulatory science that, if they were filled, could greatly improve product development. In the process, CAN could help develop a regulatory science toolbox that could create a more efficient pathway to develop and evaluate products. For example, Goodman noted, there is a need for end-to-end project management and support. Innovators often do not have experience managing projects or running businesses. He suggested that it could be very helpful if NIH and CAN could provide these kinds of services or connections.
In 2011, FDA issued a regulatory science plan that also addresses gaps and opportunities in the science and in product development (FDA, 2011). Though it is a high-level plan, according to Goodman, it also lists specific areas where targeted work could accelerate the development of needed products. The report lists several FDA priority areas that are relevant to CAN: