The National Cancer Institute and the U.S. Food and Drug Administration have made an interagency agreement to share resources and personnel with hopes of speeding the drug development and approval process.
The agreement was formally announced at this years annual meeting of the American Society of Clinical Oncology in a staged talk show-like discussion among FDA Commissioner Mark McClellan, M.D., Ph.D., NCI director Andrew von Eschenbach, M.D., and immediate past president of ASCO Paul Bunn Jr., M.D.
"The joint task force that were announcing today is going to improve the way that our agencies work together to achieve this goal of getting safe, effective treatments to patients as quickly as possible," McClellan said. "Its going to build on each agencys strengths in fulfilling its mission."
The agencies have not announced how much money will be budgeted for the task force, but in a follow-up interview, von Eschenbach underscored his commitment to the joint effort. "The commitment is to provide the appropriate and necessary resources to make it happen," he said. "That, I believe, is part of what we need to do as our mission."
He said that the task force will have two main objectives. The task force will look at programs that will support an accelerated discovery process, such as bioinformatics, and it will look at the process of drug discovery and approval to see if there are places where the process can be improved, redundancies eliminated, and procedures streamlined. "But the first step is to bring the right people together to do the thoughtful and careful analysis, take stock of whats already there, and then to capitalize and build on the opportunity," von Eschenbach said.
The NCI-FDA Oncology Task Force will be co-chaired by Anna Barker, Ph.D., NCI deputy director for strategic scientific initiatives, and by Theresa Mullin, Ph.D., FDAs assistant commissioner for planning.
Barker outlined a few of the areas of collaboration at a hearing before the Energy and Commerce Committee in July. "Although its early in the work of this task force, ... weve identified several areas of common interest across the continuum of research, including the development of a formal interagency agreement ...; common bioinformatics platforms; joint programs to further optimize the processes that we undertake to develop drugs, including science-based models for endpoints to assess clinical benefit in patients; and finally joint training programs and appointments for staff," Barker said
At that same hearing, Mullin described how the sharing of staff could benefit both agencies. "The NCI-FDA collaboration will provide FDA reviewers with additional exposure to state-of-the-art technologies, and that will give them a better understanding of those technologies for products and development," she said. "By the same token, NCI researchers could benefit from hands on experience with the FDA review process to understand better the kinds of evidence of safety and effectiveness that are looked for for quick approval of products."
The directors of both agencies highlighted the need for cooperation to improve the rate of drug discovery. We want to "try to create the opportunity where the science of NCI in discovery and development is wedded with the science of FDA in validation and delivery so that we can as rapidly as possible accelerate the ability to take the fruits of our research and be certain that that is translated into lives [saved and people who] will no longer have to suffer and no longer die because of a disease like cancer," von Eschenbach said.
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