Leveraging Existing Resources and Crown Jewels

By Margaret Anderson, Executive Director, FasterCures

On my way to participate in a meeting of the NIH Scientific Management and Review Board (SMRB)—formed in 2006 to advise NIH on the use of organizational authorities given to it by the NIH Reform Act—I walked through the lobby of the Clinical Center. It’s an incredible facility, the largest dedicated research hospital in the country, housing some of the nation’s best imaging equipment and clinical research expertise. In the lobby area of the Clinical Center, I saw clusters of people, many of them families and friends of patients, their faces reflecting two things: fear and hope.

Our nation’s research crown jewel ignites hope – it features some of the greatest scientific minds using the most advanced medical technologies. And yet, when we checked on its utilization a year and a half ago as part of our Task Force on NIH’s Intramural Research Program, it was far from fully utilized. Recognizing this untapped potential, the SMRB invited experts (such as Robert Califf, Art Levine, Bill Crowley and Samuel Silverstein, among others) to advise them on opportunities and challenges for expanding the use of the Clinical Center to external researchers.

They agreed that while intellectual property and conflict of interest issues would need to be addressed and operationalized, there was no major impediment to outside investigators using the clinical center, and noted that many academics and nonprofit disease research foundations were, in fact, ready and eager to start utilizing the Center’s many training and research resources immediately.

Last year, FasterCures issued a white paper developed by our Task Force on NIH’s Intramural Research Program that recommended an enhanced and expanded role for and use of the NIH Clinical Center so we were particularly pleased the SMRB decided to take this issue on. And we were not alone. In advance of the SMRB meeting, we circulated a letter within the patient advocacy community to gauge support for the premise that the Clinical Center be made available to the external research community. Within days, 86 other organizations signed-on. In the letter to Director Collins and the SMRB, the patient community recommends the NIH:

• Create streamlined mechanisms by which external researchers can more fully use the Clinical Center for projects in collaboration with the IRP (for example, giving the Clinical Center and/or Institutes the flexibility and authority to negotiate broader collaborative agreements or public-private partnerships, taking into consideration ethics rules and intellectual property rights).
• Explore the possibility of the Clinical Center controlling a pool of funds to make use of the facility feasible for investigators who otherwise could not afford it (for example, through a program similar to the existing Bench-to-Bedside Awards).

At the end of the meeting, Director Collins charged the SMRB with a new and potentially path-breaking task, to advise him on how NIH could create what he referred to as a more “integrated therapeutics program” that pulls existing NIH resources—like TRND, RAID, the CTSAs, and the newly authorized Cures Acceleration Network (CAN)—into an efficient pipeline for therapeutic development. “It’s not about shifting emphasis away from basic research, which will be more important now than ever,” Collins assured Board members. Instead, he said it’s about reorganizing NIH to better support the translation of those discoveries into medical solutions patients can use.