"One of the most difficult things to do is to usher in change," said NIH director Dr. Elias Zerhouni on Dec. 2, addressing the 91st meeting of the advisory committee to the director (ACD). "This process has essentially two goals: To allow new science that falls through the cracks to be funded quickly and to make sure new ideas have a chance. This to me is more of a venture capital fund than anything else. We do not want to duplicate what is already being done. We want to allow more flexibility and nimbleness. We want to provide dialogue about cross-cutting science areas. OPASI will provide a cone of exploration, which becomes more important in times of limited funds."

The new office will identify scientific investment opportunities based on proposals from individual scientists, stakeholders and organizations

"This to me is more of a venture capital fund than anything else...We want to allow more flexibility and nimbleness. We want to provide dialogue about cross-cutting science areas."

outside NIH, a Roadmap-like pool of funding applications, data about the burden of illness as well as considerable input from IC directors and such Office of the Director components as women's health, behavioral science and AIDS research. Projects that pass muster with a Council of Councils (representatives from all IC advisory boards) will then be funded for an initial 5-year term, with annual review. After 5 years, progress on the initiative will be evaluated; if necessary, the project can be granted another 5 years of funding. No initiative will be funded for more than 10 years.

"I want to make it clear that we are not creating a 28th institute," Zerhouni stressed. "OPASI will have minimum infrastructure. It will be managed primarily by the institutes and centers and the initiatives it funds will be short-term. We're not creating entitlements."

OPASI will have three branches: the Division of Resource Development and Analysis, the Division of Strategic Coordination and the Division of Evaluation and Systematic Assessments. Besides mining for new science, the office will help NIH classify its research into consistent categories across all ICs, which will make it easier to provide more precise information about its whole portfolio to Congress and the public.

"Never before has NIH had a mechanism for scanning or analysis of all of the applications we receive," pointed out NIH deputy director Dr. Raynard Kington, who cochairs the OPASI working group with NIA director Dr. Richard Hodes. OPASI's evaluation arm will be responsible for such a tool.

Each IC will contribute a percentage of its budget to a "common fund for shared needs" that will form OPASI's operating budget. Current Roadmap funds will determine the baseline for the Common Fund, which is 1.1 percent of NIH's total budget in fiscal year 2006. By FY 2008, the percentage is expected to grow to about 1.7.

"Fundamentally, the establishment of OPASI grew out of our success with the NIH Roadmap — it really represents an effort to 'institutionalize' the kinds of collaborations that the Roadmap made possible," Kington explained. "We feel this office will fill a critical need. We should be up and running within the next month."

OPASI has already been formally launched with an announcement in the Sept. 28 Federal Register. In addition, some functions and staff positions have already begun to be transferred to the new office, mainly from the NIH Office of Science Policy.

The following are more detailed questions the NIH Record asked about the new office and answers from the cochairs of the OPASI working group.

In what ways, if any, do you think OPASI is long overdue for NIH?
Clearly, the time is right for NIH to take a more coordinated approach to the development and funding of trans-agency initiatives. This is true not only because many of the most exciting scientific opportunities and pressing public health challenges we are facing now cut across the mission areas of multiple institutes and centers, but also because the tightening of the NIH budget requires that we be as strategic as possible in catalyzing high-impact research.

What are the next steps in establishing OPASI?
We are getting ready to appoint an interim OPASI director to lead the new office while we conduct a national search for a permanent director. We are also in the process of putting together a governance body to help oversee OPASI's activities — this will be a new working group of the NIH steering committee, cochaired by the OPASI director and an IC director.

How will OPASI improve transparency of the priority-setting process?
From the beginning, Dr. Zerhouni has been clear that the work of OPASI must be as inclusive and transparent as possible. In thinking through how the office will function, we have built in many opportunities for key stakeholders — the scientific community (both internal and external to NIH), patient advocacy groups, the lay public, Congress and others — to help shape the work of OPASI.

For example, in canvassing for possible OPASI initiatives, we will hold panel meetings with outside experts (as we did with the Roadmap), to supplement the expertise we have here at NIH. When it comes time to select initiatives for funding, we will seek input from the ACD, which includes both scientific and lay representatives.

Also, the IC directors will have a prominent role in the OPASI initiatives process.

Obesity is often mentioned as a trans-NIH issue that only recently began to be addressed that way. Is there another "next big thing" on the horizon?
Obesity was mentioned because it is such a striking example of an urgent public health need for which we were slow in developing a coordinated, agency-wide strategic plan — although individual institutes and centers were clearly supporting work on obesity. Part of the problem was that this area cut across the missions of multiple ICs.

In the future, we hope OPASI will provide the analytic resources to identify more quickly important public health challenges such as obesity, determine if the current efforts are effective and facilitate the coordination of efforts of multiple ICs to address this problem.

If necessary, research areas that do not clearly fit within the mission of any one institute or center will go through an open and defined process to determine if they are appropriate for incubation in OPASI and should be supported by use of the Common Fund. Once established, OPASI would, in effect, be constantly scanning the horizon to identify the "next big things."

Do you anticipate more of a shift toward disease- specific research with OPASI, given the concerns of Congress and the public?
We do not necessarily anticipate OPASI initiating a shift toward disease-specific research — that will depend on the initiatives that are proposed for OPASI consideration, and judgments of scientific priority and opportunity. OPASI will support science that meets the explicit criteria for consideration as an OPASI initiative — among them, that it is truly transformative and that it involves many institutes and centers, or that it represents research that "falls between the cracks."

One proposed OPASI advantage is "the ability to weigh scientific opportunity against public health urgency." In these days of immediate health advocacy, it seems that there are only "public health urgencies," and that the days of pursuing 20-year basic research projects based on intriguing scientific opportunities are over. To what extent do you think basic research is undervalued by people outside the scientific community? How would OPASI help address this?
Our hope is that people outside of the research community are becoming more aware of the critical importance of both basic and applied biomedical and behavioral science in improving the quality of their lives. At the same time, we know that any strategic scientific investment process has its limitations. Although there are numerous examples where targeted funding by NIH resulted in significant advances being achieved more quickly than otherwise would have occurred, there are also numerous examples where serendipity played an important role in advancing science to address a particular public health challenge.

Scientists who do basic research can never be sure where it will lead, and there will always be the need for a substantial NIH investment in investigator-initiated basic research that is simply about pursuing an intriguing scientific opportunity.

OPASI will help complement those investments with strategic support in areas that cut across the agency's missions and that are identified with the advice of the broader scientific community.

In effect, OPASI will build on the Roadmap efforts to address the roadblocks that are inhibiting progress on a number of scientific fronts. For example, the Roadmap is supporting a concerted effort to provide methodological breakthroughs that will allow scientists to solve the 3-dimensional crystal structure of membrane proteins. This sounds like incredibly basic research, and it is, and yet a number of human diseases — including cystic fibrosis, diabetes and Alzheimer's disease — are caused by changes or mutations in membrane proteins, and a third of the human genome codes for membrane proteins.

Clearly, this work will have broad implications in many fields of biomedical research. We expect that OPASI will support initiatives that will catalyze research being done in many scientific disciplines and that relate to the missions of many institutes and centers.

Under what circumstances, if any, will OPASI change the number/scope of existing ICs? Could OPASI recommend, for instance, that some current ICs be combined or dissolved?
While the establishment of OPASI represents a major organizational change at NIH — indeed, one that we hope will help stimulate a cultural shift, as well — the mission of the office does not encompass the authority to change the number of ICs at the agency. As Dr. Zerhouni has stated publicly, we hope that OPASI will achieve a "functional integration" in the sense that it will bring together diverse components of the agency for a common scientific purpose. With sufficient functional integration, we believe that we can overcome the challenges in trans-NIH coordination that result from the large size and structural complexity of the agency. Again, the Roadmap has shown us how effective this can be.

What's the one concept you want employees to keep in mind about OPASI?
In many respects, OPASI is about innovation and transformation — this new entity will foster the funding of innovative science, at the same time that it transforms how NIH collectively pursues cross-cutting initiatives. Our hope is that the support OPASI gives will provide an "incubator space" to accelerate critical research efforts that address major, cross-cutting NIH priorities.

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