NIH Board Approves New Translational Institute

National Institutes of Health Director Francis Collins said that his agency took a "bold step" yesterday when a senior working group voted to create a new NIH center that will focus on advancing translational medicine and therapeutics (TMAT), and which will have major implications for the National Center for Research Resources.

The new national center will be tasked with supporting, fostering, and catalyzing TMAT research and serving as a resource for the business sector, and it will do so by taking over several of NCRR's current programs, the TMAT Working Group of NIH's Scientific Management Review Board (SMRB) agreed yesterday.

"This is a momentous occasion," Collins, who aims to have the center funded by the 2012 fiscal year, told the group after the vote.

"The creation of a new center is not something that has happened at NIH very often," Collins said, explaining that the TMAT center arose out of the scientific need for new approaches and avenues for getting medicine from the lab to the clinic more swiftly and cost-effectively.

The new entity will have three central responsibilities, according to a TMAT working group report that outlines the new center.

The center will develop and provide infrastructure for translational medicine, and will support the development of new diagnostics and therapeutics, TMAT Working Group Chair Arthur Rubinstein explained in an SMRB meeting yesterday.

The TMAT center will foster new and innovative strategies for TMAT research, including strengthening and streamlining the therapeutic development process. It also will be a catalyst and a resource for collaborations and partnerships, seeking to use the strengths of NIH and the extramural research community, government, academia, and the private sector.

The working group developed the proposal at Collins' behest, who asked SMRB in May to consider what an effective translational medicine program might look like and to identify any programs, networks, or resources at NIH that could be used to start such a center.

One of the places that the group found these existing resources was at NCRR. According to their recommendations, that center's Molecular Libraries Program (MLP - which includes the Molecular Probe Production Centers Network and the NIH Chemical Genomics Center), the Therapeutics for Rare and Neglected Diseases Program (TRND), and the Clinical and Translational Science Awards program all would be relocated into the new center. The working group also agreed that the partnership with the Food and Drug Administration, the NIH-FDA Regulatory Science Initiative, would fall under the domain of the new center.

NCRR Director Barbara Alving told the TMAT Working Group yesterday that the creation of the new TMAT center "will require that NCRR actually turn into something else."

"This is a consideration that involves not just NCRR but also the grantees, stakeholders, and other centers," said Alving, who called NCRR "a center for centers" that is "essential for the research conducted by our R01 grantees."

She said that the objectives of TMAT "cover just a range" of NCRR's portfolio, adding that the center funds the purchase and development of transformative technologies and animal models, and provides training and opportunities for minority institutions.

Alving advised the group that a financial impact report will need to be conducted, and that SMRB and NIH in general will need to "engage in dialogue with stakeholders, academic health centers, other centers at NIH, and the public," among others.

"NCRR is a unique institution," Mark Lively, a member of NCRR's National Advisory Research Council, told the group yesterday during a phase of the SMRB meeting when the floor was open for public comments.

"Its research significantly affects all aspects of our programs. If you didn't have an NCRR, you'd probably find that you need to invent it," he added. "The members of the council urge you to proceed with caution."

He added that there are many stakeholders "that we feel have not been adequately represented."

Beyond the programs that SMRB expects the new center to take over, NCRR also runs and funds the Institutional Development Awards (IdeA) program, the Shared Instrumentation Grants program, the Biomedical Technology Research Centers, the National Primate Research Centers, the Research Centers in Minority Institution program, and others.

Collins and Rubinstein both said that many stakeholders will be consulted as the process of developing the new institute moves forward. But Collins added that he wants the process to move "with due speed."

Collins said that he has assigned two senior NIH officials to seek input from NCRR and other stakeholders and to draft a report on the potential side effects of the TMAT center plan, which would be ready in three months. He said that they would begin the process as early as today.

Because efforts to translate discoveries and research into medicine face many challenges, Collins explained, "Gradual evolution is not adequate to meet these challenges."

He suggested that what may be needed is "the equivalent of punctuated evolution to transform NIH structure," and said that addressing these challenges could result in a Cambrian explosion of new discoveries.

Lively, in his statements, reminded Collins that during that explosion a great number of organisms became extinct.

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