A new drug development centre run by the US government is scheduled to be up and running by October 1, Health and Human Services Secretary Kathleen Sebelius has told Congress.
The new National Center for Advancing Translational Sciences (NCATS) currently being set up within the National Institutes of Health (NIH) will “establish a focused, integrated, and systematic approach for building new bridges to link basic discovery research with therapeutics development and clinical care,” says the NIH, which hopes that Congress will provide at least $1 billion in annual funding for the new Center.
The move follows last December’s recommendation by the NIH’s Scientific Management Review Board (SMRB) that the agency should realign its resources to establish a new centre devoted to advancing translational sciences. The plan is to integrate into NCATS more than $700 million worth of selected translational research programmes currently underway at the NIH’s National Human Genome Research Institute (NHGRI), National Center for Research Resources (NCRR) and the NIH Director’s Common Fund. Another component could be the new Cures Acceleration Network (CAN), which was authorised by the Affordable Care Act but has not yet received an appropriation.
The NIH emphasizes that NCATS is not intended to replace the current translational research efforts of the agency’s other Institutes and Centers, but to complement them. Nevertheless, under the Public Health Service Act, the number of NIH Centers and Institutes cannot be more than 27. Therefore, for the first time in its history, the NIH will have to dismantle one to make way for NCATS, and it plans to do this by downgrading the NCRR. None of its existing programmes are to be eliminated, but the Clinical and Translational Science Awards, which account for almost 40% of the NCRR’s budget, will be moved to NCATS, and the rest of its ongoing work will be relocated to other Centers and Institutes.
NCATs “will do as much research as it needs to do so that it can attract drug company investment,” according to a report in the New York Times (NYT), which quotes NIH director Dr Francis Collins as emphasising that none of the work at the Center is intended to be competitive with the private sector.
“The hope would be that any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector,” he said.
Commenting on the new Center, the Pharmaceutical Research and Manufacturers of America (PhRMA) said that collaboration including industry, NIH and academia is one element driving innovation in drug development, particularly early-stage, and that proposals such as Dr Collins’ will be key.
The industry group is “encouraged” by Dr Collins’ goal of taking a sharper focus on early-stage research in the hope of improving the ultimate success rates in drug development, said PhRMA senior vice president David Wheadon.
However, he added: “the fact remains that biopharmaceutical research companies today and in the future will play a pivotal role. Our companies create the vast majority of new medicines from start to finish and, for the remainder, in close collaboration with academia and NIH, fulfil the critical final phase that transforms promising molecules into actual medicines for patients.”
• Meantime, Dr Collins has said in an interview with Nature that plans for setting up NCATS are moving head with “lightening speed” and it is expected to be included as a line item in the 2012 budget which the Administration will send to Congress in February.