Federal Research Center’s New Venture Into Drug Discovery

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New National Center for Advancing Translational Sciences works with pharmaceutical companies to develop drugs.

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Federal officials recently announced the establishment of the National Center for Advancing Translational Sciences (NCATS), within the National Institutes of Health (NIH), to develop new medicines.  NCATS is scheduled to begin operating in October, 2011.

NIH is establishing NCATS to ease the transition of basic scientific discoveries in the lab into clinically acceptable medicines.  Drug companies have traditionally done this “translational research,” but recently they have been less successful at developing drugs.

From 2006 to 2010, the Food & Drug Administration approved only 110 new drugs, 46% fewer than the 205 drugs approved from 1996 to 2000.  To combat this trend, NCATS will form partnerships with industry to reduce the failure rate of early-stage drug and therapeutic development projects, making them more attractive for private sector investment.

NIH Director Francis Collins has said that “any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

Public comments have criticized the NIH for reshuffling too quickly to establish NCATS.  For example, Dr. Jeremy Berg, Director of the National Institute of General Medical Sciences, reportedly wrote an open letter to the Scientific Management Review Board (SMRB), which oversees NIH and has endorsed NCATS, claiming that that the process requires “careful consideration” but has been “rushed,” not giving SMRB sufficient time to consider the implications of its plans.

Biotechnology and pharmaceutical companies, on the other hand, have been generally supportive of NCATS.  For example, David Wheadon, a senior vice president of PhRMA, the trade group of pharmaceutical and biotechnology companies, has said that “‘bold and ambitious’ proposals, such as Dr. Collins’, will be key to how we collectively progress in discovering novel compounds for addressing patients’ unmet medical needs.”