Francis Collins Encouraging Partnerships with the NIH Relative to Translational Research, Clinical Trials, And FDA Approval Processes

Dr. Collins states the NIH can be very helpful with identifying targets and they are currently very much involved here. He states the NIH can help out in areas to speed up processes rather than waiting entirely on biotechnology companies to go it alone. He said this is especially beneficial when it comes to the areas of research for rare diseases. Right now we are all waiting as well as Dr. Collins for a bill to be created to keep stem cell research alive too. Scientists have also sent their letters to Congress in this effort.

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In addition, Dr. Collins is also speaking at the MHealth convention this week in Washington DC to elaborate on the benefits of mobile technology as relates to the NIH and how these efforts can use some collaboration. We all talk about innovation, but we need an equal if not a greater amount of collaboration too as we will move farther ahead without everyone trying to build the better mouse trap on their own.

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In addition, Dr. Collins also touches on the collaboration efforts of the FDA and the NIH for better regulatory paths for drugs to go through the approval process faster as this makes sense. With sharing NIH information with the FDA, this can certainly stand to have the information and research available with a faster methodology. Not too long ago I said the FDA stood to be the “most connected” government agency with working with other entities and the NIH is right up there too. NIH will create a voluntary genetic-testing registry on the more than 2,000 genetic tests on the market, offering ready information about whether the tests were cleared by the FDA.

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For some of the smaller biotech companies on smaller budgets with promising research, this makes sense to work with the NIH to create faster cures and drugs to where we can start realizing results in a faster process as so much of this has slowed down to a crawl. BD

Rather than relying on pharmaceutical and biotechnology companies to take charge of the translational research, Dr. Collins encouraged academic researchers to consider partnering with NIH, at least for those orphan disease conditions in which the federal government would not be seen as being in competition with private enterprise.

"There is a serious crisis underway in the way in which this pipeline for drug discovery has been floundering. ... Pharma has been investing a larger and larger amount of money – between $40 and $50 billion dollars a year – and yet in spite of that, FDA approvals of new molecular entities, that is genuinely new drug therapeutics, not ‘me-toos,’ have been dropping steadily over the last 15 years," Dr. Collins said.

The reasons for this are complex, he said, but a big part of the problem involves coming up with appropriate targets and targeting compounds. He said this is an area in which NIH is and can be very much involved.

With NIH assistance, more than 150 lead compounds have reached this stage over the last 4-5 years, more than half of which are "poised to go to the next step" of preclinical trials in animals, or the "Valley of Death," according to Dr. Collins, "because this is where projects often go to die."

NIH is now able to assist in this high-risk area through the Therapeutics for Rare and Neglected Diseases (TRND) program in its Office of Rare Diseases Research. The TRND was funded at $24 million in fiscal year 2009.

NIH also is positioned to assist researchers in early phase human trials of orphan diseases through its 240-bed Clinical Center, Dr. Collins said.

"And we have 50 and soon we will have 60 Clinical and Trans lational Science Awards scattered all across the country which will also be set up to conduct these sorts of trials for new molecular entities," he added.