Joint NIH-FDA Leadership Council Announced

The NIH and FDA announced “a new collaboration on regulatory and translational science to … help speed the translation of research into medical products and therapies.”

Oh, you know this is going to be good, starting with their description of the two, um, partners in this collaboration:

The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.

And, indeed, the NIH is just the partner to make it happen, according to Francis Collins:

“This collaboration … will use the NIH’s breadth of experience as a leader in biomedical sciences, to help make the regulatory review process at the FDA as seamless as possible.”

Hmm. Somehow I missed that improving the FDA’s regulatory review process was a major priority in biomedical research, though clearly the FDA does need help in that department. But wait, there’s more …

As part of the effort, the agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council [chaired by NIH Director and FDA Commissioner plus 6 members from each agency] will work together to help ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process.

I have not yet had time to view the entire hour-long videocast of this announcement, so I didn’t hear how much the NIH budget would be increased to absorb this additional effort (which will clearly need more than $6.75M to succeed).

However, this new emphasis on regulatory science does explain the latest unusual RFA issued from the Office of the Director (supported with $6M from the NIH Common Fund and $650K from the FDA), Advancing Regulatory Science through Novel Research and Science-Based Technologies (U01), which offers up to $675K in direct costs per year for 2010, 2011, and 2012. The RFA describes 5 broad areas of research to be supported … by 2-3 awards.

More big applied science, one hopes not at the expense of the most basic biomedical research needed to fill the translational pipeline with science to “shape into treatments.”

5 Comments »

  1. SaG said

    Actually I am not too surprised by this. The biggest sticking points in getting basic science to the clinic are the regulatory hurdles everyone faces. The complexity is just amazing. Since NIH has been pushing translational science for a while now it makes sense to confront this wall head on. What is not clear to me is what exactly regulatory science is, or will do. I find it hard to believe that the problems will be solved by “yet another council/committee/blue ribbon panel.”

    I am sure that they will meet and write an excellent report that is published on an impressive web page but what will really change?

    • whimple said

      The biggest sticking points in getting basic science to the clinic are the regulatory hurdles everyone faces.
      I disagree. The biggest sticking point is convincing the basic scientists to work in the human system directly and/or to validate basic science results from “model organisms” in humans. I can’t even count the number of times I’ve gone to seminars where cancer has been cured in mice. That’s great for the mice, but the human studies just aren’t being done.

      • pinus said

        Most basic scientists, who have little to no training in dealing with human subjects, are ill equipped to deal with jumping from lab to clinic, due in part to lots of regulations. I would be ecstatic to make the jump in to clinical populations with some of my work. But, I lack the resources and know-how. I know of only a handful of groups that can do this…and every time I see them I put a bug in the PI’s ear about whatever I think is cool.

      • writedit said

        Pinus, this NIH-FDA initiative won’t help you or other basic researchers link up with clinical investigators. Not that kind of regulatory (human subjects protection) type assistance … I believe it’s more to help the FDA with their oversight & safety testing of pipeline and approved drugs/devices … and my question is, where is industry in all this, given they are the ones profiting from said drugs/devices. On the other hand, the translational science component could offer what you seek (outside this new initiative).

        If you are at an institution with a CTSA, the infrastructure should be in place to help basic scientists link up with clinicians / human tissues etc. and vice versa. Helping bench scientists overcome the human subjects protection regulatory hurdles is pretty straightforward, and access to clinical specimens can usually be obtained via institutional tissue banks or biorepositories, though you need to justify your request of course.

        In addition, many clinical depts likewise would love to find bench scientists to explore/explain pathologic pathways, mechanisms, clinic observations, and so on. Part of what I do is this sort of match-making, but at BICO, such outreach (bidirectional between basic/clinical research groups) and collaboration is common and easy. In fact, refreshingly so. It’s one of the things I really like about the place.

  2. […] Having read the RFA, I’m impressed they got 59 letters of intent (all read by the NIH Director – not something you think about when jotting off these formalities). I wonder how many applications came in and how much more than the budgeted $6M will go toward this rather unusual RFA … and those to follow as part of the larger “regulatory science” initiative. […]

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