The Building Block of Drug Discovery - Pharmaceutical Executive


The Building Block of Drug Discovery
Director Francis Collins sees NIH as a catalyst for translating biomedical innovations into effective therapies, but skeptics fear it's harder than it looks. It's all in the DNA of its partnerships

Pharmaceutical Executive

New Landscape

Dedicated Resource for Partnerships
Collins sees a rapidly changing biomedical research landscape as the prime driver behind stronger NIH partnerships with the pharmaceutical industry. He's optimistic that new genetic discoveries can chart pathways for discovering new medical treatments, and that the emergence of more well-validated genes will be useful in "identifying drug targets in unprecedented numbers."

At the same time, biotech and pharma companies face serious financial challenges in funding research projects. "These are not easy times for the development of new therapeutics," Collins allows, noting that venture capital is limited and many biotech companies are struggling to stay afloat.

"So it's kind of the best of times, and worst of times," he observes. The scientific enterprise is yielding up a lot of new ideas about therapeutics. Yet, "the traditional private sector efforts to capitalize on that are taking a hammering." NIH, thus, is "an attractive alternative" for supporting new partnerships between academic researchers and industry.

This was not the case six or seven years ago, Collins said. Back then, pharma companies did not consider academic research institutes a prime source of support for drug development. Conversations with industry about collaboration were not that productive, especially suggestions that companies open up compound libraries to outside parties. The general response, Collins recalls, was "No, we're not going to share our crown jewels with you; we might find something to do with those later."

Now, says Collins, "it's all changed." He detects more private sector interest in NIH-funded preclinical and clinical testing, as well as in compound rescuing or "repurposing." Pharma companies have long lists of compounds that have been abandoned along the way, maybe because a business plan changed or the money ran out or clinical trials failed to show efficacy, Collins notes. "We have been talking with leaders in the pharmaceutical industry about an opportunity to open the freezers and make such compounds available, with appropriate intellectual property protection for them," Collins explains. "This isn't a giveaway, but could be a win-win if such a compound were found to be active for a different application than originally considered."

Yet, scientists at pharma companies maintain that it takes considerable work to identify failed or abandoned compounds suitable for further research. Providing materials to NIH for drug repurposing is not straightforward, explains Amgen R&D chief Roger Perlmutter. "Every step along the way requires real effort on the part of very busy people doing other things."

Collins has an eye out for tax provisions, patent incentives, and regulatory assistance that can encourage such collaboration. And he emphasizes that NIH won't move into full drug development, but will support projects just long enough for them to become attractive for a biotech or pharma company to pick up. For a completely new molecular entity to treat a common disease, "I suspect the interest in the private sector would be very high, very early," he says. Conversely, a treatment for a rare disease that affects only a few hundred patients is not likely to generate much interest until further along. NIH is prepared to contribute to promising projects as far down the line as it has to—"but no further," he maintains.


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