T H E   N I H    C A T A L Y S T     J A N U A R Y   –  F E B R U A R Y   2006

Many Sizes To Fit All


by Fran Pollner
Tech Transfer Material Witnesses: (left) Rochelle Blaustein, NIDDK, and Lili Portilla, NHLBI

Cindy Fuchs, NIAID

It may sound like a variation on the sardonic "We're from the government, and we're here to help you,"  but when Rochelle Blaustein says, "Tell us what you need, and we'll figure out how to get it for you,"  she's telling it like it is to NIH scientists.

And to back that promise up, there's a track record of thousands of agreements forged by Blaustein and other NIH IC tech-transfer officers whereby NIH scientists and labs have secured needed resources—material, financial, intellectual—not within their immediate reach at NIH.

Blaustein heads the Office of Technology Transfer and Development at NIDDK and co-chairs the Technology Development Coordinators Committee (TDCC), an umbrella group for all IC tech-transfer officers that meets monthly to compare notes and problem solve.

In an interview with The NIH Catalyst, Blaustein and two of her colleagues—NIAID's Cindy Fuchs, TDCC chair, and NHLBI's Lili Portilla, immediate past TDCC chair—discussed the various mechanisms at their disposal to further the research objectives of NIH scientists while also meeting NIH s obligations to facilitate the transfer of new technology to the public arena.

"We're responsible," Fuchs said, "for helping the ICs achieve their programmatic missions." The impetus for collaboration may originate in a company that is, for instance, exploring the commercial potential of a proprietary compound on which an NIH scientist has published related research. Or it could arise from within an institute that could use the services of an enterprise with certain high-throughput technology, screening assays, or preclinical models.

In each case, the IC tech-transfer office is the brainstorming center to craft the type of agreement that best serves both science and the public interest. It also assists the institute in the process of finding the right partner.

Since 1986, when the CRADA mechanism (see below) was established by Congress, NIH has executed 1,400 such joint research agreements with outside partners. In a brochure, NIAID cites the development and/or testing of hepatitis and pneumococcal vaccines and of humanized monoclonal antibody to prevent respiratory syncytial virus as examples of the many public health advances gained through CRADAs the institute has undertaken with industry.

In 2004, 87 CRADAs were approved NIH-wide; they ran the gamut from very early stage basic research through phase II clinical trials, Blaustein said.

But, she added, CRADAs account for "fewer than half of our major agreements. They are just one tool in our arsenal."

M-CRADAs, MTAs, and CTAs are others. NIAID has acquired proprietary cytokines and other biological materials through the M-CRADA mechanism for the purpose of exploring biological properties, Fuchs noted.

M-CRADAs typically arise from the interest of an NIH scientist in a proprietary material. If the involved company foresees a potential patent or product strategy, it will opt for the licensing option of an M-CRADA. Otherwise, the MTA may suffice, with such rewards as acknowledgment in any published paper or simply new knowledge.

Similarly, if a proprietary compound that is already on the market is needed for a clinical trial for a different indication, either a CRADA or a CTA could be an appropriate transfer mechanism. In each of their three institutes, dozens of CTAs are executed annually, Portilla, Fuchs, and Blaustein said. Often, they observed, the company values exchanging use of their drug or device solely for the resulting data it needs for regulatory purposes.

A key to executing the appropriate agreement is specificity, Portilla emphasized, noting that NIH tech-transfer officers are "a lot more savvy now than when we started out in 1989."

For instance, she said, "early on, NHLBI had very broad research plans" in conjunction with CRADA agreements."Now they are much more focused, so that an investigator working on a CRADA can work on other lab research without its being implicated in the CRADA."

Instead of describing research material as a cardiovascular agent, its use would be targeted to a more specific indication, such as hypercardiomyopathy. In that way, the researcher could work on a different compound applied to the same disease and in collaboration with other companies.

Blaustein offered the example of a firm's wanting to collaborate on a treatment for "inflammatory diseases," which, in her office, was narrowed down to "inflammatory autoimmune disease."

Fuchs cited the need for flexibility at the VRC, whose mandate to develop vaccines is often best met by being able to partner with different companies that have different delivery technologies. "We create the carve-out language" to allow, for example, one HIV vaccine candidate to be tested in multiple contexts, she said.                

For a list of IC technology development coordinators, visit this site.


Tools of the Tech-Transfer Trade

The NIH Office of Technology Transfer is responsible for securing patents for NIH inventions and negotiating licenses for the commercialization of products that arise from those inventions (see "From Bench to Tech Transfer and Back to the NIH Scientist,"  The NIH Catalyst, May-June 2005).

The other arm of tech transfer at NIH resides within the institutes and centers, where collaborative research and material transfer agreements between NIH labs and scientists and outside entities—industry, academia, other U.S. government agencies, and even foreign governments—are negotiated. These arrangements vary in complexity, are usually mutually beneficial, and invariably culminate in expedited scientific advances and public health benefit.

Among the most used and useful tech- transfer mechanisms are:

CRADA: Cooperative Research and Development Agreement, a mechanism created by Congress in the Federal Technology Transfer Act of 1986, under which NIH scientists and outside collaborators, typically industry or academia, contribute research know-how and materials, intellectual acumen, personnel, and, in the case of the outside partner, occasionally funds to a joint research effort that will benefit the industry partner with an exclusive option to license inventions arising from the collaboration.

M-CRADA: Materials-CRADA, generally used by NIH to gain access to otherwise unavailable proprietary material, in exchange for which the company can receive an exclusive license to inventions that arise from the defined research

MTA: Material Transfer Agreement, under which material is exchanged but no research collaboration is contemplated.

CTA: Clinical Trial Agreement, establishing ground rules for the conduct of NIH clinical studies involving proprietary materials and the respective roles of NIH investigators and collaborators 




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