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IV. Collaboration and Inventions: The "CRADA"

C. Possibilities

CRADAs have enabled a large, and growing, number of exciting projects. NIH labs and companies have been able to study therapies for rare diseases, new (perhaps high-risk) uses of existing drugs for new indications, and therapies and vaccines for diseases primarily occurring in poor countries -- technologies most companies would consider too high a financial risk to invest resources developing -- by pooling their resources and expertise. Even beyond this, NIH labs have been able to access manufacturing channels and unique research materials, often which would be prohibitively expensive to procure without the CRADA -- especially for the smaller institutes. Companies, in turn, have found they can access a unique source of expertise, and can tap a research entity whose bedrock interest is to help successful products reach the bedside, without having to rely on the assistance of a competitor. In one specific and successful example, when the NCI needed a tool to perform microdissection of cells for clinical pathology of cancerous tissue, NCI and Arcturus Engineering agreed to enter a CRADA to develop one. Laser capture microdissection was created, and is now on the market.

In the case of Gillian Niher, a Clinical-CRADA would have enabled her project and protected her interests in publishing, receiving material and financial support, and handling regulatory filings. It would also have guaranteed the NIH’s interest in protecting the patients enrolled in the clinical trial; additionally, it would have protected Neurion’s interest in ensuring compliance by Gillian with the terms of their agreement, and perhaps secured rights in Gillian’s invention involving the bare plasmid. In short, a Clinical-CRADA would have established the ground rules by which the parties would act, ensured no one operated on a misconception, and authorized them to do what they wanted to do.

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