By Karen Surabian, Thomas Stackhouse, and Jeffrey Thomas, Contributing Writers, and Bruce Crise, Guest Writer
Advancing scientific discovery is increasingly dependent on diverse and innovative partnerships, and the Cooperative Research and Development Agreement (CRADA) is an essential tool for establishing partnerships. CRADAs allow a federal laboratory to enter into collaborative research and development (R&D) projects with outside parties (commercial or nonprofit).
CRADAs have been successfully used at NCI for more than two decades, and they have led to several effective products, including Avastin (for certain types of colorectal, lung, and renal cancer, as well as glioblastoma) and Velcade (for multiple myeloma).
As the contractor operating a government-owned, contractor-operated facility like the Frederick National Laboratory for Cancer Research (FNL), SAIC-Frederick also has the legal authority to engage in CRADAs, but to date has not had an official program for CRADAs.
New c-CRADA Allows Contractor to Partner Independently
Recently, administrative staff from both SAIC-Frederick and NCI received approval for the contractual and policy modifications necessary to launch a contractor CRADA (c-CRADA) program at FNL.
Under the c-CRADA, SAIC-Frederick initiates and manages CRADA projects that do not involve direct participation from NCI staff in the research. Procedures have been established to effectively identify potential c-CRADA partners, develop the prospective c-CRADA project with the partner, review and approve the c-CRADA, and monitor the progress of the R&D project. Under these agreements, NIH CRADA subcommittee approval is not required; instead, c-CRADAs are approved locally by the NCI contracting officer, with input from the NCI technology transfer and program staff.
The new c-CRADA program was established to enhance partnering opportunities highlighting the contractor’s unique capabilities at FNL. These unique capabilities and the construction of the Advanced Technology Research Facility (ATRF), whose primary function is to foster partnerships, are the driving forces behind the c-CRADA program.
Two Kinds of Agreements Are in Place
Two c-CRADA “templates,” or model agreements, have been developed. The simpler of the two, the Technical Service Agreement (TSA), allows a partner to select from a list of unique FNL services for a set cost. TSAs are most appropriate for projects requiring a quick turnaround from the initial request through the provision of the final data package to the partner.
Second, the “full” c-CRADA is analogous to the NCI CRADA in that it anticipates a larger, joint R&D project with the partner. c-CRADAs are designed to accommodate the development of new technologies that might be used in the broader FNL research community in support of NCI’s mission, or by the public to benefit patients.
Both types of c-CRADAs provide access to the extensive scientific and technical expertise of the staff at FNL.
NCI CRADA versus c-CRADA
The type of agreement used (NCI CRADA, TSA, or full c-CRADA) depends on the specific circumstances of the proposed project. For example, all CRADAs enable both parties to provide resources, personnel, and equipment for the joint research. They also allow for external funding to support the research and grant the CRADA partner with a first option to elect an exclusive or non-exclusive commercialization license to inventions made under the CRADA.
However, inventions made by contractor (i.e., SAIC-Frederick) employees under the c-CRADA are managed by the contractor, rather than being assigned to and managed by the government, as required by an NCI CRADA.
In addition, although NCI staff may not directly participate in the research project of a c-CRADA, SAIC-Frederick staff may participate in projects established under NCI CRADAs. The latter remains unchanged from the past, and allows the unique resources and expertise of the SAIC-Frederick programs and labs to be used in collaborative projects between NCI and an outside partner.
Adding the TSA and c-CRADA to the expanding toolbox for technology transfer will assist FNL laboratories in streamlining R&D activities. Ultimately, these agreements enable more rapid development of new technologies and treatments for people living with cancer, AIDS, or other infectious disease.
The NCI Technology Transfer Center and the SAIC-Frederick Partnership Development Office can work with you to develop proposed partnership concepts and implement the appropriate agreement. For information, please call 301-846-5465.
Bruce Crise, Ph.D., is director of the Partnership Development Office, SAIC-Frederick.
If You Are Not Sure, Ask
If you have any questions or are not sure which agreement is appropriate for your research situation, contact the NCI Technology Transfer Center office:
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