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Collaborations in Cancer Research: Tools for Partnership and Commercialization
Posted By Brooke Layne Hardison On July 28, 2008 @ 12:00 am In Drug development,Partnerships | Comments Disabled
“As we move to a more personalized era of oncology, it is clear that we will require multiple agents to target multiple pathways in the same patient. Facilitating that future will challenge how we think of competition, of intellectual property, and even the language of contracts. I believe NCI must step into those areas and become the facilitator between the public, private, and academic sectors.” –NCI Director John E. Niederhuber, M.D., American Society of Clinical Oncology Annual Meeting, May 31, 2008
Collaborations, the transfer of technology, and other types of public-private partnerships, are critical to NCI’s mission of fostering the best cancer research and promoting translation of that research from the bench to the bedside. NCI is the primary means of support for cancer research in America, with 3.8 billion dollars spent in 2007 alone on cancer research conducted at institutions across the country, and another one billion spent here at the NCI. NCI’s intramural scientific program, which is housed primarily on its campuses in Frederick and Bethesda, Md. is uniquely positioned to explore innovative diagnostic and treatment development in areas such as orphan drugs or combination therapies – areas where industry and academic sectors often face difficulties due to concerns over marketability, intellectual property, competition and liability. NCI cannot do this research alone, however, particularly because the problems being addressed require special expertise and an approach that crosses many disciplines. Partnerships have become an important component of America’s investment in cancer research.
For industry partners, there can be many advantages of collaborating with NCI. NCI’s scientists use cutting-edge technologies (functional imaging, genomics, proteomics and new approaches to drug development) to drive discoveries from the bench through clinical studies. NCI has resources which make it possible to do more extensive testing of new agents and products, and has experience in regulatory issues and the requirements involved in conducting clinical trials. In addition, NCI funds extensive clinical trials networks that allow for larger studies to be conducted across the country, and NCI’s large repositories make it possible to perform tests on a wide variety of tumor types and disease settings.
In order to promote collaboration and in response to concerns about U.S. competitiveness in the global economy, Congress passed two laws in 1980 which encourage government owned and/or funded research laboratories to pursue commercialization of their research results through collaboration with outside entities. These two laws are known as the Stevenson-Wydler Technology Innovation Act of 1980 (P.L. 96-480) and the Patent and Trademark Amendments of 1980 (P.L. 96-517), also known as the Bayh-Dole Act.
The Stevenson-Wydler Act allows NIH and other federal agencies to enter into license agreements with industry partners to promote development of technologies born out of NIH research. The act provides the American public with a financial return on their investment in the form of royalty payments and fees. The Stevenson-Wydler Act was expanded in 1986 to allow federal agencies to partner, not only in the dissemination of their results, but throughout the entire research process. For more information on this type of partnership, see the section on Cooperative Research and Development Agreements below.
The Bayh-Dole Act was intended to address the barriers that can arise around intellectual property, or ownership, of the materials being developed. The Act promotes advancement of both scientific and economic development by allowing the government to enable the transfer of federally-funded technologies to the public by securing patent rights and licensing them to commercial entities. While the Stevenson-Wydler Act applies to collaborations between government scientists (i.e. federal employees) with outside agencies, the Bayh-Dole Act applies to extramural grantees and contractors, and allows the investigator’s institution to retain the title (i.e. rights) to the government-funded invention. The grantee or contractor institution is charged with the responsibility to use the patent system to promote utilization, commercialization and public availability of the invention. If the institution is not interested in pursuing the technology, the government can elect to title the invention.
Collaborations between NCI-funded clinical cooperative groups and industry partners are directed by guidelines set through the NCI Cancer Therapy Evaluation Program [1], NCI-funded pre-clinical resources are managed by the Developmental Therapeutics Program [2], and collaborations between NCI intramural scientists and industry partners are managed through the NCI Office of Technology Transfer [3]. There are several mechanisms through which the NCI, academic and industry partners work together. Some of the most common agreement-types are listed here:
Over the years there have been several advancements in cancer treatment that have resulted from successful partnerships with the National Cancer Institute. Examples include:
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Resources:
NCI Technology Transfer Center: http://ttc.nci.nih.gov/ [4]
NIH Office of Technology Transfer: http://www.ott.nih.gov/ [5]
NIH Public Private Partnerships: http://ppp.od.nih.gov/ [6]
NIH Intellectual Property Policy: http://grants.nih.gov/grants/intell-property.htm [7]
Article printed from NCI Benchmarks: http://benchmarks.cancer.gov
URL to article: http://benchmarks.cancer.gov/2008/07/collaborations-in-cancer-research-tools-for-partnership-and-commercialization/
URLs in this post:
[1] Cancer Therapy Evaluation Program: http://ctep.cancer.gov/industry/industry.html
[2] Developmental Therapeutics Program: http://dtp.nci.nih.gov/about.html
[3] Office of Technology Transfer: http://benchmarks.cancer.gov%20http://ttc.nci.nih.gov/
[4] http://ttc.nci.nih.gov/: http://ttc.nci.nih.gov/
[5] http://www.ott.nih.gov/: http://www.ott.nih.gov/
[6] http://ppp.od.nih.gov/: http://ppp.od.nih.gov/
[7] http://grants.nih.gov/grants/intell-property.htm : http://grants.nih.gov/grants/intell-property.htm
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