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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

Taxol Molecule

Taxol Molecule

“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:

  • Cooperative Research and Development Agreement. A CRADA allows an NCI-funded researcher to collaborate jointly with researchers in industry and academia to pursue a common research goal. The CRADA mechanism was established by Congress to promote competition and the rapid transfer of technologies to the marketplace. The CRADA avails external partners of the government’s facilities, intellectual property, and expertise in order to further the development of marketable products based on scientific and technological advancements. In a CRADA, government may provide personnel, services, facilities and/or equipment. In return, the collaborator may provide funding, in addition to personnel, services, facilities and/or equipment. A CRADA, which can last between one and five years, is the only mechanism in which NCI can promise intellectual property rights in advance. Additionally, the external partner receives an exclusive option to license any new inventions made by the NCI under the CRADA. There is also a streamlined version, called a materials CRADA, in which NCI is using proprietary material supplied by the industry partner. In 2007, NCI had 152 active CRADAs.
  • Clinical Trial Agreement. CTAs are used when an NCI researcher, or NCI-supported extramural investigator, is conducting research on a new drug or device and that research is being done in collaboration with an industry sponsor. The CTA covers transfer and use of materials in human subject research, but unlike the CRADA, it does not provide a license option to the inventions made by NCI scientists (except in certain limited circumstances. In 2007, NCI had 132 active CTAs.
  • Confidential Disclosure Agreement. A CDA is used to exchange confidential information. The agreement specifies how the information may be used, and addresses situations in which the information must be shared, such as under court order or the Freedom of Information Act. This agreement makes no promises about inventions made through use of this information.
  • Material Transfer Agreement. MTAs are used by NCI and other academic and for-profit organizations to send or receive research materials (such as cell lines, monoclonal antibodies or mouse models) for use by scientists in another institution. Typically these projects involve bench research as the materials are not appropriate for use in a human clinical trial. The agreement defines the terms and conditions under which the recipient may use the materials. Each year NCI signs over 1,500 new MTAs.
  • License. Each year, hundreds of new inventions are made by scientists at NCI. The NIH Office of Technology Transfer (OTT) transfers these inventions, through licensing, to the private sector for development that will benefit the public health. Most biomedical companies, whether large or small, desire worldwide patent protection to secure foreign markets or to use their assets in establishing strategic alliances which can add to the further development of the invention and distribution of its benefits to the public. The business development plan submitted as part of the license application process serves as the basis for establishing performance benchmarks that are included in a license agreement. OTT works closely with licensees to monitor performance and to adjust benchmarks, when appropriate, to ensure the successful commercial development of its inventions.

Over the years there have been several advancements in cancer treatment that have resulted from successful partnerships with the National Cancer Institute. Examples include:

  • Gardasil® human papillomavirus (HPV) vaccine, based upon technology from NCI was licensed and developed by Merck & Co., Whitehouse Station, N.J., and received regulatory approval in several countries, including the United States. The vaccine, Gardasil®, acts by preventing cervical cancer in women.
  • Kepivance®, a drug used to treat oral mucositis (a common side effect of high-dose chemotherapy and/or radiation involving painful lesions in the mouth or throat), is based on keratinocyte growth factor, which was discovered by NCI researchers in 1989. In 1992, Amgen, Thousand Oaks, Calif., was granted an exclusive license to develop potential therapeutic applications for this growth factor. NIH and Amgen scientists worked together to overcome challenges in clinical development, and Kepivance® was approved by the FDA in 2004. Kepivance® is used in approximately 11,000 cancer patients each year.
  • Velcade®, a proteasome inhibitor used for the treatment of multiple myeloma, was developed through collaboration between NCI and Millennium Pharmaceuticals, Inc., Cambridge, Mass. The active ingredient was discovered by the company Myogenetics (later renamed ProScript and then acquired by Millennium Pharmaceuticals, Inc.). NCI conducted preclinical studies for Velcade®. NCI researchers were able to develop a formulation that had a longer, more stable shelf life, and Millennium Pharmaceuticals, Inc., licensed it for further development. Velcade® is being studied for potential application in other cancers including ovarian, colon, pancreatic, lung, and prostate cancer, leukemia and non-Hodgkin’s lymphoma.
  • Laser Capture Microdissection (LCM), a method used for collecting selected cells for genetic or proteomic analysis, was conceived by researchers at the NCI and one of its sister institutes, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Researchers at NCI and NICHD invented a special thermoplastic polymer film that was activated by laser beams, and developed a prototype of the LCM using a carbon dioxide laser. A company called Arcturus Bioscience, now part of MDS Analytical Technologies, Concord, Ontario, Canada, provided the laser diode technology and developed the prototype Laser Diode System LCM. The resulting technology has been used in approximately 1,000 LCM machines for breast, prostate and pancreatic cancer research.
  • The Multi-Replica Blotting Kit, which allows simultaneous detection of up to ten different proteins from one gel, is based on Layered Expression Scanning technology developed by NCI researchers. 20/20 GeneSystems, Inc., Rockville, Md., worked with NCI researchers to refine the LES system and commercialized the Multi-Replica Blotting Kit.
  • Taxol®, an anti-cancer drug approved for the treatment of breast, ovarian, and lung cancer as well as Kaposi’s sarcoma, is based on a compound called paclitaxel, which was discovered from the bark of the Pacific yew tree by NCI researchers involved in screening natural products for anti-cancer activity. NCI researchers conducted pre-clinical and clinical testing and worked with Bristol-Myers Squibb, New York, N.Y., to develop supplies of Taxol® for clinical development. The resulting treatment has been used in over one million patients.



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