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CTSA-IP: A Solution to Identifying and Aggregating Intellectual Property across the NIH Clinical Translational Science Award (CTSA) Consortium of Biomedical Research Institutes

Authors

  • Mike Hazard B.A.,

    1. Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA
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  • Scott Steele Ph.D.,

    1. Office of Research Alliances and Public-Private Partnerships Key Function, Clinical and Translational Science Institute, University of Rochester Medical Center, University of Rochester, Rochester, New York, USA
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  • Dongwen Wang Ph.D.,

    1. Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA
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  • Thomas Pearson M.D., M.P.H., Ph.D.,

    1. Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA
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  • Mark Scheideler Ph.D.,

    1. Current Address: HumanFirst Therapeutics LLC, Silver Spring, Maryland, USA
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  • Steve Dewhurst Ph.D.

    1. Office of Translational Research, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA
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Errata

This article is corrected by:

  1. Errata: CTSA-IP: A Solution to Identifying and Aggregating Intellectual Property across the NIH Clinical Translational Science Award (CTSA) Consortium of Biomédical Research Institutes Volume 5, Issue 1, 112, Article first published online: 29 February 2012

S Steele (scott.steele@rochester.edu)

Abstract 

One of the objectives of the Consortium of Institutions with Clinical and Translational Science Awards (CTSAs) is to enhance technology transfer among the CTSAs and with public and private sector partners. Clinical and Translational Sciences Award Intellectual Property (CTSA-IP; http://www.CTSAIP.org) is a web-based, open access IP search tool that aggregates and promotes technologies from member institutions of the National Institutes of Health’s (NIH) CTSAs consortium. Its ultimate aim is to stimulate collaborative research activity by encouraging the formation of public-private partnerships with CTSA institutions and the NIH. First launched in 2009, CTSA-IP has grown rapidly and met its first objectives of developing wide member institution participation and site usage. This communication will discuss the strategy employed in the initiative of aggregating IP across institutional boundaries, the promise that lies therein, as well as the challenges encountered and lessons learned in promoting CTSA-wide engagement. Clin Trans Sci 2011; Volume 4: 328–331

Vision of Aggregating Intellectual Property and Resources

The Clinical and Translational Sciences Award (CTSA) program was initiated by the National Institutes of Health (NIH) in 2006, and presently includes 60 member institutions in 30 states plus the District of Columbia. The CTSA member institutions serve as a consortium that shares five overall goals. These goals include the building of a national clinical and translational research capability, enhancement of consortium-wide collaborations, and advancement of translational research that moves basic laboratory discoveries and knowledge into clinical testing.1 Related to these goals, the NIH has proposed a new National Center for Advancing Translational Sciences (NCATS) that would aggregate several NIH intramural translational research programs and house the CTSA Program.2 The proposed goals for NCATS include leveraging translational research to bring new ideas and materials to the attention of the private sector, ultimately catalyzing the development of novel drugs, diagnostics, and therapeutics.

The goals of promoting consortium-wide collaborations and advancing translational research require new interactions between member institutions and a more effective partnership between the public and private sectors—to include the biotech, device and pharmaceutical industries, private foundations, as well as NIH and other federal agencies as essential stakeholders. Recent analysis of the translation of University inventions into approved therapeutics, showing both significant numbers and high clinical impact, makes a compelling case for the role of public sector research and intellectual property (IP) in drug development.3 The successful establishment of new public-private partnerships will be contingent on the CTSA consortium’s ability to identify areas of mutual research interest and strength, and to rapidly align resources to capitalize on collaborative research opportunities. With this in mind, the CTSA Intellectual Property (CTSA-IP) website (http://www.CTSAIP.org) was created as part of an infrastructure needed to accelerate translation of basic laboratory research and novel technologies into clinical practice.

The fragmentation of university-promoted IP across a multitude of individual technology transfer sites creates a significant block in the formation of translational research projects. The low transparency of available technology makes it difficult to identify and assemble the multiinstitutional partnerships that are often required for the successful bench-to-bedside transition of new discoveries. The creation of CTSA-IP represents an important first attempt by a leading consortium of universities to address this problem and engage academic institutions in a community-oriented approach to technology transfer in the public sector.

The immediate goal of this initiative has been to create a set of open-access online information resources and tools to rapidly identify and align technologies and IP available within member institutions. It is intended that CTSA-IP will aid CTSA consortium efforts to translate basic science discoveries into new clinical applications and first-in-human studies. The innovative development of database integration, visualization, and other informatics tools will ultimately allow CTSA member institutions and their partners to aggregate and rapidly search information on their collective research activity, resources, technologies, and IP.

Identification of a Need for IP Aggregation and the Implementation of CTSA-IP

At the outset of the CTSA-IP initiative, we conducted a survey to identify the existing tools utilized by Technology Transfer Offices (TTOs) of the CTSA consortium members. The results showed that various efforts, including SparkIP, OceanTomo, and Flintbox, had been adopted to different extents by CTSA member institutions, primarily as means to organize and analyze their IP information.4 As feedback was gathered from member TTOs on what are effective and future requirements, a small advisory group consisting of six CTSA consortium TTOs prioritized the key features necessary to create a value-added IP aggregation system. The fundamental requirements for the CTSA-IP tool included the following: (1) ease of use and open-access, (2) low effort required by TTOs in mapping their data to the CTSA-IP data model, and (3) availability of site analytics to members, allowing review of the technology terms most frequently searched. In addition to functional requirements, a key initial goal was to identify the potential challenges to recruiting CTSA member sites to participate in, and to contribute to, the CTSA-IP project.

Working with the TTOs from these initial CTSA participants, we developed a simple process to extract IP information from existing institutional databases and to import the data into a central CTSA-IP server housed at the University of Rochester. Rather than creating a new data format, it became a priority to support multiple data import mechanisms, allowing member institutions to continue to use and develop their individualized systems. With this in mind, a core data schema was built allowing all TTOs to support the initial CTSA-IP tool.

CTSA-IP has been specifically designed with the goal of encouraging broad participation from CTSA member institutions. Features intended to promote this goal include (1) incorporation of IP and technologies that are already publicly available through individual member institutions’ websites so as to minimize the potential “data protection” hurdle, (2) direction of user queries back to member institutions’ websites and TTOs, thereby enhancing institutional technology marketing efforts, and (3) designed to specifically interface with a variety of data import mechanisms (Excel spreadsheets, XML files, and iBridge5 exports).

A “phase-1” site was launched at the end of May 2009 with the original six organizations that participated in the advisory group (five CTSA member institutions, plus the NIH Office of Technology Transfer). From the end-user’s perspective, the site enables users to search technology across all participating CTSA institutions or from a single institution. The site also enables visitors to save their searches to a “shopping cart,” where they can then generate PDF documents of all their saved technologies.

In establishing the CTSA-IP Initiative, a community of self-selected CTSA Institutions (and TTOs) was created that has a strong interest in collaborating with other institutions to share resources and work effectively with the private sector.

Technical Aspects and Growth of CTSA-IP

Technical development of CTSA-IP has focused on a simple database design concept,6 in order to facilitate data import and analysis without need for a detailed ontology that would impose a barrier to broad participation by institutions and their TTOs.

Site contributors can rank most popular technologies and identify keywords that bring visitors to the site—recognizing that as currently configured, a keyword that is found in the title of the technology will be ranked higher than one that matches in the summary. In addition, site contributors can also examine visitor searches on the CTSA-IP site itself and use this information to create technology descriptions and keyword collections that more closely match searches that are performed on the site.

As of Q1 of 2011, more than 9,000 technologies were posted in CTSA-IP, reflecting its rapid adoption and growth (Figure 1). A current listing of participating member institutions is shown in Table 1. In addition to these institutions, University of North Carolina, Indiana University, and New York University are in the process of supplying their technology data for the site.

Figure 1.

Rapid growth and adoption of CTSA-IP. This figure shows the growth in the cumulative numbers of institutions/organizations participating in CTSA-IP (left axis) and in the total number of active technologies aggregated within CTSA-IP (right axis), since its inception.

Table 1.  Current CTSA-IP participating institutions (Q1, 2011).
Columbia UniversityUniversity of Cincinnati
Emory UniversityUniversity of Colorado
Fred Hutchinson Cancer Research CenterUniversity of Michigan
Oregon Health and Science UniversityUniversity of Pennsylvania
Rockefeller UniversityUniversity of Pittsburgh
Stanford UniversityUniversity of Rochester
The Ohio State UniversityUniversity of Wisconsin
Tufts UniversityVanderbilt University
University of Alabama at BirminghamWashington University in St. Louis
University of ChicagoNational Institutes of Health
Harvard UniversityUniversity of California, San Diego

Also as of Q1 of 2011, we have recorded over 16,000 visits and 30,000 page views to the CTSA-IP website. Importantly, for many searches, the Google “page ranking” of CTSA-IP exceeds that of the individual member institution’s TTO websites. CTSA-IP, because of its relatively large size, ranks high. For example, two of the top 10 hits generated by the Google search string “cardiac + technology + licensing” mapped to the CTSA-IP site, and all of the top three hits generated by the Google search string “Alzheimer + technology + licensing” mapped to CTSA-IP.7 CTSA-IP is especially useful for raising the profile of technologies listed by smaller CTSA institutions (e.g., the Google search string “CaMKII + stroke” returned a CTSA-IP page linking to technology at University of Colorado on the very first results page, but failed to yield a single hit that linked directly to the Colorado TTO office anywhere on the first five results pages returned).

This analysis demonstrates that aggregating multiple sites into a single, simple search interface significantly raises the profile of participating member’s IP, increasing the likelihood that these technologies will be found by a potential audience via a web-based search. The comparative effectiveness of IP aggregation through CTSA-IP is further underscored by an analysis of the distribution of disease-related technologies across participating CTSA-IP institutions in four representative domain areas. For this purpose, we examined the distribution of technologies that were returned in response to the keyword queries (cancer, stroke, antibody, and nano) most commonly used to interrogate the CTSA-IP database in Q1, 2011. As shown in Figure 2, technologies within each of these various domains are broadly distributed across CTSA-IP member institutions, and are not dominated by any single institution in a given search.

Figure 2.

Distribution of disease-related technologies within CTSA-IP: The power of cross-institutional aggregation. This figure shows the distribution of technologies across participating CTSA-IP institutions in four domain areas that represent the most popular search terms applied to the site in Q1, 2011. The graph shows that technologies within these various domains are broadly distributed across CTSA-IP member institutions. Note that data reported are for CTSA-IP member institutions only (intramural NIH technologies have been excluded).

Linkage with iBridge and other Online Resources

CTSA-IP was initiated as an effort to link publicly available sources of technology transfer information and aims to establish sharing relationships with other open access tools that allow the searching of research resources, particularly those that complement the IP focus of CTSA-IP. The first such agreement to link with another powerful aggregation tool was reached last year with the iBridge Network, a program of the not-for-profit Kauffman Innovation Network that links researchers, resources, and innovations between communities of universities, companies, and entrepreneurs. More than 100 research institutions listed on iBridge are now linked to CTSA-IP members via a new CTSA Community8 listed on the iBridge site, giving the CTSA consortium member institutions the ability to jointly market their technologies as part of nearly 13,000 innovations already posted on iBridge.

Looking to the future, by linking CTSA-IP to research descriptions and researcher profiles, we expect to greatly enhance opportunities for new research partnerships and to build cross institutional collaborations in focused research/disease areas. With this objective in mind, we are developing linkages with research resource aggregators and research networking tools, including eagle-i9 and VIVO.10 Eagle-i is a web-based resource that connects researchers to research resources of interest, while VIVO is a social networking web application designed to promote collaborations within the research community. Harvard Catalyst Profiles,11 Epernicus,12 and ResearchCrossroads13 represent further examples of researcher networking systems.

Additionally, linkage to international efforts that also aim to build TTO communities, and aggregate open source IP is a natural extension to explore during CTSA-IP growth. Examples of such efforts include the Association of University Technology Managers,14 which has international members, and Europe’s Orphanet portal for licensing innovation relevant to rare diseases and orphan drugs.15

Challenges and Future Goals

The CTSA-IP initiative has developed rapidly in its first 2 years, providing valuable insights regarding opportunities for development and challenges. First, while CTSA-IP presently generates metrics on page views, Google ranking, and site visitors, the ability to gauge the success of CTSA-IP will ultimately depend upon our ability to track the progress of a query from initial site visit to the finalized licensing of a technology, or creation of a new collaborative research partnership.

Second, interactions with site users—including private companies—will be enhanced by the implementation of confidential communication tools that permit secure searching of the site and more active interactions with CTSA members. This would move beyond a model that pushes out technologies, but is responsive to targeted queries. Adding a secure communication tool to the site would allow users to communicate directly, securely, and confidentially with CTSA-IP members (both individually and collectively). In conjunction with this effort, implementation of a Memorandum of Understanding would ensure the confidentiality of requests; this would preclude the sharing of information regarding specific areas of interest with other users or third-parties, yet allow our open access model of IP information sharing to be maintained.

Third, we envisage CTSA-IP moving toward a new role as data provider to external applications, including linkages with research resource aggregators. In this model, CTSA-IP would act as an open-source, cloud-based database that could be connected to many current or future applications, and enable applications that can remotely access CTSA-IP data. In the current model, the only way to interrogate the database is via a dedicated web interface. Applying a more refined ontology to CTSA-IP data, such as the MeSH ontology developed by the National Library of Medicine (NLM)16 would further increase the value of such an effort but is not a requirement of the cloud-based computing model.

As the scope and size of CTSA-IP is further expanded, it will also facilitate the formation of disease-oriented academic coalitions that, in partnership with the NIH, private foundations and the biotech/pharmaceutical industries can more efficiently develop and test new therapeutic approaches. Recent trends in technology transfer and public-private partnership formation point to the need and impact of cross institutional searching of University IP. There are an increasing number of pharma-university partnerships being created that take the form of virtual therapeutic discovery project teams.17 In addition, cross-institutional venture funds are being formed to finance commercialization, with active, continuing participation of the nonprofit organizations.18 The expanded participation of CTSA-IP to all 60 members of the CTSA consortium and their affiliates will broaden and enhance its impact in serving to further these initiatives.

Conclusions

CTSA-IP has rapidly developed by merging the contents of multiple, diverse IP data sources via flexible searching functions, and by allowing open-access mining of IP and technologies across the CTSA consortium. The intent of the initiative is to facilitate the formation of research collaborations between CTSA member institutions, and partnerships of these institutions with the private sector, disease foundations, and government. Current use of the site demonstrates a strong community interest and shows that it can enhance the visibility of university-based inventions. CTSA-IP has immediate, further value in promoting a TTO community with the ability to initiate working groups that can develop and propose cross-institutional collaboration and licensing arrangements in focused research project areas. In the future, the CTSA-IP initiative can link technologies with precompetitive research domains and allow CTSA institutions to self-identify complementary capabilities in the consortium. This is expected to lead to increased partnering of resources and funding and speed the translation of research knowledge into clinical application.

Acknowledgements

The authors gratefully thank Dr. Bonnie Harbinger of NIH for assistance and advice throughout the development of this project. This project was supported by a Supplement to Award Number UL1 RR024160 from the National Center for Research Resources, NIH, CTSA program, part of the Roadmap Initiative, Re-engineering the Clinical Research Enterprise. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

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