Funding

Osteoarthritis Initiative

Updated June 24, 1999

Summary of Administrative/Management Subcommittee Discussions

Subcommittee participants:

Steve Stimpson, chair (GlaxoWellcome)
Greg Downing (Office of Science Policy, Office of the Director, NIH)
Deborah Freund (Indiana University)
Mary Wacholtz (Johnson & Johnson)
Janet Woodcock (Center for Drug Evaluation and Research, U.S. Food and Drug Administration)
Annette Levey (Office of General Counsel, Office of the Director, NIH)
Barbara McGarey (Office of Technology Transfer, Office of the Director, NIH)
Gayle Lester (University of North Carolina)
Sudhir Srivistava (National Cancer Institute)
Susana Serrate-Sztein (National Institute of Arthritis and Musculoskeletal and Skin Diseases)
_____________
1representing the Arthritis Foundation

Focus questions for consideration include:

  • Administration of the Consortium/Collaboration

    • Governance issues

      • What management structure is needed?

      • How should all parties be represented on the management organization?

      • Can the Consortium be developed to maintain flexibility and accommodate needs and expectations of the organization's members?

    • What are the terms of membership to the Consortium? What are the benefits of membership in the Consortium? Would these privileges be denied to non-members?

    • What role would each partner play in developing and maintaining the consortium?

    • What are potential barriers that exist to public-private partnerships?

    • How would technology transfer, licensing agreements, intellectual property rights be approached?

    • How would decisions about access to information, specimens, data, etc. be made?

    • What mechanisms are available to support OA biomarker research proposals (contracts, CRADAS, R01s, cooperative agreements, etc)?

    • What role would industry, professional societies, and academic scientists have in developing the request for proposals, contracts, cooperative agreements, and other funding mechanisms?

  • Management

    • Can we begin to anticipate the management needs of the consortium?

    • How will procedures, protocols, plans for the research activities be developed?

    • What means will be used to communicate with the members of the collaboration, research community, etc.

    • What are critical functions of the management team? Examples:

      • oversight of data collection, specimen repositories, imaging repositories

      • record keeping, statistical analysis, etc.

    • What will be needed to maintain standardization of sampling acquisition, processing, and analysis among sites?

    • What committee structures will be needed?

  • Infrastructure

    • What are the critical infrastructure needs for the collaboration?

      • specimen and imaging repositories

      • data collection/recording centers

      • "validation laboratories"

      • data analysis centers

    • Are there personnel needs and, if so, what are they?

    • What are the communication needs to support the consortium? websites, dedicated computers, etc.?

    • Structure of Organization

    Subcommittee discussions focused on possible structures for the consortium. It was determined that this type of discussion is very difficult without a clear mission for the consortium and the identification of questions to be asked. The mission of the consortium must be defined and focused. Some of the crucial questions are:

    • Who are our partners?

    • What partners are needed who are not currently at the table?

    • What specific benefits are partners seeking?

    • What knowledge is pre-competitive vs. proprietary?

      • Can there be a period of exclusivity for knowledge?

    • Can some resources be defined as

      • Existing

      • Created

      • Enabled or based on results

      • What is the access to resources by partners?

    • What are the outcomes?

      • Research tools

      • Diagnostics

      • Proof of concept

      • ENABLING technology

    The need for definition of the mission of the consortium was stressed with particular reference to the scientific scope and focus with prioritization of efforts. An additional concern was "Who will be the partners?". Would there be various categories of partnership? There was agreement that who the partners would be could not be ascertained until there was agreement on what would be the benefit to the partners. Once this is determined, details of partnership could be developed.

    The subcommittee also agreed that we needed more industry representation in this group. There were only two industry representatives present and they did not feel comfortable speaking for other possible partners.

    It was decided that by the winter meeting the subcommittee would have prepared several structure options to be submitted to the Consortium for consideration. These models would include various management/ structural options as well as options/requirements for partnership. Several examples exist currently: EDRN for NCI-industry relations, Moffit Center for FDA-industry relations, and JIFSAN. Efforts will be made to evaluate these various structures. A presentation on the NCI biomarekrs project, the Early Detection Research Network, was made to the group.

    The very important issue of intellectual property was discussed. Representatives from the Office of Technology Transfer and the Office of the General Counsel offered suggestions for arrangements to allow some flexibility. The subcommittee agreed that what is proprietary before the Consortium would remain so (pre-competitive knowledge). There was acknowledgement that some proprietary information might be shared with members of the Consortium. There was discussion of periods of exclusivity for Consortium discoveries. It was decided that any IP resulting from the Consortium through NIH grants or contracts must be public knowledge but that discoveries made within the confines of the industrial partners could be exclusive.

    It was concluded that there needed to be more extensive conversation between members of the subcommittee and possible partners to identify needs and propose possible structures for the Consortium. These contacts will be made during the months between now and the Winter meeting.