The Office of Portfolio Analysis and Strategic Initiatives (OPASI):

The Office of Portfolio Analysis and Strategic Initiatives (OPASI) provides the National Institutes of Health (NIH) and its constituent Institutes and Centers (ICs) with the methods and information necessary to manage their large and complex scientific portfolios, identifies - in concert with multiple other inputs - important areas of emerging scientific opportunities or rising public health challenges, and assists in the acceleration of investments in these areas, focusing on those involving multiple ICs.

Roadmap Implementation Coordinating Committee (RICC) Responsibilities:

The primary role of the Roadmap Implementation Coordination Committee (RICC) is to provide the governance, set policy and provide oversight for the overall NIH Roadmap. Its input is provided to the Director of the NIH through the Assistant Director for NIH Roadmap Coordination (ADRC) and the NIH’s Deputy Director.To carry out this role, the Committee, at a minimum, will receive routine reports from:

1. NIH Roadmap Implementation Working Groups (RIWGs) for the evaluation of the progress and critical assessment of the quality of the initiatives
2. NIH Office of the Budget for fiscal and human resource issues
3. NIH Office of Science Policy for the evaluation of the overall Roadmap
4. NIH Office of Extramural Research and Office of Intramural Research for policy issues related to the respective NIH components
5. NIH Office of Communications and Public Liaison for the implementation and feedback regarding communication of the Roadmap activities
6. NIH Office of Legislative and Policy Affairs for issues related to Congressional reports and activities
7. Roadmap IC Liaisons for issues raised by IC staff and extramural communities

Specifically, the Roadmap Implementation Coordination Committee:

1. Establishes and applies a set of operating principles for the Roadmap’s implementation
2. Maintains oversight for overall progress facilitated by an annual review of the RIWGs and coordination Roadmap activities
3. Reviews information copies of key initiative pre- and post-award items as specified in the Framework for Roadmap
4. Initiative Pre- and Post-Award Management (RFAs/RFPs; funding plans; progress reports, etc.)
5. Reviews RIWG waivers from the Framework after review by the ADRC
6. Contributes to the design of the evaluation of the overall Roadmap
7. Reviews proposals from RIWGs for initiatives to be terminated, or markedly reduced in scope
8. Recommends options for dispensation of funds not used by the RIWGs
9. Reviews personnel and budget resources and determines if there is a need for shifts among RIWGs
10. Reviews new concepts emerging from the RIWGs in the context of the overall Roadmap
11. Ensures coordination and communication among RIWG initiatives, including extracting experiences of one initiative that can be relevant to others, identification of unexpected emerging opportunities, addressing issues of data release and other related activities

Membership:

Chairs of the nine Implementation Working Groups and representatives from OD, NIH offices (OSP, OER, OIR, OB, OM, OCPL and OLPA)

Molecular Libraries and Imaging Implementation Group (MLIIG) Responsibilities:

The Molecular Libraries and Imaging Implementation Group is co-chaired by the Directors of NHGRI and NIMH and is composed of representatives from each of the participating NIH Institutes, Centers, and Offices, including the principal leads designated by the co-chairs. The MLIIG develops and implements approved initiatives, identifies emerging issues that may warrant revisions of the implementation plan, and proposes concepts for new initiatives. Specific approved initiatives are managed by Project Teams. The MLIIG reviews and recommends approval of:

1. funding plans developed by the Project Teams for each of the MLI initiatives; and
2. requests for reallocation of resources (funds and FTEs) between MLI initiatives.

The MLIIG coordinates responses to requests for information from the NIH Roadmap Office, including:

1. updates on the development, implementation, and evaluation of MLI initiatives;
2. periodic progress reports on timelines and milestones of the MLI initiatives; and
3. reports on staffing needs and budgetary reports.

NIH MLSCN Project Team Director Responsibilities:

The NIH MLSCN Project Team Director is an extramural staff scientist who will have responsibility for coordinating the activities of the NIH MLSCN Project Team and interactions with the MLSCN centers and NCGC. The Project Team Director may also serve as a Program Official.

1. Chair the NIH MLSCN Project Team.
2. Participate in the MLSCN Steering Committee meetings as a member.
3. Serve as the NIH contact for the External Scientific Panel. Provide materials to the External Scientific Panel needed to review and evaluate the progress of the centers in meeting their individual and collective milestones. Provide a concise summary of the External Scientific Panel meetings within 14 days to the panel members, center PIs, Program Officials, Scientific Program Managers, Network Science Officers, and NIH MLSCN Project Team.
4. Carry out continuous review of all activities to ensure objectives are being met.

NIH MLSCN Project Team Responsibilities:

The NIH MLSCN Project Team will serve as the trans-NIH body overseeing and coordinating MLSCN activities. Project Team membership will include one or more representative(s) from each of the NIH Institutes and Centers participating in the Molecular Libraries and Imaging Initiative. Program Officials, Scientific Program Managers and Network Science Officers can be members of the NIH MLSCN Project Team. Each participating IC and Center will have a single vote on the Project Team, no matter how many members from the IC or Center are involved. The Project Team Leader will chair meetings and serve as the Project Team Director of the MLSCN centers and NCGC on behalf of the NIH MLSCN Project Team. The Project Team will receive recommendations from the MLSCN Steering Committee and will be overseen by the MLIIG.The NIH MLSCN Project Team will have the following involvement:

1. Review and implement MLSCN guidelines and policies based on recommendations from the MLSCN Steering Committee.
2. Communicate, through its chair, policy information to the MLSCN Steering Committee, Small Molecule Repository, PubChem, and the MLIIG.
3. Review the Assay Access Review Committee (SEP) summary statements and develop a prioritized list of assays to develop a balanced portfolio consistent with NIH-wide programmatic needs; the list of assays are presented to the MLSCN Steering Committee for implementation within the Network
4. Review the recommendations of the MLSCN Steering Committee regarding the choice and distribution of assays to specific centers within the MLSCN and make final assignments of these assays to specific centers on a timetable that will ensure efficient operation of the Network.
5. Monitor the progress of HTS and probe development for individual assays to determine the appropriateness of the use/continued use of MLSCN resources (e.g., for implementing particularly difficult assays, or developing chemical probes)
6. Oversee the addition of new compounds to the Small Molecule Repository.
7. Review the plan for distribution of compounds from the Small Molecule Repository to individual MLSCN centers, and monitor the centers’ rate of use compounds.
8. Evaluate progress of the MLSCN program in consultation with the External Scientific Panel and the MLIIG.
9. Attend the External Scientific Panel meetings and MLSCN Network meetings.

MLSCN Steering Committee Functions:

The MLSCN Steering Committee is the operational group responsible for coordination of the activities of the MLSCN screening centers and the committee through which the NIH MLSCN Project Team interacts with the MLSCN Network. The MLSCN Steering Committee will identify scientific and policy issues that need to be addressed at the Network level, develop recommendations to the NIH MLSCN Project Team for addressing such issues, coordinate the primary recommendations for assay distribution within the Network, and coordinate the dissemination of screening data, assay protocols, and other materials with the wider scientific community.The MLSCN Steering Committee membership will include the PI of each of the extramural centers and the NCGC (the NIH intramural center), the NIH Scientific Program Managers, the Director of the NIH MLSCN Project Team, and two representatives of the NIH Network Science Officers. The PI of the Small Molecule Repository, the Project Officer for the Small Molecule Repository, the PubChem designee, and the NHGRI Program Official will be ex officio (non-voting) members of the MLSCN Steering Committee.

The PI of each center (or designee) will have one vote on the MLSCN. The NIH Scientific Program Managers, the NIH MLSCN Project Team Director, and Network Science Officers may vote, but the total votes will count as a maximum of one-third of the total MLSCN votes. Membership on the Steering Committee becomes effective upon issuance of the Notice of Grant Award. The MLSCN Steering Committee may establish additional subcommittees or workgroups for specific tasks. The NIH Program Officials, Scientific Program Managers, NIH Network Science Officers, and NIH MLSCN Project Team Director may not chair any committee or subcommittee.

The MLSCN Steering Committee will:

1. Convene at least twice yearly. The purpose of these meetings is to assess scientific progress, identify new research opportunities, establish priorities, consider policy recommendations, and discuss strategies. One of the meetings will be in conjunction with the annual meeting of the External Scientific Panel to allow the MLSCN center Directors to meet directly with the External Scientific Panel.
2. Make decisions by a majority vote of a quorum, with an attempt for a consensus. A quorum will be the presence of a majority of the center PIs or their designees, at least one Scientific Program Manager, and the NIH MLSCN Project Team Director. Outside consultants/experts may be asked to participate in these discussions as nonvoting advisors.
3. Establish a chair, subcommittees, or workgroups for specific tasks; the NIH Program Officials, Scientific Program Managers, NIH Network Science Officers, and NIH MLSCN Project Team Director may not chair any committee or subcommittee.
4. Hold conference calls of the full committee and any subcommittees as needed; monthly calls are anticipated in the first year of the program.
5. Develop a plan for distribution of assays to specific centers within the Network based on the NIH MLSCN Project Team’s prioritization of assays acceptable for implementation, and information about available capacity and expertise of each center. The NIH MLSCN Project Team will give final approval for assay assignments to individual centers.
6. Develop a plan for distribution of compounds from the Small Molecule Repository to individual centers and for the proposed rate of use of compounds.
7. Develop recommendations for guidelines and policies for quality control and quality assurance of assay validation, screening, data reliability and quality, and chemical probe optimization; implement and monitor quality control/quality assurance procedures to assure consistency across centers.
8. Develop recommendations for a set of minimal characteristics that will have to be met in order to designate a compound as a “chemical probe,” which is operationally defined as the final product of the MLSCN center’s activity in the context of the MLSCN program.
9. Develop recommendations for guidelines for optimization of candidate compounds within the goals of the MLSCN program.
10. Develop recommendations for guidelines for standardizing the reporting of screening data and protocols for different types of assays to PubChem; develop policies to facilitate the timely deposition of screening data and protocols to PubChem in accordance with the MLSCN program’s data release policy.
11. Serve as a venue for coordination on improving the state-of-the-art HTS in the academic sector by reporting progress, disseminating best practices, and collectively evaluating new procedures, resources, and technologies.
12. Identify opportunities to increase the inter-operability of centers in the Network; centers will be expected to have a high degree of flexibility and be willing to adopt uniform policies and procedures recommended by the Steering Committee and approved for implementation by the NIH MLSCN Project Team.
13. Develop recommendations for guidelines for publication of screening data, assay protocols, chemical probe optimization, HTS technology development, and global data analyses, etc. resulting from the MLSCN effort.
14. Address recommendations made by the External Scientific Panel and approved for implementation by the NIH MLSCN Project Team.
15. Each MLSCN Center will be expected to use the model agreement language approved by the MLSCN Steering Committee for transfer of assays and materials into the individual MLSCN Centers.

External Scientific Panel:

The External Scientific Panel will be responsible for reviewing and evaluating the progress of the MLSCN centers in meeting their individual and collective milestones and goals, and making recommendations about the progress and directions of the MLSCN network and individual centers to the NIH MLSCN Project Team and the MLIIG. The External Scientific Panel will be composed of 6-8 senior non-federal scientists who are not directly involved in the activities of the MLSCN. The NIH MLSCN Project Team will appoint members with concurrence from the MLIIG. The NIH MLSCN Project Team will select one member as chair. The NIH Program Officials, NIH Scientific Program Managers, NIH MLSCN Project Team Director, NIH Network Science Officers, and NIH MLSCN Project Team members may attend the External Scientific Panel meetings as non-voting participants.The External Scientific Panel will have the following involvement:

1. The chair will schedule, develop agendas, and oversee the annual meetings and conference calls. The membership of the Panel may be enlarged permanently, or on an ad hoc basis by action of the original members.
2. The External Scientific Panel will meet at least once a year and quarterly by conference call. During part of this meeting, there will be a joint meeting with the MLSCN Steering Committee to allow the Panel members to interact directly with the MLSCN center Directors, including the PI of the NCGC, and the PIs of the Small Molecule Repository, and PubChem.
3. The External Scientific Panel will review progress of the MLSCN network and individual centers, and make recommendations regarding any changes that may be needed in the direction of the MLSCN program to the NIH MLSCN Project Team and the MLIIG.
4. The External Scientific Panel will be consulted by the NIH Scientific Program Managers and NIH MLSCN Project Team Director when changes in a center’s funding level are being considered because of either outstanding or poor technical performance, or for other reasons.
5. Any MLSCN center PI who considers a MLSCN Steering Committee decision unacceptable may appeal to the External Scientific Panel.

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