MDA-CAP Project Management Plan

 

Background, Lessons Learned, Assumptions, and Guiding Principles

 

Organizational Structure of MDA-CAP

 

Executive Committee

 

Administrative Core

 

Scientific Advisory Board

 

External Advisory Board

 

Operational Guidelines

 

Background, Lessons Learned, Assumptions, and Guiding Principles.

 

The MDA-CAP project management plan is built upon the successes and experience from the JDIP consortium that came together in the late summer of 2003 in response to the first CAP program announcement from the USDA. 

 

In brief, through a series of teleconference and physical meetings, we formulated the core beliefs or raison d’etre of MDA-CAP.  These key assumptions have guided our strategic decisions from the programs inception, and remain as relevant today as when first proposed.  The three fundamental assumptions to which all members of MDA-CAP subscribe are:

 

  • The success of MDA-CAP depends on the creation and maintenance of functional and flexible research teams that are interdisciplinary, multi-institutional, and use cutting-edge technology.

 

  • MDA-CAP must help reduce timelines for translating basic science research in bTB and JD into useful products and procedures by bringing together teams of interdisciplinary scientists who are supported by enabling core resources. And,

 

  • MDA-CAP must strive to provide real-world solutions based on scientific excellence to help prevent or mitigate the losses associated with bTB and JD. 

 

With these key assumptions in mind, we developed a set of principles to help us achieve our strategic objectives and guide us in the implementation of the program.  These six Guiding Principles are:

 

  1. We will organize ourselves along a translational pathway for the development of diagnostics, vaccines, and management strategies for preventing and controlling bTB and JD.

  2. We will make funding and programmatic decisions based on the quality of science in order to help achieve mutually agreed upon goals.

  3. We will support core activities based on community needs, quality of science, and the availability of expertise in order to provide maximum support to scientific projects and access as a community resource.

  4. We understand that we will not be able to ensure equal distribution of funds, nor will we be able to include all the excellent research in bTb and JD at each of the participating institutions.

  5. We will institute a mechanism for the regular evaluation of scientific programs and cores and reallocate our resources based on documented progress and programmatic needs.

  6. We will strive to promote programs in scientific and career development, education, and extension relating to bTB and JD in response to stakeholder needs.

These principles represent the “core values” or the “DNA” of JDIP, and help guide us in the development and implementation of the management plan.  They form a framework for responding to change and the natural evolution of the program.  Given our track record and the documented successes of the program thus far, it is clear that the basic assumptions and guiding principles of JDIP have served us well, and have placed us firmly on the path to long-term success.  Hence, it is not surprising that the members of MDA-CAP remain committed to working together to move the field rapidly forward in the quest for science-based solutions to bTB and JD.  Overall, we strongly believe that the primary benefit of coming together as a consortium is to enable collaborative research and a sharing of intellectual and physical resources that are critical to reducing the unusually long timelines for bTB and JD basic science research leading to useful products and procedures.

Organizational Structure of MDA-CAP

MDA-CAP is comprised of an Executive Committee, the group that is responsible for all strategic, scientific, and management policy decisions, and advises the PI and the Administrative Core on the overall management of the program.  The PI serves as Director of the Administrative Core, and is responsible for implementing and facilitating programmatic goals and is the primary liaison with USDA.  All of the MDA-CAP Research Programs and Cores are overseen by the Executive Committee, as are the Developmental Projects.  An External Advisory Board that consists of public and private stakeholders (regulatory agencies, members of industry, and prominent scientists from related disciplines) provides strategic advice on programmatic matters and ensures that MDA-CAP stays true to its mission and remains responsive to current and emergent needs of the community.  The External Advisory Board also reviews the scientific programs and other MDA-CAP activities, and provides intramural resource allocation guidance and oversight to the Executive Committee during the annual MDA-CAP meeting and as needed.

 

A detailed description of each of the administrative components of the proposed program and project management plan is provided below:

 

 

 

MDA-CAP Executive Committee

 

 

The MDA-CAP Executive Committee (EC) serves as the governing board of the program and is responsible for all strategic, scientific, and management policy decisions regarding MDA-CAP.  The following represent the salient features of the EC:

 

  1. Composition, Voting, and Membership of the EC.  The MDA-CAP EC is comprised of a total of nine members including the PI, representing individuals with leadership in bTB and JD research, extension, and education, a documented commitment to helping the community realize a shared vision, and a history of working together as a team.  In order to ensure efficiency in operations, each member is delegated and responsible for an agreed upon set of activities, and reports on their progress to achieving objectives back to the EC during weekly conference calls or as called upon.  Other salient features of the EC include:

 

  1. Each member of the EC commits a minimum 10% effort to MDA-CAP administration.  The PD and co-PD commits a minimum 30% effort to program administration.  Taken together, this represents more than 1 FTE of senior leadership time and effort commitment to the management of the MDA-CAP, and is a strong indicator of the dedication of the leadership to the long-term success of the program.

 

  1. The current members of the EC, their expertise, and their primary areas of responsibility are:

 

  • John Bannantine, PhD. (National Animal Disease Center, USDA-ARS).  As a senior Research Microbiologist, Dr. Bannantine specializes in the molecular genetics, genomics and diagnostics of MAP.  Dr. Bannantine focuses his efforts on identifying opportunities for integration of activities amongst basic science projects and cores, especially in the area of diagnostics and microbial genomics.

 

  • Luiz Bermudez, M.D. (Oregon State University).  Dr. Bermudez is Professor and Head of the Department of Biomedical Sciences, College of Veterinary Medicine, and specializes in basic biology and pathogenesis of mycobacterial diseases.  Along with Dr. Quinn, Dr. Bermudez’ efforts will be focused on identifying, evaluating and translating MDA-CAP research into promising vaccine candidates.

 

  • Paul Coussens, Ph.D. (Michigan State University).  Dr. Coussens is Professor of Microbiology and Molecular Genetics and serves as Director of the Center for Animal Functional Genomics (CAFG) with a focus on the immuno-pathogenesis of mycobacterial infections of animals.  Dr. Coussens will serve as the co-PD of the MDA-CAP, and together with Dr. Kapur, be responsible for the overall management of the project.

 

  • Yrjö Gröhn, DVM, PhD. (Cornell University). Dr. Gröhn is a Professor of Epidemiology, and served as the Chair of the Department of Population Medicine and Diagnostics Sciences, and specializes in veterinary epidemiology, economic modeling, and food safety.  With Dr. Wells, Dr. Gröhn focuses his efforts on ensuring the integration of the translational projects.  He is also the Co-PD of the epidemiology project.

 

  • Vivek Kapur, BVSc. PhD. (The Pennsylvania State University). Dr. Kapur is Professor of Veterinary and Biomedical Sciences and Associate Director of the Huck Institutes for the Life Sciences and specializes in microbial genomics and pathogenesis of animal and human pathogens including MAP.  Dr. Kapur has served as the PI of the JDIP program and lead investigator in the MDA multi-state initiative and is responsible for implementing EC decisions as Director of the Administrative Core.  This includes serving as the primary liaison with the funding agency, the External Advisory Board, and other private and public stakeholders. In addition, together with Drs. Sreevatsan and Coussens, Dr. Kapur helps with the integration of activities amongst the diagnostic project and developmental grant projects, respectively.

 

  • Donald Lein, D.V.M., Ph.D. (Cornell University).  Dr. Lein is Professor emeritus of Population Medicine and Diagnostic Sciences and the former Director of the Cornell Animal Diagnostic Laboratory with a strong interest in mycobacterial and zoonotic infectious diseases.  Dr. Lein has served in senior leadership roles at the state and national levels, including at the USAHA and will serves as the chair of MDA-CAP external advisory board.

 

  • Kenneth Olson, Ph.D. (KEO Consulting).  As Outreach Coordinator, Dr. Olson facilitates and coordinates the MDA-CAP external stakeholder communication program with a primary focus on delivery of information to producers and industry representatives via industry trade journals and other stakeholder venues.  He reaches other animal science professionals with information about MDA through professional organizations including the American Dairy Science Association, the American Society of Animal Science, the United States Animal Health Association and the National Johne’s Work Group. 

 

  • Fred Quinn, Ph.D. (University of Georgia).  Dr. Quinn is Professor and Head of the Department of Infectious Diseases at the University of Georgia College of Veterinary Medicine.  Dr. Quinn has considerable experience in the area of pathogenesis, diagnostics, and vaccines for mycobacterial diseases, including at the CDC where he was Chief of the Pathogenesis branch in the Division of AIDS, STD and TB.  Along with Dr. Bermudez, Dr. Quinn will focus his efforts on identifying, evaluating and translating MDA-CAP research into promising vaccine candidates and diagnostics.

 

  • Scott Wells, DVM, PhD. (University of Minnesota).  Dr. Wells is the Director of Education for the Department of Veterinary Population Medicine and specializes in epidemiological studies related to the control of manure-cycle pathogens in dairy cattle and other food producing animals, including bTB and MAP.  Together with Dr. Olson, Dr. Wells will focus his efforts in coordinating the efforts of MDA-CAP with related federal and state initiatives in bTB and JD.

 

  1. All strategic, scientific, and management policy decisions will be made by consensus.

 

  1. EC members will be appointed for a two-year term with opportunity for annual renewal based on a continued willingness to serve and EAB approval.  Barring unforeseen circumstances, in order to ensure continuity of effort at the senior leadership level, we do not anticipate significant turnover of EC members.

 

  1. In the event of change in composition of the EC due to voluntary or involuntary circumstances, nominations for new members will be sought from the membership and voted on at the next annual meeting of JDIP investigators and approval by the EAB.

 

  1. Chair of the EC.  The PI serves as the Chair of the EC.

 

  1. Responsibilities of the EC. The EC serves as a governing entity of MDA-CAP and is responsible for the overall management and administration of the program. 
    1. The EC makes all responsible efforts to achieve unanimous consent.  A non-unanimous vote has not occurred in the past five years. 
    2. The EC decides the overall scientific strategy of the program including the direction of research efforts and appropriate venues and teams for such research.  In this capacity, the EC is responsible for all decisions regarding changes in direction or termination of Projects and Cores.
    3. The EC appoints sub-committees (that may comprise of non-EC members) whenever needed in order to make flexible and informed decisions and provide guidance to the EC.
    4. The EC nominates and votes on the composition of the EAB.
    5. The EC advises the PI and the Administrative Core on issues relating to the overall strategic, scientific, and management policy decisions regarding JDIP for implementation.

 

  1. Mechanism by which the EC will exercise its authority.  The EC advises the PI and the Administrative Core on issues relating to the overall strategic, scientific, and management policy decisions regarding JDIP for implementation.

 

 

 

Administrative Core

 

 

Mission. The mission of the Administrative Core (AC) is to: (1) implement and facilitate programmatic goals and objectives as laid out by the MDA-CAP Executive Committee; (2) serve as the primary interface with the USDA; (3) facilitate intramural and stakeholder communications; (4) facilitate interactions with the advisory board and stakeholders; (5) provide oversight of project, core, and developmental grant activities; (6) organize the annual MDA-CAP meeting; And, (7) serve as the grants administration liaison for MDA-CAP.

 

Core Description.  The AC is responsible for overall program administration and ensure strategic decisions are effectively communicated, implemented and overall program goals achieved.  The AC also serves as the primary liaison with the funding agency, external advisory board, and external stakeholders.

Core Activities. The AC performs five specific tasks:

 

Task 1.  Implement the program management plan, coordinate and supervise MDA-CAP activities so as to ensure that the program goals are being achieved and recommendations of the Executive Committee are implemented.  Specific activities include monitoring progress of scientific projects and core activities, extension related programs, and developmental and education programs.

 

Task 2.  Organize weekly teleconference calls of the MDA-CAP EC and monthly teleconference of the MDA-CAP SAB, organize meetings of subcommittees when needed, facilitate electronic communication among MDA-CAP members through mailing lists and website, develop and distribute the MDA-CAP newsletter, and organize the MDA-CAP annual meeting.

 

Task 3.  Oversee MDA-CAP Developmental Projects (seed grants) and Career Development and Education Programs to facilitate access and recruitment of new technologies and investigators to MDA-CAP. This will enable the program to expand the range and scope of research activities, as well as recruit new investigators and institutions to MDA-CAP.

 

Task 4.  Facilitate interactions such that MDA-CAP resources, investigators and cores are made available to investigators across all participating institutions, as well as to Government, Industry, and other stakeholders as needed.

 

Task 5.  Facilitate extramural communications so as to share key technical achievements of the program with external stakeholders impacted by MDA-CAP activities.  This will be accomplished by lay audience and stakeholder presentations as well as technical and educational publications and briefings regarding MDA-CAP through stakeholder focused trade publications.

 

Core Members and Location: The AC will be located at The Pennsylvania State University and Directed by the PI of MDA-CAP (Kapur).  To facilitate and coordinate our external stakeholder communications program, we have recruited a leading expert in the field, Dr. Kenneth Olson, Director of Educational Programs for the National Institute for Animal Agriculture (NIAA), and a past chairman of the board of the NIAA.  Dr. Olson has established the National Johne’s Education Initiative that NIAA coordinates with a grant from USDA/APHIS/Veterinary Services.  He has also established “Johne’s Information Central”, a website supporting the efforts of the National Johne’s Education Initiative (www.johnesdisease.org).  Dr Olson is responsible for coordinating the communication and education program activities.

 

Core Deliverables: AC short and medium-term deliverables will include: (i) implementation of the MDA-CAP program as approved by the funding agency and per recommendations of the Executive Committee; (ii) execution of the management plan including assembling the EAB;  (iii) maintenance of the MDA-CAP web-site, newsletter, and annual report; And, (iv) organization of MDA-CAP teleconferences and annual meeting.

 

 

 

MDA-CAP Scientific Advisory Board

 

 

 

The MDA-CAP Scientific Advisory Board (SAB) provides advice on programmatic matters relating to setting research, education, and extension related priorities, based on a rigorous peer-review of the process of all projects and cores. They also evaluate the scientific progress and merits of all projects, cores, and developmental grant activities to ensure that MDA-CAP stays true to its mission, capitalizes on recent scientific advances, and responds to needs in the field:

 

 

  1. Composition, Voting, and Membership of the SAB.  The MDA-CAP SAB is comprised of 12 members, including two representatives (one representing bTB and the other MAP) from each of the five research, extension, and education project areas and the shared animal resource, the PI and the Chair or other nominee of the EAB.

 

  1. The PI exercises a vote on the SAB only if required to break a tie.  The Chair of the EAB is a non-voting member

 

  1. On an annual basis, the PI will solicit nominations for a single representative from each of the Projects and Core Facilities to act as the leader of the group and serve on the SAB in this capacity. 

 

  1. Members of each Project or Core will be asked to elect their representatives to the SAB at the annual meeting of MDA-CAP investigators.  Whilst regular rotation of project leaders is expected through regular elections with re-nomination of a project leader beyond a two-year term discouraged, core Directors will encouraged to continue for a longer term due to the fact that the frequent transfer of key infrastructure resources will be disruptive to the overall program and not be consistent with developing a self-supporting facility in the long-term.

 

  1. Chair of the SAB.  The position of Chair of the SAB will rotate on an annual basis between MDA-CAP Project Leaders and Core Directors as decided by consensus or simple majority vote.

 

  1. Responsibilities of the SAB. The SAB is responsible for identification of knowledge gaps and setting research priorities, and peer-review evaluation of the scientific progress of continuing and developmental program activities.
    1. The SAB makes reasonable efforts to achieve unanimous consent.  However, in case this is not possible, the SAB decides by a simple majority vote of its members.
    2. The SAB routinely evaluated all continuing and developmental scientific projects and cores under the auspices of MDA-CAP and make specific recommendations to the EC regarding changes in direction or termination of Projects and Cores.
    3. The members of the SAB each assume a leadership role in their specific project or core activity, are responsible for continually canvassing the community for new ideas, and remain available to provide guidance to new investigators in the field.
    4. Members of the SAB are responsible for the formulation of annual progress reports for their respective areas, and present this at the annual meeting of MDA-CAP.

 

  1. Mechanism by which the SAB exercises its authority.  The SAB advises the PI and the Administrative Core on issues relating to the overall strategic, scientific, and management policy decisions regarding MDA-CAP for implementation.

 

 

 

 

External Advisory Board

 

 

The External Advisory Board (EAB) of MDA-CAP serves a key role in the success of the program – its members consist of prominent scientists and public and private stakeholders including from regulatory agencies and members of industry.  The EAB provides advice on programmatic matters and ensures that MDA-CAP stays true to its mission and capitalizes on recent scientific advances while responding to needs in the field.  The EAB reviews the scientific programs and other MDA-CAP activities, makes the final decision on funding recommendations, and provides advice on programmatic issues to the Executive Committee at least once a year during the annual MDA-CAP meeting or as needed on an ad-hoc basis.  A brief overview of the salient features of EAB is given below:

 

  1. The MDA-CAP Executive Committee is the appointing authority of the EAB.  The initial appointment of a member to the EAB will be for a period of two years, with the possibility of a one-year extension and or reappointment to ensure continuity.

 

  1. The EAB is responsible for providing oversight regarding scientific and programmatic progress of MDA-CAP.  This occurs by participating in setting programmatic goals that are communicated in the annual RFA, and making the final decision on funding recommendations by having the authority to approve or deny requests for the funding of specific program or core activities as recommended by the EC following peer-review.

 

  1. The Chair of the EAB is responsible for preparing an independent annual report regarding progress of MDA-CAP in achieving its objectives and milestones to the USDA.

 

  1. EAB members will be requested to attend the annual general meeting of MDA-CAP investigators, and may be requested to participate in quarterly project updates via teleconference. From time-to-time, EAB members may be requested to participate in special teleconferences with the Executive Committee to discuss key strategic issues.

 

Recognizing the importance of the EAB, we have assembled a powerful and well-represented board for MDA-CAP that includes both new and continuing members from the highly successful JDIP CAP program. 

 

Individuals who currently serve on our EAB is provided here. The EAB will be chaired by Don Lein. (EAB Chair) Cornell University, Ithaca, NY. Dr. Lein is Professor Emeritus of Pathology and Theriogenology, former Chair of the Department of Population Medicine and Diagnostic Sciences, and Director of NYS Animal Health Diagnostic Laboratory, College of Veterinary Medicine, Cornell University . Dr. Lein was the founder of the Johne's program in NY. He is the recipient of a number of national and international honors and awards in animal health. He has served as president of the AAVLD and is past president of the USAHA and has served as Chair of JDIP EAB.

 

The outstanding caliber and track-record of the EAB along with their documented willingness and commitment to continue to participate on the MDA-CAP EAB and help develop the program through its formative years and beyond, are strong indicators that MDA-CAP will stay true to its mission and capitalize on recent scientific advances while responding to emergent needs in the field of bTB and JD research, education, and extension.

 

 

 

MDA-CAP Program Operational Guidelines

 

 

 

In order to ensure the continued success of MDA-CAP, we have put in place an administrative structure that serves to guide us in making key decisions through our future.This structure has been developed through an evolutionary process and in consultation with our EAB and USDA program staff. Hence, based on our experience and documented track record of operating as a collaborative and integrated team, we already have in place a well-developed program administration plan and governing principles for defining the collaborative and consortium arrangements between participating investigators and individuals.

 

An overview of the MDA-CAP program administration plan is provided in the sections below:

 

    Description and Procedures for Standing Committees. 

 

          1.        Description and Procedures for Standing Committees. 

 

Descriptions of the Executive Committee, External Advisory Board and Scientific Advisory Board have already been detailed in the preceding sections.

 

2.        Procedures for selecting and evaluating the most promising research programs.  

 

To ensure identification of the most promising programs for future research, education, and extension, we will develop an RFA for MDA related grants each year from year 2 onwards.  This is made available on the MDA-CAP website, and sent out via e-mail to the membership and as well as to Research Deans at participating institutions and to other mailing lists including the AABP, NMPF, NCBA, ASI, CRWAD, and other relevant e-mail list-servers.  On receipt of applications, the AC assigns external reviewers to review and score the proposals as per standard procedures for USDA and NIH study sections (by assigning a numeric score of 1 to 9). The AC calculates an overall score in order to rank the applications.  The review criteria is similar to those applied to USDA and NIH applications (Relevance, Scientific Merit, and Facilities) and special consideration given to new investigators or those whom have not before received federal funding for bTB or JD research.  EAB and funding agency input are then solicited for all projects deemed meritorious for funding in order to ensure accountability and relevance.

 

Mechanism for Funding of Seed Grants.  Applicants will be able to request funding for a one-year project for materials and supplies costs associated with the seed-grant. These funds may be used to enable new programs to obtain key preliminary data so as to transition to mature independently funded programs capable of delivering products into translational pipelines.  Justification for budgets and project milestones will be required in the applications and developmental grants will be dispersed to the investigators sponsoring institution(s) directly from the Administrative Core at The Pennsylvania State University.

 

Criteria for evaluation of programmatic success and ensuring accountability. Clear criteria have been established for the evaluation of all MDA-CAP sponsored projects.  In general, projects will be evaluated through the following mechanisms:

 

  1. Regular interactions with designated Executive Committee members who will serve as mentors or advisors for MDA-CAP sponsored projects;
  2. Brief progress report submitted to the SAB at 6 months after funding summarizing progress, problems, and expectations for continued progress in achieving agreed upon milestones;
  3. Presentation of the research results at the annual MDA-CAP meeting; And,
  4. Annual progress report detailing progress on project aims and plans for submitting proposals for extramural funding (to USDA, NIH, and other agencies).

 

Criteria for Project Continuation or Termination. Continued funding of the MDA-CAP-sponsored projects will be determined through two mechanisms.

 

  1. Productive projects of high priority will be encouraged to continue as full research programs and seek funding from extramural sources.  If requested by the investigators, designated mentors and/or suitable collaborators will be identified from within the MDA-CAP consortium to help with project development and provide other support needed to increase likelihood of receiving extramural funding.

 

  1. Projects with no demonstrated progress in a six-month period will be put on a formal alert and required to provide a special update at the 9-month funding anniversary.  If these continue to fail in demonstrating progress at 9 months and show little likelihood of success, the Executive Committee will be notified and the project recommended for being terminated.  The Executive Committee, in consultation with and approval from the EAB, will make the final decision regarding discontinuation of funding, and all unexpended funds will be required to be returned to Developmental Projects Fund of the MDA-CAP program.  It is understood that, for certain types of projects, significant progress will not be able to be achieved in the six-month period and hence progress will be evaluated on the basis of milestones agreed upon prior to the start of funding.

 

3.        Procedures for evaluating and developing new resources through the scientific core facilities.

 

Rationale for development of core facilities.  A key factor in the success of the JDIP program was the quality and effectiveness of its core facilities that helped provide access to standardized and state-of-the art facilities, intellectual resources, and reagents to the community. 

 

Developing metrics of success for core facilities.  Similar to the projects, each of the core facilities are required to demonstrate progress on achieving programmatic goals and attaining agreed upon project milestones. However, as outlined in the Program Description section, Core facilities have several key distinguishing features when compared with projects:

 

  1. While research projects are focused on discovery and translational research, core facilities primarily provide a service function;
  2. Unlike research projects, core facilities provide service to all members of the MDA-CAP community including external stakeholders;
  3. Unlike research projects, core facilities are expected to partially support themselves through the generation program revenue and mature to full cost-recovery based programs; And, finally,
  4. Whilst it is expected that research projects will be ephemeral, successful core facilities will likely endure through the life of the program.

 

The most important benchmarks for success of the scientific core facilities are documented by: (i) how widely they are used as a community resource (for example, by measuring the number and frequency of use); (ii) the impact that they have on multiple programs, including through facilitation of collaborative research; (iii) documenting that the support of activities through the core mechanism prevents duplication of research facilities and or research expenses; And, (iv) demonstration of leverage by obtaining extramural/matching funding and or support through user-fees.

 

Criteria for evaluation of success and ensuring accountability of core facilities. Clear criteria have been established for the evaluation of all MDA-CAP sponsored core facilities.  In general, cores will be evaluated through the following mechanisms:

 

  1. Brief (one page) progress reports submitted by the Core Facility Director to the SAB at 6 months after funding summarizing progress, problems, and expectations for continued progress in achieving previously agreed upon milestones;
  2. Presentation of the core facility capabilities, use, and research results (if applicable) at the annual MDA-CAP meeting; And,
  3. An annual (2-3 page) progress report detailing progress and plans for submitting proposals for support of core activities for extramural funding (USDA, NIH, other) if practicable or achieving self-sufficiency through charge-backs and/or user-fees.

 

 

Criteria for Continuation or Termination of Core facilities or Activities. Continued funding of the MDA-CAP-sponsored projects will be determined through two mechanisms.

 

  1. Productive core facilities with a documented track record of supporting multiple MDA-CAP investigators and projects will be encouraged to continue and seek funding from extramural sources wherever applicable or achieve self-sufficiency through charge-backs and or user-fees.
  2. Core facilities with no demonstrated progress for the entire core or specific activities of the core in a six-month period will be put on a formal alert and required to provide a special update at the 9-month funding anniversary.  If the core continues to fail in demonstrating progress at 9 months and shows little likelihood of future success, the Executive Committee will be notified and the Core facility or specific core activity recommended for being refocused or terminated.  The Executive Committee, in consultation with and approval from the EAB, will make the final decision regarding discontinuation of funding, and all unexpended funds will be required to be returned to Developmental Projects Fund of the MDA-CAP program.  As with the projects, It is understood that, for certain types of core activities, significant progress will not be able to be achieved in the six-month period and hence progress will be evaluated on the basis of milestones agreed upon prior to the start of funding.

4.    Plans for ensuring easy community access to core facilities.  As described above, a key function of the core facilities will be to provide broad-based community access to enabling technologies and research facilities, standardized reagents and resources, and simultaneously ensure economies of scale.  In addition, the core facilities will also serve to promote linkages with public and private stakeholders including commodity groups, pharmaceutical and biotech industry, federal, state, and local agencies to foster translational research in bTB and JD by a broad range of qualified scientists.  Hence, special emphasis will be made in communication of core facility resource information to community and stakeholders. 

 

        In order to ensure easy community access to core facilities, a easy to navigate user-friendly website for the MDA-CAP core facilities and resources including a menu of services, price lists, and order forms (wherever applicable) will be hosted on the MDA-CAP webs-site. In addition, information regarding new resource availability will also be communicated through the MDA-CAP newsletter, web-site links, as well as relevant scientific and stakeholder newsgroups and list-servers.

 

5.     Plans for translation of research results into useful products and procedures

 

        Detailed plans for communication of research results that have been developed into useful products and procedures will be developed through the extension and education core.

 

        MDA-CAP will not endorse any specific company and or commercial product.  However, it will, through the Administrative Core, Steering Committee, and EAB strive to serve as liaison with relevant biotech or pharmaceutical industry contacts, as well as with the regulatory agencies in order to facilitate the development and dissemination of new products and procedures of relevance to bTB and JD diagnosis, prevention, and control.

 

6.     Procedure for dissemination of research results.

 

        The primary means of communication of research results will be through peer-reviewed publication in high-impact scientific journals.  As a condition of sponsorship, all MDA-CAP-supported research will be encouraged to acknowledge the funding source (specifying the USDA-NIFA AFRI funding program).

 

        Another means of communication of research results will be through abstracts and presentations at Annual Meeting of MDA-CAP investigators.  This will serve as an important means of summarizing novel findings relating to bTB and JD and communicating preliminary or soon-to-be-published results to a motivated and interested audience.

 

        All summaries of MDA-CAP sponsored research will be communicated through the MDA-CAP web-site which will also serve as a forum for providing links to relevant online reviews and an annotated bibliography of bTB and JD related research publications

 

        Finally, the MDA-CAP will also sponsor through its website, an online scientific discussion group and archive in order to facilitate communications and collaboration between and among MDA-CAP investigators and other scientists.

 

7.     Additional Factors For Success.  Documented Commitment of the Principal Investigator, Project Leaders, and Institutions to MDA-CAP.  A major consideration in ensuring the success of MDA-CAP is the commitment of program leadership and participating Institutions to the initiative.  In this regard, the PIs and JDIP leaders, including members of the Executive Committee commit at the very minimum, 10% of their effort to MDA-CAP.  Together with the substantial commitment of effort of the PI and co-PD to this initiative (30%), this has helped ensure that the success of MDA-CAP remain a high priority for program leadership.

 

 

In sum, we believe this management plan has put in place the administrative framework to help develop a set of management principles that will continue to serve to guide us in making key decisions and ensuring success of the MDA-CAP program.