Assuming proposals of sufficient merit, this competition is expected to fund about 5 grants for an aggregate total cost of $9 million USD over two years. Individual grants are eligible for up to $1.5 million per project.

Since the output of this program may lead to innovative technologies and/or products that will result in improved diagnostics for those that need of them most in the developing world, the successful development of these high priority products may require substantial involvement and support of private sector industries as sub-contractors, and may also involve collaborations with multiple organizations, including academic and/or non-profit research institutions. It is the intent of this program to support the formation of appropriate public-private partnerships that are essential to meet these urgent global health needs. Intellectual property (IP) rights and the management of IP rights are likely to play an important role in achieving the goals of this program. To this end, the foundation requires that, even at the LOI stage, all applicants seriously consider their willingness to submit a full proposal in compliance with the foundation’s proposal guidelines, a portion of which asks for certain information and intentions regarding intellectual property and global access concerns. Specifically, the Bill & Melinda Gates Foundation requires that you agree to use good faith efforts to conduct and manage the research, technologies, information and innovations involved in the Project in a manner that enables (a) the knowledge gained during the Project to be promptly and broadly disseminated, and (b) the intended product(s) to be made available and accessible at reasonable cost to the developing countries of the world. The foundation refers to this as “Global Access.”

As part of the foundation’s review and evaluation of each full proposal, due diligence will be conducted with respect to each participant’s ability and commitment to manage intellectual property in a manner consistent with the stated scientific and charitable goals of the Bill & Melinda Gates Foundation. Due diligence activities may include inquiry into an applicant’s:

1) Freedom to operate (FTO) and ability to freely use and acquire needed background technology;

2) Commitment to promote the utilization, commercialization and availability of inventions for public benefit in developing countries

In order to facilitate this due diligence process applicants are encouraged to provide information with respect to the items above in their submission materials.

Applicants are also expected to make new information and materials known to the research and medical communities in a timely manner through publications, web announcements, progress reports to the foundation, and other appropriate mechanisms. These concepts may be discussed at some length with the applicants invited to submit full proposals, and will be addressed (to the extent appropriate) within each final grant agreement. The Global Access Strategy will also include provisions defining these concepts.

Yes, you are encouraged to address multiple topics. Alternatively, you may address a portion of a listed topic or portions of multiple topics; proposers are expected to list all applicable topics that they plan to address on the application form and on the title page of their proposal.

The foundation will not be providing any specimens or samples to grantees. In some unique cases, the foundation may help to facilitate collaborations to address the access to specimen issue.

Yes, please use the foundation application portal Unison to submit a Letter of Inquiry. Please review the Letter of Inquiry instructions and complete the application in accordance with the rules and guidelines for the request. Instructions can be found here.

Significance. Is the approach likely to deliver validated biomarker(s) that accurately reflect the physical and physiological integrity of the gut in children in the developing world? Could the biomarker(s) proposed facilitate the future development of robust diagnostic test(s) for use in pediatric populations in low resource settings? Do the biomarker(s) proposed represent an important advance in the field through an innovative approach, robust validation plan, and/or potential to test a long standing but as yet unproven candidate marker?

Approach. Are the conceptual framework, design, methods, and analyses innovative, adequately developed, well integrated, and appropriate to the aims of the proposal? Does the proposal acknowledge potential problem areas and consider alternative tactics? Is the likelihood of successful project completion high? Are the proposed time line and milestones appropriate, feasible, and technically sound?

Best Value. Proposals will be evaluated for the cost of the proposed effort relative to the complexity of the proposed work and the degree of risk and advancement proposed. Proposals that have execution plans which represent particularly thoughtful and efficient use of resources will be preferred over proposals representing comparable efforts that do not represent the same value for the investment.

Organizational and Investigator Capability. Is the research team appropriately trained, experienced, and positioned to carry out this work? Is there strong evidence of substantive organizational capability and commitment? Does the environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environments including partnerships with industry or employ useful collaborative arrangements? While the foundation fosters collaborations and formation of consortiums, these will have to be set up by the proposer, as this will not be done by the foundation.

Invitations to submit full proposals will be issued in March 2012. These time periods are subject to change if the volume of applications exceeds the number expected and thus requires additional time for processing and evaluation. All applicants will be notified by email in a timely manner of any change to the notification and full proposal deadline dates.