2017RFP

Male Contraceptive Discovery and Development: 2017 Request for Proposals

Program Summary

Funding for US $500,000 total for up to three years will be granted for a research project or projects focused on the development of a new, reversible male contraceptive. Funding for the first year will be for up to $175,000 and funding beyond the first or second year will be contingent on satisfactory progress and availability of funds. MCI will not consider projects that:

  • are hormonal,
  • focus on early-stage sperm development (pre-spermiogenesis), or
  • use immunological approaches.

Partly because they should lead to a more rapid onset of effective contraception, we are especially interested in proposals focusing on:

  • late stages of sperm maturation,
  • sperm function, and
  • sperm transport.

Special consideration will be given to targets or compounds with demonstrated promise (such as identification and validation of a target, druggability, passing toxicity tests, and proof of concept in preclinical trials), for future development as a male contraceptive. This includes prior evidence of specificity and effectiveness in animals and a well-developed strategy for further studies. All projects must provide proof of concept, preferably in an animal model, but a knock-out model or other approaches might be acceptable.

Proposals sought will validate and refine the usefulness of potential male contraceptives and address evaluation of the safety, reliability and reversibility of their use. Proposals are expected to include plans for how current and proposed studies will lead to or include Phase I clinical trials.

Awardees will participate in quarterly teleconferences with MCI to discuss progress and will provide an annual written progress report. All publications derived from the project and future work must be published as open access either by paying an open access fee or by publication in an open access journal. Awardees will also be expected to provide a plan to ensure that any resulting product will be available at public sector pricing in both developing and developed countries. More specifically, awardees should protect intellectual property appropriately, and follow the principles of the Gates Global Access policy (See Appendix). MCI does not intend to receive any royalties or other monetary rewards from an eventual product. MCI reserves the right to modify the conditions for the award and for continuation of funding.

How to Apply

Letter of Intent:

Prospective applicants must submit a Letter of Intent to apply by March 1, 2017 to contact@malecontraceptive.org concisely outlining the proposed research project to be considered. The Letter should not include confidential information. Subject line must be: “MCI Research Grant LOI 2017”

Submit letter as a one-page pdf document (single-spaced, 11 point Arial or Times Roman font, at least 0.5 inch margins). The letter should include:

  1. Applicant’s name, title, institution (or private sector organization), and contact information
  2. Project title
  3. Research plan and strategy for how the proposed research will achieve development of a male contraceptive   

Prospective applicants whose Letter of Intent adheres to these guidelines and meets the goals indicated in the Program Summary will be invited to submit an application. All applicants will be notified by March 7, 2017 whether they are invited to submit an application.


Research Grant Application:

Invited applications are to be submitted by May 1, 2017 to contact@malecontraceptive.org. The application must be in pdf format, 11 point Arial or Times Roman font, with at least 0.5 inch margins. Subject line must be: “MCI Research Grant Application 2017”  Applications must include:

Section 1:

Title Page (one page):

  1. Applicant’s name, title, institution, and contact information
  2. Collaborator’s (if any) name(s), title, institution, and contact information
  3. Signature of institutional official verifying approval of MCI conditions for award
  4. Project Title
  5. Research Abstract

Section 2:

Research Proposal (not to exceed 6 pages, excluding references):

  1. Specific Aims: Concise summary of rationale of aims, questions to be addressed, hypotheses, predicted outcomes, novelty of compound or target being studied.
  2. Background: Key published and unpublished data underlying the proposed studies and the relevance of the methods and approaches to be used.
  3. Research Plan: Describe design and sequence of studies to address Specific Aims; how proposed studies will validate and refine the usefulness of the potential male contraceptive under study; address evaluation of the safety, reliability and reversibility of its use; propose potential alternative approaches. Provide plans for how current, proposed and future research will lead to Phase I clinical trials.
  4. References

Section 3:

Project Management (up to 2 pages)

  1. Applicant’s role and responsibilities in performance of proposed research
  2. Roles of key collaborators (if any)
  3. Novel or essential facilities, equipment, and resources available for the proposed studies or how they will be accessed if not available
  4. Project evaluation: Provide specific year-by-year benchmarks for demonstrating successful research progress

Section 4:

Requested Budget: (years one, two, three and total, including overhead; two page maximum)

  1. Personnel: names, prior experience, roles in project, percentage of salary and benefits to be covered for each
  2. Reagents: cost for general categories, except for unique compounds and reagents
  3. Animals: institutional cage costs, number and species to be used, IACUC-approved protocol numbers
  4. Equipment: essential equipment not available and required for project, manufacturer, cost based on bid from supplier (up to a maximum of $25,000 for the project)
  5. Overhead: 15% of total for Personnel, Reagents, Animals, and Equipment

Section 5:

Curriculum Vitae (up to five pages each for awardee and key collaborators, the NIH biosketch format is preferred (available at https://grants.nih.gov/grants/forms/biosketch.htm)  

  1. Education, current and prior positions and appointments
  2. Current and prior research experience, source and amount of current and prior research support
  3. Publications relevant to application

Section 6:

Appendix (optional, up to 4 pages)

Supporting data, figures, or unique methods and materials

Review

Process and Confidentiality

A panel of expert reviewers will sign confidentiality agreements and be required to destroy, delete or return to MCI all copies of information acquired or created during the course of performing a review.

If applicants have questions regarding the grant and application requirements inquire by email to: contact@malecontraceptive.org with subject line “MCI Research Grant Application 2017”. If a question leads to a change or significant clarification of the grant application instructions, other applicants who have submitted a letter of intent will be notified of the change or clarification.

During the review, MCI may share non-confidential information that you provide to us (either orally or in writing) – such as provided in the letter of intent – with third parties, including key partners and potential co-funders.

For awarded grants, MCI is required by the IRS to publish a list of its grantees. MCI also provides general descriptions of its grants on its web sites, in press releases, and in other marketing materials.

Progress Reports & Monitoring

Continuation of funding beyond the first or second year is contingent on satisfactory progress and availability of funds. MCI may arrange for confidential meetings with consultants with pharmaceutical industry expertise to facilitate development of products resulting from funded projects.

The Awardee is responsible for submitting a Progress Report 60 days before the end of the funding year to contact@malecontraceptive.org with “Research Grant Progress Award” in the subject line.  It is to be in pdf format, using 11 point Arial or Times Roman font and with at least 0.5 inch margins. The Progress Report will be a confidential document. It is to include:

Accomplishments (two pages maximum):

What were the major goals and objectives of the project for the current year and what was accomplished for these goals?

What were the benchmarks for the current year, were they met, and what is the evidence of successful research progress?  

Were there problems or delays or changes to original goals and objective that require modification of research plans?

Budget (one page maximum):

Provide a proposed budget for the coming year and justify amounts and purposes of planned expenditures.    

Review Criteria

Response to Program Summary:  How well does the proposal address one or more of the research areas identified?

Demonstrated promise: Is the proposal based on a target or compound likely to be developed as a male contraceptive? Is there evidence of specificity and effectiveness in animals? Is there a strong scientific premise for the project?

Research plan: Does the proposal provide a well-designed plan for validating and refining the usefulness of a potential male contraceptive and address the evaluation of the safety, reliability and reversibility of its use? Are the studies well-focused and is the scope of work, overall strategy, methods and approaches appropriate to achieve the specific aims of the study within the budget and time available (first and subsequent years of support)?  Are potential problems and alternative strategies considered?

Contraceptive development: Does the proposal provide a plan for extending current and future studies to a Phase I clinical trial?

Investigator: Does the applicant have the knowledge, training and experience needed to perform the research?  Will the investigator be able to devote sufficient time and effort to the project for it to be successful?

Environment: Are the facilities, equipment and institutional support available to the applicant sufficient for the proposed studies to be successful?  Is the support plan to facilitate the proposed research well-conceived?

Applications that do not directly address research areas designated in the Program Summary will not be considered for review. Accepted applications will receive confidential review by a panel with expertise in research in male reproductive biology and in strategies leading to product development. The panel will be advisory to the MCI Board of Directors which has the final responsibility for funding decisions. Reviewers will certify adherence to the Conflict of Interest and Nondisclosure Rules adopted by NIH.

 

Appendix:

Bill & Melinda Gates Foundation

THE ROLE OF IP IN GLOBAL ACCESS

Global Access is a creative concept we came up with in 2003 that requires our grantees and partners to commit to making the products and information generated by foundation funding widely available at an affordable price, in sufficient volume, at a level of quality, and in a time frame that benefits the people we’re trying to help. What role does Intellectual Property play in the foundation’s approach to furthering Global Access? Intellectual Property provides a great opportunity to think creatively and strategically about how we can reach our ultimate beneficiaries. The careful and deliberate management of IP (patents, copyrights, trademarks, trade secrets, and rights in data) and the associated rights created or accessed through foundation-funded projects, is a critical component to achieving Global Access. Global Access commitments also apply to collaborations with for-profit entities. Whether it is a groundbreaking diagnostic tool or a new toilet that does not require a sewer connection or electricity, they are allowed to sell what they develop with foundation funding at a profit in the developed world, as long as the products are made available to the people who need them most.

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