2009 Guidelines For Submission

I. Program Eligibility

1. Who May Apply?
   Anyone with rights as a principal investigator and whose employer is Harvard University is eligible to apply.


2. Field:
   The focus of the proposal must be in the Life Sciences.


3. Research Eligible for Funding:
   Examples of the type of research that would be considered eligible for funding include, but are not limited to:
   • Structure-based design and synthesis of small molecule modulators of novel drug targets
   
   
   • Testing of small molecules in cell-based and/or animal models of disease to investigate their therapeutic relevance or demonstrate proof-of-concept
   
   
   • Medicinal chemistry on compelling hits obtained from high-throughput screens (e.g. to define structure-activity relationships, increase potency or optimize target selectivity, improve metabolic stability for in vivo testing)
   
   
   • Testing of monoclonal antibodies and other biologics for diagnostic or therapeutic uses (in vivo, ex vivo)
   
   
   • High-throughput screens for modulators of novel, high-value targets with the goal of generating probes of molecular function ("tool compounds")
   
   

II. Funding Levels

Within the established budgetary parameters, projects will be funded at the level deemed necessary to achieve the proposed research objectives. Depending on the nature of the research and the objectives, it is anticipated that typical awards will range between $100,000-$150,000 for a period of one year, although exceptions may be made as appropriate.

One such exception relates to proposed optimization of small molecules discovered via high-throughput screening - "medicinal chemistry" projects - for which we have a new roadmap. In general these projects will begin with a "pilot grant" of approximately $10,000 - $25,000 for a period of three to six months. During the term of the pilot grant, the investigator will work with the Chief Scientific Officer of the Accelerator Fund and OTD staff to answer key questions related to suitability of the compound(s) for full medicinal chemistry. These questions will include:

1. Have the relevant high-throughput screening "hits" have been repurchased (or re-synthesized) and their activities confirmed by dose-response curve in the primary screening assay?
2. Have the compounds have undergone analytical testing (e.g. mass spec, NMR) to confirm their structures?
3. Has a medicinal chemistry plan been drafted which clearly articulates the goals for the optimization and identifies key liabilities of the molecules that need to be addressed? This plan should identify an initial target set of analogs which can be purchased or synthesized and tested to determine whether the project is a good candidate for a large-scale medicinal chemistry effort.
4. Is an appropriate, robust bioassay (molecular or cell-based) for analog testing currently implemented and validated in the investigator's lab?
In cases where the above requirements have already been met at the time of application, a project will be considered for immediate full-scale Accelerator funding (~$100,000-$150,000 for a period of one year). Otherwise, if a project awarded a "pilot grant" yields favorable results, this project will then be considered by the Accelerator Advisory Committee for full Accelerator funding.

III. Budget and Resources

All proposals should include a detailed budget.

1. Funding will not be subject to Harvard indirect expense charges.
2. Funding may only be used for research directly related to, and budgeted under the project, and may not be used for any other purpose. Budget items may not include PI salary, capital equipment or travel. The research project may be structured such that some, or even a large portion of the approved, budgeted activities will be outsourced to one or more approved contract research organizations (CROs). OTD will assist the PI to identify qualified CROs, and OTD will negotiate a work-for-hire agreement on behalf of the PI.

IV. Proposal Review and Selection Process



1. Pre-proposals

Applicants should work closely with the OTD team to develop a short pre-proposal. Only one proposal per applicant will be accepted. Pre-proposals should be no more than 2 pages in length. In order to identify the most promising projects, the pre-proposals will be subject to a preliminary review and triage process by the OTD team. Those applicants whose proposals are deemed to best satisfy the Accelerator threshold evaluation criteria (see below) will be invited to submit a full proposal. It is anticipated that approximately 10 applicants submitting pre-proposals will be invited to submit full proposals.

Format for Pre-proposals: The pre-proposal should address and contain the following:

Section 1 - Background and Significance
1. Need and Significance (highlighting the novelty, risk and potential benefits of the project).
2. Briefly describe recent research directly relevant to the proposal, including others in the field and, in particular, your own work.
Section 2 - Proposed Research Plan
1. Specific Aims and Objectives - For each specific objective, provide a rough estimate of the cost and time required for completion.
2. Describe the criteria that will be used to determine if the specific aims have been achieved.
3. Total amount requested.
Section 3 - Investigator Data
1. Principal Investigator(s)
2. Collaborators and/or other key project participants, if any
3. Identify all prior, current and/or pending sources of support to your lab related to the proposed research project.
4. P.I. curriculum vitae (in brief)
Appendix - Relevant publications/manuscripts (no more than 5)

2. Full Proposals

Full proposals must be prepared in accordance with the outline in attached Appendix A. Such proposals should be no longer than 20 pages long. OTD will work closely with PIs to provide assistance in the development of full proposals, in particular the establishment of sound technical milestones and appropriate budgets. Full proposals will be reviewed by the Accelerator Fund Advisory Committee, a small group of external technical advisors and experts appointed by the Provost. The Advisory Committee (in consultation with OTD) will make all award decisions, which decisions will be final. OTD will facilitate the implementation of Advisory Committee recommendations, as appropriate.

V. Threshold Evaluation Criteria

Selection of proposals for funding will be based on an equal weighting of criteria related to scientific/technical merit, commercial potential, the potential of obtaining broad, enforceable patent protection, and the potential for technology transfer. The following factors comprise the major threshold evaluation criteria which will be taken into consideration as part of the proposal review process:

Scientific and Technical Merit

• Quality of the proposed research and scholarship.
• Innovation and novelty of the proposed research and/or technology in question.
• Technical feasibility and risk of the project and/or technology in question.
• Probability of achieving project goals within the proposed budget.
• Clarity and focus of the research objectives and proposed technical milestones.
• Potential impact and significance of research results on human health and public benefit.
Potential for Technology Transfer
• Probability that research results will enable and support obtaining a strong patent position, or enhancing an existing patent position.
• Significance of market need and opportunity.
• A relatively clear and short path to a commercially viable technology.
• Whether, and the extent to which, the technology in question offers a competitive advantage over currently available technologies
• Probability that funding will result in significant advances leading to additional extramural funding (from industry) and/or technology transfer.

VI. Duration of Funding Period

Proposals will be funded for up to 12 months of effort. Extensions or renewals for a second year may be granted, subject to demonstrated progress, submission of a new application and approval by the Accelerator Advisory Committee. An exception is if during this 12-month period, funding support for the same project is secured from industry, in which case the remaining (unused) funds provided by the Accelerator will be returned to the Accelerator.

VII. Reporting Requirements

Progress reports will be prepared and submitted three times per year, inclusive of a final report. The final report is due within 30 days of the end of the grant period. The final report should specifically address research results relative to each specific aim and a statement of any inventions made in the course of the performance of the funded project. Periodic financial reports will be run to verify appropriateness of expenses to the project.

VIII. Other Requirements: Terms and Conditions of the Award



1. Time and Effort: The PI will commit his/her time and effort, as appropriate, to lead and oversee the project.
2. Inventions and Intellectual Property: It is not necessary for there to be any background or pre-existing inventions, nor that there be any prior intellectual property, however if there is any background intellectual property it must have been assigned to Harvard. In the event that any new inventions are conceived or reduced to practice in the course of performing a research project supported by an Accelerator award, it must be disclosed to the Office of Technology Development and, thereafter, assigned to Harvard. The PI must report any and all inventions to OTD in advance of a public disclosure, within 30 days of the disclosure, in order to allow OTD staff to determine if such public disclosure contains new potentially patentable subject matter.
3. Research Plan: Any significant mid-course revisions to the research plan will require approval by OTD and the Accelerator Advisory Committee.
4. Milestones: The applicant's proposal must comprise a research plan that includes proposed objective technical milestones, which need to be accepted by OTD and the Advisory Committee. The achievement of such milestones will serve as key decision points for the assessment of progress and the determination of continued funding. A project may be terminated if agreed-upon technical milestones have not been met.
5. Funding Status: In the event that a proposed project should receive funding support from industry during the interval between the date the proposal is submitted to the Accelerator for review and the time funding decisions are made, it will no longer be considered eligible for Accelerator funding. Moreover, as stated above, if a project is awarded Accelerator funding, but during the 12-month funding period, funding support for the same project is secured from industry, the remaining (unused) funds provided by the Accelerator will be returned to the Accelerator.

Submission of Proposals

Pre-proposals must be received by no later than 6:00PM on March 2, 2009 in Microsoft Word (.doc) or Adobe Reader (.pdf) format. Proposals should be submitted via e-mail to: curtis_keith@harvard.edu. The subject line should read "Accelerator Proposal."

If you have any questions please call: (617) 496-0478.

	Schedule and Deadlines - 2009
January 26, 2009	RFP
March 2, 2009	Deadline to submit pre-proposals
March 16, 2009	Announce decisions/solicit full proposals
April 27, 2009	Deadline to submit full proposal
	= Advisory Committee Review Period and Meeting =
May 28, 2009	Awards announced by the Provost

Appendix A: Format for Full Proposal
Cover Page
Budget
PI Name, Department
Project Title

Section 1 - Project Summary or Abstract

1. Describe the need, problem or opportunity, and significance of the project
2. Describe the potential benefits of the project
3. State the research objectives, research plan and anticipated results
Section 2 - Project Description
1. Research Objectives
   1. describe your specific research objectives in order of priority
   2. for each objective, estimate the cost and time required for completion
   3. identify any objectives that may require more time to complete or are contingent upon completion of earlier stage objectives
2. Research Plan and Milestones (a.) provide a brief introduction to the area of investigation (b.) describe the experimental methods you will utilize to achieve each objective (c.) describe the anticipated results (d.) provide a 12 month work performance schedule or GANTT chart (e.) proposed objective technical milestones
3. III. Related Research and Research Support (a.) describe significant recent research related to this proposal, including your own work and others in the field.
Section 3 - Intellectual Property (if applicable)
1. provide a brief description of any inventions you have already made related to the proposed research
2. provide a statement about the current status or stage of the invention.
3. describe how the proposed research will add value to and enhance the invention's patentability and/or commercial potential and/or importance
Section 4 - Budget and Budget Instructions (create a budget worksheet)

Section 5 - Key Personnel & Collaborators
Brief Bios

Appendix: Manuscripts/Publications
Download PDF version
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