Request for Proposals

BLAVATNIK FUND for INNOVATION at YALE
= REQUEST FOR PROPOSALS =
Release date: September 19, 2016
Notice of Intent: October 28, 2016
Pre-proposal submission deadline: November 15, 2016
Full proposal submission deadline: March 31, 2017
Funding start date: June 30, 2017

Background and Purpose: The Blavatnik Fund for Innovation at Yale supports Yale faculty in the commercialization of applied research and technology in the life sciences. A significant obstacle to the development of early-stage university discoveries is the lack of funding for the proof-of-concept and validation studies needed to demonstrate commercial potential. To overcome this barrier, the Fund provides funding and business development support to help validate nascent technologies and identify potential industry partners to advance these technologies to the marketplace.

The Fund seeks to support innovative, investigator-initiated research aimed at extending preliminary observations, with proof-of-concept and the generation of robust intellectual property as key objectives. The Fund is designed to accommodate projects of varying magnitude, as appropriate. Its primary goal is to advance technologies to the point where additional support from industry and/or technology transfer is achieved.

Supported projects may include such areas as therapeutics, diagnostics/biomarkers, medical devices, or research instruments, among others. The expected goal of completed projects will be partnerships with industry, through licenses to existing biopharmaceutical companies and startup firms (some launched from the Fund-supported technology) or via major industry-sponsored research agreements. It is expected that these alliances will lead to additional industry-sponsored research support. The Fund is structured as a sustainable, “evergreen” program, with a portion of the revenue from successfully launched technologies cycled back to support ongoing and future Fund projects.

The Fund and the progress of its supported projects are managed by the Office of Cooperative Research (OCR) under the auspices of the Office of the Provost, in consultation with an independent Investment Advisory Board comprising leaders from the various sectors of the business and investment community.
 

I. Application Timeline
 

Monday, September 19, 2016:
RFP release

Friday, October 28, 2016:
Deadline for Notice of Intent (email: yale.blavatnikfund@yale.edu)

Tuesday, November 15, 2016:
Deadline for pre-proposals (5 pm ET)

Friday, February 10, 2017:
Announcement of projects selected for full proposals

Friday, March 31, 2017:
Deadline for full proposals (5 pm ET)

June 2017:
Announcement of FY2018 awards

Friday, June 30, 2017:
FY2018 funding start date
 

II. Program Eligibility
 

Applicant: Any principal investigator (PI) or researcher, whose employer is Yale University and who has an obligation to assign intellectual property (IP) rights to Yale, is eligible to apply.

Activities Eligible for Funding: The focus of the proposal must be applied research/development in the life sciences. Examples of studies eligible for funding include but are not limited to:

  • Structure-based design, synthesis, and testing of small molecule modulators of high-value targets
  • High-throughput screens and confirmatory studies to identify modulators of high-value targets
  • Medicinal chemistry optimization of lead compounds (e.g., to define structure-activity relationships, increase potency or target selectivity, and improve pharmaceutical properties including solubility and metabolic stability for in vivo testing)
  • Development of therapeutic or diagnostic monoclonal antibodies or other biologics
  • Testing of lead molecules, monoclonal antibodies, or other biologics in cell-based and/or animal models of disease to confirm their clinical or diagnostic relevance
  • Development and validation of clinical biomarkers and/or relevant diagnostic methods
  • Development and validation of novel vaccine technologies
  • Fabrication of proof-of-principle prototypes and creating “minimum viable products” for technical, clinical and consumer feedback.
  • Demonstration of feasibility and utility of novel research instrumentation

III. Award Types and Funding Levels

Fund awards will be made in two categories: Pilot Grants and Development Grants. Within the established budgetary parameters, projects will be supported at the level deemed necessary to achieve the proposed development objectives.  It is anticipated that in most cases all funds will be used to support studies outside of the university through contract research organizations (CROs), corporate partners, etc.

Pilot Grants: Pilot Grant awards will be funded at a maximum of $100k for a period of 12 months. Pilot Grants are intended to support proof-of-concept activities that (if successful) would establish a basis for a subsequent Development Grant proposal. For example:

  • Performance of a high-throughput screen for candidate therapeutic compounds or antibodies, and confirmation of specific biological activity in identified hits
  • Demonstration that a candidate modulator elicits a functional therapeutic response in a suitable animal model

Development Grants: Development Grants will be funded at $200k-300k total for a period of 12-24 months. A formal project review will be conducted at the end of the first year, and approval of second- year funding will be contingent on the achievement of first-year milestones. Development Grants are intended to support efforts that may reasonably be expected to result in technology of direct interest to potential commercial partners within the proposed timeframe. For example:

  • Medicinal chemistry optimization and preclinical studies of lead therapeutic molecules
  • Determination of a candidate vaccine’s ability to elicit protection against pathogen challenge, formulation/stability studies
  • Validation of a biomarker and an appropriately sensitive and specific detection method using clinical samples, correlation of biomarker status with clinical outcomes
     

IV. Proposal Review and Selection Process

1. Pre-proposals (submission deadline: November 15, 2016 at 5 PM ET)

Applicants should notify Yale.BlavatnikFund@Yale.edu as soon as possible and no later than October 28th, 2016, of intent to submit a pre-proposal.  OCR staff will work closely with applicants to develop a pre-proposal according to the format in Appendix A. Based on recommendations from the Investment Advisory Board, a subset of applicants will be invited to submit a full proposal.  Pre-proposals will be due by Tuesday, November 15, 2016.

2. Full proposals

Full proposals must be prepared in accordance with the outline in Appendix B. OCR staff will work closely with PIs to assist in the development of full proposals, in particular with respect to determining a technology’s commercial potential and establishing sound technical milestones to enhance that commercial potential. Full proposals will be reviewed by the Investment Advisory Board and a small group of external technical advisors and experts. The Investment Advisory Board (in consultation with OCR) will make all award decisions. It is anticipated that 5-7 Pilot Grants and 3-5 Development Grants will be awarded in the FY2017 cycle.

3. Evaluation criteria

The goal of the Fund is to advance technologies to the point where additional funding from industry and/or technology transfer is achieved. Thus, proposals will be evaluated on overall potential for technology transfer, including scientific/technical merit, need, and most importantly, commercial potential of the technology and strong commitment of the PI and team. The following evaluation criteria will be taken into consideration during the review process:
 

Scientific and Technical Merit

  • Innovation and novelty
  • Feasibility and risk
  • Clarity of the research objectives and proposed technical milestones
  • Potential impact and significance for human health and public benefit

Commercial Potential

  • Likelihood of enabling a strong patent position or enhancing an existing patent position
  • Significant market need and opportunity
  • A relatively clear and efficient path to the market.
  • Competitive advantage over currently available technologies
  • Significant de-risking or value inflection point without which the technology would not be able to attract commercial partners
  • No third party encumbrances
     

V. Budget and Funding Period

Pilot Grants (up to $100,000) will be funded for up to 12 months of effort and Development Grants (up to $300,000) will be funded for 12-24 months of effort. No-cost extensions may be granted, subject to demonstrated progress and approval by the Fund.

For both Pilot and Development Grants:

During the funding period, if support for the same work is secured from industry or other sources, any remaining (unused) funds provided by the Fund will be returned to the Fund.

Blavatnik Fund support will not be subject to Yale indirect expense charges. 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[1], capital equipment, or travel. The research project should be structured such that most budgeted activities are outsourced to one or more approved contract research organizations (CROs). Fund staff will assist the PI in identifying qualified CROs and developing work plans, and OCR will negotiate work-for-hire agreements on behalf of the PI.
 

VI. During the Award
 

For each Fund project, a project team will be assembled with support from OCR to match the project’s particular needs and monitor progress throughout the funding period. In addition to the PI, team members may include Fund/OCR staff, research personnel, and external consultants with specific technical expertise (e.g., product development and commercialization).
 

VII. Other Requirements: Terms and Conditions of the Award
 

1. Time and Effort: All personnel on funded projects must commit time and effort appropriate to their roles on the project.

2. Inventions and Intellectual Property: There is no requirement for any background or pre-existing inventions, nor any prior intellectual property. However, if there is any background intellectual property, it must have been assigned exclusively to Yale, and not have any third-party encumbrances. Any new inventions that are conceived or reduced to practice in the course of performing a Fund-supported research project must be disclosed to OCR and, thereafter, assigned exclusively to Yale. The PI must report any and all inventions to OCR no fewer than 60 days in advance of a public disclosure to allow OCR staff to determine if such public disclosure contains new, potentially patentable subject matter.
 
Intellectual property conceived, reduced to practice or otherwise made, improved or further developed with Fund support and assigned to Yale will be managed in accordance with Yale’s Patent Policy, and any Net Royalties received on account of the licensing or other distribution of such intellectual property will be done per that Policy.

3. Research Plan and Milestones: Each Fund award is made for a research plan with proposed objective technical milestones that are accepted by the Fund. 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 are not met. Any significant mid-course revisions to the research plan must be approved by the Fund.

4. Funding Status: In the event that a proposed project secures funding support from industry during the interval between the date the proposal is submitted to the Fund and the time funding decisions are made, it will no longer be eligible for Fund funding.

5. Research Compliance: Fund grants are an internal funding mechanism and will therefore not require Office of Sponsored Projects approval. The PI and his or her department are responsible for meeting all compliance requirements associated with the award.

6. Publications: “The Blavatnik Fund for Innovation at Yale” should be cited in all publications that describe work supported by the Fund. Reprints of all publications containing this acknowledgment must be provided to the Fund in a timely manner. As noted above, the PI must report any and all inventions to OCR no fewer than 60 days in advance of a public disclosure to allow OCR staff to determine if such public disclosure contains new, potentially patentable subject matter.

7. Reporting Requirements: Progress updates and reports will be required regularly (quarterly) with the expectation of due dates on November 1, March 1, and July 1 during the funding period. A final report is due within 30 days of the end of the funding period. Each 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 reporting will also be included in these updates to verify the appropriateness of project expenses.

Appendix A: Pre-proposals

LETTER OF INTENT:  Applicants should notify Yale.BlavatnikFund@Yale.edu as soon as possible and no later than October 28 with a Letter of Intent to submit a pre-proposal.  Applicants should work closely with OCR staff to develop a pre-proposal.

APPLICATIONS HAVE CLOSED AT THIS TIME

The following information will be required:

(i)    PI name and department

(ii)    Project title

(iii)    Total budget request

(iv)    Non-confidential executive summary (150 words maximum): please note that this non-confidential summary will be shared with industry partners to obtain preliminary comments. If an applicant has concerns about sharing information with industry, OCR will work with the applicant to address those concerns.

Section 1: Market Opportunity/Background and Significance

(i)    Need and Significance: describe the biomedical need for the technology, its novelty, and the envisioned potential applications. Compare the proposed applications to the current state of the art and competing technologies.

(ii)    Briefly describe recent research directly relevant to the proposal, including that of others in the field and, in particular, your own work.

Section 2: Research Plan

(i)    Specific Aims: For each aim, provide a specific statement regarding its value for commercialization activities, and an estimate of the time required for completion.

(ii)    Describe the criteria that will be used to determine if the specific aims have been achieved.

(iii)    Total budget requested: provide estimated costs by category (salary, supplies, services and fees, etc.).

Section 3: Supporting Information

(i)    Describe the current intellectual property position of the proposed technology, indicating whether the technology is based on already reported inventions, and whether the IP for such inventions is held solely by Yale, jointly with other institutions or has been licensed to a partner.
 
(ii)    Curriculum vitae (2-page maximum each) for the Principal Investigator, collaborators, and any other key project participants.

(iii)    Identify all prior, current, and pending sources of support to the PI’s lab related to the proposed research project.

(iv)    Relevant publications/manuscripts (maximum of 3).
 

Appendix B: Full proposals

Full proposal submission deadline:

PIs are expected to work closely with OCR staff in the development of full proposals, particularly with respect to the commercial development analysis and establishing technical milestones to enhance the technology’s commercial potential. Proposal submission link will be available here at a later date.

(i)    PI name and department

(ii)    Project title

(iii)    Total budget request

Section 1: Executive Summary (suggested 250 word maximum)

(i)    Describe the biomedical need or opportunity and the significance of the proposed technology.

(ii)    State the major research objectives of the project and how they will advance the technology and enhance its patentability or commercial potential.

Section 2: Background, Significance, and Research Plan

(i)    Brief introduction to the area of investigation.  Summarize significant recent research related to this proposal, including your own work and others in the field.

(ii)    Specific research objectives and the experiments planned to achieve each. Describe how the proposed research will enhance the invention’s patentability, commercial potential, and/or importance.

(iii)    Key technical milestones, including a description of anticipated results and go/no-go decision points where possible.

(iv)    Estimated cost and time required for each objective, including a work performance schedule or Gantt chart.

(v)    Reference list

Section 3: Commercial Development Analysis

Based on past experience, it is anticipated that OCR staff will have primary responsibility for preparing the commercial development analysis for the proposed technology, working in close consultation with the PI. Specific arrangements will be made for this when applicants are invited to submit full proposals.
 
(i)    Intellectual property: describe any inventions that have already been made related to the proposed research, and provide a statement about the current IP status of the invention. Also describe how the proposed research will enhance existing IP.

(ii)    Market potential: estimate the size and composition of the potential market, including comparisons to current technologies (if any). Describe the competitive landscape, including current development efforts, and what position the proposed technology occupies within this landscape.

(iii)    Commercialization strategy: describe potential commercialization strategies that could be pursued for the technology if the research aims are achieved. Include specific input from potential partners (e.g., companies, investors).

Section 4: Detailed budget

A detailed budget should be provided for the entire proposed funding period (up to 24 months for Developmental Grants). The budget should provide estimated costs by category:

(i)    Salary (please state percent effort)

(ii)    Supplies

(iii)    Services and fees

(iv)    Other (please specify)

Section 5: Supporting Information

(i)    Curriculum vitae (2-page maximum each) for the Principal Investigator, collaborators, and any other key project participants.

(ii)    Identify all prior, current, and pending sources of support to the PI’s lab related to the proposed research project.

(iii)    Support letters: a support letter must be included if any research objective will require substantial involvement of collaborators (e.g., use of any core facility, collaboration with investigators who are not directly funded by the Fund for the proposed work). Support letters are not required from contract research organizations, but CRO quotes may be submitted as budget justification.

(iv)    Relevant publications/manuscripts (maximum of 3).

 


[1] Except in the event that the faculty member can demonstrate that they do not have the necessary salary support to provide the requisite time and effort appropriate to their role in achieving a successful outcome for their project.