Request for Applications

Timeline
January 12, 2004	Letters of Intent to apply must be e-mailed to CIHR (epalencsar@cihr-irsc.gc.ca) on this date.
January 26, 2004	Full proposals must be courier stamped by this date.
mid-March 2004	Notification of decision.
March 1, 2004	Effective date of grant.
Duration of projects	Up to 12 months (non-renewable).
Funds Available	Grants awarded will range from $50,000 to $100,000 from CIHR.

Table of Contents

Introduction
Background
Specific Objectives and Eligible Research Areas
Who is Eligible to Apply?
Specific Eligibility Requirements
Mechanism of Support
Funds Available
Allowable Costs
How to Apply
Confidentiality
Evaluation Process and Criteria For Peer Review
Common Peer Review Committee Concerns
General CIHR Guidelines and Conditions of Funding
Performance Measurement and Evaluation
Contact for Further Information

Proof of Principle Questionnaire
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(Please note that the questionnaire has changed. Only this new version will be accepted.)

Links to resources for UILO and applicant

Introduction

The Canadian Institutes of Health Research is pleased to announce the launch of the second 2003/04 Proof of Principle Initiative, which includes funding opportunities through:

• Proof of Principle Grants (POP)
• Proof of Principle Partnered Grants (POPP)

Proof of Principle (POP) Grants will fund proof of principle research projects of up to 12-months duration designed to advance discoveries/inventions towards commercializable technologies, with a view to attract new investment and create new science-based businesses.

Proof of Principle Partnered (POPP) Grants will fund previous POP grantees at the co-investment stage undertaking follow-on proof of principle activities in partnership with a non-academic investor. This new funding opportunity is aimed at providing a platform to better enable the academic institution/researcher to move the discovery/invention further down the innovation pipeline.

CIHR is Canada's premier federal funding agency for health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products, and a strengthened Canadian health care system. Part of CIHR's mandate is to encourage innovation, facilitate the commercialization of the results of health research in Canada and promote economic development through health research in Canada.

CIHR is committed to enabling universities and hospitals to maximize the impact of their knowledge and technology resources for the betterment of healthcare and the societal and economic benefits that flow from it. With respect to commercialization, CIHR endeavours to facilitate the development and delivery of Canadian health discoveries and related products and services for domestic and international markets.

Background

Knowledge and technology diffusion and application are key to building an innovative society and enabling economic benefit through decreased health costs, improved efficiencies and successful commercialization of the Canadian knowledge base. While knowledge creation is an essential element in the equation, it is knowledge translation activities that deliver knowledge in the form of policy, information, products and services to government, communities, users and the public.

In recognition of this, academic institutions (universities and hospitals) have been implementing mechanisms to increase the socioeconomic relevance/impact of academic research, resulting in an increasing number of technology disclosures. Yet attention to facilitate commercial benefit to Canada from these disclosures has not kept pace and additional resources are required to better validate opportunities that would otherwise be missed or exploited by others.

Many of the inventions/discoveries arising through academic research are at a stage beyond discovery-driven research and yet are often of uncertain commercial utility or insufficiently developed to be of interest to relevant receptor companies and potential investors. Such intellectual property may never be licensed or commercialized, or take years to do so, without additional targeted research, market research, investment and business development activities. These activities are of paramount importance, because they serve to validate, better define and add value to the intellectual property, particularly proof of principle research and prototype development. Such activities require resources that typically cannot be obtained through the traditional funding mechanisms. CIHR's Proof of Principle Initiatives aim at filling part of this funding gap.

Specific Objectives and Eligible Research Areas

The goal of the Proof of Principle (POP) Initiative and the Proof of Principle Partnered (POPP) Grant Initiative is to facilitate and improve the commercial transfer of knowledge and technology resulting from academic health research for the benefit of Canadians. At the conclusion of the POP project, the academic institution/researcher should have a better knowledge of the discovery/invention (intellectual property) and its scope of application. This enhanced knowledge base will make the technology more attractive to potential investors (research, commercial, etc), and enable a better allocation of academic resources to the further development of the discovery/invention.

The stage of research that best fits the program, is one where the IP that has been subjected to an initial technology assessment; and where one has already worked out what the novel invention is, what is needed to be protected (or is protected), what will be the product/process/service, and what will be commercialized. Usually applicants have significant data and are planning or expanding critical and confirmatory proof of principle tests in the proposal.

The stage that best fits the POPP initiative is one where the basic principle has been proven and the applicants have acquired interest from companies willing to invest in the new technology.

The specific objectives of this RFA are as follows:

• To promote academic health research and technology transfer activities that support the commercialization of IP;
• To provide the opportunity to enhance and strengthen the value of IP (or IP portfolio);
• To provide the opportunity to ascertain the potential for commercial viability of IP;
• To improve the academic institutional / researcher's business prospects and potential for downstream investments on the IP;
• To accelerate the technology transfer/commercialization of IP residing in academia.

Definition of Intellectual Property (IP): Intellectual Property means all materials, concepts, know-how, formulae, inventions, improvements, industrial designs, processes, patterns, machines, manufactures, compositions of matter, compilations of information, patents and patent applications, copyrights, trade secrets, technology, technical information, software, prototypes and specifications, including any rights to apply for protections under statutory proceedings available for those purposes, provided they are capable of protection at law.

Who is Eligible to Apply?

Individuals: The eligibility criteria for all CIHR research funding (grant) programs apply. Please refer to Eligibility for Research Funding Programs.

Institutions: The business office of the institution of an eligible Principal Investigator generally administers CIHR funds. Please refer to the eligibility requirements for Institutions on the CIHR website in the Financial Administration of Funds Guide.

Groups: For group applications involving more than one institution, inter-institutional agreements must be in place. For agreements with foreign institutions/organizations, CIHR requests a statement from the Canadian academic institution confirming that every reasonable effort has been made to have the results of the supported research exploited in Canada for the benefit of Canadians.

Co-Investors (POPP grants only): Non-academic institutions with which CIHR co-investment will be considered include venture capital, provincial and municipal governments, start-up companies and SMEs. Canada's research based pharmaceutical (Rx&D) companies are directed to apply through the CIHR/Rx&D Research Program.

Specific Eligibility Requirements

POP & POPP:

1. Funding consideration is open to researchers who have an established track record of recognized, competitive, peer-reviewed funding from recognized agencies for research in areas related to the proposed project.
   
2. Letters of Intent and Full Applications must be supported and signed by the Director of the Technology Transfer Office (or equivalent) of an eligible institution.
   
3. In cases where the applicant(s) and/or TT Officer fully or partly owns or is affiliated with the identified receptor company, the applicant(s) must declare and describe his/her ownership situation. It is anticipated that the management of such situations will be done in accordance with the Conflict of Interest Policies of the applicant's academic institution.

   POP only:

4. It is expected that the applications put forth be for proof of principle research on intellectual property that has been subjected to an initial technology assessment and selected for its significant commercial potential.
   
5. The IP must NOT be licensed (e.g., the royalty rates have been set), sold, or otherwise assigned to any party (e.g., to a spin-off company) other than the academic institution and/or the researcher-inventor-applicant.
   
6. The IP may be a new therapeutic use of a compound that is not covered under an existing license.
   
7. The first right of refusal or option on the IP must NOT have been exercised at the time of application.
   
8. The IP proposed must NOT be or have been in the IP portfolio of a company. Exceptions are possible where all rights and the management of the IP have been returned to the academic institution and/or the researcher-inventor-applicant at least 12 months prior to the application deadline and the company confirms that it has no future claims on the IP and requests no rights for future consideration.

   POPP only:

9. For Proof of PrincIPle Partnered Grants, only previous POP grantees are eligible.
   
10. Principal applicants affiliated with the non-academic institution investor must meet the CIHR Policy on Eligibility of Applicants to Industry-Partnered programs.

Mechanism of Support

The Proof of Principle Initiatives are designed to provide up to 12 months of operating funds to researchers for the support of proof of principle research including the advancement of scientific or technical knowledge and the conduct of technology transfer activities on the IP. For POPP grants, operating costs are shared between CIHR and an investor.

Funds Available

CIHR will contribute $50,000 to $100,000 per grant (non- renewable). The maximum amount awarded for a single grant is $100,000. For POPP grants, investors must contribute two thirds of the funding for a total maximum value of $300,000 ($100,000 from CIHR, $200,000 from investor).

Allowable costs

The Full Application must provide a detailed justification of all costs (research/technical/ commercial) requested from the CIHR as well as contributions by all other sources in order to be recognized and approved through peer review.

Applicants should review CIHR's guidelines on Eligible Expenditures for Research Funding Programs for a complete listing and description of allowable costs and activities. Typically eligible costs will include the following:

• Direct costs of research;
• Personnel, services, and travel;
• Consumables and equipment for research.

In addition, because of the nature of the POP initiative and expected outcomes, up to 20% of the requested budget can be for eligible expenses incurred through the implementation of the commercial plan for the specific IP. Such eligible expenses are as follows:

• Patenting costs, (up to 50% for protection of IP and no more than $10,000);
• Consulting fees, where services and expertise are not available;
• Market studies, to determine market potential;
• Communication and Networking costs, e.g., web-based information or seminar to attract investors;
• Collaborative Trips;
• Resource materials.

For small institutions, the use of outside expertise for the preparation of the commercial plan will be considered an eligible expense (capped at $5000) in POP applications if it is a contract with another academic institution, a business development office, a private consultant, or equivalent.

How to Apply

Letters of Intent and Full Applications should be prepared and submitted by the Principal Investigator in cooperation with the Technology Transfer Office (or equivalent) of an eligible institution. There is no registration step required.

For group applications, a nominated Principal Investigator from a lead institution must be designated and its Technology Transfer Office Director (or equivalent) must support and sign the application on behalf of the group.

There are two steps in applying to this RFA:

Step 1 - A Letter of Intent needs to be submitted by e-mail to CIHR (epalencsar@cihr-irsc.gc.ca), copying the Technology Transfer Office, by the deadline indicated above.

A letter of intent consists of:

1. a cover page including the title of the proposal, the amount requested from CIHR, the name and contact information (full address, e-mail and phone number) of the Principal Investigator and of the Technology Transfer Office Director (or equivalent) of the lead academic institution.
   
2. a 1-page summary of the proposal (suitable for a multidisciplinary scientific audience)
   
3. the POP questionnaire completed by the Technology Transfer Office Director (or equivalent) of the lead academic institution.

An acknowledgement will be sent via e-mail to both the Principal Investigator and the TTO confirming the receipt of the LOI. Please contact epalencsar@cihr-irsc.gc.ca if you have not received a confirmation e-mail within one week of the submission of your LOI.

Please note that due to time constraints, we will not be "inviting" applicants to submit a full application. Only those applications in which eligibility concerns have been raised will be contacted.

Step 2 - A full application must be submitted by the deadline indicated above. Full Applications without Letters of Intent will NOT be considered. One (1) original full application as well as three (3) additional copies of the application should be submitted.

- For the Full Application, please note that no application number is assigned at the LOI stage and that in order to apply to CIHR you must have a CIHR or MRC Personal Identification Number (PIN). If you do not already have a PIN, please follow the application procedures and allow at least one working day to receive confirmation. More than one working day may be required in peak periods - late January and early August.

The following CIHR application forms (modules) are required:

For POP applications:

1. CIHR Research Module, including research proposal (p12)
2. CIHR Operating Budget Module, which fully justifies each item of funding requested.
3. CIHR C.V. Modules for all investigators /team members.

For POPP applications:

1. CIHR Research Module, including research proposal (page12) and progress report (page10)
2. CIHR Operating Budget Module, which fully justifies each item of funding requested.
3. CIHR Partnership and Industry Module, which must be completed and signed by the investor.
4. CIHR C.V. Modules for all investigators /team members.

In completing CIHR forms/modules, be sure to refer to both the Grants and Awards Guides and the guidelines for completion specific to each module.

Specific Guidelines for the completion of the Research Module:

1. To ensure that application is forwarded to the appropriate CIHR staff, indicate "Proof of Principle Initiative" or "Proof of Principle Partnered Grant Initiative" under the heading "Strategic Initiative/RFA" in the Research Funding Programs section of the Research Module webform and on the Routing Slip and page 7 of the PDF form.
2. The Technology Transfer Office Director (or equivalent) must be a signatory on the Research Module signature page 2a.
3. Pages 5, and 9 of the Research Module are not required.
4. Page 10 of the Research Module requesting a progress report is not required for POP grants. For POPP grants, please follow the guidelines for the progress report section outlined below.
5. Page 11 requesting a response to previous reviews is required for applications that have been previously reviewed and are being resubmitted.
6. Appendix 1, #3, of the Research module permitting attachment of publications is not required or accepted.

Progress Report (for POPP grants only)

5 pages - identify as pages 10 a to e

The progress report should describe the 12 months of activity supported by the previous POP grant. Describe the progress made against original objectives and milestones set out in the previous POP grant. Applicants are encouraged to adhere to the proposed presentation layout as follows:

1. Advancement of knowledge of IP;
2. Progress in technology transfer and commercialization activities;
3. Hurdles encountered and how they were addressed.

Research Proposal (for both POP and POPP grants)

Applicants are encouraged to adhere to the following presentation layout, keeping in mind the evaluation criteria laid out under "Evaluation Process and Criteria for Peer Review." Please note that page limitations must be respected. Figures and references are not included in page limitations.

1. Overview - 1 page - identify as page 12 a
   
   1. Description of discovery/invention (i.e., IP).
      
   2. Description of business opportunity.
      
   3. Justification for proof of principle grant funding (provide a convincing argument for the potential commercial success based on the initial technology assessment).
      
   
   
   
2. Research and Technical Plan - 5 pages - identify as 12 b to f
   
   1. Background of the discovery/invention (IP).
      
   2. Summary of the relevant literature.
      
   3. Advantages and disadvantages of discovery/invention (IP).
      
   4. Required research question(s) (describe the scientific or technical requirements to move the IP toward commercialization).
      
   5. Research and Methodologies (present hypotheses and describe available expertise and experimental plan to test them).
      
   6. Time lines (layout of milestones and deliverables for the Research and Technical Plan during the term of the project).
      
   
   
   
3. Commercialization Plan - 5 pages - identify as 12 g to k

   ** This section must be completed in collaboration with the TTO office (or equivalent). Please refer to the section entitled "Common Peer Review Committee Concerns" when completing this section.

   1. Intellectual Property (describe status of the IP and plan with respect to the potential for protection, patent status, related patents, prior art, freedom to operate, where applicable).
      
   2. Market (describe market potential, target, characteristics, barriers - including regulatory hurdles, etc.).
      
   3. Opportunity (describe competitive advantage and available business expertise).
      
   4. Commercialization strategy (present plan to overcome disadvantages and barriers with respect to IP protection and market penetration; justification for licensing, spin-off venture, choice of receptor, or other route).
      
   5. Timelines (layout milestones and deliverables for the execution of the Commercialization Plan during the term of the project; include a description of the follow-on steps - by the researcher and/or institution - after the funding period).
      
   6. Impact (describe expected economic impact and/or social and health benefits).
      

Specific guidelines for the completion of the Operating Budget Module:

• use item "Other" to describe and justify expenses associated with the implementation of the commercial plan.
• ensure that contributions from ALL sources are justified. Please label this section clearly in the additional pages allowed for budget justification.
• provide a Detailed Budget Justification for Commercialization Plan. This section must be completed in consultation with the Technology Transfer Office and signed by the TTO director. This section must justify funding requested in the following areas:

1. Patenting
2. Consultants
3. Market Research
4. Communication/Networking
5. Academic Collaboration
6. Resource Materials

Send Full Applications by Courier to:

RE: "Proof of Principle Initiative"
Canadian Institutes of Health Research
Research Portfolio
410 Laurier Avenue W., 9th Floor
Address Locator 4209A
Ottawa, ON
K1A 0W9

Confidentiality

All applications are treated with confidentiality and all reviewers are subject to a non-disclosure and confidentiality agreement. Please visit the CIHR website to review CIHR's Policy on Confidentiality.

Evaluation Process and Criteria for Peer Review

To be considered for support, POP and POPP applications will be evaluated by a peer review committee established by CIHR and comprised of experts in health research, intellectual property management, technology transfer, commercialization, institute-industry relationships, entrepreneurship, and/or venture capital investors. Names of committee members are published on the CIHR website. The committee will follow the CIHR peer review process.

For each application, the research and technical plan will be assessed together with essential elements of a commercial plan. Each application is evaluated on its own merit in relation to the objectives of the POP/POPP Initiatives and using the following evaluation criteria. Please note that if either the research plan or the commercialization plan is given a rating in the non-fundable range, the application will not be funded.

1. Criteria for Research and Technical Plan
   
   • Importance and originality of the research question.
   • Importance and originality of the expected contributions. (What is the potential to extend knowledge and to address a medical or health issue?)
   • Relevance and description of the scientific and/or technical requirements to move the invention/discovery toward commercialization.
   • Qualifications/training/experience of the researcher(s) associated with the project; track record of applicant's scientific and technological advances. (How appropriate to the research proposed is the training or track record of the applicant(s)?
   • Demonstrated familiarity with literature in the field, and current competitive, or emerging technologies (How completely and objectively is the relevant literature appraised and evaluated?)
   • Formulation and feasibility of the research plan and appropriateness of methodologies (How well will the proposed experiments address the hypotheses or questions? How appropriate are the methods to be applied and the proposed data analyses? How well have the applicants anticipated difficulties in their approach and considered alternatives?)
   • Extent to which the proposed experiments will strengthen the intellectual property position or generate new intellectual property of potential commercial utility?
   • Appropriateness of budget; cost efficiency.
     
   
   
   
2. Criteria for Commercialization Plan
   
   • Demonstration of a business opportunity. Is the most appropriate product or service being proposed? Is the product meeting a need? Where does the product fit in the value chain?
   • Demonstration of the need for proof of principle research based on an initial technology assessment.
   • Appropriateness of strategy (technology and market evaluations, protection, marketing, licensing, company formation if intended) and business plan (including human resources) to advance the commercialization process. Have the essential elements/steps in the commercial plan been identified? Is the chosen commercialization route appropriate? Has the applicant appropriately addressed Prior Art and Freedom to Operate (where applicable)?
   • Intellectual Property - Appropriateness of patenting process and strategy, if any. Has a patent search and/or patent opinion been completed? Has a patent application been filed (when, what jurisdiction)? Is there a lot of related patent activity? What are the next steps and when and how will these be conducted during the term of the proposed project?
   • Market - Extent of market opportunity as demonstrated through an assessment of competing technologies and companies (new market or successful competing position in existing market), benefits of the new technology vs. the current technology within the intended markets and how are alternative technologies progressing? Have market characteristics (size, segment, value, growth rate) and market considerations (barriers, environmental market forces, regulatory environment) been adequately addressed? Extent of market interest and evidence of key industry and business contacts related to the commercialization of the invention/discovery. Is the receptor company appropriate (based on potential alternate receptors, receptor's experience in area)?
   • Qualifications/track record of persons currently associated with the commercial aspects of the project and the identification of business expertise that may be needed to complete the plan.
   • Effective use of human and technical resources, high quality research, superior management, innovation, creativity, and entrepreneurship.
   • Appropriateness and feasibility of deliverables and milestones of commercial plan.
   • Capacity, ability and commitment of applicant's institution to take the project from a successful completion forward through the commercialization process.
   • Appropriateness of the follow-on steps planned at the conclusion of the proposed POP project.
   • Extent of potential economic returns and if applicable, social returns and/or health benefit for Canadians.
   
   
   
3. The Progress Report will be reviewed for:
   
   • Advancement of knowledge of IP;
   • Progress made against original objectives and milestones:
   • Progress in technology transfer and commercialization activities;
   • Hurdles encountered and how they were addressed;

On completion of the peer review, applications passing on each of the above criteria will be ranked according to merit scores (ratings) and the funding recommendations of the committee will be submitted to CIHR. Applications will be funded from the top-ranked down as far as the quality of the applications and the budget will allow.

Common Peer Review Committee Concerns

In 2002, the most common issues raised during peer review of POP Grants were:

• Commercialization plan not well thought out or articulated;
• Incomplete description of IP management;
• Lack of detail or omission of relevant information in research proposal;
• Failure to address barriers such as potential technical shortcomings, market, competition, and freedom to operate;
• Proposal may be premature for Proof of Principle Initiative.
  
  

General CIHR Guidelines and Conditions of Funding

All conditions, as specified in CIHR's Grants and Awards Guides, shall apply to those funded through this initiative. Conditions cover areas such as Applicant and Institutional Responsibilities, Ethics, Official Language Policy, Access to Information and Privacy Acts, Acknowledgement of CIHR support etc. Successful applicants will be informed of any special financial conditions when they receive CIHR's Authorization for Funding Form (AFF).

In addition to CIHR standard guidelines and requirements the following shall apply:

• Reporting Requirement
  Grantees will be required to provide a final report on the use of POP and POPP grant funds in which reference must be made to the milestones and baseline activity in the original application.
  
  Grantees and Technology Transfer offices (or equivalent) of the grantee's institution will be required to respond to follow-up surveys on the tangible and intangible outcomes of the funded activities.
  
  
• Communication Requirement
  Recipients who receive funding are required to acknowledge the CIHR in any communication or publication related to the grant.
  
  

Performance Measurement and Evaluation

CIHR will assess the performance of the Proof of Principle Initiatives through ongoing monitoring and periodic evaluation. CIHR is committed to informing Canadians about the performance of all its initiatives and the results that they deliver.

The following table is intended to further clarify objectives by linking them to expected outcomes and measures. All funded applicants will be expected to participate in the evaluation strategy, contributing advice, data and reports as required for assessment purposes.

Objective	Outcome	Measure / Indicator
To promote academic research and technology transfer activities that support the commercialization of IP	Increased scientific and technical knowledge of IP Increased undertaking of POP research on health research results by academic researchers Increased interactions between academic researchers and Technology Transfer Office of institutions	Research contributions (publications; technical Reports) Participation in POP Initiative (e.g., number of applications) Disclosures of IP to Technology Transfer Offices
To provide the opportunity to ascertain the potential for commercial viability of the IP	Increased knowledge of technical, protection, and market barriers related to IP Confirmed application of IP as a product or service Reduce risk and better decision on additional academic investment on IP	Improved or redirected commercialization strategy Decision to abandon commercialization plan Success of commercializing of disclosed IP
To provide the opportunity to strengthen the value of the IP (or IP portfolio)	More valuable IP Better defined IP; Increased equity position of the academic institution / researcher in business negotiations on IP; Attract investments	Successful patent applications Investments on IP (licenses; assignments; spin-off ventures; receptor company interests)
To accelerate technology transfer/commercialization of IP in academia	Greater* success rate in technology transfer/ commercialization of IP; Increased flow of IP through technology transfer / commercialization process	Success of commercializing of disclosed IP Speed of commercialization
To improve the academic institutional/researcher's business prospects and potential for downstream investments on the IP	Greater* economic return on academic investment on IP Attract downstream investments, which move the IP through the market place	Economic returns on investments (e.g., royalty rates) Receptor company, venture capital or other investments in additional follow-on research and development of IP Marketed IP

* Greater than historical

Contact for Further Information

Kristina Coderre
Program Coordinator
Canadian Institutes of Health Research
410 Laurier Avenue West, 9th floor, Address Locator 4209A,
Ottawa, ON K1A 0W9
Telephone: (613) 952-4256

Fax: (613) 941-4646
Email: kcoderre@cihr-irsc.gc.ca