form - CQDM

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Quebec/France 2015

Joint Program

DEADLINE: April 7 th 2015, 17h00

This form must be filled in with “Arial 11” font, typed at 1.15 line spacing

TITLE OF THE PROJECT (In English)

CONFIDENTIAL

For internal use

File # :

TITLE OF THE PROJECT (In French)

DELIVERABLES

IDENTIFICATION OF THE PRINCIPAL INVESTIGATOR (PI) (Quebec)

Last Name:

Organization/University:

Department/Faculty:

Address:

City:

Country:

Province:

Phone #:

Email:

IDENTIFICATION OF THE PRINCIPAL INVESTIGATOR (PI) (Alsace or Rhône-Alpes)

First name:

Postal Code:

Ext:

Last Name:

Organization/University:

First name:

Department/Faculty:

Address:

City:

Country:

Email:

Province:

Phone #:

Postal Code:

Ext:

Full Project Application

SECTION 1. IDENTIFICATION OF THE RESEARCH GROUP (PIs and CO-INVESTIGATORS). Add lines if necessary

Numeration

(to be used in sections 6 and 12)

Name

Affiliation

(Organization, Country)

Email

Contribution to the project

Academia or private sector

% of the budget allocated to this group

1

CONFIDENTIAL

Discipline

2

3

4

5

6

7

8

Quebec/France joint program 2015 Page 2 of 15

SECTION 2. PROJECT SUMMARY (maximum 1 page)

CONFIDENTIAL

Quebec/France joint program 2015 Page 3 of 15

CONFIDENTIAL

SECTION 3. SUMMARY FOR LAY AUDIENCE AND PRESS RELEASE (in both English and French, maximum ¼ page each)

(In English)

(In French)

SECTION 4. KEY WORDS (up to 5 words that describe the project, in both English and French)

English

French

Quebec/France joint program 2015 Page 4 of 15

SECTION 5. DESCRIPTION OF THE PROJECT (maximum 10 pages, please include references in Appendix)

CONFIDENTIAL

Describe the project by outlining the following aspects of your research:

Rationale

Background and preliminary results

Objectives

Research Plan o Methodological approach (Include appropriate power analysis for animal and human studies. For human studies, define the recruitment process and elaborate on your ability to recruit the necessary number of patients.) o Principal steps o Expected results o Milestones and go/no go decision points: Milestones are major events or significant steps in a project. Make sure to define your project with a milestone at every 6 months. Each milestone should be accompanied with a specific set of metrics or quantifiables that allows a third party to assess progress. If the project is completely dependent on a specific milestone, address it as a go/no go decision point o Deliverables: The deliverables are the concrete, tangible work products. Define clearly the tangible assets that will result from your work and its intended use in the drug R&D process. Additionally, explain how the deliverables may be transferable to and used by the industry in biopharmaceutical research.

Quebec/France joint program 2015 Page 5 of 15

SECTION 6. TIMELINES OF THE RESEARCH PROJECT (maximum 1 page)

CONFIDENTIAL

1. Insert the principal steps of the project as well as milestones, deliverables and go/no go decision points (as described under section 5) in a Gantt chart .

2. Identify in the Gantt chart the specific contribution of each PI and co-investigator (by referring to the numbers associated with the investigator as listed in Section 1) at the different steps of the project and specify the cost of each step.

Quebec/France joint program 2015 Page 6 of 15

SECTION 7. COMPETITIVENESS AND POSITIONNING OF THE PROJECT (maximum 2 pages)

CONFIDENTIAL

1. Describe the originality and the innovative character of the proposed research (technology, computational tool or device).

2. Describe the market targeted by the technology, computational tool or device derived from the research proposal (if applicable).

3. Identify the most important international competing technologies, computational tools or devices (existing or in development; direct or indirect) that aim to achieve the same goal as your proposed project, by a similar or different technology. Clearly state the names of competing teams in academia and in private organisations.

4. Position and compare your proposed technology, computational tool or device with respect to the identified competition (at the local and international levels) focusing specifically on the scientific and usability aspects of the technology, computational tool or device and not on the excellence of the team and/or facilities.

Quebec/France joint program 2015 Page 7 of 15

CONFIDENTIAL

SECTION 8. IMPACT OF THE PROPOSED RESEARCH (maximum 1.5 page)

1. Socio-economic impact of the project (for Quebec, Alsace and/or Rhône-Alpes).

2. Impact on the drug discovery and/or development process:

Explain how the generated results/deliverables are expected to impact the drug discovery and/or development process in the near-term following completion of the project;

Identify the most important challenges currently faced by the pharmaceutical industry in relation to personalized medicine and describe how your proposed project will address them;

Describe how the proposed research will address important challenges in biopharmaceutical research.

3. Select which main step(s) of the drug discovery and/or development process your project is most likely to impact:

Target identification Discovery / screening Lead optimization Preclinical studies Clinical development

4. Long term development plan:

The focus of this competition is on innovative technologies or products that can be implemented in pharma or brought to market within the very near term on completion of the 3-year funding period. Please outline how you envision this to occur by detailing the overall anticipated plan, identifying who would perform this, and additionally the time required to implement the plan, as well as its associated costs.

Quebec/France joint program 2015 Page 8 of 15

SECTION 9. DESCRIPTION OF THE RESEARCH TEAM (maximum 2 pages)

CONFIDENTIAL

1. Discuss the role of the PIs and co-investigators in the achievement of the research.

2. Describe their experience and expertise relevant to the proposed research.

3. Discuss the synergies and complementarities of the team.

4. If the researchers are affiliated to a private organization:

Provide some corporate information;

Describe how the organization is qualified in relation to the achievement of the research;

Discuss how the proposed research is integrated into the overall corporate objectives of the company.

Quebec/France joint program 2015 Page 9 of 15

SECTION 10. RISK MANAGEMENT (maximum 1 page)

CONFIDENTIAL

Describe the potential risks associated with the project as well as their levels of significance. Explain how you intend to manage these risks. The risks may include technical and scientific challenges or may be related to human resources, access to specific material, infrastructure support, IP or other issues.

Please use the following table (add lines if necessary)

Risks Impact on the project

Probability of occurrence

Risk mitigation

Technological

Human resources

Access to specific material

Infrastructure

Financial

IP

Others

Quebec/France joint program 2015 Page 10 of 15

SECTION 11. INTELLECTUAL PROPERTY

11.1 IS THERE ANY PRE-EXISTING INTELLECTUAL PROPERTY (IP) LINKED TO YOUR PROJECT?

Yes

CONFIDENTIAL

No

If yes, please answer the following questions (maximum 1 page):

1. Who are the IP owners?

2. What is the invention?

3. Who holds the rights to the IP?

4. Do the principal investigator and the co-investigators of this project have the legal authorization to use the pre-existing IP?

5. Are there any commercial relationships or agreements (e.g. licensing agreements) with regards to the preexisting IP? If so, please describe.

Quebec/France joint program 2015 Page 11 of 15

11.2 WILL YOUR PROJECT GENERATE NEW INTELLECTUAL PROPERTY (IP)? Yes

CONFIDENTIAL

No

If yes, please describe (maximum 1 page):

1. The technology that will result in the creation of the new IP.

2. Who will be the inventor(s)?

3. Who will hold the IP rights? Is that person/organization aware of the CQDM/Alsace BioValley /Lyonbiopôle licensing policy (described under Section 5 of the guidelines)?

4. Describe the overall strategy regarding data and IP sharing.

Quebec/France joint program 2015 Page 12 of 15

SECTION 12. FINANCIAL ASPECT OF THE PROJECT

Please, report here the first page from the financial table.

12.1 TOTAL FUNDING

Year 1 Year 2 Year 3

CONFIDENTIAL

Total

Amount requested from CQDM ( in Dollars $)

Amount requested from Alsace ( in Euros €)

Amount requested from Rhône-Alpes ( in

Euros €)

TOTAL PROJECT (in Dollars $ and in Euros €)

12.2 BUDGET

Year 1

Quebec Alsace

$ €

Year 2

Rhône

Alpes Quebec Alsace

€ $ €

Year 3

Rhône

Alpes Quebec Alsace

€ $ €

Total

Rhône

Alpes Quebec Alsace

€ $ €

Rhône

Alpes

ESTIMATED COSTS OF THE

PROJECT

Salaries and benefits (research staff, payment to students) (see next section for more detailed salary budgeting) 1

Materials and supplies 2

Travel expenses (conferences, seminars, symposia, fieldwork, collaborations)

Publication and dissemination costs

Services 3

Other (please specify) 4

Overheads (maximum 15%)

GRAND TOTAL OF ESTIMATED

COSTS

0

0

0

0

0

0

0

0

0

0

0

0

0

0

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0

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0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Quebec/France joint program 2015 Page 13 of 15

CONFIDENTIAL

SECTION 13. SIGNATURE OF PIs AND ALL CO-INVESTIGATORS (add pages, if necessary)

Please note that the full proposal must be signed by the PIs and all the co-investigators

1.

I authorize CQDM, Alsace BioValley and LyonBioPôle to exchange all information relating to this application for analysis or evaluation purposes, provided that all persons granted access to this information treat it in the strictest confidence.

2.

I understand that the intellectual property resulting from this project will belong to the inventor(s) and their institutions and that a non-exclusive end-user license option will be granted to the CQDM industrial sponsors. The terms of said license option will be negotiated before the beginning of the project no later than 3 months following the confirmation of the funding.

3.

I agree that, if this project is retained for funding, I will facilitate the signing of an agreement with respect to the option on the IP generated by this project.

4.

I certify that all information provided in this application is complete and accurate to the best of my knowledge.

Signature of the PI (Quebec):

Name:

Date:

Signature of the PI ( Alsace or Rhône-Alpes ):

Name:

Date:

Signature of the co-investigator:

Name:

Date:

Signature of the co-investigator:

Name:

Date:

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RESEARCH ENTITIES SIGNATURE (add pages, if necessary)

CONFIDENTIAL

1.

I certify that I am a signing officer of the research entity representing investigator(s)* _______________________

________________________________________ and that I have the authority to commit the research entity with my sole signature.

2.

I read the content of this application and I certify that the information provided in this form is complete and accurate to the best of my knowledge.

3.

The research entity supports this application and agrees to provide the functional laboratories or research facilities and the equipment necessary for conducting this research project.

Signature :

Name:

(

Print

)

Title:

Organization :

Date:

*List the name(s) of the investigator(s) submitting this application who are affiliated to your research entity.

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