MATWIN 2013CONFIDENTIAL Project Application Form

CONFIDENTIAL

Research project title

/ Cancerôpole partner
Please type your title here

Project acronym

/ Reception date (official use)
Please type your acronym here

Key words

/ File number (official use)
Please type key words here

Project coordinator

Title (i.e.: PhD, MD, Pr…)
First Name
Last Name
Position
Department/laboratory
University / Faculty / School
Host Institution
Address
E-mail
Phone (direct line) / mobile / +33 / +33 6
Technology Transfer Office details
Technology Transfer Office
Contact name
Address
E-mail
Phone (direct line) / mobile / +33 / +33 6

Requested budget & total duration of the project

Requested budget (k€, ATI): / Total duration (months)
MATWIN is a nationwide programme, unique in Europe, that identifies and support the maturation of oncology research projects up to the preclinical Proof of Concept (POC) stage. It is intended to support specific world-class oncology projects, to the tune of €3 - 4 M over a 3 to 4-year period and until industrial transfer. The assessment of your project is therefore a major step to towards gaining funding of this magnitude and to assess the merit of the projects from an industrial value-added perspective. This financial support is not a Grant but an investment on an agreement basis
The present application form helps you to present your project from an industrial point of view. Your project will be assessed according to five main criteria: Innovation Components & Value, Translational Potential, Commercial Potential & Competitive Landscape, Technology Transfer Setup & Value Creation, and Project Feasibility & Project Management.
To complete the present Project Application Form, do not hesitate to ask your Technology Transfer Office or another office and your institution partner (Cancerôpole, research institution…) for assistance.
We regret that failure to complete any required section of the Application Form or to provide any requested accompanying information may result in your application being delayed or deferred to a later MATWIN session.


Deadline and contact details

The Project Application Form must be returned at the latest before September 15th 2013 both to :
1) MATWIN PlatformBy e-mail in pdf format to:
2) Your Cancéropôle By e-mail the pdf format and by mail the original copy to the following address
Cancéropôle CLARA: 60 avenue Rockefeller, 69008 Lyon
- : 04 37 90 17 14
Cancéropôle GE: Hôpital de Hautepierre, 1, Av. Molière, 67098 Strasbourg
 - : 03 88 12 75 43
Cancéropôle GO: Maison Recherche Santé, 5, Allée l’Ile Gloriette, 44093 Nantes cedex 01
 - : 02 53 48 28 75
Cancéropôle GSO: Hôpital La Grave, Place Lange - TSA 60033, 31059 Toulouse cedex 9
 - : 06 82 76 75 07
Cancéropôle NO: 1 Avenue Oscar Lambret - B.P. 90005, 59008 Lille cedex
 - : 03 20 74 35 83
Cancéropôle PACA: Faculté Médecine-Timone, 27 boulevard Jean Moulin, 13005 Marseille
 - : 04 91 32 47 02
Cancéropôle IDF or others institutions: MATWIN SAS - Institut Bergonié, 229 cours de l’Argonne, 33076 Bordeaux
: 06 84 01 61 70

MATWIN timetable

Call for projects / 2013 April 1st
Expression of interest - Deadline “Letter of Intent“ / 2013 May 15th
Notification of acceptance for “Letter of Intent” / From 2013 June 10th
Deadline for submission of “Project Application Form” / 2013 September 15th
Multidisciplinary analysis of projects / 2013 September to November
Letter to selected or unselected applicants / From 2013 December
Coaching session: Review of research plan and training / 2014 January to April
Project Presentation to the MATWIN International Board / 2014 May

Executive summary (1 page max)

WARNING:This executive summary must present briefly your project, in one page max.
Title

Application domain (indication & use)

Target Population

Innovative component

Objectives

Target Profile

Abstract – application domain, objectives, expected outcomes (400 words max)


Table of contents
I / Coordination and partners / p 7
II / Intellectual property / p 9
III / Research and development plan / p 11
IV / Project management and feasibility / p 16
V / Commercial potential and competitive landscape / p 17
VI / Other key information / p 19
VII / Undertaking / p 20
VIII / Appendices / p 22
  1. Coordination and partners

I.1 Project coordinator - Supplementary details regarding applicant

Title (i.e.: PhD, MD, Pr…)
First Name
Last Name
Position
Year of doctoral degree:
Former positions relevant to the project:
Know-how, scientific and technical competences:
Experience relevant to the project (national, international collaborations training entrepreneurial, industrial experience, technology transfer experience…):
I.2 Applicant’s competencies and role in the project, especially in terms of project management and coordination of different partners

I.3 Summary associated teams/partners (scientific and non–scientific) table

Partner / Name / Position / Organism / Laboratory / City / Partner expertise
1
2
…

I.4 Partners and collaborators (to be completed for each Partner) details

Partner number
Title (i.e.: PhD, MD, Pr…)
First Name
Last Name
Position
Department / laboratory
University / Faculty / School
Host Institution
Address
E-mail
Phone (direct line) / mobile / +33 / +33 6
I.5 Publications and awards of the applicant and his partners
Main publications of associated partners (limited to 5 publications for each partner and with scientific and technical relevance to this project)

All current and pending research awards held by yourself and any partners. For each award, please indicate the leader, title, duration, level of support, funding body and type of award and how it will fit in with any current awards.

  1. Intellectual property

II.1 Patents

If any documents regarding the intellectual property are available (patentability report, patentability study, patentability opinion), please join them to the present project application form as they can be useful for the assessment of your project. Complete a table for each patent you already filed or that you are planning to file
Patent n° 1
Invention title
Field of application
Inventors
Patent co-owners (institutions)
IP status
Invention disclosure / date of disclosure
Patent filing / date of filling or expected date of filing
Patent Cooperation Treaty / PCT number
Awarded patent / patent number / awarded countries:
TTO responsible for managing the patent
Is there any agreement potentially limiting the use of this IP?
Patent n° …
Invention title
Field of application
Inventors
Patent co-owners (institutions)
IP status
Invention disclosure / date of disclosure
Patent filing / date of filling or expected date of filing
Patent Cooperation Treaty / PCT number
Awarded patent / patent number / awarded countries:
TTO responsible for managing the patent
Is there any agreement potentially limiting the use of this IP?
II.2 Potential Intellectual property
Describe intellectual property expected by the end of the project:

II.3 Existing partnerships
Are there any partnerships (existing or in progress)? If YES, list involved parties and indicate partnership conditions

II.4 Key competing intellectual property
Please list and indicate status of any competing intellectual property and specify how it could impact on your modality development. You can find competing intellectual property by using the following link: Complete a table for each one.
Publication reference (journal, date, authors) or PCT (applicants, priority data, Number, designated states)

How does it impact on the development of your modality?

  1. Research and development plan

III.1 Scientific background (state of the art) and rationale (2 pages max):
Description of existing results (published or generated within the applicant’s and Partners’ laboratories) relevant to and supporting the project (with figures, legends and comments): description of the mechanism of action, proof of concept in animal models, supporting clinical & epidemiological data…

III.2 Innovative components and description of unmet medical needs: relevance to cancer, potential applications (prognosis, diagnosis, treatment…) (2 pages max):
  • Based on the scientific background above, introduce the potential clinical indications
  • Describe the critical unmet needs and the health issues that your project may overcome
  • Describe the economic and social impact of the targeted health issue, i.e. the added value your project will bring in terms of economic and social benefits


III.3 Target (Product/Device) Profile (2 pages max): to help you, please read
  • Describe what will be the end product/device shall the project be successful and explain innovative aspects of the expected target product/device
  • Describe what would be delivered to patients and healthcare professionals and the expected benefits for patients and healthcare professionals compared to existing solutions: innovative therapeutic agent or strategy (drug, monoclonal antibody, cell therapy, gene therapy etc…), Medical device, Diagnostic tool etc…
  • If available, describe the clinical indication and patient population your modality is targeting.


III.4 Project objective
Indicate briefly the objective of your project:

III.5 Research status
Indicate clearly the research step for which you are requesting funding[1] (e.g.: credentialing, supporting tools, modality creation, preclinical development, in vivo/in vitro…)

III.6 Scientific description of the project (10 pages max)
You are requested to present the project scientific description and work plan from an industrial perspective. Your presentation should at least describe: scientific hypothesis and rationale, milestones and Go/No-Go criteria for each milestone, methodology (task, experimental method & design, deliverables…), regulatory constraints if possible, Gantt chart indicating tasks, deliverables & timelines, expectations in terms of technology transfer (license, start-up creation…). Do not hesitate to use the guidance below to assist you in the writing of the work plan.

List supporting references for the project

III.7 Work Plan Guidance
A work plan is a planning and management instrument (tool) which provides a framework for planning the work, and is a guide during the period in question for carrying out that work. The work plan is a scientific roadmap with increased clarity. In order to obtain the finance indicated in the budget, the work plan serves as justification for the release of funds. When approved, the work plan serves as a guide to actions to be taken in order to reach the objective, written so as to be transparent to anyone and justifying the actions to be taken. Following sections have been prepared in order to help you to structure your work plan from an industrial perspective.
Examples of questions related to your work plan
•Animal Studies: Does your research include animal models? If YES, has an appropriate licence been obtained? If NO or pending, status of animal licence approval within your research proposal?
•Human Studies: Does the work involve human tissue samples? (Including blood and other bodily fluids)? Is the work likely to lead to a clinical trial within the lifetime or shortly after completion of the project? What is the target group size? In France / in the World?
•Ethics committee: Does the work require the approval of an Ethics Committee? If YES, has an appropriate approval been obtained? If YES, state your Ethical Approval reference here and include evidence with the application. If NO or pending, please detail the status of ethical approval within your research proposal.
•Regulatory approval: Does the work require regulatory approval? If YES, has the appropriate approval been obtained? If relevant, please state the regulatory authority here and include evidence with the application? If NO or pending, please detail the status of regulatory approval within your research proposal
•Specific Technologies to be used: Does the work involve the use of any type of stem cells? Does the work require the use of microarray & other post-genomic technologies? If YES, is the resource available locally?
•High Throughput Screening (HTS): Does the work require High Throughput Screening (HTS)?
Guidance related to the project milestones
•Milestones and decision-making process: A milestone is a scheduled and important check point in the work plan that marks the completion of a work package (a major deliverable or a set of deliverables have been completed after successfully conducting the planned work (tasks)). Milestones are used in the industry as project checkpoints to validate how the project is progressing and make Go/No-Go decisions based on progress measured against objectives and on project value. Project deliverables are reviewed at each milestone to validate if Go/No-Go criteria are met and to decide whether to further proceed with the project. As a consequence, it is essential to formulate as precisely as possible, milestones, deliverables and Go/No-Go criteria. There should not be more than 3-5 milestones in your project.
•Main tasks, main deliverables by milestone: To describe main tasks and deliverables required in order to reach and achieve the milestones. For each deliverable, you have to describe the key success criteria and the decisions to be made if the criteria are not met, as well as timelines and partners implicated.
•Gantt chart & timelines: The Gantt chart should ideally specify the tasks, deliverables and timelines. If you have used a specific numbering to describe the milestone, tasks, and deliverables, please ensure to use the same numbering in your Gantt Chart
III.8 Milestones and decision-making process
List the workpackages of the project with a brief description. By workpackage, you have to describe
  • each task with the main objective, the partners involved and the timeline (year, duration, starting, ending)
  • the deliverable, the go/no-go criterion and the taken decision function of the obtained criterion.

Main objective / Partners involved / Timeline
(Year, Month)
Workpackage 1 (WP1) title
Task 1
Task 2
…
Deliverable 1
The identified risks of the WP 1
Go - No-Go criterion
Decision if GO criterion is met
Decision if GO criterion is not met
Workpackage … (WP…) title
Task 1
Task 2
…
Deliverable …
Go - No-Go criteria
Decision if GO criteria are met
Decision if GO criteria are not met
III.9 Gantt chart & timelines
The Gantt chart should ideally specify the tasks, deliverables and timelines. If you have used a specific numbering to describe the milestone, tasks, and deliverables, please ensure to use the same numbering in your Gantt Chart
Deliverables / Year 1 / Year 2 / Year …
1 / 2 / 3 / 4 / 1 / 2 / 3 / 4 / 1 / 2 / 3 / 4
WP 1 _ Task 1
WP 1 _ Task 2
….

III.10 Human resources

Skills and roles of the partners and the collaborators for every objective of the project.
WP / Task / Partner / Name / Position / Competencies and role / Time contribution to the project (%) / 1- employed
2- to be hired
n°… / n°… / n°…

III.11 Equipment resources

Contributions to equipment costs in ATI will only be considered if they are essential to the research proposal and have been justified as such. Non-standard equipment requests will only be considered for those that are central to the conduct of the project and are fully justified.
Equipment / Partner who has the need / Cost (ATI)

III.12 Subcontracting resources

Please list the internal or external subcontracting
Subcontracting / Partner who has the need / Cost (ATI)

III.13 Work Plan Budget

Duration / Staff costs / Running costs / Equipment costs / Subcontracting / Total budget
WP1
Task 1
Task 2
…
WP…
Task 1
Task 2
…

III.14 Breakdown of the approximate budget (% it represents of the total budget)

Staff costs / %
Running expenses / %
Subcontracting internal & external[2] / %
Equipment costs / %

III.15 Other funding

Please list any aspects of the proposed project funded from other sources
Funding sources / Project’s aspect / Amount k€ (ATI) / Obtained / Expected / Date
 / 
 / 
 / 

  1. Project management and feasibility

IV.1 Specify activities and decision points along the path by which fundamental scientific discoveries are transformed into clinical modalities in this section.
Describe the project management process and coordination between partners (meetings with partners, progress tracking, regular reporting,…)

Describe the process by which decisions will be taken to track project progress (decision-making process)

Describe project feasibility

  1. Commercial potential and competitive landscape

V.1 Targeted market
As far as it is in the public domain, please indicate the current and forecasted size of the worldwide market, or as a minimum, provide an indication that may help the experts to assess commercial potential of your modality (price of products/devices your project will compete with, number of patients,…) :

V.2 Competitive landscape
Which of the following options would best describe your proposed work? Place an “X” in the appropriate box:
Fulfils a currently unmet need / 
Competes with current alternatives / 
Improves on current alternatives / 
V.3 Products/devices already on the market that your modality will compete with or replace
As far as it is in the public domain, please describe the products/devices currently on the market and used by healthcare professionals that your modality would compete with or replace. For each product/device, please indicate the name(s) of the company marketing the product/device:

V.4 Competing academic/industrial groups and research development stage of their projects
As far as it is in the public domain, please list academic and industrial research groups who are conducting research on projects that could compete with your modality once in the market. For each research group, please specify the topic and stage of their research, the expected launch date of their project compared with your modality and the competitive advantage of your modality.

V.5 SWOT analysis
A SWOT analysis is a strategic planning method used to evaluate the Strengths, Weaknesses, Opportunities, and Threats involved in a project. It involves specifying the objective(s) of the project and identifying the key internal (S,W) and external (O,T) factors that are favourable and unfavourable to achieving that objective. External factors can be existing or upcoming competitors, regulatory or ethical issues, technology acceptance by professionals/patients …
Strengths / Weaknesses
 / 
Opportunities / Threats
 / 
  1. Other key information

VI.1 Indicate below eventual key additional information that you have not indicated previously:

  1. Undertaking

The applicant, partner leaders, Head(s) of Department and appropriate administrative authorities are required to sign this form to accompany an application for the MATWIN Call for Expertise. The original signed copy of this form must be submitted by the application deadline.

VII.1 Partner leaders
“I enclose an application for a research project/proposal for approval, completed in accordance with the guidelines published with the application form. I am not aware of any relevant information that has been withheld or of any information given in the application that is misleading. I have read the relevant undertakings and any supplementary terms and conditions published with and/or referred to in the application form and, if this application is successful, I agree to abide by them. I understand that the Terms & Conditions may change during the tenure of an award and I would then be required to sign my agreement to the new Terms & Conditions or possibly forfeit the award if I cannot comply.”