info session tbm call 2017 - uza · 17/01/2017 2 overview 1. mission and key facts fwo 2. research...

25
17/01/2017 1 Info session TBM call 2017 Applied Biomedical research with a primary Societal goal

Upload: trannhi

Post on 25-Aug-2019

214 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

1

Info session TBM call 2017Applied Biomedical research with a primary Societal goal

Page 2: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

2

Overview

1. Mission and key facts FWO

2. Research Integrity

3. Focus of the TBM programme

4. Basic features of the TBM programme

5. Submission of a TBM project proposal

6. Evaluation process

7. Practical recommendations

8. Additional information

3February 2017 Information session FWO

1. Mission and key facts FWO

Page 3: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

3

1. Mission and key facts

• Mission of the FWO

• Funds fundamental scientific research (‘frontier research’) and strategic research

5

1. Mission and key facts

• Target groups of the FWO

• Young researchers

• Postdoctoral researchers

• Established researchers

• Research teams

• Top-researchers and high-potential researchers

6

Page 4: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

4

1. Mission and key facts• Funding schemes of the FWO

• Funding for individual researchers• Pre- and postdoctoral fellowships, bench fees and grants

• Funding for research teams• Research projects, Big Science, Bilateral agreements, TBM, SBO, …

• Supporting mobility, international contacts and collaborations• travel grants, sabbatical leaves, scientific research communities, organization of

conferences in Belgium, international coordination actions, collaboration agreements, …

• Attracting excellent researchers, active abroad, to Flanders• Odysseus, Pegasus

• Awarding scientific prizes• Research Infrastructure• VSC

7

1. Mission and key facts

• Budget 2016: 320 million EUR, ca. 79% from Flemish Government

• Budget 2017: 341 million EUR

8

€0

€50.000

€100.000

€150.000

€200.000

€250.000

€300.000

€350.000

€400.000

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Evolution budget 2007-2017 (in kEUR)

Federal Government

Flemish Government

Total

Page 5: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

5

• As part of FWO Policy:

• Clause in call text, application and contract on commitment to RI

• Profiles for (co)promoters and researchers

• Adaptations in General Regulation on procedure and sanctions in case of RI violation

Please read the detailed information on our website: http://www.fwo.be/en/the-fwo/organisation/research-integrity/.

Every applicant and beneficiary is expected to know the rules and what (s)he will be committed to.

9

2. Research Integrity

February 2017 Information session FWO

3. Focus of the TBM programme

Page 6: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

6

3. Focus of the TBM programme

Policy goal on the longer term:

To contribute to the realisation of new therapies and diagnostic techniques that would otherwise not reach the patient (due to a lack of industrial interest).

Key characteristics:

1. Aimed at the development of a new therapy, diagnosis and/or specific prevention of a human disease or a comparison of existing procedures in order to find out their relative efficacy and cost-effectiveness.

2. Late stage translational research focus on the translation of a scientific finding towards the clinic (with proof of concept reached).

3. Added value for the Flemish health situation, with a positive medical impact for a specific patient group or a cost reduction for the healthcare system.

4. Lack of industrial interest.

Budget 2017: 14 M euro

11February 2017 Information session FWO

3. Focus of the TBM programme

Criterion 1: development of a new therapy, diagnostic tool or prevention of a specific disease or a comparison of existing procedures in order to find out their relative efficacy and cost-effectiveness

What kind of research does NOT fit in the TBM programme:

Research aimed at improving the general health situation Epidemiological studies Evaluations of health organizations Structural financing Introduction into Flanders of a therapy or diagnosis used abroad …

12February 2017 Information session FWO

Page 7: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

7

3. Focus of the TBM programme

Criterion 2: late stage translational research

What kind of research does NOT fit in the TBM programme:

Fundamental research, primarily focused on de novo knowledge creation

Basic research (no proof-of-concept yet)

Pure implementation activities

Market research for the utilization of the project findings

13February 2017 Information session FWO

3. Focus of the TBM programme

Criterion 3: Added value for Flemish health situation with a

positive medical impact for a specific patient group or a cost

reduction for the healthcare system

What kind of research does NOT fit in the TBM programme:

Research focused on a disease that has no incidence in Flanders

Research focused on a development that has neither a medical impact nor acost reduction for the healthcare system

For research focusing on a cost reduction for the Flemish health care system,this reduction should be substantiated by a preliminary health economicanalysis/argumentation.

14February 2017 Information session FWO

Page 8: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

8

3. Focus of the TBM programme

Criterion 4: lack of industrial interest

What kind of research does NOT fit in the TBM programme: Research directed towards one specific company Research for which no collaboration with the industry has been

sought yet in order to be able to achieve better transfer conditions in the future

Research without industrial interest due to a high scientific risk (conflict with criterion 2, SBO programme)

Research that could lead to the establishment of a new spin-off company, once sufficient financial resources are available

Research for which reasonable industrial interest can be expected (in Flanders or abroad), but in which industry does not invest because of the economic crisis or company priorities

15February 2017 Information session FWO

3. Focus of the TBM programme

Criterion 4: lack of industrial interest in the project

Possible commercial reasons for a lack of industrial interest:

No possibility for patenting

No possibility for a standardized product (patient-specific products, e.g., autologous cell therapy, tissue engineering)

Profit margins too low

Patient populations too small (‘return on investment’ too small)

16February 2017 Information session FWO

Page 9: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

9

3. Focus of the TBM programme

Criterion 4: lack of industrial interest in the project – possible reasons

The absence of legal obligation for the producer of a medical application (e.g., a medical device) to test its efficacy.

possible to submit a project that is directed towards the evaluation of the efficacy, safety and cost-effectiveness of a medical device that is marketed by a company.

ONLY UNDER THE CONDITION THAT THE STUDY IS CONDUCTED INDEPENDENTLY FROM THE COMPANY• Argumentation in the project proposal

• Formal declaration of the applicants

• In publications resulting from the study, the independency should be mentioned

17February 2017 Information session FWO

4. Basic features of the TBM programme

Page 10: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

10

4. Basic features of the TBM programme

Applicants (= entities that will be the beneficiary of the financial support): limited to research centers!!!

A research center is defined as an entity (such as universities or research institutes, technology transfer agencies, innovation intermediaries, research-oriented physical or virtual collaborative entities), irrespective of its legal status (organized under public or private law) or way of financing, whose primary goal is to independently conduct fundamental research, industrial research or experimental development or to widely disseminate the results of such activities by way of teaching, publication or knowledge transfer. Where such entity also pursues economic activities the financing, the costs and the revenues of those economic activities must be accounted for separately. Undertakings that can exert a decisive influence upon such an entity, in the quality of, for example, shareholders or members, may not enjoy preferential access to the results generated by it.(definition of a ‘research and knowledge-dissemination organisation’ as stated in Article 2, section 83 of the Regulation (EU) No651/2014 of the commission of June 17, 2014).

19February 2017 Information session FWO

4. Basic features of the TBM-programme

Applicants:

Limited to research centers => e.g., universities, university hospitals, university colleges, strategic research centers. If there are any doubts about your organization meeting this definition, compliance with this definition should be supported by means of an independent legal advice.

One applicant or a consortium of several applicants, but participation of a Flemish hospital* is required (min 10% of the total project budget).

Participation of non-Flemish research centers is possible, but is limited to max. 20% of the total project budget.

20

* Or ITM

February 2017 Information session FWO

Page 11: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

11

4. Basic features of the TBM programme

Subcontractors (receive compensation for their costs via the applicants):

Not limited to research centers; other organizations such as companies are also allowed!!

Only for tasks without creative input

Max. 30% of the budget.

=> Organizations that do not fulfill the criteria for a research center can participate in a TBM project as a subcontractor for regular tasks such as the inclusion of patients, etc.

21February 2017 Information session FWO

4. Basic features of the TBM programme

Advisory committee (not funded!):

highly recommended to set up an advisory committee already during the preparation of a TBM project.

consists of societal stakeholders (regulatory authorities, patient associations, etc.) who will later be involved in the further utilization path – composition specific for each project!

their advice should increase the likelihood of an effective and broad implementation of the TBM project results in clinical practice.

the composition of the committee and the commitment of its members will be taken into account during the assessment of the TBM proposals.

22February 2017 Information session FWO

Page 12: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

12

4. Basic features of the TBM programme

Advisory committee:

The applicant should add a motivated letter of intent for each member of the advisory committee:

On the deadline for submission of the application.

Letters should indicate the engagement to participate in the advisory committee and should motivate the added value of each member.

In case of an organization: each letter should be signed by a legal representative of the organization.

23February 2017 Information session FWO

4. Basic features of the TBM programme

Budget and subsidy:

Programme budget: 14 M euro

Project budget: between 250,000 euro and 1,000,000 euro

for large or multicentric trials, exceptionally budgets up to 1,500,000 euro are allowed, given a thorough motivation!

Project period:

2 to 4 years

Start of the project: 1 October 2017

cannot be extended, but at the final financial verification, costs made after the official project period can be accepted as follows:

o Staff cost: project period + 1 year

o All other costs: project period + 2 years

Subsidy: 100% of the acceptable costs

Succes rate 2016: ca 41%

24February 2017 Information session FWO

Page 13: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

13

5. Submission of a TBM project proposal

5. Submission of a TBM project proposal

• Before submission: transfer of application to host institution in FWO e-portal: deadline 18 April at 5 PM

• Final submission: 25 April at 5 PM by host institution

In English According to the template on the e-portal

February 2017 Information session FWO 26

Page 14: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

14

E-portal FWO

February 2017 Information session FWO 27

E-portal FWO

February 2017 Information session FWO 28

• Supervisor of the project logs in to the e-portal and creates the new application.• If you do not have an account for the e-portal yet, you need to register.

Page 15: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

15

E-portal FWO

February 2017 Information session FWO 29

5. Submission of a TBM project proposal

February 2017 Information session FWO 30

Page 16: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

16

5. Submission of a TBM project proposal

Tabs:

GENERAL: title, project duration, …

SUMMARY:

non-confidential summary for communication purposes

innovation goal for inclusion in the FWO agreement (when funded)

APPLICANTS:

= organizations (i.e. not at the level of the research unit!) that are part of the consortium

consortium = ‘main applicant’ or ‘main applicant + co-applicant(s)’

31February 2017 Information session FWO

5. Submission of a TBM project proposal

Tabs:

CO-SUPERVISORS:

The person who completes the information in the e-portal with his/her account automatically receives the status of supervisor. He/she is the contact person for the main applicant.

Co-supervisors = representatives from the different research units in the consortium. For each co-applicant, one of these co-supervisors must be appointed as contact person for this co-applicant.

REFEREES - EXCEPTIONNALY:

If you can give a good reason why FWO should not contact certain experts for the evaluation of your proposal, you can provide these names (including a motivation). The list should be limited!

32February 2017 Information session FWO

Page 17: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

17

5. Submission of a TBM project proposal ETHICS: you have to indicate whether your study involves ethical

aspects that require an approval by an ethical committee.

BUDGET:

o Rules are explained in the Cost model on the website (see also next slide).

o Sub-budget for each applicant. Total budget = sum of the sub-budgets.

o Budget has to be prepared in the excel template (available on the website), and should be uploaded in the e-portal afterwards. Quotes for large subcontractors have to be uploaded in the e-portal as well.

o Next to the uploading of the excel-sheet, an overview of the total costs should be entered in the e-portal.

33February 2017 Information session FWO

5. Submission of a TBM project proposal BUDGET

Staffing costs (gross salaries):

o Only research staff and valorization preparing staff working on the project

o Double financing is not allowed

Other costs: real costs up to a maximum of € 40,000/person year:

o Direct costs (materials, IT-costs, traveling expenses, depreciation costs for research equipment, subcontractor costs < € 8.500): max. € 20.000/person year

o Indirect costs or overhead costs: max. € 20.000/person year

Large subcontractor costs (for subcontractor costs > € 8.500):

o At market price (full cost + margin)

o Quote necessary

Large cost (exceptional!! Needs detailed motivation):

o E.g., very expensive tests such as imaging

o Only accepted when this cost cannot be added in the previous categories

34February 2017 Information session FWO

Page 18: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

18

5. Submission of a TBM project proposal PROJECT DESCRIPTION

o Template available in e-portal, to be uploaded as PDF

o Sections:

“Fit” in the TBM programme

Positioning towards the state of the art & project goals

Work programme

UTILIZATION RESULTSo Template available in e-portal, to be uploaded as PDF

EXPERTISE AND TRACK RECORDo Template available in e-portal, to be uploaded as PDF

EXTRA DATAo To be uploaded as PDF in the e-portal

o Letters of intent of the advisory committee, declaration with regard to independency from company, …

35February 2017 Information session FWO

5. Submission of a TBM project proposal

February 2017 Information session FWO 36

Transfer to host institution: before April 18, 2017 at 5 PM

Page 19: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

19

6. Submission of a TBM project proposalAfter transfer to main-applicant, submission by main-applicant via e-portal before April 25, 2017Who has access to the e-portal?

• Katholieke Universiteit Leuven (incl. UZ Leuven)• Universiteit Hasselt• Universiteit Antwerpen• Universiteit Gent• Vrije Universiteit Brussel (incl. UZ Brussel)• UZ Antwerpen• Universitair Ziekenhuis Gent• Prins Leopold Instituut voor Tropische Geneeskunde• Vlaams Instituut voor Biotechnologie

February 2017 Information session FWO 37

5. Submission of a TBM project proposal

Declaration (after transfer of the application to FWO):• Letter of intent/declaration per participating legal entity

• Authorization of inquiries, declaration of absence of double financing, & declaration of research organization

• Checkbox in e-portal for applicants with e-portal back office

• If applicable: for organizations without e-portal back office, FWO will contact the supervisor and request (a) signed letter(s) of intent for these organizations (template: see website)

February 2017 Information session FWO 38

Page 20: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

20

7. Evaluation procedure

7. Evaluation procedureEligibility

Eligibility criteria:

o Submitted before the deadline (25 April 2017; 5 PM)

o Submitted in English and according to the requested format (pagelimits, …)

o All applicants are “research centers”

o Submitted by at least one Flemish hospital

o All required declarations (applicants) are present

o No manifest mismatch with the goals of the TBM programme

Decision by the board of directors of FWO within 30 days

Applicants of ineligible proposals will be informed as soon as possible

40February 2017 Information session FWO

Page 21: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

21

7. Evaluation procedureOne selection round

Evaluation in dedicated panels of experts (June)

One panel of experts per (large) topic

Possibility for a short interaction between the applicants and theexperts (preliminary dates: June 9, 12, 22 and 27)

Evaluation of the “fit” in the TBM programme, the scientific quality& the utilization/valorization potential => see score grid on thewebsite

Scoring in consensus

Ranking of the proposals (based on the total project score) within theavailable budget

Decision by the FWO board of directors (July)

41February 2017 Information session FWO

7. Evaluation procedureScore grid – criteria

Scientific criteria• Focus on new therapy, diagnosis, specific prevention of a disease or comparison of

existing procedures in order to find out their relative efficacy and cost-effectiveness (FIT)• Positioning in the path from discovery towards an actual application (FIT)• Added value towards the state-of-the-art• Relevance of the scientific approach to achieve the scientific goals • Balance between the risks and the feasibility of the scientific project goals• Quality of the project plan + management• Competence and infrastructure

Utilization criteria• Relevance of the project to achieve the utilization goal• Intrinsic feasibility of the utilization goal • Expected impact for the individual patient (FIT)• Expected social potential for Flanders (FIT)• Lack of industrial interest (FIT)• Quality and feasibility of the utilization approach• Competence with regard to transfer of the results towards an application

42February 2017 Information session FWO

Page 22: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

22

6. Evaluation procedureScore grid – criteria

Possible scores that can be awarded per criterion are:

• Unacceptable Critical

• Poor -2

• Reasonable -1

• Positive 0

• Excellent +1

43February 2017 Information session FWO

8. Practical recommendations

Page 23: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

23

8. Practical recommendations when preparing a proposal

Carefully read the documents on the website and contact FWO in case you have questions ([email protected]).

Before you start writing the proposal, send an abstract to [email protected] in order to get an idea about the fit of the project in the TBM programme.

Give a clear argumentation for the fit in the TBM programme (e.g., why is industry not interested?, ...).

Make sure your project has a clear focus.

Make sure the scientific goals are well aligned with the utilization goals.

45February 2017 Information session FWO

8. Practical recommendations when preparing a proposal

Pay attention to power analysis (for clinical studies).

Pay attention to the patient inclusion strategy (dropouts, feasibility).

Pay attention to the utilization planning.

Don't forget to include the overhead costs in the project budget.

Interact early with the university services (for the preparation of the budget, declarations, …).

Interact early with potential members of the advisory committee.

Contact the FWO helpdesk for the e-portal (e-mail: [email protected]; phone: 0800 23326, during working days) when you would have questions regarding the functionality of the e-portal.

46February 2017 Information session FWO

Page 24: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

24

9. Additional information

9. Additional information This presentation contains only the key characteristics of the TBM

programme. Please consult the documents and e-portal on thewebsite:

• http://www.fwo.be/nl/mandaten-financiering/onderzoeksprojecten/tbm-projecten/ (NL)• http://www.fwo.be/en/fellowships-funding/research-projects/tbm-projects/ (EN)• http://www.fwo-eloket.be/FWO.ELoket.WebUI/Login.aspx (FWO e-portal)

TBM contact: [email protected]

Helpdesk e-portal:

[email protected]

• 0800 23326 (during working days from 09:00 until 17:00)

48February 2017 Information session FWO

Page 25: Info session TBM call 2017 - UZA · 17/01/2017 2 Overview 1. Mission and key facts FWO 2. Research Integrity 3. Focus of the TBM programme 4. Basic features of the TBM programme 5

17/01/2017

25