info session tbm call 2020 - vlaanderen (fwo) · other costs: real costs up to a maximum of...

Info session TBM call 2020Applied Biomedical research with a primary Societal goal

Overview

1. Mission and key facts FWO

2. Focus of the TBM programme

3. Basic features of the TBM programme

4. Submission of a TBM project proposal

5. Evaluation process

6. After the decision

7. Practical recommendations

8. Additional information

3December 2019 Information session FWO

1. Mission and key facts FWO

• Mission:

• Funding of fundamental & strategic research

• Funding programmes• Individual researchers (pre-, post-doc, international mobility)

• Research teams (projects, SBO, TBM, brain gain Odysseus, …)

• Research infrastructure

• Scientific prizes

• Interuniversity competition


2. 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 particular human disease/medical issue or a comparison of existing therapies, diagnostics or preventive methods 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.



Criterion 1: development of a new therapy, diagnosis and/or specific prevention of a particular human disease/medical issue or a comparison of existing therapies, diagnostics or preventive methods 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 …



Criterion 2: late stage translational research


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

…



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


Research focused on a disease that has no incidence in Flanders

Research focused on a development that results in neither a medical impactnor a cost 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.



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



Criterion 4: lack of industrial interest in the project

Possible commercial reasons for a lack of industrial interest:

No possibility for patenting

High costs of individual treatment that squeeze profit margins (e.g., autologous cell therapy, tissue engineering);

High commercial risk (e.g., gene therapy, xenotransplant)

If the expert panel has serious doubts about the absence of industrial interest and no convincing argumentation is presented in the proposal, a critical score (instead of a poor score) will be appointed to this criterion.



Criterion 4: lack of industrial interest in the project – possiblereasons

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 independence should be mentioned



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).


3. Basic features of the TBM-programme

Applicants:

Limited to research centers => e.g., universities, university hospitals, university colleges, strategic research centers. Each applicant has to declare that the organization fulfills the definition of research center.

One applicant or a consortium of several applicants, but participation of a Flemish hospital* as applicant 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.

15

* Or ITM

December 2019 Information session FWO


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.



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.



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 commitment 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.



Budget and subsidy:

Programme budget: 11.7 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

Official start of the project: 1 October 2020

Project period 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

Success rate 2019: ca. 29%



• Before submission: transfer of application to host institution in FWO e-portal: deadline 12 March at 5 PM

• Final submission: 23 March at 5 PM by host institution In English According to the templates on the FWO e-portal Applicants are:

= 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)’

December 2019 Information session FWO 21

E-portal FWO


• 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.

4. Submission of a TBM project proposal 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 - EXCEPTIONALLY:

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!


4. Submission of a TBM project proposal 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.


4. 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



Declaration (on the submission deadline):• 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, please upload a letter of intent before the submission deadline via the Extra data tab (template: see website)


4. Submission of a TBM project proposalWho has access to the back office module of 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


5. Evaluation procedure

5. Evaluation procedureEligibility

Eligibility criteria:

o Submitted before the deadline (12 March/23 March 2020; 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


5. Evaluation procedureOne selection round Evaluation in dedicated panels of experts (June)

One panel of experts per (broad) topic Possibility for a short interaction between the applicants and the

experts (preliminary dates: June 3, 4, 9 and 12) Evaluation of the “fit” in the TBM programme, the scientific quality

& the utilization potential => see score grid on the website Scoring in consensus

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

Overall appreciation score is awarded to non-funded proposals =>consequences to resubmit within the subsequent TBM call

Decision by the FWO board of trustees (early July)


5. Evaluation procedureScore grid – criteria

Scientific criteria• Focus on new therapy, diagnosis, specific prevention of a disease/medical issue 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


6. After the decision• Grant agreement: end of August• Cooperation agreement: to be sent to FWO by end of

December 2020• Approval ethical committee: to be sent to FWO as soon

as available• Registration clinical trial: FWO requires that clinical trials

are registered in a suitable clinical trial database (e.g., https://www.clinicaltrials.gov). When the first patient is included in the trial, FWO should be informed

• Data management plan: to be sent to FWO after approval of the project


7. Practical recommendations

7. 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.


mailto:[email protected]


7. 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.

As of 2020 CO2 compensation can be budgeted for travel.

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]) if you have questions regarding the functionality of the e-portal.



8. Additional information

8. Additional information This presentation contains only the key characteristics of

the TBM programme. Please consult the documents ande-portal on the website:

• 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]


http://www.fwo.be/nl/mandaten-financiering/onderzoeksprojecten/tbm-projecten/

http://www.fwo.be/en/fellowships-funding/research-projects/tbm-projects/

http://www.fwo-eloket.be/FWO.ELoket.WebUI/Login.aspx



info session tbm call 2020 - vlaanderen (fwo) · other costs: real costs up to a maximum of...

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