info session tbm call 2021 - fwo · 2020. 12. 9. · info session tbm call 2021 applied biomedical...

Info session TBM call 2021Applied Biomedical research with a primary Societal goal

Overview1. Focus of the TBM programme2. Basic features of the TBM programme3. Submission of a TBM project proposal4. Evaluation procedure5. Practical recommendations6. Additional information

Relevant changes since last call => (check TBM manual!)

3December 2020 Information session FWO

1. Focus of the TBM programme

1. Focus of the TBM programme▪ Policy goal on the longer term:

▪ 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 or specific prevention of a particular human disease/medical issue

or: aimed a comparison of existing therapies, diagnostics or preventive methods in order to evaluate their relative efficacy and cost-effectiveness

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

3. Added value for the Flemish health situation: at least 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 or specific prevention or a comparison of existing therapies, diagnostics or preventive methods

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

▪ …


Q & A: focus = new diagnostic/therapy for human disease

• Is it possible to add 'side-studies'? How to include them in the project proposal?

• Is TBM also open to psychotherapy research?

December 2020 Information session FWO 7


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

▪ …


Q & A: late stage translational research

• What is the required project status for the application to be considered?

• Are proof-of-concept data for the applied methodology sufficient?

• => See TBM manual for some examples. You must citeevidence that the intervention could work (studies backed byepidemiological data, large trials, pilot data, …)



Criterion 3: Added value for Flemish health situation: positive

medical impact for a specific patient group or a cost reduction

for the healthcare system


▪ Research focused on a disease that is not prevalent 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



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 available

▪ Research for which 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 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


Q & A: lack of industrial interest

• Is TBM compatible with ongoing AAL-projects in which industrial partner is involved?


2. Basic features of the TBM programme

2. Basic features of the TBM-programme

Applicants:

▪ Limited to research centers => e.g., universities, university hospitals, university colleges, strategic research centers.

▪ 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.

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* Or ITM

December 2020 Information session FWO


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

▪ Not limited to research centers! Other organizations or 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.


Q & A: advisory committee

• To what extent do we have to involve 'stakeholders’? What does this mean, how do we get them?



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

▪ their advice should increase the likelihood of an effective and broad implementation of the TBM project results

▪ the composition of the committee and its commitment will be taken into account during the assessment of the proposals



Advisory committee:

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: letter signed by legal representative of the organization.



Budget and subsidy:

▪ Programme budget: 11.8 M euro

▪ Project budget: between 215,000 euro and 850,000 euro

▪ For large or multicentric trials, exceptionally budgets up to 1,275,000 euro are allowed, given a thorough motivation!

▪ Project period:

▪ 2 to 4 years

▪ Official start of the project: 1 October 2021

▪ 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 + 2 years

o All other costs: project period + 2 years

▪ Subsidy: 100% of the acceptable costs

▪ Success rate 2020: ca. 23%


3. Submission of a TBM project proposal

Q & A: how to submit an application• Is there a standardized format for the application?

• We are currently writing a summary of our proposal. Can we upload our document if ready?

• How to pick correctly the expert panel when your topic is in the borderline of two disciplines? For example artificial intelligence and medical imaging diagnosis.



• Before submission: transfer of application to host institution in FWO e-portal: deadline 4 March at 5 PM

• Final submission: 18 March at 5 PM by host institution▪ In English▪ According to the templates▪ 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)’


E-portal FWO


• Supervisor of the project creates the new application in FWO e-portal

3. Submission of a TBM project proposal▪ SUPERVISOR:

▪ person who completes the application in e-portal automatically receives the status of supervisor (and contact person for main applicant)

▪ CO-SUPERVISORS:

▪ co-supervisors = representatives from the different research units in the consortium (= also contact persons for respective co-applicants)

▪ REFEREES - EXCEPTIONALLY:

▪ You may ask FWO to not involve certain experts in the evaluation of your proposal, provided good motivation


3. Submission of a TBM project proposal▪ BUDGET:

o See rules in COST model on the website

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

o Budget has to be prepared in the Excel template, 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.


3. Submission of a TBM project proposal▪ BUDGET

▪ Staffing costs (gross salaries):

o Only research staff and valorization preparing staff

o Double financing is not allowed

▪ Consumables:

o Materials, IT-costs, traveling expenses, small equipment of less than €20,000 per unit, subcontractor costs < € 8,500, etc.

o Large subcontractor costs (for subcontractor costs > € 8,500):

o At market price (full cost + margin)

o Quote necessary

▪ Equipment

o Costs for depreciation of equipment (max. €150,000)



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


4. Evaluation procedure

Q & A: evaluation process• What is the acceptance rate?

• Are there criteria to resubmit a proposal?

• If a project got a C as general appreciation score during the last call, it can't be resubmitted during the next call. However, if the project is rewritten with a totally different scientific approach, making it scientifically much stronger and making it a totally different study, can it then be resubmitted during the next call?

• We submitted our proposal two year ago, it was ranked high but not high enough to get funding. Last year, we took into account the feedback and resubmitted, we got an 'A' but no funding. Should we resubmit? We don’t know what to further improve in the proposal...


4. Evaluation procedureEligibility ▪ Eligibility criteria:

o Submitted before the deadline (4 March/18 March 2021; 5 PM)o Submitted in English and according to the requested format (page

limits, …)o All applicants are “research centers”o Submitted by at least one Flemish hospitalo All required declarations (applicants) are presento No manifest mismatch with the goals of the TBM programmeo For resubmissions: no C-score

▪ Decision by the board of directors of FWO within 30 days▪ Applicants of ineligible proposals will be informed as soon as possible


4. Evaluation procedureOne selection round, evaluation in dedicated panels of experts (June)

▪ One panel of experts per topic

▪ Short virtual interaction between applicants and experts (preliminary dates:June 8, 10, 14 and 15)

▪ See score grid, evaluation of the:▪ “fit” in the TBM programme

▪ scientific quality

▪ utilization potential

▪ Scoring in consensus

▪ Ranking of the proposals (based on the total score) within available budget

▪ Overall appreciation score (A/B/C) awarded => consequences to resubmitwithin the subsequent TBM call

▪ Decision by the FWO board of trustees (early July)


4. 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


5. Practical recommendations

5. 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.

▪ Use our template and 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.

▪ Pay attention to power analysis (for clinical studies).

▪ Take into account CONSORT guidelines when reporting clinical trials.


mailto:[email protected]


5. Practical recommendations when preparing a proposal

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

▪ Pay attention to the utilization planning.

▪ 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.



6. Additional information

6. 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)

• https://fwoweb.fwo.be/ (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/

https://fwoweb.fwo.be/



info session tbm call 2021 - fwo · 2020. 12. 9. · info session tbm call 2021 applied biomedical...

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