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Transformational Medical Research -Transformationeel Geneeskundig Onderzoek -TGO

10 april 2023

Katrien Swerts

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Transformational Medical Research - TGO

Context

Transformational Medical Research – TGO

Key features TGO programme

Technicalities

Questions

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Context TGO-programme

Recently, a remarkable progress has been made in the field of medical basic research. New discoveries do not always result in new, effective medicines.

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Context TGO-programme

The classical drug development path (clinical phase I, II and III studies) may form an obstacle for the development of innovative therapeutics.

Long and expensive drug development process

0 1 3 3.5 5 7 9 12

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Context TGO-programme

The classical drug development path (clinical phase I, II and III studies) may form an obstacle for the development of innovative therapeutics.

Low success rate

Context TGO-programme

Consequences: Patients need to wait for quite a long time before

new, sometimes lifesaving drugs reach the market. New drugs are quite expensive.

Increasing health care expenditures in Flanders, Belgium, Europe,…

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Context TGO-programme

We need to reform the drug development process in order to speed up the development of innovative, more effective drugs.

Bridge the ‘innovation gap’ Redesign clinical trials Implement biomakers in order to identify specific target

populations Increase the cost effectiveness of

the process …

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Transformational Medical Research programme

The Flemish government (Min Ingrid Lieten) decided to step in and launch the Transformational Medical Research (TGO) programme:

Accelerate development of more effective, safe and affordable drugs

Strengthen the Flemish biopharma cluster Make Flanders an attractive region for innovative clinical trials Provide our society with access to the best therapies …

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Transformational Medical Research programme

The Flemish government (Min Ingrid Lieten) decided to step in and launch the Transformational Medical Research (TGO) programme:

Budget Call 2012-2013: 10 million EUR. Call will be organised by IWT.

Key features TGO-programme

Key features of TGO-programme: Support relevant collaborations between companies, research

organizations and clinical centres Focus on adaptive clinical research projects with an economic and

social added value A substantial contribution to the current state of the art is mandatory Use of biomarkers and/or biological samples from biobanks is

encouraged.

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Key features TGO-programme

Key features of TGO-programme: Support relevant collaborations between companies,

research organizations and clinical centres

Consortium: Companies, research organisations and clinical centres. Consortium consists of at least one company and one research organisation.

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Key features TGO-programme

Consortium: Companies, research organisations and clinical centres. Consortium consists of at least one company and one research organisation.

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Key features TGO-programme

Balanced consortium

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Key features TGO-programme

Key features of TGO-programme: Focus on adaptive clinical research trials with an economic and

social added value TGO projects have a double finality Important feature compared to other IWT programmes (e.g.

R&D, SBO-E versus SBO-M, TBM) Reach a relevant social goal, bringing in industrial expertise

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Key features TGO-programme

Key features of TGO-programme: Focus on adaptive clinical research trials with an economic and social added

value Substantial valorisation potential Economic valorisation in Flanders

Investments / Employment Large utilisation of project results Impact on the Flemish health care situation Positive medical impact on a specific patient population

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Key features TGO-programme

Adaptive clinical trials:A clinical trial design that uses accumulating data to decide on how to modify aspects of the

study as it continues, without undermining the validity and integrity of the trial. (Gallo et al., 2006)

Size of cohort Clinical end points Dose Response criteria Inclusion criteria …

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Key features TGO-programme

Adaptive clinical trials:

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Key features TGO-programme

Key features of TGO-programme: A substantial contribution to the current state of the art is

mandatory

Knowledge creation is essential! Clinical Phase III trials without inventive approach or clinical

trials, focused on registration will not be funded.

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Technicalities TGO-programme

IntegrationThe modules should form an integrated project.

AdditionalityConsortium approach should have an added value compared to individual R&D, SBO or TBM projects.

Intellectual property

Technicalities TGO-programme

Module 1Research and Development

Module 1Research and Development

Owner project resultsCompanyCompany

Research organisation

- Clinical centre

Research organisation

- Clinical centre

Subcontractor: Market price or cost + margin No IP rights

Research partner: Actual cost Participate in generated IP (Agreements should not hinder industrial valorisation)

Technicalities TGO-programme

Owner project results

Module 2Strategic

Basic Research

Module 2Strategic

Basic Research

Research organisation

- Clinical centre

Research organisation

- Clinical centre

Transfer of results to companies / spin-off:

Market conform transfer Consortium partners do not have preferential access to the results. Interested companies may have a ‘right of first negotiation’. Revenues should be reinvested in R&D.

Transfer of results to social actors

Subcontractors: no IP rights

Technicalities TGO-programme

Owner project resultsResearch

organisation -

Clinical centre

Research organisation

- Clinical centre

No transfer of results to companies / spin-offs.

Industry is not interested in the project results

Subcontractors: no IP rights

Module 3Applied

Research

Module 3Applied

Research

Intellectual property

Budget

Technicalities TGO-programme

Budget Module 1

Research and Development

Budget Module 1

Research and Development

Budget Module 2

Strategic Basic Research

Budget Module 2

Strategic Basic Research

Budget Module 3

Applied Research

Budget Module 3

Applied Research

Total project budget

Total project budget

Budget Company 1

Budget Company 1

Budget Company 2

Budget Company 2

Budget Research partner

Budget Research partner

Budget IWT cost model: see website: www.iwt.be

Technicalities TGO-programme

Payroll costs (human resources and real salary costs)

Payroll costs (human resources and real salary costs)

Other costsDirect costs

Indirect costs

Other costsDirect costs

Indirect costs

SubcontractorsSubcontractors

Subsidy Total project subsidy between 1.000.000 EUR and

3.500.000 EUR. Subsidy percentage differs per Module.

Technicalities TGO-programme

Subsidy

Technicalities TGO-programme

Module 1Research and Development

Module 1Research and Development

Module 2Strategic Basic

Research

Module 2Strategic Basic

Research

Module 3Applied

Research

Module 3Applied

Research

Research: 50% Development: 25% Adaptive clinical trials: 37,5% Phase I/II clinical trials: 25% Phase III / Registration: 0%

Research organisations: 100% Clinical centres: 100%

Research organisations: 100% Clinical centres: 100%

Evaluation procedure

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Technicalities TGO-programme

Prior to submission1.Information meeting

Based on abstract (max. 2 pages) + specific questions

Topics to be discussed: Fit of project proposal Programme related issues (budget, eligibility

partners, etc.) Interested? Contact IWT: tgo@iwt.be

Technicalities TGO-programme

Prior to submission2. Pre-registration meeting

Deadline: November 26th, 2012 Based on preliminary project proposal Topics to be discussed:

Consortium composition Project structure Valorisation Added value Budget Etc.

Interested? Contact IWT: tgo@iwt.be

Technicalities TGO-programme

Prior to submission2. Pre-registration meeting

IMPORTANT: First time right! No instruction meeting! Project proposals cannot be changed once they are

submitted.

Technicalities TGO-programme

Technicalities TGO-programme

Submission Electronic submission (E-mail tgo@iwt.be (max 10

MB) or CD-rom) Submission according to the template on the

website

Technicalities TGO-programme

Eligibility Formal eligibility criteria

(See TGO-manual for complete list) On time? According to template? Consortium composition Etc.

Decision: January 8th, 2013

Technicalities TGO-programme

Evaluation IWT consults at least 4 international experts per

project proposal Two general evaluation dimensions:

Quality Social and economic valorisation

Module specific criteria

Technicalities TGO-programme

Evaluation Quality

Project focuses on the development of more effective and affordable drugs

Contribution to the current state of the art Relevance of the scientific approach Risks and feasibility of the scientific approach Quality project plan Project management and track record Competence and infrastructure

Technicalities TGO-programme

Evaluation Social and economic valorisation

Valorisation potential and feasibility valorisation goals

Relevance project for valorisation goals Social impact of project results Economic impact of project results Competence and track record Broad utilisation Added value compared to existing IWT

programs

Technicalities TGO-programme

Evaluation Module specific criteria

Quality Social and economic valorisation

Technicalities TGO-programme

Evaluation Decision:

Meeting Board of Directors April 2013.

Technicalities TGO-programme

Tips and tricks Carefully read the documents on the website and

contact IWT in case of questions (tgo@iwt.be) Before you start writing your full proposal, send an

abstract of the proposal to tgo@iwt.be in order to get some feedback regarding the fit of your project in the program

Ask for a pre-registration meeting

Technicalities TGO-programme

Tips and tricks Make sure your project has a clear focus Make sure the project modules are integrated Make sure the scientific goals are in line with the

valorisation goals Go for an innovative approach (risk and added

value state of the art) Etc.

Technicalities TGO-programme

Timing:

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Technicalities TGO-programme

Opening callOpening call June 2012

Submission deadlineSubmission deadline December 17th, 201212:00 (Noon)

EligibilityEligibility January 8th, 2013

Funding decisionFunding decision April 18th, 2013

More information:http://www.iwt.be/subsidies/tgo

tgo@iwt.be

IWT Team:Liesbeth BiesmansMia CallensHendrik De BondtPatricia MentenDirk VeelaertKatrien Swerts (Programme coordinator)Maarten Sileghem (Responsible director)

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Technicalities TGO-programme

Koning Albert II-laan 35, bus 16

B-1030 Brussel

Tel.: +32 (0)2 432 42 00

Fax.: +32 (0)2 432 43 99

E-mail: info@iwt.be

www.iwt.be

agentschap voor Innovatiedoor Wetenschap en Technologie