presentatie iwt tgo-infosessies
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Presentatie IWT TGO-infosessiesTRANSCRIPT
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agentschap voor Innovatiedoor Wetenschap en Technologie
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agentschap voor Innovatiedoor Wetenschap en Technologie
Transformational Medical Research -Transformationeel Geneeskundig Onderzoek -TGO
6 juli 2012
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
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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.
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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
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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
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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.
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Intellectual property
Technicalities TGO-programme
Module 1Research and Development
Owner project resultsCompany
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)
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Technicalities TGO-programme
Owner project results
Module 2Strategic
Basic Research
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
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Technicalities TGO-programme
Owner project resultsResearch
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
Intellectual property
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Budget
Technicalities TGO-programme
Budget Module 1
Research and Development
Budget Module 2
Strategic Basic Research
Budget Module 3
Applied Research
Total project budget
Budget Company 1
Budget Company 2
Budget Research partner
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Budget IWT cost model: see website: www.iwt.be
Technicalities TGO-programme
Payroll costs (human resources and real salary costs)
Other costsDirect costs
Indirect costs
Subcontractors
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Subsidy Total project subsidy between 1.000.000 EUR and
3.500.000 EUR. Subsidy percentage differs per Module.
Technicalities TGO-programme
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Subsidy
Technicalities TGO-programme
Module 1Research and Development
Module 2Strategic Basic
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%
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Evaluation procedure
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Technicalities TGO-programme
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Prior to submission2.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: [email protected]
Technicalities TGO-programme
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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: [email protected]
Technicalities TGO-programme
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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
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Technicalities TGO-programme
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Submission Electronic submission (E-mail [email protected] (max 10
MB) or CD-rom) Submission according to the template on the
website
Technicalities TGO-programme
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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
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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
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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
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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
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Evaluation Module specific criteria
Quality Social and economic valorisation
Technicalities TGO-programme
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Evaluation Decision:
Meeting Board of Directors April 2013.
Technicalities TGO-programme
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Tips and tricks Carefully read the documents on the website and
contact IWT in case of questions ([email protected]) Before you start writing your full proposal, send an
abstract of the proposal to [email protected] in order to get some feedback regarding the fit of your project in the program
Ask for a pre-registration meeting
Technicalities TGO-programme
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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
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Timing:
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Technicalities TGO-programme
Opening call June 2012
Submission deadline December 17th, 201212:00 (Noon)
Eligibility January 8th, 2013
Funding decision April 18th, 2013
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More information:http://www.iwt.be/subsidies/tgo
IWT Team:Liesbeth BiesmansMia CallensHendrik De BondtPatricia MentenDirk VeelaertKatrien Swerts (Programme coordinator)Maarten Sileghem (Responsible director)
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Technicalities TGO-programme
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Koning Albert II-laan 35, bus 16B-1030 BrusselTel.: +32 (0)2 432 42 00Fax.: +32 (0)2 432 43 99E-mail: [email protected]
agentschap voor Innovatiedoor Wetenschap en Technologie