Tgo infosessie
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agentschap voor Innovatiedoor Wetenschap en Technologie
agentschap voor Innovatiedoor Wetenschap en Technologie
Transformational Medical Research II -Transformationeel Geneeskundig Onderzoek II -TGO II
10 april 2023
Katrien Swerts
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Context TGO-program
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-program
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
Hit ID Lead optimization
Candidate stage NME Phase I Phase II Phase III
0 1 3 3.5 5 7 9 12
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Context TGO-program
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-program
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-program
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 trails Implement biomakers in order to identify specific
target populations Increase the cost effectiveness of
the process …
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TGO I
In 2012, the Flemish government (Min Ingrid Lieten) decided to launch the Transformational Medical Research (TGO) program:
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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TGO I
TGO I: Budget Call 2012-2013: 10 million EUR. Results: 4 projects were (partially) funded
Project Coordinator
Biomarker based adaptive development in Alzheimer disease (BioAdaptAD)
Proof-of-mechanism in psoriasis: towards a novel drug therapy and tools for its clinical evaluation
ARGX-110 Adaptive Phase I Clinical Trial & Companion Diagnostic Kit Development
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TGO I
TGO I: Budget Call 2012-2013: 10 million EUR. Results: 4 projects were (partially) funded
Project Coordinator
Optimized anti-RSV development through Exploratory and Adaptive Design
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TGO II
TGO I was quite successful and IWT / Minister Lieten received a lot of positive feedback
The Flemish government decided to launch TGO II
The TGO program was adapted based on the feedback from the program committee (industry, academia, clinical centers):
Simplify structure of a TGO-project Enlarge the scope of the program Projects should have a positive effect on the health
care costs
Budget TGO II: 5 million EUR
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Key features TGO II
Key features TGO II 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 II
Balanced consortium
Key features TGO II
Key features TGO II Focus on the development of more efficient,
cheaper, safer drugs / medical devices. Clinical samples (from biobanks) Modern molecular medicine Diagnostic / theranostic biomarkers Innovative technologies / statistical analysis /
clinical trial design
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Key features TGO II
Key features TGO II: 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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Key features TGO II
Key features TGO II Projects results have an impact on the Flemish
health care situation. Moreover, they have a positive medical impact on a specific patient group.
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Key features TGO II
Key features TGO II Projects has a positive impact on the affordability of
the health care system TGO projects have a double finality
Economic valorisation in Flanders Investments / Employment
Societal valorisation in Flanders Reach a relevant social goal, bringing in
industrial expertise
Technicalities TGO II
Technicalities: How is the programme structured?
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Technicalities TGO II
Module 1Research and Development
Module 2Strategic Basic
Research
Module 3Applied Research
Transfer to companies and social partners
outside consortium
Social valorisation
without interest from the industry
Industrial valorisation + social added
value
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Technicalities TGO II
IntegrationModules 1 and 2 should form an integrated project.
AdditionalityConsortium approach should have an added value compared to individual R&D or SBO projects.
How can you participate?
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Technicalities TGO II
Module 1Research and Development
Company
Main applicantIndustrial partner
Coordinator
How can you participate?
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Technicalities TGO II
Module 1Research and Development
Research Organisation
Research partnerSubcontractor
Module 2Strategic Basic
Research
Main applicantPartner/Contractor
How can you participate?
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Technicalities TGO II
Module 1Research and Development
Clinical Centre
Research partnerSubcontractor
Module 2Strategic Basic
Research
Partner/ContractorSubcontractor
Intellectual property
Technicalities TGO II
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)
Technicalities TGO II
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
Budget
Technicalities TGO II
Budget Module 1
Research and Development
Budget Module 2
Strategic Basic Research
Total project budget
Budget Company 1
Budget Company 2
Budget Research partner
Use new IWT
cost model!
Subsidy Total project subsidy between 1.000.000 EUR and
2.500.000 EUR. Subsidy percentage differs per Module.
Technicalities TGO II
Subsidy
Technicalities TGO II
Module 1Research and Development
Module 2Strategic Basic
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%
Duration Project duration: 2 to 4 years
Starting date Beginning 2015
Technicalities TGO II
Evaluation procedure
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Technicalities TGO II
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: [email protected]
Technicalities TGO II
Prior to submission2. Pre-registration meeting
Deadline: August 1st, 2014 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 II
Prior to submission2. Pre-registration meeting
IMPORTANT: First time right! No instruction meeting! Project proposals cannot be changed once they are
submitted.
Technicalities TGO II
Submission
Deadline: September 1st, 201412:00 (Noon)
Technicalities TGO II
Submission Electronic submission (E-mail [email protected] (max 10
MB) or CD-rom) Submission according to the template on the
website
Technicalities TGO II
Eligibility Formal eligibility criteria
(See TGO-manual for complete list) On time? According to template? Consortium composition Etc.
Decision: September 9th, 2014
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 Impact on health care costs Competence and track record Utilisation and added value
Technicalities TGO-programme
Evaluation Module specific criteria
Quality Social and economic valorisation
Technicalities TGO-programme
Evaluation Decision:
Meeting Board of Directors December 2014.
Technicalities TGO-programme
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
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 call January 2014
Submission deadline September 1st, 201412:00 (Noon)
Eligibility September 9th, 2014
Funding decision December 18th, 2014
More information:http://www.iwt.be/subsidies/tgo
IWT Team:Liesbeth BiesmansMia CallensHendrik De BondtPatricia MentenTom Van de PutteDirk VeelaertKatrien Swerts (Contact point)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: [email protected]
www.iwt.be
agentschap voor Innovatiedoor Wetenschap en Technologie