Transcript Transformational Medical Research (TGO) programme

agentschap voor Innovatie
door Wetenschap en Technologie
agentschap voor Innovatie
door Wetenschap en Technologie
Transformational Medical Research Transformationeel Geneeskundig Onderzoek TGO
13 april 2015
Katrien Swerts
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.
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1
Hit ID
3
Lead
optimization
3.5
Candidate
stage
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NME
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Phase I
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Phase II
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Phase III
Long and expensive drug development process
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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,…
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.
Key features TGO-programme
 Key features of TGO-programme:
 Support relevant collaborations between
companies, research organizations and clinical
centres
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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
 Consortium:
 Companies, research organisations and clinical
centres.
 Consortium consists of at least one company and
one research organisation.
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)
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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
 Integration
The modules should form an integrated project.
 Additionality
Consortium approach should have an added value
compared to individual R&D, SBO or TBM projects.
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Technicalities TGO-programme
 Intellectual property
Company
Module 1
Research and
Development
Research
organisation
Clinical
centre
 Owner project results
 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 2
Strategic
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
Technicalities TGO-programme
 Intellectual property
 Owner project results
Module 3
Applied
Research
Research
organisation
Clinical
centre
 No transfer of results to companies /
spin-offs.
 Industry is not interested in the
project results
 Subcontractors: no IP rights
Technicalities TGO-programme
 Budget
Total project
budget
Budget
Module 1
Research and
Development
Budget
Company 1
Budget
Module 2
Strategic Basic
Research
Budget
Company 2
Budget
Research
partner
Budget
Module 3
Applied
Research
Technicalities TGO-programme
 Budget
IWT cost model: see website: www.iwt.be
Payroll costs
(human resources and real salary costs)
Other costs
Direct costs
Indirect costs
Subcontractors
Technicalities TGO-programme
 Subsidy
 Total project subsidy between 1.000.000 EUR and
3.500.000 EUR.
 Subsidy percentage differs per Module.
Technicalities TGO-programme
 Subsidy
Module 1
Research and
Development
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Research: 50%
Development: 25%
Adaptive clinical trials: 37,5%
Phase I/II clinical trials: 25%
Phase III / Registration: 0%
Module 2
Strategic Basic
Research
 Research organisations: 100%
 Clinical centres: 100%
Module 3
Applied
Research
 Research organisations: 100%
 Clinical centres: 100%
Technicalities TGO-programme
 Evaluation procedure
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Technicalities TGO-programme
 Prior to submission
1. 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
 Prior to submission
2. Pre-registration meeting
 Deadline: November 26th, 2012
 Based on preliminary project proposal
 Topics to be discussed:
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Consortium composition
Project structure
Valorisation
Added value
Budget
Etc.
 Interested? Contact IWT: [email protected]
Technicalities TGO-programme
 Prior to submission
2. Pre-registration meeting
 IMPORTANT: First time right!
 No instruction meeting!
 Project proposals cannot be changed once they are
submitted.
Technicalities TGO-programme
 Submission
 Deadline: December 17th, 2012
12:00 (Noon)
Technicalities TGO-programme
 Submission
 Electronic submission (E-mail [email protected] (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 ([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:
Opening call
June 2012
Submission deadline
December 17th, 2012
12:00 (Noon)
Eligibility
January 8th, 2013
Funding decision
April 18th, 2013
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Technicalities TGO-programme
 More information:
http://www.iwt.be/subsidies/tgo
[email protected]
 IWT Team:
Liesbeth Biesmans
Mia Callens
Hendrik De Bondt
Patricia Menten
Dirk Veelaert
Katrien Swerts (Programme coordinator)
Maarten Sileghem (Responsible director)
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agentschap voor Innovatie
door Wetenschap en Technologie
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