TGO Program Accelerates Medical Research

agentschap voor Innovatie
door Wetenschap en Technologie


Transformational Medical Research
-Transformationeel Geneeskundig Onderzoek -
TGO

6 juli 2012

Katrien Swerts

Transformational Medical Research - TGO

 Context

 Transformational Medical Research – TGO

 Key features TGO programme

 Technicalities

 Questions

3

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.

4


 The classical drug development path (clinical phase I,
II and III studies) may form an obstacle for the
development of innovative therapeutics.
0 1 3 3.5 5 7 9 12

Long and expensive drug development process

5


 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
6


 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,…


 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
 …

8

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
 …

9

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.

10

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.


 Support relevant collaborations between
companies, research organizations and clinical
centres

12


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

13


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

Balanced consortium

14


 Focus on adaptive clinical research trials with an
 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

15


 Focus on adaptive clinical research trials with an
 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

16


 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
 …

17


 Adaptive clinical trials:

18


 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.

19

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.

20


 Intellectual property

Company  Owner project results
 Subcontractor:
 Market price or cost + margin
Module 1 Research
 No IP rights
Research and organisation
 Research partner:
Development -
 Actual cost
Clinical
 Participate in generated IP
centre
(Agreements should not hinder
industrial valorisation)


 Owner project results
 Transfer of results to companies /
spin-off:
 Market conform transfer
Research  Consortium partners do not have
Module 2
organisation preferential access to the results.
Strategic
-  Interested companies may have a
Basic
Clinical ‘right of first negotiation’.
Research
centre  Revenues should be reinvested in
R&D.
 Transfer of results to social actors

 Subcontractors: no IP rights


 Intellectual property

 Owner project results
Research  No transfer of results to companies /
Module 3 organisation
spin-offs.
Applied -  Industry is not interested in the
Research Clinical
project results
centre
 Subcontractors: no IP rights


 Budget

Total project
budget

Budget Budget Budget
Module 1 Module 2 Module 3
Research and Strategic Basic Applied
Development Research Research

Budget
Budget Budget
Research
Company 1 Company 2
partner


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

Payroll costs
(human resources and real salary costs)

Other costs
Direct costs
Indirect costs

Subcontractors


 Subsidy
 Total project subsidy between 1.000.000 EUR and
3.500.000 EUR.
 Subsidy percentage differs per Module.


 Subsidy

 Research: 50%
Module 1  Development: 25%
Research and  Adaptive clinical trials: 37,5%
Development  Phase I/II clinical trials: 25%
 Phase III / Registration: 0%
Module 2
 Research organisations: 100%
Strategic Basic
 Clinical centres: 100%
Research

Module 3
 Research organisations: 100%
Applied
 Clinical centres: 100%
Research


 Evaluation procedure

28


 Prior to submission
2.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


2. 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


2. Pre-registration meeting
 IMPORTANT: First time right!
 No instruction meeting!
 Project proposals cannot be changed once they are
submitted.


 Submission
 Electronic submission (E-mail tgo@iwt.be (max 10
MB) or CD-rom)
 Submission according to the template on the
website


 Eligibility
 Formal eligibility criteria
(See TGO-manual for complete list)
 On time?
 According to template?
 Consortium composition
 Etc.

 Decision: January 8th, 2013


 Evaluation
 IWT consults at least 4 international experts per
project proposal
 Two general evaluation dimensions:
 Quality
 Social and economic valorisation
 Module specific criteria


 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


 Evaluation
 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


 Evaluation
 Module specific criteria
 Quality


 Evaluation
 Decision:
 Meeting Board of Directors April 2013.


 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


 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.


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

tgo@iwt.be
 IWT Team:
Liesbeth Biesmans
Mia Callens
Hendrik De Bondt
Patricia Menten
Dirk Veelaert
Katrien Swerts (Programme coordinator)
Maarten Sileghem (Responsible director)
43


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

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