Tgo infosessie

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Information about Tgo infosessie
Technology

Published on March 4, 2014

Author: liesl

Source: slideshare.net

agentschap voor Innovatie door Wetenschap en Technologie

agentschap voor Innovatie door Wetenschap en Technologie Transformational Medical Research II Transformationeel Geneeskundig Onderzoek II TGO II 4 maart 2014 Katrien Swerts

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. 3

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. 0 1 3 3.5 5 7 9 12 Long and expensive drug development process 4

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 5

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,…

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  … 7

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  … 8

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 9

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 10

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 11

Key features TGO II  Key features TGO II  Support relevant collaborations between companies, research organizations and clinical centres 12

Key features TGO II  Consortium:  Companies, research organisations and clinical centres.  Consortium consists of at least one company and one research organisation. Balanced consortium 13

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

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. 15

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. 16

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 17

Technicalities TGO II  Technicalities:  How is the programme structured?

Technicalities TGO II Industrial valorisation + social added value Transfer to companies and social partners outside consortium Module 1 Research and Development Social valorisation without interest from the industry Module 3 Applied Research Module 2 Strategic Basic Research 19

Technicalities TGO II  Integration Modules 1 and 2 should form an integrated project.  Additionality Consortium approach should have an added value compared to individual R&D or SBO projects. 20

Technicalities TGO II  How can you participate? Module 1 Research and Development Main applicant Industrial partner Company Coordinator 21

Technicalities TGO II  How can you participate? Module 1 Research and Development Research partner Subcontractor Module 2 Strategic Basic Research Main applicant Partner/Contractor Research Organisation 22

Technicalities TGO II  How can you participate? Module 1 Research and Development Research partner Subcontractor Module 2 Strategic Basic Research Partner/Contractor Subcontractor Clinical Centre 23

Technicalities TGO II  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 II  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 II  Budget Use new IWT Total project budget Budget Module 1 Research and Development Budget Company 1 Budget Company 2 cost model! Budget Module 2 Strategic Basic Research Budget Research partner

Technicalities TGO II  Subsidy  Total project subsidy between 1.000.000 EUR and 2.500.000 EUR.  Subsidy percentage differs per Module.

Technicalities TGO II  Subsidy Module 1 Research and Development Module 2 Strategic 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%

Technicalities TGO II  Duration  Project duration: 2 to 4 years  Starting date  Beginning 2015

Technicalities TGO II  Evaluation procedure 30

Technicalities TGO II  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: tgo@iwt.be

Technicalities TGO II  Prior to submission 2. 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: tgo@iwt.be

Technicalities TGO II  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 II  Submission  Deadline: September 1st, 2014 12:00 (Noon)

Technicalities TGO II  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: 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 (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: Opening call January 2014 Submission deadline September 1st, 2014 12:00 (Noon) Eligibility September 9th, 2014 Funding decision December 18th, 2014 44

Technicalities TGO-programme  More information: http://www.iwt.be/subsidies/tgo tgo@iwt.be  IWT Team: Liesbeth Biesmans Mia Callens Hendrik De Bondt Patricia Menten Tom Van de Putte Dirk Veelaert Katrien Swerts (Contact point) Maarten Sileghem (Responsible director) 45

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: info@iwt.be www.iwt.be

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