1 / 44

agentschap voor Innovatie door Wetenschap en Technologie

agentschap voor Innovatie door Wetenschap en Technologie. Transformational Medical Research -Transformationeel Geneeskundig Onderzoek - TGO. 16 september 2014. Katrien Swerts. Transformational Medical Research - TGO. Context Transformational Medical Research – TGO

london
Download Presentation

agentschap voor Innovatie door Wetenschap en Technologie

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. agentschap voor Innovatie door Wetenschap en Technologie

  2. Transformational Medical Research -Transformationeel Geneeskundig Onderzoek -TGO 16 september 2014 Katrien Swerts

  3. Transformational Medical Research - TGO • Context • Transformational Medical Research – TGO • Key features TGO programme • Technicalities • Questions

  4. 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.

  5. 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

  6. 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

  7. 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,…

  8. 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 • …

  9. 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 • …

  10. 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.

  11. 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.

  12. Key features TGO-programme • Key features of TGO-programme: • Support relevant collaborations between companies, research organizations and clinical centres

  13. Key features TGO-programme • Consortium: • Companies, research organisations and clinical centres. • Consortium consists of at least one company and one research organisation.

  14. Key features TGO-programme • Consortium: • Companies, research organisations and clinical centres. • Consortium consists of at least one company and one research organisation. Balanced consortium

  15. 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

  16. 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

  17. 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 • …

  18. Key features TGO-programme • Adaptive clinical trials:

  19. 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.

  20. 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.

  21. Technicalities TGO-programme • Intellectual property • 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) Module 1 Research and Development Company Research organisation - Clinical centre

  22. Technicalities TGO-programme 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. • Owner project results • Subcontractors: no IP rights • Transfer of results to social actors

  23. Technicalities TGO-programme • Intellectual property Module 3 Applied Research Research organisation - Clinical centre • No transfer of results to companies / spin-offs. • Industry is not interested in the project results • Owner project results • Subcontractors: no IP rights

  24. Technicalities TGO-programme • Budget Total project budget Budget Module 1 Research and Development Budget Module 2 Strategic Basic Research Budget Module 3 Applied Research Budget Company 1 Budget Company 2 Budget Research partner

  25. 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

  26. Technicalities TGO-programme • Subsidy • Total project subsidy between 1.000.000 EUR and 3.500.000 EUR. • Subsidy percentage differs per Module.

  27. Technicalities TGO-programme • Subsidy Module 1 Research and Development • 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% Module 2 Strategic Basic Research Module 3 Applied Research • Research organisations: 100% • Clinical centres: 100%

  28. Technicalities TGO-programme • Evaluation procedure

  29. Technicalities TGO-programme • Prior to submission • 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

  30. Technicalities TGO-programme • Prior to submission • 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

  31. 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.

  32. Technicalities TGO-programme • Submission • Deadline: December 17th, 2012 • 12:00 (Noon)

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

  34. 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

  35. 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

  36. 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

  37. 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

  38. Technicalities TGO-programme • Evaluation • Module specific criteria • Quality • Social and economic valorisation

  39. Technicalities TGO-programme • Evaluation • Decision: • Meeting Board of Directors April 2013.

  40. 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

  41. 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.

  42. Technicalities TGO-programme • Timing: Opening call June 2012 April 18th, 2013 January 8th, 2013 December 17th, 2012 12:00 (Noon) Submission deadline Eligibility Funding decision

  43. Technicalities TGO-programme • More information: • http://www.iwt.be/subsidies/tgo • tgo@iwt.be • IWT Team: • LiesbethBiesmans • Mia Callens • Hendrik De Bondt • Patricia Menten • Dirk Veelaert • KatrienSwerts (Programme coordinator) • Maarten Sileghem (Responsible director)

  44. 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

More Related