+ All Categories
Home > Technology > Tgo infosessie

Tgo infosessie

Date post: 14-Dec-2014
Category:
Upload: liesl
View: 1,292 times
Download: 3 times
Share this document with a friend
Description:
 
Popular Tags:
46
agentschap voor Innovatie door Wetenschap en Technologie
Transcript
Page 1: Tgo infosessie

agentschap voor Innovatiedoor Wetenschap en Technologie

Page 2: Tgo infosessie

agentschap voor Innovatiedoor Wetenschap en Technologie

Transformational Medical Research II -Transformationeel Geneeskundig Onderzoek II -TGO II

10 april 2023

Katrien Swerts

Page 3: Tgo infosessie

3

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.

Page 4: Tgo infosessie

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.

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

Page 5: Tgo infosessie

5

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

Page 6: Tgo infosessie

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,…

Page 7: Tgo infosessie

7

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 …

Page 8: Tgo infosessie

8

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 …

Page 9: Tgo infosessie

9

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

Page 10: Tgo infosessie

10

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

Page 11: Tgo infosessie

11

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

Page 12: Tgo infosessie

12

Key features TGO II

Key features TGO II Support relevant collaborations between

companies, research organizations and clinical centres

Page 13: Tgo infosessie

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

13

Key features TGO II

Balanced consortium

Page 14: Tgo infosessie

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

Page 15: Tgo infosessie

15

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.

Page 16: Tgo infosessie

16

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.

Page 17: Tgo infosessie

17

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

Page 18: Tgo infosessie

Technicalities TGO II

Technicalities: How is the programme structured?

Page 19: Tgo infosessie

19

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

Page 20: Tgo infosessie

20

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.

Page 21: Tgo infosessie

How can you participate?

21

Technicalities TGO II

Module 1Research and Development

Company

Main applicantIndustrial partner

Coordinator

Page 22: Tgo infosessie

How can you participate?

22

Technicalities TGO II

Module 1Research and Development

Research Organisation

Research partnerSubcontractor

Module 2Strategic Basic

Research

Main applicantPartner/Contractor

Page 23: Tgo infosessie

How can you participate?

23

Technicalities TGO II

Module 1Research and Development

Clinical Centre

Research partnerSubcontractor

Module 2Strategic Basic

Research

Partner/ContractorSubcontractor

Page 24: Tgo infosessie

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)

Page 25: Tgo infosessie

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

Page 26: Tgo infosessie

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!

Page 27: Tgo infosessie

Subsidy Total project subsidy between 1.000.000 EUR and

2.500.000 EUR. Subsidy percentage differs per Module.

Technicalities TGO II

Page 28: Tgo infosessie

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%

Page 29: Tgo infosessie

Duration Project duration: 2 to 4 years

Starting date Beginning 2015

Technicalities TGO II

Page 30: Tgo infosessie

Evaluation procedure

30

Technicalities TGO II

Page 31: Tgo infosessie

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

Page 32: Tgo infosessie

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

Page 33: Tgo infosessie

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

Page 34: Tgo infosessie

Submission

Deadline: September 1st, 201412:00 (Noon)

Technicalities TGO II

Page 35: Tgo infosessie

Submission Electronic submission (E-mail [email protected] (max 10

MB) or CD-rom) Submission according to the template on the

website

Technicalities TGO II

Page 36: Tgo infosessie

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

Page 37: Tgo infosessie

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

Page 38: Tgo infosessie

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

Page 39: Tgo infosessie

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

Page 40: Tgo infosessie

Evaluation Module specific criteria

Quality Social and economic valorisation

Technicalities TGO-programme

Page 41: Tgo infosessie

Evaluation Decision:

Meeting Board of Directors December 2014.

Technicalities TGO-programme

Page 42: Tgo infosessie

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

Page 43: Tgo infosessie

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

Page 44: Tgo infosessie

Timing:

44

Technicalities TGO-programme

Opening call January 2014

Submission deadline September 1st, 201412:00 (Noon)

Eligibility September 9th, 2014

Funding decision December 18th, 2014

Page 45: Tgo infosessie

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

[email protected]

IWT Team:Liesbeth BiesmansMia CallensHendrik De BondtPatricia MentenTom Van de PutteDirk VeelaertKatrien Swerts (Contact point)Maarten Sileghem (Responsible director)

45

Technicalities TGO-programme

Page 46: Tgo infosessie

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


Recommended