Transcript Slide 1

EFPIA EHR Integration Workshop
Topic: The Innovative Medicines Initiative
Brussels 10-03-2007
Marc Peeters Ir.
Leopoldstraat 18
2300 Turnhout
Belgium
[email protected]
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What is IMI (1)
Preparatory Phase Active Phase
From ETP to JTI
IMI Joint Undertaking
15-09-06
SRA
approved
10-10
IMI JTI
approval
20-12
Council
approval
04-02
Publication
-EC DG RTD: Irene Norstedt
-EFPIA: RDG & Ian Ragan
-Stakeholder workshops
•
03-03
1st Board
Meeting
< 1st May
1st Call
published
IMI JU
autonomous
-IMI Governance Board
-IMI Executive Office & Scientific Committee
-IMI Member States Group & Stakeholder Forum
From European Technology Platform (ETP) to Joint Technology Initiative (JTI)
– ETP:
Create Strategic Research Agenda (SRA)
+ Initiate pilot project (InnoMed)
– JTI:
Create Statutes and Regulations (Structure, R+R, procedures,
processes)
– Prepare hand-over: 1st IMI call / call topics documents
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What is IMI (2)
Preparatory Phase Active Phase
From ETP to JTI
IMI Joint Undertaking
15-09-06
SRA
approved
10-10
IMI JTI
approval
20-12
Council
approval
04-02
Publication
-EC DG RTD: Irene Norstedt
-EFPIA: RDG & Ian Ragan
-Stakeholder workshops
•
•
•
•
03-03
1st Board
Meeting
< 1st May
1st Call
published
IMI JU
autonomous
-IMI Governance Board
-IMI Executive Office & Scientific Committee
-IMI Member States Group (MSG) & Stakeholder Forum
IMI is a legal entity, a Commission Body, that will call for-, review-, approve-, fundand oversee Research Projects implementing the IMI Research Agenda.
It results from new and innovative approaches to Community R&D introduced with
FP7 (Research Council, Joint Technology Initiatives) and as such is part of FP7 and
funded by FP7 budget. JTIs are based on industry led R&D topics.
It is a EU JTI embodied in a joint undertaking between the European Commission
and the Pharmaceutical Industry represented by EFPIA.
Is funded by the European Commission (cash, 1Billion Euro, public sector and SMEs)
and the BioPharmaceutical Industry (in kind, 1Billion Euro). This covers the
operations of the Executive Office (4% max) and the IMI Research Projects.
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The drivers for action
•
The need to enhance European’s competitiveness
– Academic – industrial platform for bio-medical research
– Network of SMEs with expertise in various niche areas
– Capabilities development
•
The potential for increased cooperation between stakeholders
– The convergence of disciplines creates the necessity for multidisciplinary
research
– The scale of the landslide change is such that a collaborative effort is required
•
Wealth of novel opportunities from genomics
– New undestanding leads to a continuous development of new subdisciplines
– Biomolecular findings become tools for the further exploration of biomolecular
mechanisms with an acceleration of new findings and potential industrial
application as a consequence
•
Timelines and cost of drug development
– Attrition rates and their associated costs become an unacceptable burden.
– New science based Pre-dictive tools understood by scientists and by
regulators.
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EFPIA Research Directors Group (RDG)
....Others
In line with the ETP concept of industry led R&D the Biopharma industry took
responsibility for the creation of the Strategic Research Agenda (SRA) under the
direction of the EFPIA RDG. Multiple workshops with representatives from all
the stakeholders (Academia, University hospitals, Patient organisations, SMEs,
Regulators, non-Pharma- and Pharma industry, EU Commission) shaped the SRA.
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The Strategic Research Agenda (1)
•Is an umbrella programme that describes the kind of advanced pre-competitive
research needed to broaden throughout the EU Union, the academic and industrial
know-how and skills required to successfully discover and develop novel medicinal
products at acceptable cost.
•It is based on the the identification of the current drug development bottlenecks
and suggests the drug development tools and processes that need further R&D to
overcome these bottlenecks. Developing drugs is not within the scope.
•It emphasizes close collaboration with the regulators to promote the acceptance
and use of these new methods and tools.
Discovery
research
Predictive
pharmacology
Efficacy
Safety
Preclinical
development
Predictive
toxicology
Identification
of biomarkers
Translational
medicine
Clinical
develop.
Patient
recruitment
Pharmaco
vigilance
Validation of
biomarkers
Benefit/Risk
assessment
with regulatory
authorities
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The Strategic Research Agenda (2)
•
Identifies pre-competitive bottlenecks in the
R&D process
•
Proposes recommendations to address these
bottlenecks
– Safety
– Efficacy (Cancer, Brain Disorders, Metabolic
diseases, Infectious diseases, Inflammatory
diseases)
– Knowledge Management (KM)
– Education and Training (E&T)
•
Proposes a new model of Public-Private
collaborations to implement these
recommendations
•
http://www.imi-europe.org
“Publications” tab
under
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Synopsis
•
•
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EC + EFPIA initiative
ETP >>> JTI >>> IMI Joint Undertaking
Strategic Research Agenda (SRA)
•
Predictivice Safety and –Efficacy tools, methods and expertise
– IMI is about R&D processes including regulatoy approval
– IMI is about tools and understanding of diseases, not about medicinal products
– IMI is about public and private sector collaboration in pre-competive biopharmaceutical
research
– that can lead to treatments that affect disease progression and ultimately to the cure of
diseases.
•
4 Pillars:
Pre-clinical
•
•
Safety
Efficacy KM
Pharmaco
Vigilance
5 Disease
Areas
E&T
Trans
lation
al KM
Integrated
Data
Exploration
Platform
Implementation based on calls (call topics).
Project funding stems in equal amounts from EC funding and EFPIA company
contributions in kind.
I.e. In a typical Research Project half of the costs are covered by in kind
contributions from the participating BioPharma and other industry companies and
the other half by IMI cash contributions to the participatns from SMEs and the
Public sector.
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The Pilot Project ‘InnoMed’
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InnoMed is a FP6 project
It is a pilot demonstrating successful pre-competitive collaboration between 16
BioPharmaceutical companies, 14 Universities and 8 SMEs.
Two targets: Toxicogenomics and Alzheimer disease.
PredTox
www.innomed-PredTox.com
For a number of compounds from each of the participating Pharma companies
create a database of toxicity profiles.
Integrating the traditional endpoints with new data from transcriptomics,
metabonomics and proteomics.
In search of new hepatitic toxicity biomarkers.
AddNeuroMed
www.innomed-QAddNeuroMed.com
In search of diagnostic markers
markers of progression
markers of response / non-response
in Alzheimer disease involving animal studies/models and clinical trials.
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IMI Process - Pre-Call
IMI Research Agenda
1st Call:
Industry Scientific Priorities Survey
+ Preparatory team
Scientific Committee
Executive Office
Annual Implementation Plan
Governance
Board
RDG
MSG
Workshops
Call Topics
Call Topic Documents
Call =
Call Topic Documents
Call Guidance Documents
Pharma
Companies
RDG
Executive Office
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Call Topic ToC
•
•
•
•
•
•
•
•
•
Heading
Topic Title
Project Description (Background, Scope, Approach, Requirements, Project Plan,..)
Key Deliverables of the project (Packages, lists,...)
EFPIA participants in the project (Company, Contact person(s))
Role of EFPIA participants in the project
Indicative Duration of the project
Indicate total in kind contribution from the EFPIA companies
Indicative Expectations from the ‘Public Consortium’ (i.e. SMEs, Academia, Patient
Organisations, Regulators and non-EFPIA companies)
From 6 to 10 pages.
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IMI Process - Post-Call
Call =
Call Topic Documents
Call Guidance Documents
Call Published
Submit
Expression of Interest
Phase 1
Invitation to submission
Phase 2
Submit
Full Project Proposal
Project Agreement
Grant Agreement
Finalization
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SRA recommendations
pre-Clinical Safety
1
Establish the framework for Biomarker development and
validation with human relevance and regulatory utility in mind
•Define datapackage needed to support acceptance of Biomarkers
2
Establish a pre-Clinical Safety data warehouse, cross species and
supportive of multi-scale modelling
3
Enhance the relevance for predictive toxicology/pre-clinical, of invivo, in-vitro and in-silico models
•determine the relevance of rodent non-genotoxic carcinogenicity:
mechanistic studies to understand mechanisms of receptor-mediated
carcinogenicity
•develop widely applicable in-silico models of toxicity to improve the
predictivity of endpoints
•understand intractable toxicity….develop new animal models, cellular
models, stem cells, human tissues, imaging, …..
Knowledge Management is often embedded in the Safety and Efficacy pillar
recommendations. It is a matter of emphasis.
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SRA recommendations
Clinical Efficacy - Mechanism of Action based
1
•Tools for the rational selection of molecular targets
•Tools for assays that demonstrate real pharmacological action and predict
efficacy in human disease
•Diagnostic tests capable of early detection
Need for Understanding of the disease mechanism of action
2
•In order to use methods and endpoints that most closely reflect those
that could can be used in clinical trials
Need for In-silico models of disease pathology; i.e. ‘disease lifecycle
models’ that directly link the rationale in pre-clinical modeling to the
treatment of clinical disease. Systems Biology
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•For improved ‘confidence in the rationale’ pre-clinical experiments must
carry higher relevance in relation to the clinical experience
Need for In-vitro & in-vivo models predictive of clinical efficacy
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SRA recommendatios
Clinical Efficacy – Integrated Healthcare
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•In order
to speed-up the recruitment process and
to recruit the right patient
We need Integrated patient selection networks that involve patient
organisations and access first class electronic patient records (EHR) linked
with Biobanks
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•Baseline data for a number of observations derived from pooling EMEA
and National agency data
•EU Drug risk/benefits database compiled from patient EMR
•Healtheconomics data
Are all part of Innovative Clinical trial Designs and analysis
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Intelligent Clinical Trial Environment
•EHR – CRF integration
•Patient database of he future
The EFPIA EHR Integration Taskforce objectives and recommendation - Eligibility
broker (CRFQ framework), EHR information broker, CRF-EHR core data sets closely align with these expressed needs in the IMI umbrella research programme
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SRA recommendations
Pharmacovigilance
1
Optimise data resources and EU datawarehouse
2
Develop lifecycle approach to pharmacovigilance
3
Develop novel methods of risk prediction and benefit-risk
assessment
4
Establish EU academic network of pharmacoepidemiology
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SRA recommendations
Knowledge Management (KM)
1
Systematically integrate / embed KM in the Safety and Efficacy projects
through the Translational KM approach
2
Develop and maintain IMI Data Exploration Platform supporting the
needs of safety and efficacy researchers across projects and disease
areas.
–Develop enhanced knowledge representation models and data
exchange standards for complex systems
–Design standards for and build an expert tool to allow the
federation of local databases in a secured environment
–Build a core reference database of validated experimental data
–Integrate mechanistic multi-scale modeling and simulation tools
that operate on top of the reference database
Special attention for collaboration and reuse with DG INFSO ICT for Health.
Open offer to present the ICT for Health programme and projects and results to
IMI Governance Board and IMI staff.
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IMI Governance Board
EFPIA
European Commission
Brian Ager
Andreas Busch
Jackie Hunter
Carlo Incenti
Jonathan Knowles
EFPIA
Bayer
GSK
Genzyme
Roche
Franco Biscontin
Daniel Jacob
George Lalis
Andrzej Jan Rys
Zoran Stancic
DG
DG
DG
DG
DG
RTD
RTD
ENTR
SANCO
RTD
IMI JU
EFPIA
SCIENTIFIC COMMITTEE
MSG
EXECUTIVE OFFICE
KM
RDG
BOARD
EFFICACY
EU
COMMI
SSION
STAKE
HOLDERS
FORUM
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IMI Contact
IMI Web site
www.imi-europe.org
Go to ‘Contact’ link
Open ‘Contact Us’ form
Write the message, provide personal data and submit
Messages are handled by Question and Answer software at the IMI offices.
IMI staff checks open questions on a daily basis and will respond asap.
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