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EFPIA EHR Integration Workshop Topic: The Innovative Medicines Initiative

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Title: Slide 1 Author: Ian Ragan Last modified by: geetsis1 Created Date: 3/22/2006 4:36:21 PM Document presentation format: A4 Paper (210x297 mm) Company – PowerPoint PPT presentation

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Title: EFPIA EHR Integration Workshop Topic: The Innovative Medicines Initiative


1
EFPIA EHR Integration Workshop Topic The
Innovative Medicines Initiative
  • Brussels 10-03-2007

Marc Peeters Ir. Leopoldstraat 18 2300
Turnhout Belgium marc_dvf_Peeters_at_hotmail.com
2
What is IMI (1)
Preparatory Phase From ETP to JTI
Active Phase IMI Joint Undertaking
03-03 1st Board Meeting
20-12 Council approval
04-02 Publication
lt 1st May 1st Call published
IMI JU autonomous
10-10 IMI JTI approval
15-09-06 SRA approved
-EC DG RTD Irene Norstedt -EFPIA RDG Ian
Ragan -Stakeholder workshops
-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, RR, procedures, processes)
  • Prepare hand-over 1st IMI call / call topics
    documents

3
What is IMI (2)
Preparatory Phase From ETP to JTI
Active Phase IMI Joint Undertaking
03-03 1st Board Meeting
20-12 Council approval
04-02 Publication
lt 1st May 1st Call published
IMI JU autonomous
10-10 IMI JTI approval
15-09-06 SRA approved
-EC DG RTD Irene Norstedt -EFPIA RDG Ian
Ragan -Stakeholder workshops
-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-, fund- and
    oversee Research Projects implementing the IMI
    Research Agenda.
  • It results from new and innovative approaches to
    Community RD 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 RD 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.

4
The drivers for action
  • The need to enhance Europeans 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.

5
EFPIA Research Directors Group (RDG)
....Others
In line with the ETP concept of industry led RD
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.
6
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 RD 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.

Efficacy
Safety
7
The Strategic Research Agenda (2)
  • Identifies pre-competitive bottlenecks in the RD
    process
  • Proposes recommendations to address these
    bottlenecks
  • Safety
  • Efficacy (Cancer, Brain Disorders, Metabolic
    diseases, Infectious diseases, Inflammatory
    diseases)
  • Knowledge Management (KM)
  • Education and Training (ET)
  • Proposes a new model of Public-Private
    collaborations to implement these recommendations
  • http//www.imi-europe.org under
    Publications tab

8
Synopsis
  • EC EFPIA initiative
  • ETP gtgtgt JTI gtgtgt IMI Joint Undertaking
  • Strategic Research Agenda (SRA)
  • IMI is about RD 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
  • Predictivice Safety and Efficacy tools, methods
    and expertise
  • that can lead to treatments that affect disease
    progression and ultimately to the cure of
    diseases.
  • 4 Pillars Safety Efficacy KM ET
  • Pre-clinical Pharmaco 5 Disease Trans Integrated
  • Vigilance Areas lation Data
  • al KM 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.

9
The Pilot Project InnoMed
  • 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.

10
IMI Process - Pre-Call
IMI Research Agenda
Scientific Committee
1st Call Industry Scientific Priorities Survey
Preparatory team
Governance Board
Executive Office
RDG
Annual Implementation Plan
MSG
Workshops
Call Topics
Write
Pharma Companies
Call Topic Documents
RDG
Call Call Topic Documents Call Guidance
Documents
Executive Office
11
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.

12
IMI Process - Post-Call
Call Published
Submit
Expression of Interest
Phase 1
Peer review
Phase 2
Invitation to submission
Executive Office
Submit
Full Project Proposal
Peer review
Project Agreement Grant Agreement
Finalization
13
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 in-vivo, 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.
14
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
3 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
15
SRA recommendatios Clinical Efficacy
Integrated Healthcare
7 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
8 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
9 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
16
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
17
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.
18
IMI Governance Board
  • EFPIA European Commission
  • Brian Ager EFPIA Franco Biscontin DG RTD
  • Andreas Busch Bayer Daniel Jacob DG RTD
  • Jackie Hunter GSK George Lalis DG ENTR
  • Carlo Incenti Genzyme Andrzej Jan Rys DG SANCO
  • Jonathan Knowles Roche Zoran Stancic DG RTD

IMI JU
SCIENTIFIC COMMITTEE
BOARD
EU COMMI SSION
MSG
EXECUTIVE OFFICE
KM
STAKE HOLDERS FORUM
ET
EFPIA
RDG
SAFETY
EFFICACY
19
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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