eatris european infrastructure for translational medicine mission

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EATRIS transforms scientific discoveries into innovative and high impact medicines, diagnostics and medical devices through European collaborative consortia of academic, industrial and governmental partners. EATRIS European Infrastructure for Translational Medicine Mission

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Page 1: EATRIS European Infrastructure for Translational Medicine Mission

EATRIS transforms scientific discoveries into

innovative and high impact medicines, diagnostics

and medical devices through European

collaborative consortia of academic, industrial and

governmental partners.

EATRIS

European Infrastructure for Translational Medicine

Mission

Page 2: EATRIS European Infrastructure for Translational Medicine Mission

Translation Medicine

Models

Big Pharma

Academic centres

Virtual

Translation Medicine

Centre

Page 3: EATRIS European Infrastructure for Translational Medicine Mission

Assemble the resources of the Academic Centres

of Excellence to create a virtual Centre of

Translation Medicine

EATRIS

European Infrastructure for Translational Medicine

Approach to the Mission

Page 4: EATRIS European Infrastructure for Translational Medicine Mission

Nine European countries are participating

2012

Page 5: EATRIS European Infrastructure for Translational Medicine Mission

European collaborative consortia

Academia

Fundamental discoveries

Excellent pre-clinical development

Excellent research infrastructure

Translational expertise

Access to patients, clinical experts

Industry

Excellence in clinical development

Understanding of market mechanisms

Resources to enter risky clinical phase

Production

Global reach in distribution & sales

Governments

Access to regulatory agencies

Resources to support critical infrastructure

Coordination & dialogue among EU countries

Long-term vision for improved,

cost-effective patient care

To produce better

patient outcomes

Leveraging the combined power of stakeholders

Page 6: EATRIS European Infrastructure for Translational Medicine Mission

An European effort coordinated in Amsterdam

Board

Of Governors

Scientific

Advisory

Board

Coordination

& Support

Board of

National

Directors

DK National coordinator

FI National Coordinator

…National Coordinator

Biomarkers

Group

Vaccine

Group

Tracer

& Imaging

Group

ATMP’s

Group

Small

Molecules

Group

Prod. Dev. Regulatory Quality

Assurance

…Expert

Team …

Leveraging expertise

Page 7: EATRIS European Infrastructure for Translational Medicine Mission

The organizational 3D matrix

Horizontal & vertical expertise / diseases

Clinical Affairs

Training

Dissemination

QA/QC

Regulatory

Biomarkers

Group

Vaccine

Group

Tracer

& Imaging

Group

ATMP’s

Group

Small

Molecules

Group Expert group

Product

group

C&

S

Legal affair

IP, contracts

Access

Financing

Communication

Page 8: EATRIS European Infrastructure for Translational Medicine Mission

Five Product Groups

Drivers of scientific excellence

Biomarkers

Group

& consortia

Vaccine

Group

& consortia

Tracer

& Imaging

Group

& consortia

ATMP’s

Group

& consortia

Small

Molecules

Group

& consortia

Page 9: EATRIS European Infrastructure for Translational Medicine Mission

Each Product Group:

Drives the scientific strategy and content of the translational consortia

Comprises of leading scientists from participating centers and countries

Define the total package of services offered, communication literature, best

practice sharing within and across product groups, aligned with Medical

Sciences Research Infrastructure.

Focuses on quality (priority to benchmarking and best practice sharing)

Offers complete range of relevant services and capacities

Manages projects in the ‘product’ area.

Page 10: EATRIS European Infrastructure for Translational Medicine Mission

Supporting Expert Teams

Expert advisors support and expertise feeds into Product Groups

Clinical Affairs Training

Dissemination

QA/QC

Regulatory Legal affair

IP, contracts Access

Financing

Communication

Page 11: EATRIS European Infrastructure for Translational Medicine Mission

Expert Teams:

To support Product Groups/consortia with their expertise on

strategy, planning en product development to ensure:

“One-Stop Shop” single access port

Clinical expertise

Project, administrative & financial management

Expertise on regulatory & legal affairs

Quality assurance

IP & technology transfer

Project-tailored development teams

Development plan/milestones/timelines

Page 12: EATRIS European Infrastructure for Translational Medicine Mission

Key Value Points for the EU Translational Medicine

“One-Stop Shop”

Cross border access to centres of excellence: academia

and patients (clinicians)

Improved technology models and methods

Regulatory request compliant

Unmet diseases: i.e. “non economical” or rare diseases

Bringing translational knowledge to academia

Not for profit though co-creating value for public health

society

Cost control for new treatments ….

Page 13: EATRIS European Infrastructure for Translational Medicine Mission

Key Value Points for the single national network

“One-Stop Shop” Centralised offering and access with “non scientific” support

Synergy of the offering: access to academia and patients (clinicians) are shared

to offer a “full service”

Improved technology and methods through exchange and common development

QA/QC Harmonization: toward an European standard of Regulatory compliance

Unitary Approach to Unmet Diseases: i.e “non economical” or rare diseases

Bringing translational knowledge to academia

It results in:

Enhanced capacity to obtain funding from focused programs and to answer to

calls through preformed networks

Participation to the national Road Map

Access to the Translational Medicine Market

Page 14: EATRIS European Infrastructure for Translational Medicine Mission

Practical: Participation to calls

EATRIS responded to the FPVII call on the INFRASTRUCTURES

INFRA-2012-1.1.5. (Implementation)

Facilities for translational research in medicine

Requested 9.9 m€

I3 (Integrated Infrastructure Initiative)

(i) Networking activities,

(ii) Trans-national access and/or service activities (Pilot projects

30% of the funds) and

(ii) Joint research activities

If funded completely IATRIS will receive 1.5m€