The Innovative Medicines Initiative

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The Innovative Medic ines Initia tive

EMEA-EFPIA INFO DAY, February 5th, 2007

Karima Boubekeur

Creating Biomedical R&D Leadership for Europeto Benefit Patients and Soc iety


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Agenda

What is IMI?

Why is IMI importa nt to the EFPIA?

What c ould be the role of the EMEA in IMI?


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The Drivers for a New R&D ModelBased on Pub lic -Priva te Partnership

The need to enhance Europea ns c ompetitiveness;

Timelines and c ost of d rug d evelop ment;

Wea lth of novel op portunities from new sc ienc e andtechnologies;

The potentia l of inc rea sed c oopera tion betweenstakeholders.

European Commission a nd EFPIA will p ropose in 2007the c rea tion of the IMI Joint Tec hnology Initia tive.


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Identifies p re-c ompetitive

bottlenec ks in the R&D proc ess Prop oses rec ommendations to

address these bottlenec ks

Proposes a new model ofPub lic -Priva te c ollabora tions toimp lement these

recommendations

The IMI Strategic Research Agendahttp:/ / www.imi-europe.org


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How to Provide More Effec tive, SaferMedic ines Faster?

IMI is about R&D proc esses inc lud ing reg istra tion;

IMI is about tools and understand ing of d iseases,not about med ic ina l p roduc ts;

Pa tient Centred Projec ts will address the p rinc ipa lc auses of delay in the b iomed ic a l R&D proc ess;

IMI is a unique p ublic and p rivate sec torc ollabora tion in b iopharmac eutic a l researc h.


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For EFPIA, IMI is the top R&D Priorityfor 2007


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Why is IMI a Top Priority for EFPIA?

Faster interpreta tion of sa fety find ings through sharing p re-c ompetitive toxic ology da ta ;

Red uc tion of anima l use in sa fety eva luation;

Va lida tion of new assessment methods e.g . b iomarkers;

Fewer pa tients needed in p ivota l tria ls; Faster approva ls through better c ollabora tion with EMEA;

Fewer post-marketing w ithdrawa ls;

More skilled p rofessiona ls.

More c ost-effic ient R&D


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IMI is Aligned with the EMEA RoadMap to 2010

Top-qua lity sc ientific assessment

network of exc ellence

Continuous monitoring o f med ic inal p rod uc ts

pharmac ovigilanc e network

Acc ess to informa tion

information to p a tients and hea lthc are p rofessiona ls,

transparenc y, measures for SMEs Allow rap id ac c ess to sa fe and effec tive med ic ines

partnering with interested pa rties


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About the European Centre of DrugSafety Research (ECDSR)

Sma ll and independent centre c omp osed of a c ore g roup

with a wide network of ac ademic s, industry sc ientists andregulators;

Non-c linic a l sa fety;

Pharma c ovig ilance & Risk ma nagement; Ob jec tives:

c o-ord ina te resea rc h needs in sa fety sc ienc es,

enhance tra ining and ed uca tion o f drug sa fety sc ientists,

ma teria lise the benefits of knowled ge manag ement.


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Proposed Partic ipation of the EMEA inthe IMI Governanc e Struc ture

IMI Projects:

- Public-Private Collaborations

- Answering Calls

Member States Group

IMI Board

European Commission & EFPIA

Scientific Committee

Executive Office

Safety Efficacy KM E&TOffice Operations

Stakeholder Forum

Public Community

Patient Centred Projects:

- Public-Private Collaborations

- Answering Calls

Member States Group

IMI Board

European Commission & EFPIA

Scientific Committee

Executive Office

Safety Efficacy KM E&TOffice Operations

Stakeholders Forum

Public Community


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Resources of the IMI Patient Centred Projec ts

e.g. Imaginge.g. Imaging

RegulatorsIn-kind

Funding Funding

Patients

Small &Medium

SizedEnterprises

Academia

EFPIA

Companies

PROJECT

RESOURCES

IMI Project Participants

Funding

Expertise

EuropeanCommission

cash


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Roles of the EMEA in IMI

Direc t impac t on dec isions through partic ipa tion in

the IMI Board , the Sc ientific Committee andStakeholders Forum;

Direc t p artic ipa tion in IMI Pa tient Centred Projec ts;

Regula tory expertise to help identify needs andsolutions;

Co-ord ina tion with regula tory initia tives.


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Impac t of IMI on Benefit/ Risk Assessment

Op en and sc ientific forum a llowing ea rly

involvement and c ollabora tion of a llstakeholders;

Acc ess to pre-c ompetit ive knowled ge tha t was

previously out o f reac h; Faster app lic a tion of new tec hnolog ies for

regula tory purposes;

Improved sc ientific information to supportdec ision making in regula tory approva ls;

Fewer post-marketing withdrawa ls.


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IMI Implementation Plan

Adop tion by the European Commission March

Submission to the European Counc il Ap ril

Consulta tion of the European Parliament Ap ril

Approva l by the Europ ea n Counc il November

Start of Researc h Projec ts 2008


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The Ultimate Benefic iaries ...

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All EU c itizens

Documents

The Innovative Medicines Initiative