Earma Annual Conference 23 june 2011 - Magali Poinot (part 1)

The writing and implementation of the Innovative Medicines Initiative projects

Part I

Elisabetta VaudanoPrincipal Scientific Manager

EARMA Annual Meeting23rd June 2011

What is IMI ?

An European Public-Private Partnership Focused on

Needs Common toPharmaceutical Industry and Patients


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The History of IMI2000: Lisbon Strategy wants to make Europe most

competitive and dynamic knowledge-based economy by 2010

2004: Industry-led European Technology Platforms (ETPs) develop Strategic Research Agendas addressing bottlenecks to competitiveness

2007: 7th Framework Programme for Research establishes the European Research Council and Joint Technology Initiatives

2008: Establishment of the Joint Undertakings to implement the Joint Technology Initiatives

2009: Appointment Executive Director & Autonomy IMI JU EARMA Annual Meeting

23rd June 2011

Governance


IMI Executive Office as a Neutral Third-Party

• To implement programmes and activities in the common interest of all stakeholders

• To monitor the combined use of public funds and industry investment

• To guarantee fair and reasonable conditions for optimal knowledge exploitation and dissemination


Source: Burrill & Company; US Food and Drug Administration.

Why IMI? The Productivity Gap in Pharma R&D

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…M&A Impact on R&D Innovation

Munos B., Nature Reviews Drug Discovery 8, 959-968 (December 2009)

1+1=1Big is not Beautiful


Why IMI? Society and Patients Need Innovative Treatments

Alzheimer’s Drugs: Summary of Recommendations

The medicines used to slow mental decline in people with Alzheimer's disease are not particularly effective. When compared with a placebo, only 10 to 20 percent more people taking an Alzheimer's drug seem to benefit at all. And it is the rare person who has a significant delay in the worsening of their symptoms over time.

However, there is no way as yet to predict who will respond and who will get little or no benefit from one of the five drugs approved to treat Alzheimer's disease. Thus, the decision to try one is a gamble and judgment is based on whether the treatment is worth the cost and the risk of side effects.


IMI Objectives

• Making the pharmaceutical R&D process faster and more effective, rather than directly delivering new drugs

• Accelerating the development of safer and more effective medicines for patients in Europe

• Improving the environment for pharmaceutical R&D in Europe

• Boosting the biopharmaceutical sector in Europe


Page 502

Collaborative Innovation to Deliver Innovative Medicines

Clinical pharmacology & Therapeutics | VOLUME 87 NUMBER 5 | MAY 2010

Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Precompetitive Research to Boost Innovation in Biomedicine


IMI Supports Precompetitive Research

IMI


2 Billion Euro

1 Billion €1 Billion €

Public PrivatePartnership

Innovative Medicines Initiative:the Largest PPP in Life Sciences R&D


EMA Supports IMI Research


N ENGL J MED 362: 865-869, March 11, 2010

Patients are Active IMI Stakeholders


The Four Pillars of the original IMI Strategic Research Agenda



IMI Projects Overview Call 1 &2

Call 1 Call 2 TotalProjects 15 8 23

EFPIA Companies 21 21 23

Academic teams 195 103 298SME teams 24 23 47

Patients’ organisat. 9 2 11

Total Budget (M€) 281 172 453

Call 1 Call 2 TotalProjects 15 8 23

EFPIA Companies 21 21 23

Academic teams 195 103 298SME teams 24 23 47

Patients’ organisat. 9 2 11

Total Budget (M€) 281 172 453

EFPIA Member Companies

Participating companies (Q2 2011):


http://www.lundbeck.com/

NEWMEDS

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Develops biomarkers and tools and models to allow better targeted

treatments for schizophrenia and depression

19 Partners – 9 EFPIA companies

– 7 Public organisations

– 3 SMEs

Has assembled the largest known repository of antipsychotic clinical trail data. The database contains information on 23 401 patients from 67 industry sponsored studies. Bringing together data from public projects and 3 companies on the genetics

and clinical response in 1800 well characterized patients with depression.

Nature, 11 November 2010First achievements


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U-BIOPRED By comparing data from several hundreds of people, the team will characterise different kinds of severe asthma, paving the way towards a new classification of asthma and personalised treatments for patients

19 Partners - 8 EFPIA companies - 7 Academic Institutions - 3 Patients’ organizations

Thorax, in press

First achievements Consensus statement on the definition of severe refractory asthma


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eTOX Builds a large searchable database containing drug toxicity-related data extracted from relevant pharmaceutical pre-clinical legacy reportsDevelops innovative methodological strategies and novel software tools to better predict in silico the toxicological profiles of new molecular entities in early stages of the drug development pipeline, using its database background

25 Partners– 13 EFPIA companies– 8 Public organisations– 4 SMEs

An innovative multi-scale modelling strategy for the prediction of cardiotoxicity has been developed, successfully tested and published

First achievements

J. Chem. Inf. Model. 2011; 51:483-92


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SAFE-T Addresses the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury to the kidney, liver and vascular tissues in man, which is a major hurdle in drug development

20 Partners- 11 EFPIA Pharma Companies- 5 Academic Institutions- 4 SMEs

First achievements

153 potential biomarker candidates for drug-induced injury of the kidney, liver and vascular system have been evaluated and are currently undergoing clinical evaluation. The strategy adopted has been agreed with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Drug Discov Today, in press


IMI Education and Training Projects


The IMI Scientific Research Agendais under Revision


The Pharmaceutical Industry is under pressure

The Product replacement Ratio is the ratio of revenue from new products (that is, those launchedin the previous 5 years) to the revenue lost from declining products.A ratio of less than 1reflects a failure to replace former successful products with new revenue drivers.

Harrison C., Nature Reviews Drug Discovery 10, 12-13 (January 2011)


The Health-care Ecosystem is Changing….

• Health care reform and health IT, are driving the system to include many companies not traditionally involved in the health care business.

• Patients from been traditionally relatively passive participants in health delivery are been empowered by technological progress to become educated super-consumers with a much more active role in management of their health care.


Pharma

Patients

Academia Physicians

BiotechsInsurers

Digital healthcare

Governments

CROs

MedTech

Social media

Regulators

The New Environment of “Big Pharma”


Idea generationBasic researchand non-clinical

testingHuman testing

Marketeddrug

Regulatory approval

and Health technology assessment

Make Drug R&D processes in Europe more efficient and effective and enhance Europe’s competitiveness in the Pharma sector

Primary focus ofearly IMI calls

Primary focus ifwe want to make EU competitive

The Focus of IMI Research has to Become Broader


Step 2:Consortia eligible for EU fundingcompete through expressions of interestwhich are ranked by independent experts

Step 1:A set of EFPIA companiesdefine a topic on which they commit to collaborate

Acad 1 Acad 2 Acad 3

Acad 4Patients’Organ 1

Regul 1

Patients’Organ 2

Other*

SME 1 SME 2

Pharma 1

Pharma 5

Pharma 2

Pharma 3Pharma 4

Pharma 6

Pharma 1

Pharma 5

Pharma 2

Pharma 3Pharma 4

Pharma 6

Acad 1 Acad 2 Acad 3

Acad 4Patients’Organ 1

Regul 1

Patients’Organ 2

Other*

SME 1 SME 2

Step 3:The top-ranked EU-fundable consortium join the EFPIAcompanies to form thefinal consortium which developsthe full proposal, subject to peer-review before final approval

Building a IMI Consortium

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Key Concepts

• Open collaboration in final consortia

• Non-competitive research for EFPIA companies

• Competitive calls for IMI JU beneficiaries


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Building a IMI Project (1) IMI Research Agenda

(multi-annual plan)

Annual Scientific Priorities

Definition of research topics

Detailed description of research topics

Launch of the Call

Call definition and launch

• Contains EFPIA priorities • Advice of Scientific Committee (SC)• Consultation of States Representatives Group (SRG)• Approval by IMI Governing Board

• Proposed by EFPIA• Consultation of SC and SRG• Approval by IMI Governing Board

• Proposed by EFPIA

• EFPIA + IMI Executive Office• Consultation of SC and SRG• Approval by IMI Governing Board

•IMI Executive Office


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Building a IMI Project (2)

Submission of Expressions of Interest

First Peer review

First ranked consortium

Invitation to submitFull Project Proposal

Competition between

applicants’ consortia

(potential IMI JU beneficiaries)

• By applicants’ consortia (academics, SMEs, Patient org….)

• Independ. experts + EFPIA coordin.

• Independ. experts

• Approved by IMI Governing Board

• to first ranked applicants’ consortium + EFPIA consortium

assessment

ranking


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Submission of Full Project Proposal

Second Peer review(including ethics)

Approval of Full ProjectProposal

Joint Preparation of

Full ProjectProposal

• By full project consortium (first ranked applicants’ consortium + EFPIA consortium)

• Independent experts

• by IMI Governing Board


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assessment

ranking

Preparation of

Approval ofProject budget

Signature of Project Agreement

Contract negotiation

• by full project consortium + IMI JU Executive Office

• by IMI Governing Board

• by full project consortium

Grant agreement

Project agreement • by full project consortium

Signature of Grant Agreement

• by full project consortium + IMI JU Executive Office


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CALL 4 TOPICS (1)

Cluster A: Medical Information System• A European medical information framework (EMIF) of

patient-level data to support a wide range of medical research

• eTriks: European translational information and knowledge management services

Cluster B: Chemistry, Manufacturing and Control• Delivery and targeting mechanisms for biological

macromolecules• In vivo predictive biopharmaceuticals tools for oral

drug delivery• Sustainable chemistry – Delivering medicines for the

21st centuryEARMA Annual Meeting

23rd June 2011

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CALL 4 TOPICS (2)

Cluster C: Technology and Molecular Disease Understanding

• Human induced pluripotent stem (hiPS) cells for drug discovery and safety assessment

• Understanding and optimising binding kinetics in drug discovery

Indicative total financial contribution from IMI JUfor the 7 full projects Up to 105 M€


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CALL 4 TIMELINE • Open Info Day: 17 June 2011

• Official Launch: End June 2011

• Deadline submission of Expression of Interests: End October 2011

• Peer-review Evaluation: November 2011

• Deadline submission Full Project Proposals: March 2012

• Approval of Full Project Proposals: May 2012


THANK YOU !

www.imi.europa.eu


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Earma Annual Conference 23 june 2011 - Magali Poinot (part 1)

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