IMI-1: De nouvelles opportunités

29 Novembre 2013

Michel Goldman, Executive Director Magali Poinot, Legal Manager

New Calls

2

Call 10

Topic Title: Immunological Assay Standardisation and Development for use in Assessments of Correlates of Protection for Influenza Vaccine

IMI Budget EUR 6,100,000

EFPIA Budget EUR 6,100,000

Duration 5 years

Expected Launch Date 29 October 2013

EoI Submission Deadline 28 January 2014

Project Start Date mid of Q4 2014

3

Call 11: Topics under consideration

PROPOSED TOPICS Indicative Budget (€)

EFPIA IMI Innovative clinical end-points for osteoarthritis

7,50m 7,50m

European platform for proof of concept trials for Alzheimer’s disease (EPOC)

27,75m 25,00m

Zoonoses anticipation and preparedness initiative

7,36m 6,62m

Blood-based biomarker assays for personalized tumour therapy

9,90m 9,90m

ND4BB TOPIC 6: Clinical development of novel systemic anti-bacterial molecules

91,65m 75,34m

ND4BB TOPIC 7: Development of novel inhaled antibiotics

31,00m 27,00m

EcoRiskPrediction 21,60m 21,24m Generation of research tools for R&D 3,88m 3,00m

Call 11: Contact persons

Call 11: Timelines

Projects Duration from 4 to 5 years

Expected Launch Date mid of December 2013

EoI Submission Deadline Early April 2014

Project Start Date December 2014

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On-going activities

7

Proposals under evaluation (Call 9)

8

Call 9: Eligible Applicants per Country

9

New countries joining IMI (vs. Calls 7&8) Lithuania Croatia Estonia Kosovo Bulgaria Serbia Slovenia Czech Republic

Call 9: Eligible EoI Participations by Type

10

Projects to be launched (Call 8)

Clinical studies supporting development of MEDI4893, a monoclonal antibody targeting S. aureus alpha toxin

Discovery and development of new drugs combatting Gram-negative infections

New classification for systemic lupus erythematosus arthritis

New classification for neurodegenerative disorders

European Induced Pluripotent Stem Cell Bank

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IMI projects’ achievements

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Innovative Medicines Initiative: Joining Forces in the Healthcare Sector

IMI portfolio – budget breakdown up to call 11

> 6000 researchers

Collective intelligence networks Improved R&D productivity of pharma industries

Innovative approaches for unmet public health needs

17 regulators

120 SMEs

25 patient

org.

Key Figures IMI Projects up to Call 9

650 Academic & research

teams

409 EFPIA teams

0,0 1,0 2,0 3,0 4,0 5,0

Rheumatology

Pharmacology & Pharmacy

Endocrinology & Metabolism

Neurosciences

Clinical Neurology

Biochemistry & Molecular Biology

Psychiatry

Genetics & Heredity

Research & Experimental Medicine

Immunology

Overall

IMI papers EU papers

average 2.04 average 1.13

19% of IMI publications are highly cited

Citation impact 2010-1012

16

IMI vs. Welcome Trust

Number of

papers

2010-2012

Citation impact

(normalised)

Percentage of

highly-cited

papers

IMI project research 269 2.04 19.3%

Welcome Trust research 15 483 2.08 22.3%

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Quality increases over time Bibliometric indicators trend analysis

0

1

2

3

4

5

6

R1, Oct-12 R2, March-13 R3, Oct-13

Citation impact

Normalised citation Impact Raw citation impact

0%

5%

10%

15%

20%

25%

R1, Oct-12 R2, March-13 R3, Oct-13

% highly cited papers

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Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions)

Performance of IMI projects Calls 1-3

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scale = 10% highly-cited papers

eTOX

EUROPAIN

IMIDIA

NEWMEDS

Pharma-Cog

PROTECT

SUMMIT

U-BIOPRED

BTCure

Onco Track

Open PHACTS

Quic-Concept

EU-AIMS

0,5

1,5

2,5

3,5

4,5

0 5 10 15 20 25 30 35 40

Citation impact

Number of papers

IMI (all projects)

Collaboration improves quality IMI project publications

0

0,5

1

1,5

2

2,5

3

Cross-institution Cross-sector International

Citation impact

Collaboration vs. quality

Collaborative Non-collaborative

Type of

collaboration

Percentage of

publications

Cross-institution 61%

Cross-sector 75%

International 50%

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IMI stimulates collaboration across EU Co-authorship between IMI-supported researchers Calls 1-4

Pre IMI funding award Post IMI funding award

Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions)

21

Mapping Collaborative Networks

Data & analysis: Thomson Reuters Custom Analytics & IP Solutions

Outcomes of external evaluations

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Objective and Methodology

• Objective to

o assess the effectiveness of PPPs

o identify IP and business opportunities

o identify successful components and characteristics to apply in future

biomedical PPPs

• 6 Case studies from different fields: neuroscience (NEWMEDS), metabolic

(SUMMIT, IMIDIA), respiratory diseases (U-BIOPRED), knowledge

management projects such as development of platforms for toxicity prediction

(eTOX) and integrated pharmacologic data (Open PHACTS)

Hilde Stevens and Isabelle Huys

Research Centre for Clinical Pharmacology and Pharmacotherapy, KU Leuven,

Belgium

Centre for Intellectual Property Rights (CIR), KU Leuven, Belgium

Conclusions

• IMI projects reflect successful partnerships towards innovative scientific

research build upon trust

o Unique dynamics, openness, transparency, constructive, constant peer-review

o Need for business plans

• IMI portrays the important paradigm shift in business models at companies and

academia (e.g. IP strategy)

o Timing of patenting and value consideration

o Honest broker model as basis for sharing (non-) confidential data

• Sharing resources and outcomes create a multiplication effect in terms of

scientific and business outcomes

o Open EFPIA-Academia collaboration

o Standardization and harmonization of scientific tools and protocols

• Value of IMI projects for SMEs is high, feasibility to participate could be improved

Outcome of 2nd Interim Evaluation

Positive outcome: "It emerged clearly that this PPP is

seen both in Europe and globally, especially in the USA, as

a model for the future. It has a unique role in consolidating

the European pharmaceutical research base. IMI therefore

can be seen as one of the key means to underpin future

European competitiveness through support of the essential

European competence of collaborative medical research."

Appropriate follow-up given to recommendations

from 1st interim evaluation: "The panel agreed with the

Governing Board (GB) and the IMI Executive Office that the

IMI had been responsive to the recommendations of the

first interim review and had made much progress in

implementing them, for example, in demonstrating

scientific excellence and improved stakeholder

engagement."

Intellectual Property

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ONE policy for MULTIPLE interests

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TRUSTED THIRD PARTY

Strengths of the IMI policy

FLEXIBILITY

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Strengths of the IMI policy

Freedom of Access

Incentive to participate

Dissemination of information

Support to EU industry

Compensation for IP

Ownership of Foreground and Sideground

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Foreground and Sideground belongs to the participant who generated it

unless otherwise agreed

European Lead Factory

Antibiotic Clinical Trials

iP Stem Cells Bank

Jointly owned Foreground

31

Individual use of joint Foreground is possible

provided prior notice and fair & reasonable compensation to the other joint owners

all IMI projects

32

Foreground may be transferred to affiliates

and subcontractors

without prior notification

all IMI projects

Unprotected valuable Foreground

may be transferred

not used yet

Transfer of Foreground

Research Use of Foreground

33

Access to Foreground for further developments - except commercialisation - granted on royalty-free

basis or under fair & reasonable conditions*

European Lead Factory

Antibiotic Clinical Trials

Antibiotic Discovery Platform

*may include financial terms and/or other conditions

Granting modalities

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Granted on written request

unless otherwise agreed

Almost all IMI projects agreed that access

rights to Background are granted without

any additional administrative step

Time-limits for requesting access

along the most appropriate needs

1/5 of the existing consortia have

agreed on restricted time-limits based on projects’ purposes

Access rights to Foreground for third parties

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Possibility to exclude specific elements of Background

Europain

European Lead Factory

Real Effectiveness

Dissemination modalities

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Obligation to disseminate the Foreground

as soon as reasonably practicable

European Lead Factory

Antibiotic Clinical Trials instead of COMBACTE

Antibiotic Discovery Platform instead of ENABLE

MERCI POUR VOTRE ATTENTION

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