Innovative Medicines Initiative:

IMI 2 and new Calls

Maria Teresa De Magistris

Principal Scientific Manager

IMI

2008 - 2013

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

2 Billion Euro

1 Billion €1 Billion €

Public Private

Partnership

EFPIA = European Federation of Pharmaceutical Industries and Associations

The IMI portfolio

EoI – Applications per Country

FPP – Participation per Country

IMI 2 budget

€3.276 bn

Partnership

2014 - 2024€1.638 bn€1.638 bn

+ other Companies*

EFPIA = European Federation of Pharmaceutical Industries and Associations

* Imaging, Diagnostics, IT for health etc.

Stronger focus on needs of patients and society

Research Agenda aligned with WHO priorities

Increased emphasis on improving patient access to

innovative medicines (in addition to medicines

development)

Focus on personalised medicine

IMI is evolving

IMI (under FP7)

IMI2 (under Horizon2020)

New Rules in IMI2

The Innovative Medicines Initiative under H2020 (IMI 2)

EFPIA=European Federation of Pharmaceutical Industries and Associations

New

Receive EC funding

in cash

EFPIA

ACADEMIA

HOSPITALS

PATIENTS’ORGANISATIONS

SMALL AND MEDIUM-SIZED

ENTERPRISES

REGULATORS

Pharma 4Pharma 1

Pharma 5Pharma 2

Pharma 6Pharma 3

Other life

science industriesContribute

in kind

MID-SIZED COMPANIES

Associated Partners

Academic institutions

Small & medium-sized enterprises (SMEs)

Mid-sized enterprises (≤ €500m)

Non-profit organisations e.g. research organisations, patient

organisations, NGOs, public bodies, intergovernmental

organisations etc.

Established in:

EU Member States

Associated Countries

At least three legal entities

Who is eligible for funding?

Other countries:

No funding unless

- participation deemed essential by IMI

for carrying out the action

- Annual Work Plan / Calls documents

New!

In IMI2: a more attractive funding model

20%?

Real?

Single model:100% +

25 % Flat Rate

IMI1

• For all beneficiaries eligible for funding and all activities:

100% reimbursement of eligible costs for Research & Innovation

projects

Flat rate of 25% reimbursement for indirect costs

Research:

75% ?

Mgt: 100% ?

New!

Upcoming Calls

CALL 6

Topic 1: Development of Quantitative System Toxicology (QST)

approaches to improve the understanding of the safety of new

medicines

Scope: 1) develop QST models for drug-induced toxicity with the focus

on: heart, liver, kidney and the gastrointestinal (GI)-immune system,

and 2) use this QST approach for the prediction of clinical toxicity.

The models are expected to incorporate key events from one or more

levels of biological organization (molecular/pathway level, cellular,

organ level) that are involved in drug-induced pathogenesis and

repair.

IMI JU budget EUR 8 000 000

CALL 6

Topic 2 Establishing impact of RSV infection, resultant disease

and public health approach to reducing the consequences.

Scope: To develop a detailed understanding of the clinical, economic

and social impacts of RSV infection in infants, the elderly and other

high risk populations.

The project will:

- explore the feasibility of developing biomarkers and establishing

biobanks (repository of biological materials) for RSV infection

-Investigate the long term implications of RSV infection including

wheezing and asthma

CALL 6 – A new Programme in IMI

Big Data for Better Outcomes Programme (BD4BO)

The programme’s objective is to maximise the potential of large amounts

of data in healthcare. It will support the evolution towards value-based

and more outcomes-focused healthcare systems in EU.

The programme is expected to be composed of several topics that will

provide a platform for developing outcomes transparency evolution

together with payers, patients, regulators, healthcare decision makers.

Digital and non digital sources will be referred to as ‘big data’ in the context of this initiative.

In Call 6 two topics of BD4BO are launched Alzheimer’s Disease and

Hematologic Malignancies:

Topic 3: Real World Outcomes Across the AD Spectrum (ROADS)

to Better Care

Topic 4: Development of an outcomes-focused data platform to

empower policy makers and clinicians to optimize care for

patients with hematologic malignancies

A BD4BO Coordination and Support Action (CSA) is expected to be

launched in the following weeks and align with the timelines of the

current call.

Joint influenza vaccine effectiveness surveillance

Coordination and Support Action (CSA) for the Big Data for Better Outcomes programme

Future calls

Tips for success

Common Mistakes

The proposal does not address all the objectives

Applicants do not have the capabilities to address all

of the objectives or there is redundancy between

partners

A proposal is scientifically excellent but will have

limited impact

Ethical issues not addressed

Tips

Read all the Call-relevant material that is provided

on the IMI website – www.imi.europa.eu

Understand IMI 2 rules and respect them

If in doubt, ask a member of the Programme Office

Your proposal should provide reviewers with all the

information requested to allow them to evaluate it

Start working early (pre-materials available before)

A single set of evaluation criteria

Two-stage evaluation: only Excellence and Impact considered at

stage 1

Thresholds and weighting in the Call documents

Minimum of 3 independent experts (possibility of 2 in a two-stage

process)

NEW! Each proposal evaluated ‘as it is’, not as ‘what could be’

Standard criteria

Excellence ImpactQuality &

efficiency

Stay in touch

Visit our website

www.imi.europa.eu

Sign up to our newsletter

bit.ly/IMInewsletter

Follow us on Twitter

@IMI_JU

Join our LinkedIn group

bit.ly/LinkedInIMI

E-mail us

infodesk@imi.europa.eu

www.imi.europa.eu

@IMI_JU

Thank you!

mariateresa.demagistris@imi.europa.eu

Focus on unmet needs

Non-competitive collaborative

research

Competitive Calls for proposals

Open collaboration in public-private

consortia

Data sharing, dissemination

of results…

Industry contribution is in kind

Aligned on Horizon 2020 (rules,

templates, cost model…)

A Public-Private Partnership

between EU Commission and

the Pharmaceutical Industry

IMI – key concepts

EFPIA: European Federation of Pharmaceutical Industries and

Associations

Partner Search Tool

www.imi.europa.eu/content/partner-

search

http://www.fitforhealth.eu/

Common Mistakes

Admissibility/Eligibility criteria not met:

submission deadline missed

proposal out of scope

(if you have doubts on how to respond to the Call

contact us)

submitted text does not respect the proposal

template (sometimes received even slides!)

A minimum of three legal entities

IMI2 Current and upcoming calls

More information

IMI 2 budget (2014 – 2024)

€1.638 bn

€1.425 bn

Other

€213 m

IMI 2 total budget

€3.276 billion

EU funding goes to:

Universities

SMEs

Mid-sized companies

Patient groups

etc…

EFPIA companies

receive no funding

contribute to projects ‘in kind’

Associated Partners e.g. charities, non-EFPIA companies

Submitting a proposal

Measures of SUCCESS

Impact on

regulatory

framework

New models

developed &

published

Setting new

standards

Use

by industry

Better Science = Better Decisions

Accelerating the development of safer and more

effective medicines for patients (remove bottlenecks)

Boosting the biopharmaceutical sector in Europe

Create a collaborative environment for academia,

industry, SMEs, regulators, patients

Main Objectives

Focus on unmet needs

Non-competitive collaborative

research

Competitive Calls for proposals

Open collaboration in public-private

consortia

Data sharing, dissemination

of results…

Industry contribution is in kind

Aligned on Horizon 2020 (rules,

templates, cost model…)

A partnership between EU

Commission and the European

Federation of Pharmaceutical

Industries and Association

(EFPIA)

IMI – key concepts

Strategic Research Agenda

Antimicrobial resistance

Osteoarthritis

Cardiovascular diseases

Diabetes/Metabolic disorders

Neurodegenerative diseases

Psychiatric diseases

Respiratory diseases

Immune-mediated diseases

Ageing-associated diseases

Cancer

Rare/Orphan Diseases

Vaccines

Key Deliverables of

Non-Competitive Research

• Establishment of common databases

• New tools for identification of drug targets

• Standardization of models and assays

for drug efficacy and safety

• Patient reported outcomes

• Classification of diseases

Pooling expertise, knowledge and resources;

cross-fertilization

Developing incentives to address major unmet

medical needs

Providing a neutral trusted platform to align public

and private interests

Public-private partnership: why?

A more attractive funding model

An example

Direct

costs

Indirect

costs

Total

costs

% EU

contribution

EU

contribution

Flat-rate (20%)

(or actual)100 20 120 75% € 90

Direct

costs

Indirect

costs

Total

costs

% IMI2

contribution

IMI2

contribution

100/25 Funding 100 25 125 100% € 125

Majority of

beneficiaries

EFPIA and Associated Partners contribution

EFPIA companies

Other industries and partners (= Associated Partners to IMI2) New!

In-kind (actual direct and indirect costs or average FTE) + cash

contributions

Based on the usual management principles and accounting

practices

Contributions from affiliated entities as part of in-kind

When relevant to IMI2 objectives: up to 30% non-EU in-kind

contribution

Topic

definition

Typical IMI project life cycle

Grant awardStage 1

Identification of

topics and

willingness to

collaborate

Project

Agreement

Grant

Agreement

Applicant

consortia

submit short

proposals

Patients’

organisations

Academics

Regulators

Hospitals

SMEs

Mid-size

enterprises

Industry

Assoc

partners

Stage 2

Full consortium

submits full

proposal

Industry

APs

Applicant

consortium

Call launch

Merger: applicants &

industryFinalisation Project

launch!

Evalu

ati

on

Evalu

ati

on

Keeping the momentum

Maximum Time To Grant: 8 months from submission of full proposal

5 months

for informing applicants

of scientific evaluation

3 months

for signature of grant

agreement

NEW Legal entity validated in parallel

Simplified model Grant Agreement

Core textSpecial

clauses

General

conditions Annex II

Specific

provisionsAnnex III

Signed between IMI2

JU and Coordinator only

(no more Managing

Entity)

Accession form by the

other beneficiaries

Judith Hackett

5.10.2014 IMI webinar

Establishing Impact of RSV infection, Resultant Disease and Public Health Approach to Reducing the Consequences

Objectives of the full project

This project will develop a detailed understanding of the clinical,

economic and social impacts of RSV infection in infants, the

elderly and other high risk populations.

The collated data will drive new approaches to the prevention and

treatment of RSV and its consequences and give a better

understanding of the resource requirements and costs associated

with RSV.

Explore the feasibility of developing biomarkers and establishing

biobanks (repository of biological materials) for RSV infection

Investigate the long term implications of RSV infection including

wheezing and asthma

Scope of the Project

To produce a robust dataset that will increase our

understanding of RSV disease and its clinical, economic

and social impact and that will lead to better treatment

and preventative options.