Elisabetta Vaudano 20150116 Marseille

IMI2: Goals and main changes versus IMI (1)

IMI – Europe’s partnership for health

> €5 bn

Partnership

2008 - 2024

€2.5 bn

€2.5 bn

IMI – key concepts

§ 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

Collaboration by design in, and

outside IMI

IMI’s flexible intellectual property policy

Support to industry

Freedom of access

Compensation for IP

Dissemination of information

Incentive to participate flexibility

+

trusted

party

IMI in FP7 (2008-2014)

€ 1 945 135 308

€ 759,185,796

Infectious diseases

€ 214,136,227

Drug discovery

€ 182,980,698

Brain disorders

€ 116,880,300

Metabolic disorders

€ 116,287,312

Drug safety

€ 78,225,417

Stem cells € 72,710786

Cancer

IMI funding

Corporate contribution

€ 70,310,746

Data management

€ 69,739,527

Inflammatory disorders

€ 55,930,958

Biologicals

€ 49,310,000

Geriatrics

€ 37,966,496

Lung diseases

€ 37,378,289

Education and

training

€ 30,601,855

Sustainable

chemistry

€ 20,426,255

Drug delivery

€ 18,118,249

Drug kinetics

€ 14,910,397

Relative effectiveness

NATURE MEDICINE | NEWS

Partners

AiCuris Johnson&Johnson

Animal Health Medimmune

Division of Sanofi Merck

Astellas Merck Sharp

AstraZeneca & Dohme Corp

Basilea Merial

Boehringer Ingelheim Novartis

Cubist Pfizer

GSK Rempex

Janssen Sanofi

AstraZeneca Novartis

Bayer Pfizer

Janssen Sanofi

Lundbeck UCB

Merck

Abbott Janssen

AbbVie Lundbeck

AC IMMUNE Merck

Amgen Novartis

Astellas NOVO NORDISK

AstraZeneca Orion Corporation

BIOGEN IDEC Pfizer

Boehringer Ingelheim Roche

Eisai Sanofi

Eli Lilly SERVIER

ESTEVE UCB

Grunenthal Vifor

GSK

First phase of Europe’s IMI effort: budget

breakdown

REGULATORS ON

BOARD OF

12

PROJECTS

50% of projects have

REGULATORY

AUTHORITIES

representatives in

Scientific Advisory

Boards

61% of projects

reported some form

of PATIENT

INVOLVEMENT

An international, cross-sector community

IMI’s IP policy allows unprecedented levels of sharing

Companies

pooling legacy

toxicity data

European

platform for

antibiotic

development

Companies

pooling &

sharing old

trial data

European

Lead Factory

compound

collection

Project

partners

validate each

other’s

findings

0 1 2 3

IMI

FNIH

Wellcome Trust

TI Pharma

World average

Citation impact

0% 10% 20% 30%

Percentage of highly cited papers

Delivering excellent science

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

SME success stories

Thanks to IMI the company went from 6 to 50 employees.

Now they are ready to further expand.

“1st product released to the market in 2013 – IMI was instrumental

in validation of the first cell line product, 2nd product release

planned this year, 3rd diagnostic product in development.

In preparation: a new patent filing to protect technologies for the

creation of third generation human beta cell lines.

Developing a blood panel for AD for diagnosis, stratification and

companion diagnostics in AD. The Panel was tested on 300

patients in IMI project.

Developed in silico models for predicting toxicity, which were

validated by pharmas in eTOX. Now they have signed a contract

with one of the companies to use their models in house.

Promoting Patient Involvement

§ IMI makes efforts to enhance patient centric approach

− Patient dedicated workshops

− Involving patients at all levels

− Providing forum for discussion

§ IMI best practice examples:

EUPATI

U-BIOPRED

PROactive

Collaboration

Key collaborative activity areas:

Diabetes, CNS disorders, Tuberculosis, Patient Reported Outcomes,

Cancer, Preclinical Safety and Education & Training.

IMI signed horizontal agreements with:

Critical Path, Juvenile Diabetes Research Foundation as well as with

Clinical Data Interchange Standards Consortium.

IMI projects have signed

14

MEMORANDA of UNDERSTANDING

with other international consortia

The measures of success

SUCCESS

New models

developed &

published

Setting new

standards

Implement-

ation by

industry

Impact on

regulatory

guidelines

Better Science = Better Decisions

The conundrum of brain disorders

Brain disorders affect 1 in 3

Europeans

And cost the economy € 798

billion / year

Developing new drugs to treat

brain disorders takes longer,

costs more and has an higher

attrition rate than for other

diseases

There are few effective

treatments in this area IMI projects are tackling these

issues

Qualification Advice from EMA Regulatory advice on endpoints and biomarkers

19

§ First neuropsychiatric consortium that submitted core protocol for QA

on biomarker approaches and methodologies

§ EMA endorsed biomarker approaches and methodologies (27

queries, 5 topics)

§ Example: EMA accepted large number of endpoints/ analyses,

emphasized need for replication

§ Prefers a sample of identical but also diversified endpoints in clinical

studies

§ Biomarkers not accepted as clinical endpoints (i.e. eye-tracking)

§ Focus on test retest reliability

Sharing data to improve clinical trials for schizophrenia

By redesigning clinical trials, you could:

Ø make them shorter (6 weeks à 4 weeks)

Ø require fewer people (79 à 46 patients per arm)

Ø cut costs (savings of €2.8 million)

Ø gain insights into effects of treatment on negative symptoms (e.g.

lack of emotion)

23 000 patients

67 studies

25 countries 1

database

IMI addresses Alzheimer’s Disease

IMI invests €167 million in 4 projects aiming at:

§ Developing a biomarker matrix to predict the efficacy of drug

candidates (Call 1- PharmaCog)

§ Developing a platform for the re-use of medical data,

connecting data on 40 millions of individuals to research risk

and protective factors (Call 4- EMIF, EMIF-AD)

§ Developing a knowledge base for an unbiased mechanistic

Identification of disease subgroups to tailor made therapies to

the different causal factors involved (Call 8- AETIONOMY)

§ Implementing innovative trial designs (Call 11 – EPAD)

January 2014

IMI in H2020 (2014-2024)

IMI 2 – building on successes of IMI1

24

§ Focused: stratified medicines and healthcare priorities

§ Healthcare solutions: prevention and treatment

§ End-to-end: R&D, regulatory and access – move

integration a step further

§ Multi-sector: within and beyond life sciences

European

Commission

From H2020

1638 mln

Associated

Partners

213 mln

A

EFPIA &

Partners in

Research

1425 mln

IMI2

3276 mln

The Vision for IMI2

Molecular diagnosis

based on biological

knowledge

We “treat” a population.

Some respond and some don’t

We “treat” a targeted population

They all respond

From population to individual

25

Goals of IMI 2 programme

§ Increase the success rate of clinical trials of new

medicines & vaccines

§ Speed up the earlier stages of drug development

§ Develop new treatments for areas of unmet need

§ Develop new biological markers to diagnose diseases and

assess treatments

§ Improve the drug development process by creating tools

to assess the efficacy, safety and quality of medicines

27

Scientific focus

§ 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

Changes– from IMI 1 to IMI 2

Rules & procedures

§ More entities eligible for

funding

§ Simpler funding rules

aligned with H2020

§ Open to projects with other

sectors (ICT, diagnostics,

imaging, animal health..)

and with non industrial

associated partners

§ Simpler reporting

procedures

Data intensive sciences must:

• Use descriptive Metadata

• Describe quality of the data

• Use standards to ensure syntactic and semantic

interoperability

(Ref e-IRG Data Management Task Force 2009)

IMI has invested intensively on DKM:

eTRIKS project, CDISC membership, CFAST, Code of

Practice on secondary use of Medical Data in Research

Focus on excellence on data and knowledge

management

IMI 2 Projects are expected to:

§ Use open access for dissemination of scientific publications and research

data

§ Used documented data management procedures for collection, processing

and generation of research data.

§ Consider data protection of personal data by using controlled access digital

repositories and adequate data governance.

§ Use well-established data format and content standards in order to ensure

interoperability to quality standards (existing standards, e.g. CDISC) or

development of new standards (CFAST IMI collaboration).

§ Disseminate a description of resources according to well-established

metadata standards such as the Dublin Core (ISO15836) to make the

resources included and generated by the IMI Actions discoverable for metrics

and re-use.

Examples of Resources are (a collection of) biosamples, datasets, images,

publications etc.

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

31

Priority Themes

1. Neuro-degeneration

2. Immuno-inflammation

3. Diabetes & Metabolic disorders

4. Infection control

5. Translational Safety

Enablers

Patient access to innovative solutions

(MAPPs):

• Target validation

• Stratified medicine, precision medicine

• Innovative trials

• Data generation and interpretation

• Prevention, disease interception

• Patient adherence

• Health disease management

• Regulatory framework

• Reimbursement/patient access

1. Imaging

2. ICT

3. Medical devices….

Support Technologies

The new phase of IMI: enlarging the partnership, focussing the science

IMI2 Strategic Governing Groups

32

§ Scope: to ensure the coordination of IMI’s work in certain

strategic areas and work to make the development of new

topics more transparent and effective.

§ Composition: representatives of companies active or

interested in the area, representatives from the European

Commission, the IMI Programme Office and the IMI

Scientific Committee.

§ Currently there are 6 SGGs one of which is the SGG

Neurodegeneration (lead Janssen, co-lead Eli Lilly and

Abbvie)

http://www.imi.europa.eu/content/strategic-governing-

groups#neurodegeneration

SGG Roles and expected outputs

• Improvement of internal processes

for getting commitment and

speeding up the idea maturation

process

• Coordinated strategic approach

within and across portfolios of

existing projects and programmes

• Coherent planning and exploitation

of results

• Structure for review and integration

of proposals from industry and third

parties

• Interacting as appropriate with

other sectors and key stakeholders

IMI2 idea generation http://imi.efpia.eu/imi2/imi2-idea-

generation