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Open Information Day – Brussels, 8 June 2010

Arnd Hoeveler, HoU F5/Health BiotechnologyJaques Remacle, F4/Genomics & Systems Biology

Gesa Hansen, F1/Horizontal Aspects and Coordinaion

High Impact Research Initiatives -

Concept & features, pilot initiatives and evaluation

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Open Information Day – Brussels, 8 June 2010

High Impact Research Initiatives:

I) Concept, features, procedures

II) High impact research initiative on better immunisation

III) High impact research initiative on the human epigenome

IV) Evaluation and selection of high impact reseach initiatives

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High Impact Research Initiatives – the ideas behind

● Major strategic research investments to foster European competitive position in target areas with important economical/societal return

● Strategic recruitment of forefront research on key issues crucial for application and valorisation

● Programmatic approach (structuring the ERA): several research components/topics in a thematic area addressed in an integrated way, allowing synergies

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High Impact Research Initiatives – what are they like ?

● Not a new instrument, but larger than usual Cooperative Project (30 mill €)

● Programme implementation through a multi-component project jointly managed by key institutions highly integrative

● 15% Industry/SME participation: guarantees applicational orientation

● More flexibility and independence for consortium to handle scientific and horizontal priorities: calls & tenders, training, infrastructures ..

● Transparence and clean governance, competent external experts group monitor and advise

See explanatory note & special session at Infoday

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High Impact Research Initiatives are

• not a new instrument

● not an umbrella of existing actions

● not pre-determined

● not for old customers

● not fundamentally driven

● not only « one model »

● not short term oriented

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● Call for 30/07/2010 (tbc), submission deadline 10/11/2010 (tbc)● Regular evaluation rules (COM(2008)4617), suggested option:

extended single-stage procedure with panel hearing● Evaluation steps:

remote evaluation, at least 7 top level reviewers

consensus group of evaluators meets in Brusselsconsensus group select proposals above thresholds, prepare questions

coordinators receive questions and invitation to Brussels for hearing

panel meeting evaluators in Brussels (several weeks after consensus), & coordinators for hearings

hearings: coordinators reply to panel questions

after hearing the panel finalises the evaluation, scores and ranking

High Impact Research Initiatives –how evaluated & selected ?

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Open Information Day – Brussels, 8 June 2010

High Impact Research Initiatives:

I) Concept, features, procedures

II) High impact research initiative on better immunisation

III) High impact research initiative on the human epigenome

IV) Evaluation and selection of high impact reseach initiatives

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High Impact Research Initiative for better immunisation, topic 1.4-4 in orientation paper, some key issues:

• new vaccines/immunomodulators for prevention and cure of infections

● underlying fundamental questions, e.g. interplay of different branches of the human immune system, age-/gender-specific issues impacting on human immune responses, …

● identified issues in vaccinology: adjuvants, platforms, routes, schemes, longevity, specific target groups, therapeutic vaccines ..

● applications-oriented components (technologies, methods, clinics) should drive the programme

● key role of vaccines/immunotherapeutics companies, SMEs (15% of budget SMEs)

● integrated programmatic approach comprises training, management, governance

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Why a High Impact Research Initiative on better immunisation ?

● Vaccines cost-effective and high-impact intervention tool, thus most powerful tool in case of pandemics or for eradication of diseases

● European manufacturers account for > 50% of global vaccine sales

● Vaccine market grows relatively faster as compared to drugs, with good opportunities for SMEs

● Vaccines for specific target groups: the elderly, newborns ..

● Europe traditionally strong in immunology, yet translation into strategies and technologies for vaccination lagging

● Widely recognised major knowledge gaps: key issues in vaccinology still addressed trough try-and-error: better harness immunology research

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What’s the expected impact of a High Impact Research Initiative on better immunisation ?

● new immunomodulating vaccines/therapeutics

● generic knowledge boosting vaccinology to reduce costly try-and-error

● boost European SMEs/industry active in vaccines/immunomodulation

● structure ERA in the field of immunology rersearch/vaccinology

● more focus on preventing/curing infections of the elderly and very young

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Thematic area immunology for vaccines

• Adjuvants, immune modulators, delivery platforms

• Routes, schemes of vaccination

• Specific target groups, immunesenescence

• Therapeutic vaccines

Cluster 1 Cluster 2 Cluster 3 Cluster ..

HPI on Immunisation technologies: umbrella programme run by key institutions

infrastructurestraining

global initiativesSMEs !

Composed of:

thematic clusters

launching calls

Health research work programme

HIP on better immunisation -what it could look like ?

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Open Information Day – Brussels, 8 June 2010

High Impact Research Initiatives:

I) Concept, features, procedures

II) High impact research initiative on better immunisation

III) High impact research initiative on the human epigenome

IV) Evaluation and selection of high impact reseach initiatives

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12/07/2010

Why the Human Epigenome?• The genome gives the letters, the epigenomes make the words,

paragrafs and chapters needed to write the story explaining life • Booming field of research with impact on human health and diseases

(life-style diseases, cancer, ageing, stem cell differentiation).• International Human Epigenome Consortium to generate Human

Epigenome reference maps• Train the next generation of researchers to translate the epigenome

knowledge in innovative sciences and therapeutic approaches• NIH Epigenome Road Map programme: 190m$/5 years.

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High Impact Research Initiative on the Human Epigenome

• This research project should aim to characterise the human epigenome in human health and disease.

• This project should address how histone modifications, nucleosome positioning and remodelling, DNA methylation, and small and non-coding RNAs are governing the way in which genomic information is organized within the cell and how these phenomena play a role in regulating gene expression and in controlling specific cellular functions in health and disease.

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High Impact Research Initiative on the Human Epigenome

Reference Human Epigenome Maps

(IHEC)

Validation of Epigenetics markers in diseases

High througtput epigenetics mapping technologies

New compounds interfering with Epigenetics mechanisms

Network activitiesTraining and Communication

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Generation of reference epigenome maps in health anddiseases

• This project component should implement powerful andstandardised high throughput approaches to generate at least100 reference human epigenomes in conditions relevant tohuman health and diseases.

• This large data gathering component should follow theInternational Human Epigenome Consortium (IHEC) policiesconcerning data release and accessibility.

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Identification and validation of epigenetics makers in humandisease(s)

• This project component should address the epigenetic mechanisms atthe origin of human disease(s) and where appropriate may in part relyon studies performed on relevant model organisms.

• The important aspect of this action will be to demonstrate causalitybetween the epigenetic changes and disease whether the mechanism isdirect or indirect as an expression of genomic alteration.

• Where relevant the influence of environmental and life style factorsshould be considered.

• This component should also identify and validate important epigeneticmarkers of human diseases that will open avenues for new diagnostictools and for therapeutic approaches.

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High throughput technologies for epigenome mapping inhealth and diseases

• The project component should catalyse the development oftechnologies that will accelerate high throughput epigenomemapping.

• The project should decrease substantially the cost of epigeneticmapping thereby making these approaches feasible for futureclinical use.

• Research-intensive SMEs involvement is required for thiscomponent and this will be considered in the evaluation of theproposal.

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Identification of new compounds interfering withthe regulators of epigenetics profiles

• This research-intensive SME-based component shouldscreen for new compounds interfering with the enzymesthat are important regulators of epigenetic mechanisms.

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Networking activities

• The research activities should be linked together through anetworking component that should facilitate the flow of knowledgebetween basic research and the more applied research component(technology development and compounds screening).

• The project will also develop an open-access data managementstrategy to enable data storage and dissemination. Thereby, theconsortium should establish a common website and database thatwill increase the visibility and relevance to the scientific communityof this important European effort.

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Training and communication

• This multi-component project should also implement a joint trainingprogramme that will offer training opportunities across the spectrumof research (from basic to applied research).

• Importantly, this project should implement an efficientcommunication plan to the public and other stakeholders (scientificcommunity, industry and patient associations).

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Open Information Day – Brussels, 8 June 2010

High Impact Research Initiatives:

I) Concept, features, procedures

II) High impact research initiative on better immunisation

III) High impact research initiative on the human epigenome

IV) Evaluation and selection of high impact reseach initiatives

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Overview Evaluation Process for single-stage

Final rankinglistFull Proposal

Proposalforms

Evaluators

Eligibility

Evaluators Evaluators

PanelSubmission ConsensusIndividual evaluation

Proposals insuggestedpriority order

Rejection list

Finalisation

CriteriaCriteria Criteria

COMMISSION (+ evaluators)

COMMISSION

Role of experts

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Eligibility criteria● Most of these are checked by the Commission:

Receipt before deadline Firm deadlines

Minimum number of partnersAs set out in work programme and the call

Completeness of proposal Presence of all requested forms

Other criteria may apply on topic basis; eg. for high impact initiatives in health research

max EUR 30 000 000 funding can be requested from EUmin 15% of EU funds go to SMEs

● The following question is checked mainly by evaluators:“Out of scope”

A proposal will only be deemed ineligible in clear cut case

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The criteria for single-stage

● Criteria adapted to each funding schemespecified in the work programme/topic

● Three main criteria:

S&T Quality (relevant to the topic of the call)Concept, objective, progress beyond state-of-art, work-plan

ImplementationManagementIndividual participants and consortium as a wholeAllocation of resources

ImpactContribution to expected impacts listed in work programmePlans for dissemination/exploitation

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Who can participate in proposals?

● Participants from Member States and Associated States and USA: fully eligible for funding

● Participants from ICPC countries: funding can be provided

● Participants from other countries: can receive funding if the contribution is essential for carrying out the project

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Proposal scoringsingle-stage

● Each criterion is individually scored 0-5 by evaluatorshalf-scores allowedScores must pass thresholds if a proposal is to be considered for funding

● Thresholds apply to individual criteria…Default threshold is 3 for all criteria in a single stage call

● …and to the total scorehigher than the sum of the individual thresholdsDefault threshold for single stage is 10

However, at consensus meetings the evaluation stops after the first criterion failing a threshold

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Overview Evaluation Process for single-stage

Final rankinglistFull Proposal

Proposalforms

Evaluators

Eligibility

Evaluators Evaluators

PanelSubmission ConsensusIndividual evaluation

Proposals insuggestedpriority order

Rejection list

Finalisation

CriteriaCriteria Criteria

COMMISSION (+ evaluators)

COMMISSION

Role of experts

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Hearings of applicants during panel meetings

● Co-ordinators whose proposals have passed the thresholds in consensus meetings are invited to hearings, which will take place in the subsequent evaluator panel meetings in Brussels

● Hearings are intended to clarify any points raised by the evaluators, and sent to the coordinators, in advance of the hearing

● Not an occasion to ‘improve’ the proposal

● Not an occasion for a multi-media show

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Ethical Review● Triggered by the evaluators or the Commission

Possibly following a screening stage by ethical expertsAbove threshold proposals only

● The Ethical Review panel might discuss :The awareness of the ethical aspects and the social impact of

the research they propose

Respect for the FP7 ethical standards

Application of relevant European Directives, conventions etc

Whether the consortium is seeking the approval of relevant local ethics committees

The balance between the research objectives and the means the applicants intend to use

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● Call for 30/07/2010 (tbc), submission deadline 10/11/2010 (tbc)● Regular evaluation rules (COM(2008)4617), suggested option:

extended single-stage procedure with panel hearing● Evaluation steps:

remote evaluation, at least 7 top level reviewers

consensus group of evaluators meets in Brusselsconsensus group select proposals above thresholds, prepare questions

coordinators receive questions and invitation to Brussels for hearing

panel meeting evaluators in Brussels (several weeks weeks after consensus), & coordinators for hearings

hearings: coordinators reply to panel questions

after hearing the panel finalises the evaluation, scores and ranking

Summary: High Impact Research Initiatives – how to be evaluated & selected ?