successful applications from eu12 countries & tips for success imi open info day, bucharest 10...

Successful applications from EU12 countries & Tips for success

IMI Open Info Day, Bucharest 10 December 2012

Magali Poinot, Legal ManagerAngela Wittelsberger, Scientific Project Manager

Participants from EU12 countries in IMI projects


Project Acronym

Research field Coordinator/ Managing Entity

Legal Name City Country

PROTECT Pharmacoepidemiological Research

EMA/DKMA-Danish Medicines Agency

Poznan University of Medical Sciences

Poznan Poland

U-BIOPRED Biomarkers for the Prediction of Respiratory Disease Outcomes

Novartis/Amsterdam Medical Center

Uniwersytet Jagiellonski Krakow Poland

Semmelweis University Budapest Hungary

Pharmatrain Pharmaceutical Medicine Training Programme

European Federation of Courses/University Basel

Semmelweis University Budapest HungaryFaculty of Medicine University of Belgrade

Belgrade Serbia

EMTRAIN European Medicines Research Training Network

AstraZeneca/Medical University Vienna

Ministry of Human Resources, Medical Research Council

Budapest Hungary

BTCURE BeTheCure UCB/Karolinska Institute

Revmatologicky ustav Praha Czech Republic

PREDECT New Models for Preclinical Evaluation of Drug Efficacy in Common Solid Tumours

Servier/University of Helsinki

University of Tartu TARTU Estonia

EHR4CR Electronic Health Record systems for Clinical Research

AstraZeneca/EuroRec Medical University of Warsaw Warsaw Poland

ABIRISK Immugenicity of biopharmaceuticals

GSK/Inserm Univerzita Karlova v Praze Prague 1 Czech Republic

MIP-DILI Prediction of Drug-Induced Liver Injury

AstraZeneca/University of Liverpool

SOLVO BIOTECHNOLOGY ZRT SZEGED Hungary

Compact Macromolecular Pharmaceuticals

Sanofi/University of Utrecht

PHARMACOIDEA Development and Service Ltd.

Szeged Hungary

EMIF European Medical Information Framework

J&J/Erasmus University MC Rotterdam

Tartu Ulikool Tartu Estonia

Unbiased Biomarkers in the Prediction of Respiratory Disease Outcome

The Objective

Developing biomarker profiles from molecular, physiological, and clinical data integrated by into handprints for the prediction of clinical course, therapeutic efficacy and identification of novel targets in the treatment of severe asthma

Progress Developed an international consensus on diagnostic criteria

Creating novel phenotype ‘handprints’ by combining molecular, histological, clinical and patient-reported data – validation and refining is on-going

Two novel animal models have been identified (FCA/HDM, CT & MRI imaging of chronic HDM model)

Preparation and recruitment for cohort clinical study have started, 14 centres across Europe targeting 1025 subjects, to validate the handprints for their predictive efficacy in gold standard and experimental therapeutic intervention

Example: U-BIOPRED


University of AmsterdamUniversity of SouthamptonImperial College LondonUniversity of ManchesterUniversity of NottinghamFraunhofer institute HannoverCentr Nat Recherche Sc Villejuif ParisUniversité de Méditerranee MontpellierKarolinska Institute StockholmUniversity UmeaUniversityTor Vergata RomeUniversità Cattolica del Sacro Cuore RomeUniversity of CataniaHvidore Hospital CopenhagenUniversity Hospital CopenhagenHaukeland University BergenSemmelweis University BudapestJagiellonan University KrakowUniversity Hospital BernUniversity of Ghent

NovartisGlaxoSmithKlineAstraZenecaChiesiPfizerRoche UCBBoehringer IngelheimAlmirallJohnson & Johnson / Janssen

BiosciAerocrineSynairgenPhilips Research

Netherlands Asthma FoundationAsthma UKEuropean Lung FoundationEFAInt Primary Care Respir GroupLega Italiano Anti Fumo

U-BIOPRED: participants from EU12 country


1. Department of Medicine, University Medical Colloge, Krakow, Poland:

- Role in project: patient cohort building, data analysis- Had multi-center international trial experience- Had existing collaborations with several partners of the

consortium

2. Department of Pulmonology, Semmelweis University, Budapest, Hungary:

- Role in project: patient cohort building, data analysis, pre-clinical laboratory model studies

- Had experience from multiple multi-center international trials- Had existing collaborations with two partners of the consortium

Example: BTCure (Be the Cure)


Facts & FiguresStart Date01/04/2011Duration60 months Contributions €IMI funding 16 137 872EFPIA in-kind 14 172 302Other 7 807 923Total Cost 38 118 097

The Objective

• to further broaden our knowledge of disease causing factors and disease progression in Rheumatoid Arthritis (RA), thereby identifying improved or targeted therapeutic treatments

• development of new diagnostic methods to discover the early forms of RA as well as tools to separate the different forms of RA

Strategy

to achieve this goal by using a transnational, collaborative approach and by driving this ambitious project forward in a joint effort

Example: BTCure

EFPIAAstraZeneca AB, SwedenBoehringer Ingelheim International GMBH, GermanyBristol Myers Squibb EMEA sarl, USACENTOCOR B.V., NetherlandsF. Hoffmann-La Roche AG, SwitzerlandMerck, GermanyNovoNordisk A/S, DenmarkPfizer Limited, UKUCB Pharma, SA,Belgium

UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFITA. Fleming Biomedical Sciences Research Center, GreeceAMC/University of Amsterdam, NetherlandsCharité-University of Medicine, Berlin, GermanyDiakonhjemmet Hospital, NorwayFoundation for Research and Technology, GreeceGerman Rheuma Research Centre Berlin, GermanyHumanitas Foundation for Research, ItalyImperial College London, UKKarolinska Institute, SwedenKing's College London, UKINSERM, FranceNational University of Ireland, DublinPhadia AB, SwedenRevmatologicky Institute, Czech RepublicSpanish National Research Council, SpainStichting Catholic University NetherlandsUniversity College Dublin, Ireland,University Hospital Centre, Montpellier, FranceUniversity Hospital Leiden (LUMC), NetherlandsUniversity of Erlangen, GermanyUniversity of Glasgow, UKUniversity of Leeds, UKUniversity of Manchester, UKUniversity of Zürich, Switzerland

SMEsTcLand Expression, France

BTCure: participant from EU12 country


Institute of Rheumatology, Prague, Czech Republic:- Role in project: development of tools to search, access and share

clinical data, development of some other procedures- Previous experience with FP6 project (WP leader)- Participation in other world-wide, EU-wide, and nation-wide

studies

Tips for success

1. Writing a successful proposal


Evaluation process


• Expressions of Interest (EoIs) are reviewed and ranked by a panel of at least 5 independent experts

• Experts identified by IMI Executive Office

• Experts in the area

• Have no conflicts of interest

Evaluation criteria


• Scientific and/or technological excellence

• Excellence of Partnership

• Work-plan outline

• Ethical Issues

Scientific and/or technological excellence


• Quality and soundness of the scientific and/or technological approach

• Likelihood of the research proposal to meet all the key objectives in order to complement the EFPIA Consortium.

• Innovation (i.e. novelty in discovery, practical applicability, adaptation, etc.), progress beyond the state-of-the-art.

• Degree of scientific and/or technological impact likely to be delivered?

• Has the Applicant Consortium adequately explained the balance between potential impact and residual risks based on the proposed approach i.e. are potential complications, alternative strategies, and benchmarks for success presented?

Excellence of Partnership


• Scientific quality and technological expertise of the individual participants in the Applicant Consortium.

• Ability to provide the contributions expected from the Applicant Consortium.

• Unique features, strengths, internal complementarities and balance of the Applicant Consortium (including appropriate allocation of roles, manageability of consortium and input of each participant).

Work-plan outline / Ethics


• Conceptual quality and soundness of the work-plan outline, including approximate budget, timelines for deliverables

• Does this proposal contain ethical issues that may need further attention if selected for Evaluation Stage 2?

Common mistakes


• Submission deadline missed

• At the time of submission: parts of the EoI not uploaded (this should not be a problem anymore with SOFIA)

• Applicants are not eligible for funding (enterprises that request but are not eligible for funding can still be partners)

• Legal status of applicants is not clear

• Consortium eligibility criteria not met (e.g., a single legal entity is not a consortium)

• Applicant consortia do not have the capabilities to address all of the objectives (e.g., redundancy between partners)

Common mistakes


• Submitted text does not respect the EoI template (sometimes received even slides!)

• Submitted text so concise that it does not clearly state what is proposed in practice

• The EoI does not address all the objectives (addressing almost all the objectives is not sufficient!)

• EoI out of scope (if you have doubts on how to respond to the call contact IMI)

• Ethical issues not addressed

Make sure to:


• Read all the Call-relevant material that is provided on the IMI website www.imi.europa.eu

• Understand IMI’s Rules and respect them

• If in doubt ask a member of the IMI Executive Office

• Your EoI should provide reviewers with all the information requested to allow them to evaluate it

• Finalise your submission

• If invited to a hearing answer the questions as precisely and concisely as possible

http://www.imi.europa.eu/

Tips for success

2. How to be onboard of the winning consortium


How to find project partners

1. IMI Partner Search Tool: www.imi.europa.eu/content/partner-search

2. IMI States Representatives Group (SRG) member: www.imi.europa.eu/content/states-representatives-groups

3. Health National Contact Point (NCP): cordis.europa.eu/fp7/health/ncp_en.html

4. Keep up-to-date: • Visit www.imi.europa.eu• Sign up to the IMI Newsletter• Follow us on IMI Twitter: @IMI_JU• Join the IMI group on LinkedIn• Questions? E-mail us: [email protected]








How to be onboard of the winning consortium:







1. Clearly identify and communicate what you want and can contribute to the objectives of the Call

2. Get in touch pro-actively with the key players in the field

How to be onboard of the winning consortium:

THANK YOU !THANK YOU !

www.imi.europa.eu


successful applications from eu12 countries & tips for success imi open info day, bucharest 10...

Documents

clinical data

prediction of clinical

therapeutic efficacy

successimi open info

cohort clinical study

imi projectsimi open

ubiopredimi open info

predictive efficacy