Calls Fechadas no tema Iniciativa Tecnológica Conjunta sobre Medicamentos Inovadores

PROGRAMA JTI

TEMA Iniciativa Tecnológica Conjunta sobre Medicamentos Inovadores (6)

IMI-JU-7-2012 | 26,00 M€

De 17-07-2012 a 09-10-2012

7º Concurso IMI - 2012

Consulte abaixo os detalhes de cada Tópico a concurso nesta Call. O link para a página oficial (acima) dá acesso ao documento oficial e completo, com todos os detalhes desta Call.

1 - Developing a framework for rapid assessment of vaccination benefit/risk in Europe

2 - Incorporating real-life clinical data into drug development

IMI-JU-5-2012 | 80,00 M€

De 06-03-2012 a 16-05-2012

IMI-JU-6-2012 | 109,00 M€

De 24-05-2012 a 09-07-2012

IMI-JU-8-2012 | 143,30 M€

De 07-12-2012 a 19-03-2013

8º concurso IMI - 2012

Link para a página oficial

Consulte abaixo os detalhes de cada Tópico a concurso nesta Call. O link para a página oficial (acima) dá acesso ao documento oficial e completo, com todos os detalhes desta Call.

Combating Antbiotic resistence: NEWDRUG4BADBUGS (ND4BB)

ND4BB - Subtopic IC - Innovative Trial Design & Clinical Drug Development (work package 6 of Topic 1)

ND4BB - Topic 3 - Discovery and development of new drugs combating Gram–negative infections

DEVELOPING AN AETIOLOGY-BASED TAXONOMY OF HUMAN DISEASE

Topic a: - Approaches to develop a new classification for systemic lupus erythematosus (sle) and related connective tissue disorders and rheumatoid arthritis (RA)

Topic b: - Approaches to develop a new classification for neurodegenerative disorders with a focus on Alzheimer’s disease and Parkinson’s disease.

EUROPEAN INDUCED PLURIPOTENT STEM CELL BANK

- - European Induced Pluripotent Stem Cell Bank

IMI-JU-9-2013 | 63,12 M€

De 09-07-2013 a 09-10-2013

9º concurso IMI - 2013

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Consulte abaixo os detalhes de cada Tópico a concurso nesta Call. O link para a página oficial (acima) dá acesso ao documento oficial e completo, com todos os detalhes desta Call.

Topic 1: WEBAE - LEVERAGING EMERGING TECHNOLOGY FOR PHARMACOVIGILANCE

Topic 2 - DEVELOPING INNOVATIVE THERAPEUTIC INTERVENTIONS AGAINST PHYSICAL FRAILTY AND SARCOPENIA (ITI-PF&S) AS A PROTOTYPE GERIATRIC INDICATION

COMBATTING ANTIBIOTIC RESISTANCE: NEWDRUGS4BADBUGS (ND4BB)

ND4BB TOPIC 4 - DRIVING RE-INVESTMENT IN R&D AND RESPONSIBLE USE OF ANTIBIOTICS

ND4BB TOPIC 5 - CLINICAL DEVELOPMENT OF ANTIBACTERIAL AGENTS FOR GRAM-NEGATIVE ANTIBIOTIC RESISTANT PATHOGENS

IMI-JU-11-2013 | 171,42 M€

De 11-12-2013 a 08-04-2014

11º concurso da Iniciativa Europeia Medicamentos Inovadores

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Consulte abaixo os detalhes de cada Tópico a concurso nesta Call. O link para a página oficial (acima) dá acesso ao documento oficial e completo, com todos os detalhes desta Call.

1 - APPLIED PUBLIC-PRIVATE RESEARCH ENABLING OSTEOARTHRITIS (OA) CLINICAL HEADWAY (APPROACH)

OVERALL OBJECTIVES Enable and implement comprehensive consolidation of existing data and high quality biomarker assessment to characterise OA patient subsets and support future regulatory qualification and endpoint validation
 Define the “right patient” to treat via stratification of patient subgroups – Link OA patient subsets to potential DMOAD targets based on phenotypic biomarkers, highlight specific disease drivers and progression criteria
 Assess next generation imaging techniques and human motion analysis to enable more efficient and reliable diagnosis and treatment
 Identify mechanistic targets and create a DMOAD development roadmap

EFPIA PARTICIPANTSGlaxoSmithKline (coordinator), Merck KgaA (deputy coordinator), Servier
INDICATIVE DURATION OF THE PROJECTThe indicative duration of the project is 5 years.

INDICATIVE BUDGET OF THE PROJECTThe indicative EFPIA in-kind contribution will be up to EUR 7 500 000.
The indicative IMI JU contribution that will be made available to the applicant consortium will be a maximum of EUR 7 500 000.

APPLICANT CONSORTIUM
DESIRED EXPERTISEAcademic:
 Clinical centre expertise and access to OA patient and control cohorts
 Cutting-edge imaging and human motion analysis facilities and expertise
 Statistical and analytical expertise
 Proteomic/metabolomic discovery and technical expertise
 Mechanistic insights into the efficacy and safety aspects of DMOAD targets

Small and Medium Enterprises (SMEs):Envisioned opportunity for SME involvement, where applicable, in the areas of:
 Proteomic/metabolomic discovery WP2
 Biomarker fit-for-purpose validation WP3a
 Biochemical marker testing WP3b
 Imaging technology and analysis systems WP3b
 Novel DMOAD compounds

Patient Advocacy Groups:In addition to providing samples for assessment, a key component of patient involvement
is envisioned through providing the patient perspective in WP4 and helping design the
questionnaire to be utilised in WP3b. A good example is the currently planned initiative
of the Arthritis Foundation in the US, undertaking an OA Research Initiative, including the
development of a Pre-Competitive Consortium (PCCOA) whose mission is to advance the
development of disease modifying therapies for the treatment of patients with OA.
Regulatory Agencies:
Envision a primary role for collaborative input and guidance from members of regulatory
agencies (EMA and FDA) on WP4 to enable critical dialogue on project scope.

Healthcare Organizations:Envision healthcare organization inclusion in WP4 with the intent of providing a better
understanding of the economic burden of OA and comparison to current therapeutic
strategies being utilised to help guide future approaches.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

2 - EUROPEAN PLATFORM TO FACILITATE PROOF OF CONCEPT FOR PREVENTION IN ALZHEIMER’S DISEASE (EPOC-AD)

NEED FOR PUBLIC-PRIVATE COLLABORATIVE RESEARCH

Given that there has not been any new regulatory approved treatment for AD in the past
decade, despite a multibillion dollar pharmaceutical investment, there is a groundswell of
support building within industry, government, and academia to shift the paradigm. It has
become obvious that only cooperation between academia, government and industry
might make the clinical development of AD prevention strategies possible. Studying
prevention approaches in AD is challenging. Some of the scientific challenges include
identifying subjects at risk, developing efficient study designs, constructing appropriate
clinical endpoints, including relevant biomarkers and establishing methods for prevention.
A public-private collaborative approach will be required to enable efficient design and
execution of clinical trials aimed at exploring how to prevent AD. A precompetitive space
has to be established that enables collaborations in selecting best candidate therapies,
and advancing clinical trials methodologies that enable adaptive approaches to optimize
the investments that can be made, allowing the timely delivery of needed treatments to
the patients.
It is proposed that the risks associated with proof of concept trials for the development of
therapeutics for AD prevention are best addressed through a collective effort that
minimizes the utilization of patient, health professionals and financial resources through
duplicative efforts on the part of individual pharmaceutical companies. The shift in the
treatment development paradigm of this proposal will focus on prevention of the disease,
establishing a precompetitive space that enables collaborations in selecting best
candidate therapies, establishing the most innovative public-private partnerships and
advancing clinical trials methodologies that enable adaptive approaches to optimize the
investments that can be made.

EFPIA PARTICIPANTS

Janssen (coordinator), Eisai (deputy coordinator), Roche (deputy coordinator), AbbVie,
IMMUNE (EBE member), Amgen, Astellas, BIOGEN IDEC, Boehringer Ingelheim,
Lundbeck, Pfizer and UCB.

INDICATIVE DURATION OF THE PROJECT

The indicative duration of the project is 5 years. A sustainability aspect should be built
into the project architecture, facilitating continuation of the project beyond 5 years.
INDICATIVE BUDGET OF THE PROJECT

The indicative in kind contribution from the EFPIA companies is estimated to be EUR 28 193 000. The indicative IMI JU contribution is up to EUR 25 000 000.
Due to the complexities of running a global clinical trial designed to support regulatory submissions, it is common practice of both industry funded and FP7 projects to engage a Contract Research Organization (CRO) to implement and monitor the clinical sites to ensure compliance. It is also worthwhile noting that while this is the preferred approach, in some instances it may be preferable for a SME/CRO in collaboration with the
sponsoring company’s internal operations groups to implement these clinical trials.
There are three possible scenarios for the inclusion/selection of the CRO:
1) The applicant consortium includes CRO expertise and capability.
2) If the applicant consortium does not include CRO capabilities, Applications should assume the requirement for subcontracting to a CRO in compliance with applicable rules and regulations. The Applicants should therefore consider that a percentage of the available funding for the project should be allocated to CRO activities to implement and monitor the clinical trials. The precise amount will be worked out at the Full
Project Proposal stage. Direct financial contribution by the sponsoring EFPIA companies, if required, will supplement the CRO costs (up to 25%), incurred by public partners eligible for IMI funding ensuring that 100% of these costs will be reimbursed.
3) In the event that EFPIA are funding the CRO in its entirety as part of their contribution in kind, then the CRO will be appointed directly by the sponsoring EFPIA companies according to normal internal procurement practices. The EFPIA companies must be able to demonstrate ‘value for money’ to satisfy external auditors, otherwise this cannot be counted as contribution in kind.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

3 - BLOOD-BASED BIOMARKER ASSAYS FOR PERSONALISED TUMOUR THERAPY: VALUE OF LATEST CIRCULATING BIOMARKERS

NEED FOR PUBLIC-PRIVATE COLLABORATIVE RESEARCH

Establishment, evaluation and especially clinical validation of new methods in this area
requires the cooperation of experts from different areas with complementary expertise:
 Biotech companies with their knowledge on new technologies;
 Academia with their knowledge on molecular disease mechanisms and access to
clinical samples;
 Diagnostic companies, with well-established tissue based technologies and
expertise in companion diagnostic development;
 Pharmaceutical companies, with their knowledge on new drugs development
and companion diagnostics.
The comprehensive evaluation of several different technologies including them in clinical
studies is a major effort not feasible by one or few institutions.

OVERALL OBJECTIVES

The aim of the project is the establishment, technical and clinical validation of methods
for blood-based biomarkers enabling prediction i.e. patient stratification/ predictive
biomarkers, monitoring of treatment response i.e. surrogate biomarkers and prognosis
i.e. prognostic biomarkers.
Identification of new biomarkers per se using screening approaches (e.g. by proteomic
methods) is not within the scope of this call.
With regard to the stratification approach the ultimate goal is the development of blood
based companion diagnostics, ideally close to regulatory approval. The evaluated
technologies should therefore have a certain degree of proven technical maturity.
Such assays have significant value for patients, physicians, and payers since they will
prevent exposure of patients to drugs that are unlikely to be beneficial. Moreover
robustly validated biomarker assays are extremely important for the pharmaceutical
industry as they will help to reduce the very high attrition rate in clinical development,
the key cost driver in drug development, by selection of well characterized patients with
suitable preconditions for response.

EFPIA PARTICIPANTS

Bayer HealthCare (lead), Boehringer-Ingelheim, Eli Lilly, Menarini, Orion, Servier.

INDICATIVE DURATION OF THE PROJECT

The indicative duration of the project is 5 years.INDICATIVE BUDGET OF THE PROJECTThe indicative EFPIA in-kind contribution is EUR 7 360 000.
The indicative IMI JU contribution is up to EUR 6 620 000.
In-kind contribution: Each participating company will fund their own participation and
provide R&D resources such as staff, laboratory facilities, materials and clinical research,
where applicable. FTEs will perform hands-on scientific work in the laboratories of the
EFPIA partners and are involved in project management. Clinical samples collected by
EFPIA partners will be provided to the consortium, if useful for its purposes. Furthermore,
there is significant experience among EFPIA members with different technologies used for
CTC isolation, molecular analysis. These protocols and expertise will be made available to
the consortium.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

4 - ZOONOSES ANTICIPATION AND PREPAREDNESS INITIATIVE (ZAPI)

NEED FOR PUBLIC-PRIVATE COLLABORATIVE RESEARCH
No single industrial firm, academic centre, or governmental agency has the skills and the
capacity to be able to plan ahead to meet the complex challenges associated with
unexpected outbreaks. To meet one of these outbreaks effectively is challenging enough.
To address more than one outbreak concurrently could be paralyzing without a closely
coordinated and effective program tying together a network of actors with proven skills
and capabilities. Hereafter is a list of basic requirements to meet such a need:
Technologies
 Design of expression constructs for prokaryote or eukaryote systems enabling
very high expression levels (the general idea is to avoid the use of mammalian
cell culture systems which are prone to supply bottlenecks for technical and
logistical reasons in a context of surge capacity). Classical vaccine approaches
could be considered if the proposals provide ways to very significantly accelerate
the delivery of the commercial vaccines in the field.
 Universal antibody libraries combining immunoglobulin genes from multiple
species (ensuring highest chance for finding high affinity neutralizing antibodies).
 High throughput screening technologies for neutralizing antibodies or antibodylike
molecules.
Scientific knowledge
 Knowledge of reservoir species and of the kinetics of the immune response in
natural and experimental infection plus elementary knowledge of the
pathogenesis. In fact some diseases become worse after vaccination: such as:
aleutian disease of the mink, dengue heterologous genotype infection or
respiratory syncytial virus infection.
 Immunoprofiling/immunosignature technologies for defining protective
immunogens.
 Immunodesign technologies for designing vaccine immunogens and corresponding
antibodies (bioinformatics and immunostructural analyses).
 Comparative immunology approach for understanding common protective
mechanisms / recognition of key protective immunogens between different target
species.

EFPIA PARTICIPANTS
Merial, a Sanofi company (coordinator), Animal Health Division of Sanofi, Boehringer
Ingelheim Animal Health, Medimmune, a division of AstraZeneca

INDICATIVE DURATION OF THE PROJECT
The indicative duration of the project is 5 years.

INDICATIVE BUDGET OF THE PROJECT
The indicative EFPIA in-kind contribution is up to EUR 9 900 000
The IMI JU financial contribution will be a maximum of EUR 9 900 000

APPLICANT CONSORTIUM
The applicant consortium is expected to be a multi-disciplinary body consisting of
academic research centres and institutes, small- and medium-sized enterprises (SMEs)
and centres from national and/or supranational public and animal health bodies. The
consortium should be in a position to provide an effective communication between the
key stakeholders from academia, EFPIA, public and animal health bodies as well as
regulatory authorities. It should be providing experience well established in the field of
zoonoses research and diagnostics, immunology, microbiology, antibody library design,
neutralization and immunoprofiling assay technologies, in silico immunogen design,
interactive database development and operation, as well as for innovative expression
systems able to support the objectives of the project.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

5 - GENERATION OF RESEARCH TOOLS TO ENABLE THE TRANSLATION OF GENOMIC DISCOVERIES INTO DRUG DISCOVERY PROJECTS

ND4BB TOPIC 7 - DEVELOPMENT OF NOVEL INHALED ANTIBIOTIC REGIMENS IN PATIENTS WITH CYSTIC FIBROSIS (CF) AND PATIENTS WITH NON-CF BRONCHIECTASIS (BE)

BENEFITS OF A COLLABORATIVE APPROACHThe paradox of further increasing antibiotic resistance and decreasing development of
antimicrobials is still existent although it has been recognised since many years.
Reversion of the paradox has to be accelerated through concrete actions and
collaboration. A collaboration approach will ensure that the best and diverse expertise
around the world is gathered and data and risks are shared which will lead to a higher
chance of success in developing new antibiotics and in improving the use of antibiotics.
In particular, for ND4BB Topic 7, private partners bring in programme-specific knowledge
and general knowledge in antibiotic drug development; Basilea and Novartis will join
forces by complementing their expertise in the development of inhaled antibiotics in CF
and expertise in anti-infective development; academic and SME partners are needed for
their expertise with CF, non-CF BE, specific microbiology and epidemiology expertise;
clinical expert input is needed for clinical endpoint research; experience with data
registries and data access solutions is needed to optimally exploit the benefit of the data
that will be generated. A collaborative effort for topic 7 would lead to the following
benefits:
 Studies of combinations of inhaled antibiotics will optimise the use of antibiotics in CF
patients and might lead to additional benefits for CF patients due to synergistic
effects. The studies will inform on resistance development and emerging pathogens in
CF.
 Novel inhalation drug delivery technologies such as Dry Powder Inhalation (DPI) will
reduce treatment burden for patients, improve adherence to medication and avoid
health care associated infections through wet nebulisation.
 A novel antibiotic against difficult to treat Gram-negative bacteria especially nonfermenters
including multi drug-resistant P. aeruginosa and S. maltophilia,
Burkholderia spp, Acinetobacter spp, Achromobacter xylosoxidans, Ralstonia spp, and
Pandoraea spp may become available for CF patients.
 Two new inhaled antibiotics may become available to patients with non-CF BE and are
expected to reduce exacerbations, improve quality of life, reduce hospitalisations, and
other burden to the healthcare system.
 The clinical studies will generate data on clinically relevant endpoints in non-CF BE,
such as frequency of exacerbations and the correlation with changes in bacterial load.
For product development in non-CF BE patients the regulatory requirements related
to study designs and endpoints are not well defined. Considerations around
development of new compounds in this indication will stimulate discussions with
regulators and help define a regulatory path which will be of benefit to future
development of new treatments as well.
 Characterisation of patient’s microbiology will further inform on the relevance of
potentially pathogenic microorganisms (PPMs) (for example Proteus and Klebsiella) in
non-CF BE.
 Capability for storage of non-fermenter strain samples will be developed that will
facilitate future research in the fields of CF and non-CF BE.
 A European wide registry gathering information on several aspects of the disease of
non-CF BE that can be analysed to generate recommendations on the management
and control of patients.
 Exploration of possible collaboration with other private and public enterprises
including the European Cystic Fibrosis Clinical Trials Network
(https://www.ecfs.eu/ctn) is key to add specific expertise in microbiology,
formulation development, preclinical pharmacology, and CF study design and
execution.
 Collaboration will allow risk sharing for the development of antibiotics for the
treatment of an orphan disease (CF) and difficult indication.
 The development effort presented in ND4BB Topic 7 will benefit from and add to the
research infrastructure of the ND4BB programme.

EFPIA PARTICIPANTS
Novartis, Basilea

INDICATIVE DURATION OF THE PROJECT
The indicative duration of the project will be 5 years.

INDICATIVE BUDGET OF THE PROJECT
The indicative EFPIA in-kind contribution is up to EUR 31 000 000
The IMI JU financial contribution will be a maximum of EUR 27 000 000
Milestones related to the expected results over time will be defined for a staggered
budget release to optimally manage risk of investment.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

8 - ECORISKPREDICTION (ERP)

NEED FOR PUBLIC-PRIVATE COLLABORATIVE RESEARCHIn order to deliver the expected deliverables for this topic there is a need for many
different stakeholders to share their data and work together. It is clear that a single
entity or institution will not be able to develop the tools and methodologies required for a
systematic approach. For the realization of the project, the inclusion of interested
stakeholders is needed:
 SMEs to support the development of in-silico tools and the collection of public data
in a data base with public data; and can provide project management services
 Academia to contribute by elaborating theoretical approaches and experimental
testing programmes to define prioritization parameters
 Industry to provide input regarding their product portfolio in particular pre-clinical
and clinical data, unpublished ecological information and the contribution to
validation programmes for defining prioritization parameters.
 Regulatory Agencies (i.e., EMA, National Environment Agencies) to contribute with
available information on registered APIs within existing ERAs
 European Regulators, such as the EMA and the European Commission (DG
SANCO, DG-Environment) are key stakeholders for discussions in which way
regulators can support intelligent testing strategies and what scientific information
may be useful to get broad acceptance for a prioritization concept of old APIs.
The tools and methodologies developed during the lifetime of the project may be used by
different stakeholders in assessing environmental impacts. Therefore it is important that
those different stakeholders are involved in the definition and testing of the expected
new tools, in order to ensure future consistency between approaches applied by different
national and international agencies.

EFPIA PARTICIPANTS
Bayer Pharma (coordinator), Novartis (deputy coordinator), AstraZeneca (deputy
coordinator), Roche, Johnson and Johnson, Merck (MSD), Pfizer, Sanofi.

INDICATIVE DURATION OF THE PROJECT
The indicative duration of the project is 4 years.

INDICATIVE BUDGET OF THE PROJECT
The indicative in kind contribution from the EFPIA companies is estimated at
EUR 3 884 200.
The indicative IMI JU contribution will be up to EUR 3 000 000.

Informações adicionais no texto do concurso disponível em http://www.imi.europa.eu/content/stage-1-11

ND4BB Topic 6 - Epidemiology Research and Development of Novel Systemic Antibacterial Molecules Against Healthcare-Associated Infections due to Gram-Negative Pathogens

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Registaram-se até agora 6 convites para apresentação de propostas ao FP7 no tema Iniciativa Tecnológica Conjunta sobre Medicamentos Inovadores, cujo conteúdo descritivo por tópico pode, nalguns casos, ser consultado nesta página.