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The Innovative Medicines Initiative:
Europe’s partnership for health
Prof. Gianluca Sbardella
15.12.2017 – Università di Roma “La Sapienza”
What is IMI?
Why do we need it?
What is IMI delivering?
AMR, dementia, medicines safety, faster drug development
How does IMI work?
From legislation & research agenda to Calls for proposals
How can I get involved?
Tips for applicants
Outline
Why do we need IMI?
risky inefficient
expensive
complex
time
consuming
Because drug development is very…
Because…
Not enough
science
throughout
development
Clinical trial
designs not
always optimalRegulatory
pathways not
always optimised
Challenges in medicines development
How is IMI addressing the challenges in drug development?
Through IMI’s projects we are trying to…
put patients at the centre
share risk (among public & private players)
increase efficiency (by developing common tools)
reduce duplication of effort (esp. at early stages)
reduce timelines (by using a personalised medicine approach)
integrate the latest science into drug development
use data and knowledge management to work more effectively
We do this by creating a neutral platform where all involved in
drug development – academics, industry, SMEs, patients, regulators,
others – can engage in open collaboration on shared challenges.
IMI–key concepts
Non-competitive collaborative research
Competitive Calls for proposals
Open collaboration in public-private consortia
Data sharing, dissemination of results…
Industry contribution is in kind
IMI – Europe’s partnership for health
> €5 bn
Partnership
2008 - 2024€2.5 bn€2.5 bn
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
What is IMI delivering?
2 272 FTE jobs
directly associated
with IMI projects
20 patent
applications
200 SMEs
13 spin-offs
25+ new tools
to facilitate drug
development1 600+ scientific
publications
65 clinical studies
460+ biological marker
candidates for better
diagnosis & treatment
Antimicrobial resistance – a growing threat
25 000 killed
€1.5 billion
New Drugs for Bad Bugs
Challenge 1: Getting the
drug into the bug
TRANSLOCATION: Addressing
scientific challenge of
penetration barriers & efflux
Challenge 2: Translation
from early discovery to
clinic
ENABLE: Combine academia /
industry expertise to work on
early-stage novel molecules
Challenge 3: Clinical dvpt
long, costly & often
inefficient
COMBACTE family, iABC:
Creating sustainable clinical
investigator / laboratory /
epidemiology networks; clinical
studies
Challenge 4: Low return
on investment
DRIVE-AB: Options for a new
economic model of antibiotic
development & stewardship. Buy
in from all stakeholders
Alzheimer’s disease – a major unmet need
Alzheimer’s disease
in numbers…
46.8 million
affected globally
10.5 million
in Europe
Global cost
USD 818 billion
(EUR 732 billion)
IMI action on Alzheimer’s disease
PHARMA-COG
Matrix of
biomarkers
Test efficacy
of new
treatments
EMIF
Linking &
analysing data
Identify those
at risk
AETIONOMY
New classification
of AD/PD
Personalised
treatments
EPAD
‘Adaptive’ clinical
trials
Faster drug
development &
patient access
Total budget
€186 million
PRISM
Causes of social
withdrawal
Faster, better drug
development
Medicines safety – the challenge
A major challenge in drug development is finding medicines that
treat the disease but are not toxic to vital organs like the heart,
liver, kidneys, etc…
Too often, toxicity issues are only picked up late in drug
development, when vast amounts of time and money have been
spent on a drug.
IMI projects are developing simple tests to detect
toxicity issues earlier in drug development.
Medicines safety – an IMI success
What eTOX did
Pharma data
+
Public data
=
One big database
underlying multiple
computer-based tools
Example: Will this be toxic to the heart?
Output =
possible effect
on heart – ECG
result!
Input = 2D
structure of a
possible drug
Project partners
using tools
Reducing animal
testing
Through its European Lead Factory project, IMI
has created a state-of-the-art compound
collection & screening centre that is delivering
results for academics, SMEs & pharma
Medicines development – the challenge
High Throughput Screening (HTS) = researchers screen large
collections of chemical compounds in hunt for molecules that could
be potential drugs or be used in drug development in other ways.
Pharmaceutical companies have huge compound collections,
but access to these is usually tightly restricted…
Public compound collections exist, but are small and expertise
is scattered across many institutions.
Medicines development – an IMI success
Joint European
Compound
Collection
European
Screening Centre
320 000 cpds
from 7 pharma
companies
200 000 cpds
from public
partners
Advanced, ultra
high throughput
screening
facilities &
expertise on
logistics, medicinal
chemistry, etc.
‘Access to the European Lead Factory has
fast-forwarded our drug discovery
programme in the field of oncology by
several years.’ – Huib Ovaa, Netherlands
Cancer Institute
‘ELF support & its high quality compound
library … will allow Effecta Pharma to
expand its drug discovery efforts for
dengue and gives an important boost to
tackling this viral disease.’ – Effecta
Pharma, UK biotech company
Leading role for SMEs
Quality & diversity of compounds recognised
Award-winning IP solution
Happy users!
IMI 2 Strategic Research Agenda
Antimicrobial resistance
Osteoarthritis
Cardiovascular diseases
Diabetes
Neurodegenerative diseases
Psychiatric diseases
Respiratory diseases
Immune-mediated diseases
Ageing-associated diseases
Cancer
Rare/Orphan Diseases
Vaccines
IMI life cycle
Call topics definition
Scientific Research Agenda
Strategic Governing Groups
Annual Work Plan
Consultation Member-Associated States/Scientific Committee
Call Launch / Evaluation / Grant award
Project implementation
Consortium agreement, Grant agreement, implementation and reporting
Industrial partners align themselves around a real challenge for
industry and agree to work together and commit resources
New ideas from public sector, universities, SMEs etc. are needed to
address the challenge
Scale is a key to success and is provided by IMI funding and the
outcomes should be transformative for the industry as well as
having a clear “public” value
What does the typical IMI project look like?
A typical IMI consortium
Associated
Partners
An international, cross-sector community
Over 11 500 researchers
working for:
open collaboration
improved R&D
productivity
innovative approaches to
unmet medical needs
Introduction to IMI 2 –Call 13
IMI2 Call 13 –topics (1/2)
TOPIC 1- Assessment of the uniqueness of diabetic cardiomyopathy relative to other forms of heart failure using unbiased pheno-mapping approaches
TOPIC 2- Genome-environment interactions in inflammatory skin disease
TOPIC 3- The value of diagnostics to combat antimicrobial resistance by optimisingantibiotic use
TOPIC 4- Mitochondrial dysfunction in neurodegeneration
TOPIC 5- Support and coordination action for the projects in the neurodegenerationarea of the innovative medicines initiative
TOPIC 6- A sustainable european induced pluripotent stem cell platform
TOPIC 7- Linking digital assessment of mobility to clinical endpoints to support regulatory acceptance and clinical practice
TOPIC 8- Human tumour microenvironment immunoprofiling
IMI2 Call 13 –topics (2/2)
TOPIC 9- Conception –continuum of evidence from pregnancy exposures, reproductive toxicology and breastfeeding to improve outcomes now
TOPIC 10- Improving the preclinical prediction of adverse effects of pharmaceuticals on the nervous system
TOPIC 11- Translational safety biomarker pipeline (TRANSBIOLINE): enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease pilot programme on a clinical compound bank for repurposing
TOPIC 12- Cardiovascular diseases and diabetes
TOPIC 13- Respiratory diseases
TOPIC 14- Neurodegenerative diseases
TOPIC 15- Rare/orphan diseases
IMI 2 -Call 13
Date of Call launch: 30 November 2017
Calls text and documents are published on the: IMI2 JU website
http://www.imi.europa.eu/apply-funding/open-calls/imi2-call-13
Deadline for Short Proposal submission: 28 February 2018
Deadline for Full Proposal submission: 6 September 2018
Webinar topic presentations and recordings:
http://www.imi.europa.eu/news-events/events/webinars-imi2-call-13
Call 13 – NEW!
As of IMI2 JU call 10, use of the electronic submission service of the Horizon 2020 Participant Portal: https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020
To access the portal and submit a proposal, applicants must have:
An EU Login account (previously, ‘ECAS’ account)
Their organisation registered on the Participant Portal Beneficiary Register, with a 9-digit Participant Identification Code (PIC) number
If you do not have an EU Login account yet, you can create an EU Login account on the Participant Portal, and register your organisation.
More information: http://ec.europa.eu/research/participants/docs/h2020-funding-guide/user-account-and-roles/ecas-login_en.htm
Call 13 – NEW!
At stage 1 evaluation the budget is evaluated under criterion 3
‘Quality and Efficiency of the Implementation’
Applicants will need to provide a breakdown of costs (and not only
the overall amount, as previously the case), by filling in the budget
table in Part A of the proposal
Opportunities for SMEs in IMI2 Call 13
Why should an SME participate in an IMI project?
IMI projects are focused on translating excellent research into real
world outcomes – an opportunity for SMEs
Unique collaborative partnerships in pharmaceutical research and
development
Collaboration with pharmaceutical companies allows access to
whole value chain of drug discovery
Build research and business networks
Funding: 100% of costs reimbursed
Participation rules
A single set of rules
etc.
Covering all
H2020 research
and innovation
actions
Adaptability
where needed:
Entities eligible
for funding
IP
EU Financial
Regulation
Specific rules for
participation
COSME
Conditions for this Call for proposals
H2020 Rules for participation apply to IMI2 JU Call for Proposals and Actions except where specifically derogated
Minimum conditions
RIA: at least three independent legal entities, each established in a different EU Member State or H2020 associated country
CSA: one legal entity established in EU Member State or H2020 associated country
Two-stages
Stage 1 SPs from applicants requesting JU funding
Stage 2 merging 1st ranked SPs with industry consortia
Evaluation criteria
At stage 1, all 3 criteria are evaluated (including budget)
Conditions for this Call for proposals
Submission tool
(As of call10) SPs/FPs to be submitted through the
Electronic Submission Service of the H2020 Participant Portal
Submission deadlines
Established in the Call topic text both for stage 1 and 2
Indicative contribution
For each topic, the maximum JU contribution and the estimated industry contributions are set in the call text
Hearings
Panels may decide at stage 1 to held hearings with applicants during panel meetings. After submission deadline, coordinators will be informed about the possible date for the hearing (check SP details!)
Conditions for this Call for proposals
Information on the outcome of the evaluation:
Information to the applicants -max 5 months from submission deadline
Financial Support to Third Parties
Where relevant, applicants should develop in FPs open, transparent, objective processes and criteria for the allocation of financial support in accordance to Annex K of the H2020 WP, and article 15 of the IMI2 MGA
Plan for exploitation and dissemination
It must be included in FPs
NB: Contacts/discussions about a given topic between potential applicant consortia and members of the industry consortium are prohibited throughout the procedure until the results of the first stage evaluation.
Any legal entity, regardless its place of establishment, carrying
out work relevant to the Call objectives may be part of
applicant consortia
But… not all participating entities are eligible for funding
Attracting stakeholders
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 State
Associated Country
Art.1 Commission Delegated Regulation (EU) No 622/2014
Who is eligible for funding?
Other countries:
No funding unless participation
deemed essential by IMI2 JU for
carrying out the action
EU Member States
Associated countries
Expected consortia
Stage 1 of two stage -Short Proposals
Consortia consisting of:
IMI2 JU fundable legal entities* carrying out activities relevant
for achieving the project objectives
additional legal entities carrying out activities relevant for
achieving the project objectives.
Expected consortia
Stage 2 of two stage –Full Proposals
One Full Consortium per topic consisting of:
1st ranked SP consortium - IMI2 JU fundable legal
entities/additional legal entities
Industry consortium (EFPIA companies and IMI2 JU Associated
Partners) associated to the relevant topics
Funding rules
IMI2 Funding model
IMI2 JU is a PPP, actions are normally co-funded by:
JU funding to BRFs (beneficiaries receiving funding = legal entities eligible for funding)
In-kind/cash contribution from BNRFs (beneficiaries not receiving funding):
EFPIA constituents and affiliates
IMI2 JU Associated Partner
(future other IMI2 members)
Other legal entities may also participate as BNRFs at their own cost
One project = One rate
For all beneficiaries and all activities
100% of the direct eligible costs
Indirect costs: 25% flat rate
One single funding rate per project -BRFs
JU contribution to BRFs covers:
Personnel Wider acceptance of average personnel costs
Acceptance of supplementary payments
For non-profit organisations of up to 8000 euros/year/person
Less requirements for time records
Equipment, consumables, travels…
Subcontracting
Considering BRFs accounting and management principles
BRFs (only) may also receive Financial contribution from EFPIA/Aps to be reported as receipts
IMI2 JU Grant Agreement
Third party is a legal entity which carries out work of the action,
supplies goods or provide services for the action, but which did not
sign the grant agreement
Types of third parties:
1. Third parties directly carrying out part of the work described in
Annex 1
2. Other third parties: providing resources, goods or services to
beneficiaries carrying out the work described in Annex 1
3. Third parties receiving financial support (money) from the
beneficiary as part of the action, subject to specific conditions,
i.e. Annex K H2020 WP
Updated version of the IMI2 model grant agreement
Available from 11 December
http://www.imi.europa.eu/apply-funding/call-documents/imi2-
call-documents
The main changes in the revised MGAs are:
Article 29.3 'Open access to research data' to provide for third
party access to research data in health actions in cases of
public health emergencies;
Article 34 'Ethics and research integrity' to align the provisions
on ethical and]research integrity principles to the new European
Code for Research Integrity adopted ALLEA (All European
Academies);
The revised MGAs v5.0 will be used for grants opening from
November 2017 onwards
EFPIA and Associated Partners contribution -BNRFs
EFPIA companies
Other industries and partners (= Associated Partners to IMI2)
In-kind (actual direct and indirect costs or average FTE) and/or financial contributions (FC)*
Based on the usual management principles and accounting practices
Contributions from affiliated entities as part of in-kind
* Recipient of FC must be BRFs, i.e. eligible for JU funding
When relevant to IMI2 JU objectives: non-EU in-kind contribution (up to 30% at programme level)
Annual financial reporting is disconnected from GA periodic reports
Deadlines for reporting
Scientific reporting (full consortium) due at project deadlines (i.e.GA),
duration reporting period: 12 months
Financial reporting for:
Beneficiaries receiving JU funding, due at project deadlines (i.e.GA)
CFS: >EUR 325k at project end25.000 EUR
Beneficiaries Not receiving funding (e.g. EFPIA companies and APs),
due by 31 Jan -certification by 30 April -covering previous calendar year
IMI2 JU’s Intellectual Property (IP) rules
What is IMI and why do we need it?
One set of rules for multiple interests
Background vs. Results
Background vs. ResultsBackground
Any data, know-how or information —whatever its form or nature (tangible or intangible), including any
rights such as intellectual property rights —that:
is held by the beneficiaries before they acceded to the Agreement,
is needed to implement the action or exploit the results, and
which is identified and agreed by the Beneficiaries.
All conditions have to be met to be considered background and be subject to specific rights & obligations
Results
Any (tangible or intangible) output of the action such as data, knowledge or information—whatever its form
or nature, whether it can be protected or not
That is generated in the action, as well as any rights attached to it, including intellectual property rights
Excluded Sideground- output generated by a beneficiary under the action but outside of the action
objectives as defined in the Grant Agreement
=>Importance of Action objectives
Ownership of results
Results belong to the beneficiary who
generated it
Possible transfer of ownership
-within the consortium to affiliates
and purchasers without prior
notification
-on case-by-case basis
Research Use vs. Direct Exploitation
Research Use
Use of results or background necessary to use the results for all
purposes other than for completing the action or for direct
exploitation
Direct exploitation
to develop for commercialisation or to commercialise the results
Based on previous experience
Access rights
Access rights and third parties
Only after the end of the action for research use purposes
Time-limits to be agreed
Possibility to exclude specific elements of background (only for
existing background) under exceptional circumstances and
after a reasoned request
Based on IMI1 experience
Reference documents
H2020 Rules for Participation
IPR section: Article 1.3.c and Articles 41 to 49
IMI2 Delegated Regulation
IPR section: Articles 2 to 7
IMI2 model Grant Agreement (revised November 2017)
IPR section: Articles 23a to 31
IMI2 annotated Grant Agreement (soon)
www.imi.europa.eu/content/documents
From Call to grant award
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
A single set of evaluation criteria
Two-stage evaluation:
all three criteria considered at both stages
Thresholds and weighting in the Call documents
Minimum of 3 independent experts
Each proposal evaluated ‘as it is’, not as ‘what could be’
ExcellenceQuality &
efficiencyImpact
Evaluation Criteria (RIA)
1. Excellence
The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the call for proposals and referred to in the IMI2 annual work plan :
Clarity and pertinence of the proposal to meet all key objectives of the topic;
Credibility of the proposed approach;
Soundness of the concept, including trans-disciplinary considerations, where relevant;
Extent that proposed work is ambitious, has innovation potential, and is beyond the state of the art;
Mobilisation of the necessary expertise to achieve the objectives of the topic, ensure engagement of all relevant key stakeholders.
Evaluation Criteria (RIA)
2. Impact
The following aspects will be taken into account, to the extent to which the outputs of the project should contribute at the European and/or International level:
The expected impacts of the proposed approach as mentioned in the call for proposals;
Added value from the public private partnership approach on R&D, regulatory, clinical and healthcare practice as relevant;
Enhancing innovation capacity and integration of new knowledge;
Strengthening the competitiveness and industrial leadership and/or addressing specific societal challenges;
Improving European citizens' health and wellbeing and contribute to the IMI2 objectives; Any other environmental and socially important impacts;
Effectiveness of the proposed measures to exploit and disseminate the project results (including management of IPR), to communicate the project, and to manage research data where relevant.
Evaluation Criteria (RIA)
3. Quality and efficiency of the implementation
The following aspects will be taken into account:
Coherence and effectiveness of the project work plan, including appropriateness of the roles and allocation of tasks, resources, timelines and budget;
Complementarity of the participants within the consortium (where relevant);
Clearly defined contribution to the project plan of the industrial partners (where relevant);
Appropriateness of the management structures and procedures, including manageability of the consortium, risk and innovation management and sustainability plan.
Keeping the momentum
Maximum Time To Grant: 8 months from submission of full
proposal
NEW Legal entity validated in parallel
5 months
for informing applicants
of scientific evaluation
3 months
for signature of grant
agreement
IMI2 Grant Agreement
The new IMI2 JU MGA (v.5) will apply to Call 13
It follows H2020 Model Grant Agreement (v.5) with IMI2
specificities.
IMI2 JU Annotated Model Grant Agreement for will soon be
available, in the meantime please refer to H2020 AGA
It is e-signed between IMI2 JU and Coordinator only. Other
beneficiaries e-sign Accession Forms
EFPIA and Associated Partners are beneficiaries not receiving
funding (BNRFs, Art.9) -their financial report occurs outside the GA
IMI2 Grant Agreement
Article 41.3 -Consortium agreement may cover:
Internal organisation of the consortium, including allocation ofscientific tasks among beneficiaries
Scientific Project Leadership
Scientific Project Leader may be different from Coordinator to:
- reflect the spirit of industrial co-leadership in call topics built upon EFPIA/industry scientific priorities
- address the need for strong scientific coordination and collaborationbetween BRFs (JU funded) and BNRFs (industry)
Consortium agreement
Contractual arrangement between all participants to set out their
rights and obligations, especially governance, liability and IPR
Shall comply with the IMI2 JU Model Grant Agreement
To be agreed before the signature of the GA, IMI2 JU is not a party
To be adapted to the specific needs of each IMI action!
A template prepared by EFPIA shows what a consortium
agreement might look like:
http://efpia.eu/documents/229/141/EFPIA-Consortium-Agreement-
Template-for-IMI2-actions
Consortia may also use alternative templates if they wish.
Tips for success
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 IMI office)
A minimum of three independent legal entities (RIA) from three
different MS/AC
Common Mistakes
The proposal does not address all the objectives (in some cases
proposals have nothing to do with the topic!)
submitted text does not respect the proposal template (sometimes
received even slides!)
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
Budget, either over-estimated or not fully justified
Ethical issues not addressed
Tips
Read all the Call-relevant material that is provided on the IMI2 JU website –www.imi.europa.eu
Understand IMI2 JU rules and respect them
Consider the PPP dimension of the action (e.g. Governance, industry contribution vs IMI2 JU funding)
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)
Dedicate sufficient time to submit the proposal: create an EU login account, obtain a PIC number -don’t wait until the last day to start the submission process
More tips: www.imi.europa.eu/content/tips-applicants
Submitting a proposal
https://ec.europa.eu/research/participants/portal/desktop/en/opportun
ities/h2020
More information
Stay in touch
Visit our new website
www.imi.europa.eu
Sign up to our newsletter
via the website
Follow us on Twitter
@IMI_JU
Join our LinkedIn group
bit.ly/LinkedInIMI
E-mail us
At the IMI Programme Office
General queries: [email protected]
IP queries: [email protected]
Local contacts
IMI2 JU States Representatives Group: [email protected]
Horizon 2020 Health National Contact Points:
and
http://bit.ly/H2020_NCPs
Your contact points
www.imi.europa.eu
@IMI_JU
Thank you
Prof. Gianluca Sbardella
Università degli studi di Salerno
Italian delegate IMI2 SRG
Opportunities for SMEs in IMI2 Call 13
SMEs are particularly welcome to participate in IMI2 Call 13 topics in
the following areas:
Topic 1: Assessment of the Uniqueness of Diabetic
Cardiomyopathy Relative To Other Forms of Heart Failure
Using Unbiased Pheno-Mapping Approaches
Machine-learning
Data management
Image analysis
Imaging technologies
Metabolomics & Lipidomics analyses
Project management in the context of IMI/H2020 projects.
Opportunities for SMEs in IMI2 Call 13
Topic 2: Genome-Environment Interactions in Inflammatory Skin Disease
Advanced analytical approaches
Data management including experience in the legal and ethical challenges associated with integrating multi-centre patient-derived data
Topic 3: The Value of Diagnostics to Combat Antimicrobial Resistance by Optimising Antibiotic Use
Diagnostic tests, regulatory registered or in the registration process, including novel validated biomarkers
Services, information systems or software for data sharing, storage and analysis
Infrastructures, logistics and services for bio-banking and deep characterisation of pathogens or samples
Project management and dissemination tools including set-up of education programs and training modules to advocate on the value of diagnostic to combat AMR
Opportunities for SMEs in IMI2 Call 13
Topic 4: Mitochondrial Dysfunction in Neurodegeneration
Relevant standardised technologies and assays (see in the topic for all technical details)
Other relevant know-how
Topic 5: Support and Coordination Action for the Projects in the Neurodegeneration Area of the Innovative Medicines Initiative
Project management;
Medical/scientific writing
Outreach and communication targeted for the different stakeholders and public at large
Development of effective communication tools including websites and social media, platforms to create awareness of the programme and disseminate findings
Expertise to create training and communication materials based on results of the programme.
Opportunities for SMEs in IMI2 Call 13
Topic 6: A Sustainable European Induced Pluripotent Stem Cell Platform
Significant experience, knowledge and know-how in logistics and infrastructure to operate a European-wide cell line repository, including a mirror iPSC bank according to ISO 9001 standards are prerequisites.
Topic 7: Linking Digital Assessment of Mobility to Clinical Endpoints to Support Regulatory Acceptance and Clinical Practice
Complex data management and analysis and specifically in validation of technology-related medical tools
Expertise in wearable technologies for activity monitoring
Experience with medical device registration
Opportunities for SMEs in IMI2 Call 13
Topic 8: Human Tumour Microenvironment Immunoprofiling
‘Deep profiling’ technologies such as
Single cell RNA seq on sorted immune cell population (important)
Multi-color flow cytometry, especially of surgical specimen, realised by participating partners that have appropriate capabilities using a standardised panel of markers
Multiplex-IF including a panel of functional immune-related markers
Selected advanced technologies, e. g. CyTOF
Microbiome analysis
ctDNA and ctRNA analysis
Proximity ligation assay-based approaches for detection of e. g. receptor-ligand interactions
Opportunities for SMEs in IMI2 Call 13
Topic 9: Conception – Continuum of Evidence from Pregnancy Exposures, Reproductive Toxicology and Breastfeeding to Improve Outcomes Now
Expertise in design and analysis of existing data sets, electronic health records, epidemiological design and analytics
Experience in legal, ethics and privacy law across regions
Financial experts for advising on sustainability
Experience in use of different communication channels to reach different interest groups and professional associations, ability to communicate and translate complex medical information into lay language, expertise in handling and dissemination of information through internet and social media, expertise in qualitative analysis of social media feedback, web design and website maintenance experience
Regulatory expertise, experience dealing with regulatory agencies, professional expertise managing complex multi-stakeholder projects, professional project management capability and experience
Opportunities for SMEs in IMI2 Call 13
Topic 10: Improving the Preclinical Prediction of Adverse Effects of Pharmaceuticals on the Nervous System
Innovative assays/techniques for detection of neurotoxic effects: stem cells, organs-on-chip, subcellular systems (synaptosomes, mitochondria), micro-electrode array (MEA) technology, blood-brain barrier assay (optionally: combined with MEA, in order to correlate brain passage and neurotoxicity), continuous video monitoring in rodents and non-rodents, live-brain imaging of neuronal activity
Run prospective assays/studies with reference drugs
Data and samples management:
Data management: data access and data cleaning expertise
Biostatistics/programming: data analysis and programming expertise
Coordination and communication:
Ensuring the implementation of the coordinating tasks and running the day-to-day operation, such as project tracking and reporting, meetings, internal communication, budget management, etc
Ensuring the communication and dissemination with and/or media expertise and in developing tools
Opportunities for SMEs in IMI2 Call 13
Topic 11: Translational Safety Biomarker Pipeline
(Transbioline): Enabling Development and Implementation of
Novel Safety Biomarkers in Clinical Trials and Diagnosis of
Disease
Bioanalytical expertise for diagnostic assay development
Bioinformatic analysis
Data mining
Data and sample management
Opportunities for SMEs in IMI2 Call 13
Topic 12: Pilot Programme on a Clinical Compound Bank for Repurposing
Experience and capability to conduct all aspects of a clinical trial using an investigational medicinal product (including data analysis and reporting) under good clinical practice (GCP) in the proposed indication
Clinical and preclinical expertise as necessary for the scope of a given study
Expertise in the science of drug development including aspects of clinical pharmacology, study design and conduct
Experience and capability to submit an application for clinical trial authorisation with the European Medicines Agency (EMA)/ national regulatory authorities in all member countries of a given consortium
Capacity to recruit sufficient number of patients within a few clinical study centres
Strong project management and communication expertise
Why do we need IMI?
risky inefficient
expensive
complex
time
consuming
Because drug development is very…
Because…
Not enough
science
throughout
development
Clinical trial
designs not
always optimalRegulatory
pathways not
always optimised
How is IMI addressing the challenges in drug development?
Through IMI’s projects we are trying to…
put patients at the centre
share risk (among public & private players)
increase efficiency (by developing common tools)
reduce duplication of effort (esp. at early stages)
reduce timelines (by using a personalised medicine approach)
integrate the latest science into drug development
use data and knowledge management to work more effectively
We do this by creating a neutral platform where all involved in
drug development – academics, industry, SMEs, patients, regulators,
others – can engage in open collaboration on shared challenges.
What is IMI delivering?
What is IMI delivering?
2 272 FTE jobs
directly associated
with IMI projects
20 patent
applications
200 SMEs
13 spin-offs
25+ new tools
to facilitate drug
development1 600+ scientific
publications
65 clinical studies
460+ biological marker
candidates for better
diagnosis & treatment
Antimicrobial resistance – a growing threat
25 000 killed
€1.5 billion
New Drugs for Bad Bugs
Challenge 1: Getting the
drug into the bug
TRANSLOCATION: Addressing
scientific challenge of
penetration barriers & efflux
Challenge 2: Translation
from early discovery to
clinic
ENABLE: Combine academia /
industry expertise to work on
early-stage novel molecules
Challenge 3: Clinical dvpt
long, costly & often
inefficient
COMBACTE family, iABC:
Creating sustainable clinical
investigator / laboratory /
epidemiology networks; clinical
studies
Challenge 4: Low return
on investment
DRIVE-AB: Options for a new
economic model of antibiotic
development & stewardship. Buy
in from all stakeholders
Alzheimer’s disease – a major unmet need
Alzheimer’s disease
in numbers…
46.8 million
affected globally
10.5 million
in Europe
Global cost
USD 818 billion
(EUR 732 billion)
IMI action on Alzheimer’s disease
PHARMA-COG
Matrix of
biomarkers
Test efficacy
of new
treatments
EMIF
Linking &
analysing data
Identify those
at risk
AETIONOMY
New classification
of AD/PD
Personalised
treatments
EPAD
‘Adaptive’ clinical
trials
Faster drug
development &
patient access
Total budget
€186 million
PRISM
Causes of social
withdrawal
Faster, better drug
development
Medicines safety – the challenge
A major challenge in drug development is finding medicines that
treat the disease but are not toxic to vital organs like the heart,
liver, kidneys, etc…
Too often, toxicity issues are only picked up late in drug
development, when vast amounts of time and money have been
spent on a drug.
IMI projects are developing simple tests to detect
toxicity issues earlier in drug development.
Medicines safety – an IMI success
What eTOX did
Pharma data
+
Public data
=
One big database
underlying multiple
computer-based tools
Example: Will this be toxic to the heart?
Output =
possible effect
on heart – ECG
result!
Input = 2D
structure of a
possible drug
Project partners
using tools
Reducing animal
testing
Through its European Lead Factory project, IMI
has created a state-of-the-art compound
collection & screening centre that is delivering
results for academics, SMEs & pharma
Medicines development – the challenge
High Throughput Screening (HTS) = researchers screen large
collections of chemical compounds in hunt for molecules that could
be potential drugs or be used in drug development in other ways.
Pharmaceutical companies have huge compound collections,
but access to these is usually tightly restricted…
Public compound collections exist, but are small and expertise
is scattered across many institutions.
Medicines development – an IMI success
Joint European
Compound
Collection
European
Screening Centre
320 000 cpds
from 7 pharma
companies
200 000 cpds
from public
partners
Advanced, ultra
high throughput
screening
facilities &
expertise on
logistics, medicinal
chemistry, etc.
‘Access to the European Lead Factory has
fast-forwarded our drug discovery
programme in the field of oncology by
several years.’ – Huib Ovaa, Netherlands
Cancer Institute
‘ELF support & its high quality compound
library … will allow Effecta Pharma to
expand its drug discovery efforts for
dengue and gives an important boost to
tackling this viral disease.’ – Effecta
Pharma, UK biotech company
Leading role for SMEs
Quality & diversity of compounds recognised
Award-winning IP solution
Happy users!
IMI structure
Governing Board
The Governing Board is the main decision-making body of the
Innovative Medicines Initiative (IMI). It carries the overall
responsibility for the operations of the undertaking and oversees
the implementation of its activities. It therefore guarantees the
fulfilment of the objectives set by the organisation.
The Governing Board is composed of 10 Board members
representing equally our two Founding Members: 5 from the
European Commission, representing the European Community,
and 5 from the European Federation of Pharmaceutical Industries
and Associations (EFPIA), representing the research-based
pharmaceutical industry in Europe.
In addition, our Associated Partners may take part in Governing
Board discussions that concern their association, although they do
not have voting rights.
The way the Governing Board works is set out in the Governing
Board Rules of Procedure. Lists of the decisions taken by the
Governing Board under the IMI2 programme are published on this
page.
The roles of chair and deputy chair are held alternately by
representatives of the European Commission and representatives
of EFPIA.
Scientific Committee
The IMI Scientific Committee is an advisory group within IMI.
It is currently composed of 10 members and 1 ad hoc member that
have been appointed further to suggestions made by the States
Representatives Group.
The Scientific Committee members are top experts from a range of
different fields and participate in their individual capacity. They are
appointed for a term of two years, renewable once.
The role of the SC
The Committee gives strategic science-based recommendations to IMI and advises on the continued relevance of the Strategic Research Agenda and the scientific priorities. It is also formally consulted on our topic texts – which are based on the scientific priorities – before our Calls for proposals are launched.
More specifically, the Scientific Committee provides advice on:
scientific priorities to be included in the Strategic Research Agenda taking into account related activities in Horizon 2020;
scientific priorities to be addressed in the IMI Annual Work Plans;
scientific achievements described in the IMI Annual Activity Reports.
When requested by IMI, the members of the Scientific Committee are required to provide their consolidated advice in writing.
Scientific Committee members also take part in IMI’s Strategic Governing Groups.
States Representatives Group
The IMI States Representatives Group (SRG) is an advisory group
within IMI and consists of representatives from Member States and
countries associated with the EU’s research framework
programmes. SRG members represent their national governments.
The SRG provides opinions on IMI’s scientific priorities, and is
formally consulted on our Annual Work Plans and topic texts
before Calls for proposals are launched. By interacting with
national/regional stakeholders and authorities, SRG members aim
to ensure that our scientific priorities are in line with research
programmes on a regional, national and EU level in order to look
for potential synergies and prevent overlaps.
Additionally, SRG members:
provide opinions on our progress and achievements, and present those achievements at the national/regional level;
give recommendations or proposals to the IMI Governing Board on technical, managerial and financial matters in particular when those matters affect national or regional interests;
give opinions and advice on the involvement of small and medium-sized enterprises (SMEs) in our projects.
Members of the SRG also act as an interface with relevant stakeholder groups within their respective countries. In some countries, members give direct support to stakeholders, especially SMEs, giving them advice when applying for our Calls for proposals.
From idea to project: how SC and SRG interact
Strategic Governing Groups
The Strategic Governing Groups (SGGs) ensure
the coordination of Innovative Medicines Initiative (IMI) work in
certain strategic areas and work to make the development of new
topics more transparent and effective.
As such, the SGGs are made up of representatives
of companies active or interested in the area covered by the scope
of the SGG as well as representatives from the European
Commission, the IMI Programme Office and the IMI Scientific
Committee.
From a legal point of view, the SGGs were created on the basis of
Article 7.3.p of the legislation establishing the IMI2 programme.
This allows the Governing Board to set up advisory groups where
appropriate.
Currently, there are SGGs in the following areas, and more
information on these groups’ missions and membership can be
found below.
immunology
diabetes / metabolic disorders
neurodegeneration
translational safety
data and knowledge management
infections control
oncology
How does IMI work?
IMI2 overall objectives
improve the current drug development process through
development of tools, standards &approaches to assess efficacy,
safety & quality of health products.
develop diagnostic & treatment biomarkers for diseases clearly
linked to clinical relevance & approved by regulators
reduce time to clinical proof of concept (e.g. for cancer,
immunological, respiratory, neurological/neurodegen. diseases)
increase success rate in clinical trials of priority meds (WHO)
develop new therapies for diseases with high unmet need, (e.g.
Alzheimer’s) & limited market incentives (e.g. AMR)
reduce failure rate of vaccine candidates in phase III trials
through new biomarkers for efficacy & safety checks
- IMI2 legislation, Article 2b
Where do IMI topics come from?
Call topics definition
IMI(2) legislation
Scientific Research Agenda
Annual Work Plan
Strategic Governing Groups / EFPIA companies / Associated
partners
OR ideas from others
DRAFT TOPIC: Consultation Member-Associated States /
Scientific Committee
Agreement of IMI Governing Board
TOPICS FINAL Call launch
How can I get involved?
Start working early (on your proposal & finding partners)
Read and understand the Call documents & get informed
Ask questions
Make sure you address the requirements of the topic
Tips for applicants
Remember – the evaluators aren’t psychic!
Don’t forget to address any ethical issues
Don’t forget the basics!
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.
SMEs in IMI2 Calls for Proposals
Why should an SME participate in an IMI project
IMI projects are focused on translating excellent research into
real world outcomes – an opportunity for SMEs
Unique collaborative partnerships in pharmaceutical research
and development
Collaboration with large pharmaceutical companies allows access
to whole value chain of drug discovery
Build research and business networks
Funding: 100% of costs reimbursed
Some examples of the leading role of SMEs in IMI projects
IMIDIA delivers a world first –driven by SME involvement
IMIDIA generated the first human pancreatic
beta cell line
A French SME was at the heart of the research
‘Thanks to this collaboration, the robustness
of our beta cells has been validated by large
pharma companies – a major advantage for a
biotechnology company like Endocells.’
– Anne-Fabienne Weitsch, CEO of Endocells
Target Screening Hit-to-leadLead-to-
candidatePreclinical Phase I Phase II Phase III
European Lead Factory
Total Budget: EUR 197 million
IMI funding: EUR 80 million
SME funding: EUR 54 million
‘The ELF provided the missing piece in the puzzle – a potent,
selective compound that provides a strong starting point for further
development towards the clinic’
– Dr. Margit Mahlapuu, ScandiCure
Advanced, ultra high throughput
screening facilities
500 000 screening compounds
from pharma & SMEs
‘A great opportunity because we were part of an excellent network
of experts (drug makers, manufacturers, etc) that goes beyond the
financial support we received.
Our advice to other SMEs interested in applying to IMI is: Do it.’
EBOMAN - Vaccine manufacture capability
Established a platform capable
of rapidly producing sufficient
quantities of the vaccine
IMI IP rules consider SME’s needs
Opportunity for further development & validation of assets
Background and sideground assets protected
New results owned by the generator
Result owner decides:
Best protection modalities
Exploitation strategy
Access to expertise from the other partners on equal basis
Publication/dissemination subject to conditions, such as respect of
the legitimate interests
Tips for applicants
There are a lot of things you can do to increase your chances of
submitting a successful proposal. The following tips are based on
feedback from applicants and IMI staff observations when going
through proposals.
Start working early
Putting together a consortium and preparing a short proposal takes a lot of time. We usually publish indicative information on forthcoming Calls for proposals several weeks before Calls for proposals are formally launched. To stay up to date on news of forthcoming Call topics:
Visit the Future Topics page of the IMI website regularly
Follow us on Twitter
Join our LinkedIn group
Sign up to our monthly newsletter
It is a good idea to start working as soon as basic information on a topic is available. Note however that information on forthcoming Call topics is indicative and subject to the final approval of the IMI Governing Board. If and when a topic is launched as part of an IMI Call for proposals, read the final version of the topic text carefully as things may have changed compared to earlier versions of the text.
Get informed
Webinars and info days are an excellent way to ensure you
understand the Call topics as well as IMI’s rules and procedures.
They also represent a good opportunity to network and find
potential partners.
We advertise our events via the website, Twitter, LinkedIn, and the
newsletter. Other organisations (e.g. IMI States Representatives
Group members, National Contact Points, and national
pharmaceutical associations) also organise events locally.
For the latest information on these events and details of how to
register, contact your local representative. We also publish
information on local events on the Events page of the website.
Individual researchers are not eligible to receive funding through
IMI Calls for proposals – you will need to join or form a consortium.
Advice on how to find project partners can be found on our Finding
Partner page.
If you want to apply to take part in a new IMI project, one of your
first tasks will be to find or build an applicant consortium, and to do
this, you will need to find partners. This page provides some tips
on how to go about this.
Putting together a consortium takes time. We publish indicative
information on Call topics several weeks before the Call launch. As
soon as you see a topic that could be relevant for you, you should
get to work.
Find partners
Be proactive and be prepared to invest time and energy
Whether you are leading the formation of a consortium, or trying to
find and get into an existing consortium, you should be prepared to
invest significant amounts of time and energy in the exercise. You
will also need to be extremely proactive in terms of reaching out to
potential partners and explaining why you would be a good partner
for their consortium.
The Call text can help you here, as it sets out in some detail the
expertise expected of the consortium. Analyse the information in
the Call text and determine, in as much detail as possible, what
and how you and your organisation could contribute to the project
in terms of skills, expertise, resources, and experience. When you
get in touch with potential partners, you should highlight the areas
where your involvement would be valuable.
You should also flag up to potential partners your experience of
working in large, multidisciplinary, international projects, managing
IMI / other EU / other public funds, communication, etc.
Where to look for partners
Use your contacts The most effective way of getting into a consortium is to use your existing
professional and personal contacts.
Network at events Events that bring together leaders in your field are an excellent place to find partners
– use the coffee breaks, receptions, and any other tools to link up with fellow participants (e.g. many events have registration systems and / or apps for smartphones that include a networking module).
Use online partner search tools There are a number of partner search tools that allow you to enter your areas of
expertise and find relevant partners.
The Horizon 2020 Partner Search tool on the Participant Portal.
CORDIS also offers a partner search tool.
The German representative on the IMI States Representatives Group has is a dedicated partner search platform for IMI Calls for proposals.
Fit for Health 2.0 offers a matchmaking portal.
Use social media You can advertise your interest in a Call for proposals via the IMI LinkedIn group and
other relevant groups. If you are active on other social media platforms, e.g. Twitter, don’t hesitate to use them as well.
How many partners should our consortium have?
Two points should be considered here –
the legal viewpoint and
more practical aspects.
From a legal point of view, most IMI2 projects must have a
minimum of three partners based in three different EU Member
States or countries associated to the Horizon 2020 programme.
The exact rules for each Call for proposals are set out in the Call
documents and you should read these carefully. Applications that
do not meet the minimum legal criteria for the Call will be rejected
and will not even be reviewed by the expert reviewers.
Should I include EFPIA companies in my applicant consortium?
For a standard, two-stage IMI2 Call for proposals, the answer is
usually no. In these Calls, following an evaluation by independent
experts, the winning applicant consortium is invited to form a full
consortium with the EFPIA companies and, where relevant,
Associated Partners, in the second stage of the Call.
Sometimes, IMI runs Calls for proposals that may require the
involvement of EFPIA partners in applicant consortia.
For all Calls for proposals, details of what kinds of organisations
must be included in consortia are set out in the Call documents,
and applicants are advised to read these carefully.
Read and understand the Call documents
Read all the Call documents carefully and make sure you
understand what is required of you. This may take some time, but
this should be considered as an investment.
Ask questions
If something in the Call documents is unclear, or if you have any
questions about the Call topics or the rules and procedures,
contact us – it’s our job to help you. If certain questions crop up
frequently, or pick up on a point that is not clear in the Call
documents, a Questions & Answers document may be published
on the Call page.
Make sure you address the requirements of the topic
The topic texts set out, in some detail, the objectives of the project,
what the EFPIA and Associated Partners will contribute to the
project, and what is expected of the applicant consortium. When
preparing your proposal, you should ensure that you address all
these points and that your consortium includes all the expertise
needed to carry out the tasks expected of it. Proposals that are off
topic, or that don’t have the expertise required, will not be
successful.
Don’t forget the basics
While much of your focus will understandably be on the scientific
details of your application, make sure you don’t neglect the basic
requirements for the Call and respect the basic eligibility criteria:
make sure your consortium has the right number and type of
partners, for example.
Application format: The Call documents explain how you should submit your proposal and these rules must be respected. IMI does not accept proposals submitted by e-mail, for example.
The deadline: The deadline is always set out in the Call documents. Proposals submitted after the deadline will be rejected. The online submission tool usually opens at the same time as the Call. As it takes some time to enter all the information, applicants are advised to start working on this as soon as possible. It is possible to save an application and come back to it. When you are ready to formally submit the proposal, remember that there may be a delay of a few seconds after you have pressed the last button before the proposal submission is registered. We therefore advise you not to wait until the very last minute to submit your application. If you experience technical difficulties with the submission tool (especially on the day of the deadline), take screenshots of the problem and contact the IMI programme office immediately.
The evaluators aren’t psychic
Your proposal will be evaluated by a panel of independent experts,
and although they are extremely smart and know their subject area
inside out, they do not have psychic powers. You should therefore
ensure your proposal is well written and includes all the
information the reviewers will need to assess it. The evaluation
form is online and tells you what the evaluators are looking for.
Open Calls
IMI2 Call 8 H2020-JTI-IMI2-2015-08-single-stage
Ebola and other filoviral haemorrhagic fevers (Ebola+) programme:
future outbreaks
Action Type: RIA – Research and Innovation Actions
capture emerging scientific advances and progress them rapidly
into health care interventions
Proposals may address aspects of pre-clinical development and/or
Phase 1, 2, and 3 clinical developments of vaccines (in particular
multivalent), treatments and diagnosis of Ebola or other filovirus
infections.
Manufacturing strategies, vaccine stability during transport and storage,
and/or deployment of vaccines and treatments are also in scope.
Proposals for the development of adaptable platforms, which in addition
to filoviruses can address multiple other priority pathogens, are also
eligible.
Proposal submission information
Cut-off date 16/03/2016: 4 proposals submitted - 0 ineligible /
inadmissible - 2 funded
Cut-off date 15/09/2016: 0 proposals submitted - 0 ineligible /
inadmissible - 0 funded
Cut-off date 16/03/2017: 3 proposals submitted - 3 ineligible /
inadmissible - 0 funded
Indicative budget
Altogether, the indicative financial contribution for IMI2 Call 8 from
the IMI2 JU for the entire period of 2 years is a maximum of EUR
70 000 000.
For the fourth cut-off date of 14 September 2017, the remaining
financial contribution from the IMI2 JU was EUR 55 256 680.
The entire remaining budget for this Call was available at the
fourth cut-off date. Three months prior to each subsequent cut-off
date, the amount of the remaining budget will be published on the
IMI website.
Key dates and deadlines
Publication date: 18 December 2015
This call for proposals is continuously open for a period of two
years with the following cut-off dates for submission of proposals:
16 March 2016, 15 September 2016, 16 March 2017, 14
September 2017, 15 March 2018.
How to apply
Proposals must be submitted via the electronic submission system
of the Horizon 2020 Participant Portal. No other means of
submission will be accepted. The proposal may be updated online
prior to the Call submission deadline. Please note that the submit
button must be pressed to submit the proposal for eligibility check
and evaluation.
Synergies with CEPI
In order to fully address the objectives of the IMI2 Ebola+
programme as a programmatic approach addressing different
challenges across the entire innovation cycle and aiming at
leveraging input and multi-disciplinary expertise across
stakeholders, potential applicants are also strongly encouraged to
consider the opportunities offered through the Call for proposals
that will be launched in parallel by the CEPI alliance (Coalition for
Epidemic Preparedness Innovations).
In line with the IMI2 - Call 8 topic text, this would offer the
foundation for constructive synergies and complementarities with
other projects and initiatives focusing on preparedness to react to
future outbreaks of Ebola and other filoviral haemorrhagic fevers.
This would also avoid duplication of efforts and to create
collaboration at a global level to maximise European added value
in health research.
Future topics
To give potential applicants as much time as possible to form
consortia and prepare their proposals, IMI regularly publishes draft
topic texts on this page several weeks before the official Call
launch. To ensure you get the latest information on forthcoming
Calls, sign up to our newsletter, follow us on Twitter, or join
our LinkedIn group.
Draft topic texts are subject to consultations involving IMI's States
Representatives Group, Scientific Committee, and the European
Commission. They must also be approved by the IMI Governing
Board. Depending on the results of the consultations and approval
process, the final topic text may differ significantly from the draft
versions initially published here, and some topics may not be
included in a Call in the end.
Assessment of the uniqueness of diabetic cardiomyopathy relative to other forms of heart failure using unbiased pheno-mapping approaches
Genome-environment interactions in inflammatory skin disease
The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use
Mitochondrial dysfunction in neurodegeneration
Support and coordination action for the projects of the neurodegeneration area of the innovative medicines initiative
A sustainable European induced pluripotent stem cell platform
Linking digital assessment of mobility to clinical endpoints to drive regulatory acceptance and clinical practice
Human tumour microenvironment immunoprofiling
CONCEPTION – continuum of evidence from pregnancy exposures, reproductive toxicology and breastfeeding to improve outcomes now
Improving the preclinical prediction of adverse effects of pharmaceuticals on the nervous system
Translational safety biomarker pipeline (TRANSBIOLINE): enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease
Federated and privacy-preserving machine learning in support of drug discovery
Pilot programme on a clinical compound bank for repurposingThis programme includes the following topics:
- Cardiovascular diseases and diabetes- Respiratory diseases- Neurodegenerative diseases- Rare/orphan diseases
All information regarding future IMI Call topics is indicative
and subject to change. Final information about future IMI Calls
will be communicated after approval by the IMI Governing
Board.
SME participation in ongoing IMI2 Projects
Target Screening Hit-to-leadLead-to-
candidatePreclinical Phase I Phase II Phase III
IMI Drug Discovery Platforms - ELF
Screening deck of 500 000 compounds & ultra-HTS facilities
available free to anyone with an innovative target to screen.
Apply at https://www.europeanleadfactory.eu
49 Hit Lists already provided free of charge to European SMEs &
academics
Innovative compound library ideas also welcome – rewards available
Target Screening Hit-to-leadLead-to-
candidatePreclinical Phase I Phase II Phase III
IMI Drug Discovery Platforms - ENABLE
ND4BB Drug Discovery Platform
Lead Clinical
candidate
Phase 1 ready
Drug discovery expertise available to take your AMR lead project all
the way to Phase 1 clinical trials
Apply at http://nd4bb-enable.eu/
Support available to submit your proposal
15 programmes already selected
