innovative medicines initiative: imi 2 and new calls · in call 6 two topics of bd4bo are launched...
TRANSCRIPT
Innovative Medicines Initiative:
IMI 2 and new Calls
Maria Teresa De Magistris
Principal Scientific Manager
IMI
2008 - 2013
Innovative Medicines Initiative:the Largest PPP in Life Sciences R&D
2 Billion Euro
1 Billion €1 Billion €
Public Private
Partnership
EFPIA = European Federation of Pharmaceutical Industries and Associations
The IMI portfolio
EoI – Applications per Country
FPP – Participation per Country
IMI 2 budget
€3.276 bn
Partnership
2014 - 2024€1.638 bn€1.638 bn
+ other Companies*
EFPIA = European Federation of Pharmaceutical Industries and Associations
* Imaging, Diagnostics, IT for health etc.
Stronger focus on needs of patients and society
Research Agenda aligned with WHO priorities
Increased emphasis on improving patient access to
innovative medicines (in addition to medicines
development)
Focus on personalised medicine
IMI is evolving
IMI (under FP7)
IMI2 (under Horizon2020)
New Rules in IMI2
The Innovative Medicines Initiative under H2020 (IMI 2)
EFPIA=European Federation of Pharmaceutical Industries and Associations
New
Receive EC funding
in cash
EFPIA
ACADEMIA
HOSPITALS
PATIENTS’ORGANISATIONS
SMALL AND MEDIUM-SIZED
ENTERPRISES
REGULATORS
Pharma 4Pharma 1
Pharma 5Pharma 2
Pharma 6Pharma 3
Other life
science industriesContribute
in kind
MID-SIZED COMPANIES
Associated Partners
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 States
Associated Countries
At least three legal entities
Who is eligible for funding?
Other countries:
No funding unless
- participation deemed essential by IMI
for carrying out the action
- Annual Work Plan / Calls documents
New!
In IMI2: a more attractive funding model
20%?
Real?
Single model:100% +
25 % Flat Rate
IMI1
• For all beneficiaries eligible for funding and all activities:
100% reimbursement of eligible costs for Research & Innovation
projects
Flat rate of 25% reimbursement for indirect costs
Research:
75% ?
Mgt: 100% ?
New!
Upcoming Calls
CALL 6
Topic 1: Development of Quantitative System Toxicology (QST)
approaches to improve the understanding of the safety of new
medicines
Scope: 1) develop QST models for drug-induced toxicity with the focus
on: heart, liver, kidney and the gastrointestinal (GI)-immune system,
and 2) use this QST approach for the prediction of clinical toxicity.
The models are expected to incorporate key events from one or more
levels of biological organization (molecular/pathway level, cellular,
organ level) that are involved in drug-induced pathogenesis and
repair.
IMI JU budget EUR 8 000 000
CALL 6
Topic 2 Establishing impact of RSV infection, resultant disease
and public health approach to reducing the consequences.
Scope: To develop a detailed understanding of the clinical, economic
and social impacts of RSV infection in infants, the elderly and other
high risk populations.
The project will:
- explore the feasibility of developing biomarkers and establishing
biobanks (repository of biological materials) for RSV infection
-Investigate the long term implications of RSV infection including
wheezing and asthma
CALL 6 – A new Programme in IMI
Big Data for Better Outcomes Programme (BD4BO)
The programme’s objective is to maximise the potential of large amounts
of data in healthcare. It will support the evolution towards value-based
and more outcomes-focused healthcare systems in EU.
The programme is expected to be composed of several topics that will
provide a platform for developing outcomes transparency evolution
together with payers, patients, regulators, healthcare decision makers.
Digital and non digital sources will be referred to as ‘big data’ in the context of this initiative.
In Call 6 two topics of BD4BO are launched Alzheimer’s Disease and
Hematologic Malignancies:
Topic 3: Real World Outcomes Across the AD Spectrum (ROADS)
to Better Care
Topic 4: Development of an outcomes-focused data platform to
empower policy makers and clinicians to optimize care for
patients with hematologic malignancies
A BD4BO Coordination and Support Action (CSA) is expected to be
launched in the following weeks and align with the timelines of the
current call.
Joint influenza vaccine effectiveness surveillance
Coordination and Support Action (CSA) for the Big Data for Better Outcomes programme
Future calls
Tips for success
Common Mistakes
The proposal does not address all the objectives
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
Ethical issues not addressed
Tips
Read all the Call-relevant material that is provided
on the IMI website – www.imi.europa.eu
Understand IMI 2 rules and respect them
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)
A single set of evaluation criteria
Two-stage evaluation: only Excellence and Impact considered at
stage 1
Thresholds and weighting in the Call documents
Minimum of 3 independent experts (possibility of 2 in a two-stage
process)
NEW! Each proposal evaluated ‘as it is’, not as ‘what could be’
Standard criteria
Excellence ImpactQuality &
efficiency
Stay in touch
Visit our website
www.imi.europa.eu
Sign up to our newsletter
bit.ly/IMInewsletter
Follow us on Twitter
@IMI_JU
Join our LinkedIn group
bit.ly/LinkedInIMI
E-mail us
Focus on unmet needs
Non-competitive collaborative
research
Competitive Calls for proposals
Open collaboration in public-private
consortia
Data sharing, dissemination
of results…
Industry contribution is in kind
Aligned on Horizon 2020 (rules,
templates, cost model…)
A Public-Private Partnership
between EU Commission and
the Pharmaceutical Industry
IMI – key concepts
EFPIA: European Federation of Pharmaceutical Industries and
Associations
Partner Search Tool
www.imi.europa.eu/content/partner-
search
http://www.fitforhealth.eu/
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 us)
submitted text does not respect the proposal
template (sometimes received even slides!)
A minimum of three legal entities
IMI2 Current and upcoming calls
More information
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
Submitting a proposal
Measures of SUCCESS
Impact on
regulatory
framework
New models
developed &
published
Setting new
standards
Use
by industry
Better Science = Better Decisions
Accelerating the development of safer and more
effective medicines for patients (remove bottlenecks)
Boosting the biopharmaceutical sector in Europe
Create a collaborative environment for academia,
industry, SMEs, regulators, patients
Main Objectives
Focus on unmet needs
Non-competitive collaborative
research
Competitive Calls for proposals
Open collaboration in public-private
consortia
Data sharing, dissemination
of results…
Industry contribution is in kind
Aligned on Horizon 2020 (rules,
templates, cost model…)
A partnership between EU
Commission and the European
Federation of Pharmaceutical
Industries and Association
(EFPIA)
IMI – key concepts
Strategic Research Agenda
Antimicrobial resistance
Osteoarthritis
Cardiovascular diseases
Diabetes/Metabolic disorders
Neurodegenerative diseases
Psychiatric diseases
Respiratory diseases
Immune-mediated diseases
Ageing-associated diseases
Cancer
Rare/Orphan Diseases
Vaccines
Key Deliverables of
Non-Competitive Research
• Establishment of common databases
• New tools for identification of drug targets
• Standardization of models and assays
for drug efficacy and safety
• Patient reported outcomes
• Classification of diseases
Pooling expertise, knowledge and resources;
cross-fertilization
Developing incentives to address major unmet
medical needs
Providing a neutral trusted platform to align public
and private interests
Public-private partnership: why?
A more attractive funding model
An example
Direct
costs
Indirect
costs
Total
costs
% EU
contribution
EU
contribution
Flat-rate (20%)
(or actual)100 20 120 75% € 90
Direct
costs
Indirect
costs
Total
costs
% IMI2
contribution
IMI2
contribution
100/25 Funding 100 25 125 100% € 125
Majority of
beneficiaries
EFPIA and Associated Partners contribution
EFPIA companies
Other industries and partners (= Associated Partners to IMI2) New!
In-kind (actual direct and indirect costs or average FTE) + cash
contributions
Based on the usual management principles and accounting
practices
Contributions from affiliated entities as part of in-kind
When relevant to IMI2 objectives: up to 30% non-EU in-kind
contribution
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
Keeping the momentum
Maximum Time To Grant: 8 months from submission of full proposal
5 months
for informing applicants
of scientific evaluation
3 months
for signature of grant
agreement
NEW Legal entity validated in parallel
Simplified model Grant Agreement
Core textSpecial
clauses
General
conditions Annex II
Specific
provisionsAnnex III
Signed between IMI2
JU and Coordinator only
(no more Managing
Entity)
Accession form by the
other beneficiaries
Judith Hackett
5.10.2014 IMI webinar
Establishing Impact of RSV infection, Resultant Disease and Public Health Approach to Reducing the Consequences
Objectives of the full project
This project will develop a detailed understanding of the clinical,
economic and social impacts of RSV infection in infants, the
elderly and other high risk populations.
The collated data will drive new approaches to the prevention and
treatment of RSV and its consequences and give a better
understanding of the resource requirements and costs associated
with RSV.
Explore the feasibility of developing biomarkers and establishing
biobanks (repository of biological materials) for RSV infection
Investigate the long term implications of RSV infection including
wheezing and asthma
Scope of the Project
To produce a robust dataset that will increase our
understanding of RSV disease and its clinical, economic
and social impact and that will lead to better treatment
and preventative options.