innovative medicines initiative: achievements, ongoing [email protected] strategic...
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Giovina Ruberti MIUR Delegate in the IMI - States Representatives Group
National Research Council
Institute of Cell Biology and Neurobiology, Monterotondo (Roma) [email protected]
Salute in Horizon 2020:
Giornata Nazionale di Lancio dei bandi 2014-15
Roma, 3 dicembre 2013 Ospedale Pediatrico Bambino Gesù
Innovative Medicines Initiative: Achievements, Ongoing Projects, Call 10
and Call 11 and IMI-2 SRA
IMI– challenges and opportunities
Achievements and ongoing IMI projects
IMI2 and Horizon 2020
IMI Call 10 and Call 11
The European Union and the pharmaceutical industry
have joined forces to make
drug R&D processes in Europe more innovative and efficient,
enhance Europe’s competitiveness
& address key societal challenges
by forming
the biggest PPP in Life Science
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Innovative Medicines Initiative: Joining forces in the healthcare sector
Open collaboration in public-private consortia
(data sharing, dissemination of results)
“Non-competitive” collaborative research for EFPIA pharma companies
Competitive calls to select partners of
EFPIA companies (IMI beneficiaries)
Key Concepts
Private
Investment
in kind
(€ 1 billion)
EU Public
Funding
cash
(€ 1 billion)
EFPIA
ACADEMIA
HOSPITALS
PATIENTS’ ORGANISATIONS
SMALL AND MEDIUM-SIZED ENTERPRISES
REGULATORS
Pharma
1
Pharma
2
Pharma
3
Pharma
4
Pharma
5
Pharma
6
A Typical IMI Consortium
Applicant consortia can comprise academics, SMEs, patient groups, regulators, non-profit bodies and intergovernmental organisations. There must be at least two independent legal entities within the applicant consortia at stage one, although in order to cover all requirements of the call topics, applicant consortia are likely to be larger than this. The applicant consortia at stage one does not include EFPIA members. At stage two at least two EFPIA companies must join the consortia. The above-mentioned organisation types are eligible for funding from IMI only if they will carry out the research in an EU Member State or a country associated to the framework programme. Organisations that are not eligible for funding from IMI (for example, non-EFPIA companies that are not classified as SMEs) can participate in the applicant consortia, but must bear their own costs.
Who is eligible to form part of the applicant consortia?
SMEs and IMI funding eligibility To be eligible for IMI funding, SMEs must meet the EU’s official definition of a SME which can be summarised as follows: has fewer than 250 employees; has an annual turnover not exceeding €50 million, and/or; has an annual balance sheet total not exceeding €43 million Under IMI’s rules, SMEs that meet the EU definition when the project starts remain eligible for IMI funding throughout the project, even if they lose their SME status during the project.
Funding rates are the following (only for beneficiaries): - Research activities: a maximum of 75% of total eligible
costs - Other activities, including management and training
activities: a maximum of 100% of total eligible costs Indirect costs - actual indirect cost - or a flat rate of 20% of total eligible direct costs (excluding subcontracting costs and the costs of resources made available by third parties which are not used on the premises of the beneficiary) for organisations which do not aggregate their indirect costs at a detailed level, but can aggregate them at the level of the legal entity.
Help and advice Questions about Calls for proposals, application procedures, and funding rules: e-mail Hugh Laverty ([email protected]) Questions about intellectual property: - Visit the intellectual property (IP) web page - E-mail the IMI IP Helpdesk ([email protected]) Find project partners through our Partner Search Tool Get advice through your national IMI States Representatives Group member
14 regulators
22 patient
organisations
Key figures of 42 on-going projects
Collective intelligence networks Improved R&D productivity of pharma industries
Innovative approaches for unmet public health needs
113 SMEs
600 Academic
& research
teams
388 EFPIA teams
0,0 1,0 2,0 3,0 4,0 5,0
Rheumatology
Pharmacology & Pharmacy
Endocrinology & Metabolism
Neurosciences
Clinical Neurology
Biochemistry & Molecular Biology
Psychiatry
Genetics & Heredity
Research & Experimental Medicine
Immunology
Overall
IMI papers EU papers
average 2.04 average 1.13
19% of IMI publications are highly cited
Citation impact 2010-1012
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IMI stimulates collaboration across EU Co-authorship between IMI-supported researchers Calls 1-4
Pre IMI funding award Post IMI funding award
Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions)
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IMI accelerates the development of new therapies for major yet unmet public health needs and
diseases where treatments are lacking
The Anti-Microbial Resistance Conundrum
- Anti-microbial resistance kills 25 000 European citizens every year
- Annual costs are estimated at €1.5 billion
- Only 2 new antibiotic classes developed over the last 30 years
- Low level of industry investments in antibiotic innovation
How IMI addresses infectious diseases
Invested €229 million in projects aiming at:
Solving scientific challenges
Fostering new models of industrial collaborations for antibiotics and diagnostics development
Developing networks for clinical trials
Revisiting regulatory environment
Providing necessary incentives for industry to reinvest in the area
The conundrum of brain disorders
Brain disorders affect 1 in 3 Europeans And cost the economy € 798 billion / year
Developing new drugs to treat brain disorders takes longer, costs more than
for other diseases
There are few effective treatments in this area
IMI projects are tackling these issues
How IMI addresses brain disorders
Invested €148 million in projects aiming at:
Shedding new light on the underlying causes of autism (EU-AIMS)
Combining data to pave the way for new treatments for schizophrenia & depression (NEWMEDS)
Identifying new targets for drugs for chronic pain (Europain)
Developing models to predict the efficacy of drug candidates in Alzheimer’s patients (PHARMACOG)
Revisiting regulatory environment for drug development
Providing necessary incentives for industry to reinvest in brain disorders
Identified brain functional abnormalities that can be reversed in ASD patients by modulating brain 5HT - outcome predictor for clinical trials
Identified significant differences in cortico-cortical anatomical connectivity in ASD patients - outcome predictor for clinical trials
Identified significant differences in brain functional response to emotional sounds in infants at risk for autism - risk predictor
Published first study of EU wide prescribing in ASD
Advances in Autism
6 EFPIA companies; 15 Public organizations; 3 SME 1 patient org; Total Budget: 35.9 Mi €
2 Largest Clinical Trials for Early Detection and Monitoring of ASD Children
Identification of biomarkers that precede ASD onset
− Prospective study of 300 high-risk infants (3 and 7 months) with older siblings with ASD, and 100 low-risk
− Infant cognition, behavior, neuroimaging, neurophysiology
− Relation to symptoms/diagnosis of ASD at outcome
Accelerated longitudinal study for validation of ASD biomarkers in children and adults
− 450 ASD patients and 300 controls
− magnetic resonance imaging, event-related potential, eye-tracking
Platelets: APP metabolites, 55 kD and 25 kD fragments - AlzProtect
Lymphocytes: ~ 150 RNA transcripts related to Abeta pathway, inflammatory pathway and to immune mechanism - Exonhit (now Diaxonhit)
Red blood cells: binding of Abeta1-42 on cellular membrane and change in PKC conformation in red blood cells - Innovative Health Diagnostics (IHD)
Red blood cells: panel of inflammatory markers- Innovative Concept in Drug Development (ICDD)
COMPLETED RECRUITMENT OF 150 MILD COGNITIVE IMPAIRED PATIENTS FOR BIOMARKER MATRIX CLINICAL TRIAL
Novel Disease Markers for Alzheimer’s Disease
12 EFPIA companies; 13 Public organizations; 5 SME Total Budget: 27.7 Mi €
IMI DIABETES PLATFORM Memorandum of Understanding between IMIDIA, SUMMIT and DIRECT
for exchange of data and confidential information
€38.5 million invested in Education and Training programs
More than 1000 scientists have been trained so far
Many more scientists take advantage of industrial internships
Enhanced learning experience
IMI trains a new generation of industrial scientists and regulators, and reduces the cost of continuous
professional development for companies
Catalogued >5000 masters, PhD, CPD and short courses taught in 21 languages, from 39 countries, covering over 60 scientific, therapeutic and biomedical areas from about 1000 universities.
More than 320 students participated in various courses (50% from EFPIA companies) in 2012. Provided 20 new courses in drug safety sciences.
58 students are following the flexible and fully e-learning programme covering medicines risk identification and quantification, medicines and public health, medicine risk communication, assessing the benefits of medicines, and regulatory processes.
24 universities network + 16 universities affiliates. 685 students have been following various courses (28% from EFPIA companies).
Europe’s first Patients’ Academy on Therapeutic Innovation aiming to provide scientifically reliable information on medicines and R&D, as well as an online public library that will empower patients to engage more effectively in the development and approval of new treatments and become true partners in pharmaceutical R&D.
IMI Education and Training programs > 1000 trainees so far
On July 2013, the European Commission released its proposal for IMI2. The EC proposal is now being discussed by the European Parliament and the Eu Member States. 1. IMI2 will build on the successes and lessons learnt under
IMI. Goals: innovative vaccines, medicines and treatments to tackle Europe’growing health challenges and secure competitiveness of Europe’s pharmaceutical industry
increasing number of older people burden on public healthcare systems more reliable and faster clinical trial better regulation new service and products
IMI2
2. What is new? Common rules for all of Horizon 2020. Derogation for IMI2 limited to industry commitments (large industry will not receive EU funding) and the IP rules. Lighter financial rules. Option for other industrial partners to contribute in kind 3. Budget The budget proposed for IMI2 is €3.45 billion. EFPIA €1.5 billion in kind, other life sciences industries may contribute a further €225 million if they join IM2 4. Duration IMI will start in 2014 and will run for 10 years
IMI2
IMI2 SRA
Disease areas of focus
11 priority disease areas (Antimicrobial resistance, Osteoarthritis, Cardiovascular diseases, Diabetes, Neurodegenerative diseases, Psychiatric diseases, Respiratory diseases, Autoimmune diseases, Ageing-associated diseases/conditions, Cancer, Orphan Disease) have been highlighted in the SRA as being of high priority for both the European healthcare system and the pharmaceutical industry.
SRA IMI2 Draft – IMI2
Draft available at http://bit.ly/1axI076
Comments and suggestions are welcome: [email protected]
Strategic Research Agenda for IMI2:
The right prevention and treatment for the right patient at the right time
Innovation Investment Package and Horizon 2020 IMI2 is part of a wider €22 billion Innovation Investment Package which includes proposal for: 4 other JTI • Fuels Cells and Hydrogen 2 (FCH2) – to expand the use of
clean and effcient technologies in transport, industry and energy
• Clean Sky 2 (CS2) – to develop cleanerm quiter aircraft with significantly less CO2 emission
• Bio-based Industries (BBI) - to use renewable resources and innovative technologies for greener everyday products
• Electronic Components and Systes (ECSEL) - to boost electronics manufacturing capabilities
Joint Programmes with Member States European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) European Metrology Research Programme (EMPIR) Eurostars 2 (for SMEs) Active and Assisted Living Research and Development Programme SESAR Joint Undertaking European Air Traffic Management System (SESAR)
Rationale for IMI2
• Innovation in creating effective treatments for diseases is under significant stress/challenges: declining R&D productivity for new drug development; patent expiration; lack or loss of return on investment.
• Mismatch grows between where public health needs lie and where industry invests and succeeds in bringing new interventions to patients.
• Current model is unsustainable. The loss of this industry from Europe is a significant current risk.
• Industry cannot invest alone in disease areas that require complex and costly R&D with uncertain financial returns (market failure).
• Biopharmaceutical capabilities and data are dispersed across Europe, public intervention at individual Member State level is not enough for mobilising the necessary critical mass of knowledge and financial resources.
IMI 2 Building on succes of IMI (1)
IMI accelerates development of new therapies for major yet unmet public health needs and diseases where treatments are lacking
Improving tools for pharmaceutical research
– Developing better tools to predict safety of existing and future medicines
– Developing reproducible models of human disease, thus accelerating development of novel treatments
Public Health Impact of IMI2
IMI2 more focused on public health impact through explicit
reference to WHO Priority Medicines for Europe and the
World report, launched on 9 July
Wider scope and openness to industries beyond pharma
improves public health impact because approaches other
than pharmaceuticals can be addressed
Developing technologies and innovations that improve
people's lives, e.g. prevention and early diagnosis,
technologies that allow people to live safely in their homes
General Objectives of IMI 2
To provide European citizens with timely access to new and effective diagnostics and treatments that improve their health and wellbeing, and
Helping safeguard the future international competitiveness of the European biopharmaceutical industry and secure growth and jobs.
SME Involvement (1)
Very strong SME involvement in IMI: already now around 20% of IMI financial contribution goes to SMEs; this is much better than FP7 Health:
In 2007-2009, less than 10% of EU financial contribution from FP7 Health was awarded to SMEs
Corrective actions were taken by introducing special calls, imposing minimum amount of EU contribution going to SMEs etc.
No such ´forcing' was necessary under IMI
IMI2 will strongly contribute to the target of 20% of EU contribution from Societal Challenge 1 going to SMEs
SME Involvement (2)
Expanded scope and openess to other health-related industries further improves chances for SME involvement in IMI2
Also the possibility to exceptionally fund medium-sized companies offers the potential to even more funding from IMI2 going to SMEs
Widening Participation
Participation in IMI from EU13 Member States is currently weak
Large communication effort to promote IMI in these countries has been undertaken
Widening scope of IMI2 by addressing the entire life science research and innovation value chain and enlarging participation to health-related life science industries beyond pharma is expected to improve opportunities for participation from newer EU Member States
Call 10: just launched – deadline 28/01 Immunological assay standardisation & development for use in assessments of correlates of protection for influenza vaccines.
Call 11: to be launched mid-December
In the pipeline for Q4 2013
Call 11 currently has the following indicative topics: 1. Applied public-private research enabling
osteoarthritis clinical headway (APPROACH) 2. European platform for proof of concept for prevention in Alzheimer’s Disease (EPOC-AD) 3. Blood-based biomarker assays for personalized tumour therapy: value of latest circulating biomarkers 4. Zoonoses anticipation and preparedness initiative (ZAPI).
5. Generation of Research Tools to enable the translation of genomc discoveries into drug discovery projects 6. ND4BB: Epidemiology research and development of novel systemic antibacterial molecules against healthcare-associated infections due to gram-negative pathogens 7. ND4BB: Development of novel inhaled antibiotic regimens in patients with cystic fibrosis (CF) and patients with non-CF bronchiectasis (BE) 8. Ecorisk prediction (ERP)
How to partecipate
1. Visit the IMI website (understand the aims of IMI and the ongoing IMI Projects for sinergy);
1. Study the topic of your interest in details -expertise and/or tools required;ongoing collaborations with FP7 and/or IMI Projects listed in the call as relevant for interaction/collaboration etc.; 3. Partecipate to the IMI webinar; 4. Use the IMI Partner Search Tool; 5. Contact your national representative ([email protected]; 06-90091263)