Slides from a presentation given at the Pistoia Alliance European Conference 2015, in Zurich, Switzerland.

1. Ann Martin
14 April 2015 • Pistoia Alliance • Zurich, CH
Innovative Medicines Initiative
Update and Opportunities

2. ! What is the Innovative Medicines Initiative?
! IMI achievements
! How does IMI work?
Outline

3. ‘We must acknowledge that no
single institution, company,
university, country, or
government has a monopoly on
innovation.’
Rethinking drug discovery –
Turning the Titanic?
Elias A. Zerhouni, President Global R&D, Sanofi
Editorial in Science Translational Medicine, January 2014

4. IMI – Europe’s partnership for health
> €5 bn
Partnership
2008 - 2024
€2.5 bn€2.5 bn

5. IMI – key concepts
! 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

6. IMI 1 – € 2 bn budget breakdown
Infectious
diseases
Drug discovery
Brain disorders
Metabolic
disorders
Drug safety
Stem cells
Cancer Data
management
Inflamatory
disorders
Biologicals
Geriatrics
Lung diseases
Education &
training
Sustainable
chemistry
Drug delivery
Drug kinetics
Relative
effectiveness

7. An international, cross-sector community
650
acad-
emic
teams
120
SMEs
409
EFPIA
teams
25
patient
orgs
17
regul-
ators
Over 6 000 researchers
working for:
! collective intelligence
networks
! improved R&D
productivity
! innovative approaches
to unmet medical
needs

8. IMI achievements

9. Antimicrobial resistance – a growing threat
25 000 killed
€1.5 billion

10. IMI - New Drugs for Bad Bugs
! How to get new drugs into
bad bugs
! Pan-European network of
clinical/laboratory sites
! Collaboration on clinical
trials
! Platform for antibiotic
development
! New business models
! Part of EU AMR
programme
! €229 million
! 4 projects launched

11. Action on Alzheimer’s disease
Matrix of
biomarkers
" Test efficacy
of new
treatments
Linking &
analysing data
" Identify those
at risk
New classification
of AD/PD
" Personalised
treatments
‘Adaptive’ clinical
trials
" Faster drug
development &
patient access

12. Autism – a common disorder
! Affects 1 in 110
! Lifelong condition
! Difficulties in social
interaction &
communication,
unusual repetitive
behaviours
! Major impact on
families & carers
0

13. ! New insights into underlying
causes
! Could the brain changes be
reversed?
! Gender & autism
! 2 major clinical trials for early
detection and monitoring of
ASD in children
! Working with regulators on
treatment guidelines
IMI – delivering results on autism

14. Sharing data to improve
clinical trials for schizophrenia
By redesigning clinical trials, you could:
" make them shorter (6 weeks # 4 weeks)
" require fewer people (79 # 46 patients per arm)
" cut costs (savings of €2.8 million)
" gain insights into effects of treatment on negative symptoms (e.g.
lack of emotion)
23 000 patients
67 studies
25 countries
1 database

15. IMI contributes to drug safety
SAFE-T project
! 153 potential biomarker
candidates for drug-induced
injury of kidney, liver &
vascular system evaluated
! 17 exploratory clinical
studies
! Dialogue with regulatory
agencies
! MoU with PSTC (C-Path)

16. IMI projects deliver excellent science
0 0.5 1 1.5 2 2.5 3
IMI
FNIH
Wellcome Trust
TI Pharma
World average
Citation index

17. IMI – a partner for SMEs
15% of funding recipients
18.4% of budget
135SMEsin46
projects
Funding
Visibility
Knowledge
Access
Networking

18. IMI – a partner for SMEs in
diabetes research
! 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

19. IMI – putting patients
at the heart of drug development
U-BIOPRED – towards personalised
medicine for severe asthma
! The challenge – recruit 1 025 people
! Patients involved in project as partners &
through ethics board, safety monitoring
board, and patient input platform
! Offered patients’ perspective on
recruitment, study design, project
communication
! Project now starting to deliver results!

20. How does IMI work?

21. Goals of IMI 2 programme
$ Increase the success rate of clinical trials of new medicines &
vaccines
$ Speed up the earlier stages of drug development
$ Develop new treatments for areas of unmet need
$ Develop new biological markers to diagnose diseases and
assess treatments
$ Improve the drug development process by creating tools to
assess the efficacy, safety and quality of medicines

22. 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

23. Topic definition
phase
Typical IMI project life cycle
Negotiation
phase
Stage 1
Identification of
topics and
willingness to
collaborate by EFPIA
companies and
associated partners
Signature of Project
Agreement and Grant
Agreement
Submission of short
proposals by
applicant consortia
& evaluation by
independent experts
Patients’
organisations
Academic
research
teams
Regulators
Hospitals
SMEs
Mid-size
enterprises
Industry
consortium
Stage 2
Preparation of full
proposal &
evaluation by
independent experts/
ethical panel
Industry
consortium
Applicant
consortium
Call
launch
Invitation to
selected team
to merge with
industry team
Start of the
negotiation
phase
Project
launch!

24. Why take part in IMI projects?
! Scientific excellence
! Impact on drug development, regulatory procedures,
patients’ lives
! Access to expertise of scientists from universities,
industry, biotechs, regulators, patient groups…
! New business opportunities
! Under IMI 2 – improved funding rates
! Flexible intellectual property policy protects partners
while promoting use of knowledge

25. IMI’s flexible intellectual property policy
Support to
industry
Freedom of
access
Compensation
for IP
Dissemination
of information
Incentive to
participate
flexibility
+
trusted
party

26. IMI’s IP policy allows unprecedented
levels of sharing
Companies
pooling legacy
toxicity data
European
platform for
antibiotic
development
Companies
pooling &
sharing old
trial dataEuropean
Lead Factory
compound
collection
Project
partners
validate each
other’s
findings

27. Apply for funding
! Look out for new IMI Calls
! www.imi.europa.eu
! IMI newsletter
! Twitter, LinkedIn
! Link up with other experts
! Read and understand the
Call documents
! Info sessions /
webinars
! Contact the IMI
Programme Office
! Submit your proposal
How to take part in IMI projects
Contribute to IMI as an
Associated Partner
Your contribution is matched by
the EU
! Read the IMI Strategic
Research Agenda
! Identify points that match
your priorities
! Contact the IMI Programme
Office

28. Ann Martin
dd.mm.yyyy • Event name • City, Country
Data & Knowledge Management
Portfolio

29. Clinical
Trial
Simulator
-­‐
Prototype
v.2
Adap9ve
Op9mal
Designs
–
prototype
V.1
Model Based
Drug
Development

30. Compound
Target
Pathway
Disease
data
$ Created the Open PHACTS Discovery Platform linking information and facts from
multiple public databases
$ Created an API for drug discovery with an ecosystem of apps
$ Methodology for delivery business-relevant solutions
$ Use by bench and computational scientists
$ Established itself as a– a unique forum for partners
$ the Open PHACTS Foundation – support the existing infrastructure and widen
scientific scope

31. Efforts to Automate clinical research
1
DESIGN
Feasibility
Study
XML
XML
Regulators
Clinical Trial
Management
System
(CTMS)
Document
Management
System
2
EXECUTION
Pa?ent
Recruitment
3
EXECUTION
Data
Collec?on
FDA-­‐EMA
SUBMISSION
XML
Case
Report
Form
(CDISC
ODM)
Trial
Registry
Clinical Data
Management
System (CDMS)
XML
Protocol
(CDISC
PRM
–
SDM)

32. EMIF European Medical Information Framework
Platform
Make data available for
browsing and analysis in
multiple ways
Alzheimers Disease
Identification and validation of
markers that predict
Alzheimer’s progression
Metabolics
Discovery of predictors of the
metabolic complications of
adult and paediatric obesity
Research topics provide focus

33. " Supports collaborative projects
" Analysis needs of translational data
" Deploys open-source tranSMART
" Service with public data
" Ethics / data protection
" Standards research
" transMART Foundation
o 35 transMART implementations
o multiple development teams
o commercial services
studies
including
omics
images
clinical
assessment
data
Abirisk
Oncotrack
UBIOPRED
Predict-­‐TB
RA-­‐MAP
....
J&J
eTRIKS
TraIT
TheHyve
IDBS
Sanofi
Pfizer
Takeda
RecombinantbyDeloiPe
Thomson
Reuters
Michigan
Harvard
22
transla?onal
,
1400
gene
expression
studies
European Translational and Knowledge
Management Services

34. Multiple data types supported

35. Recognising Adverse Drug Reactions
• A mobile phone app for reporting of suspected ADRs
to EU regulators.
• Assess the use of the app to provide info on
medicines.
• Explore identification of potential safety issues from
user comments in social media.
• Develop recommendations for use mobile
technologies and social media in pharmacovigilance
and monitoring of the safety of medicines.

36. Under Evaluation Call 3, 4

37. Patient input into drug development Today
Pharma 1 Patients
Advocacy
Groups
Regulators
Pharma 2
Pharma 3

38. Future
Pharma
Patients
Advocacy
Groups
Regulators
Pharma
Pharma
Knowledge
Repository
Knowledge repository to enable patient-focus
medicine development

39. Challenges in Managing Chronic
Disease Today
• Physician visits are time-limited evaluations based on subjective
observations of both the patient and the physician or psychiatrist
• Changes in disease state for each of these diseases can occur on
timescales much shorter than the interval between physician visits
• Through technological advances over the last decade it is now possible to
objectively, remotely, and continuously measure aspects of patient
physiology, behavior and symptoms
39

40. 40
Multi-Platform Biomarker Data from
Controlled Studies
Physician Notes
Caregiver
Reports
Literature
Patents
Epidemiology
Patient Hospital Records Data
Vision of Tomorrow: Next
Generation Patient Centric
Data
MOVE FROM DIAGNOSE AND TREAT TO PREDICT
AND PREEMPT
40
Continuous Real-Time Patient Data
Home Monitoring. Remote Sensing.
(Actigraphy, Physiological)
Predict and Preempt:
" relapse in depression
" exacerbation in MS
" epileptic fit
" Onset of mania
" Psychotic break etc.
Remote Assessment of Disease and Relapse (RADAR)

41. Current Inidicative Topics

42. Current indicative topics - 1
! Patient perspective elicitation on benefits and risks of medicinal
products, supplementing benefit risk assessments by regulators
and HTAs (health technology assessments) from development
through the entire life cycle
! Development of a quantitative system toxicology (QST) platform
! Diabetic kidney disease (DKD) biomarker idea

43. Current indicative topics - 2
! Inflammation and Alzheimer’s disease (AD): modulating
microglia function – focussing on TREM2 and CD33
! Enabling magnetic encephalography (MEG) as a biomarker for
diagnosis and disease progression in mild cognitive impairment
(MCI) and Alzheimer’s disease (AD)
! Understanding the role of amyloid biomarkers in diagnosis,
clinical management and treatment of patients with cognitive
impairment
! Evolving models of patient engagement and access for earlier
identification of Alzheimer’s disease
! Bringing apolipoprotein E (APOE) biology to validated
Alzheimer’s disease targets

44. Future IMI Calls - timelines & info
! Find out more: http://bit.ly/futuretopics
! Call launch: Summer 2015
Disclaimer - 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.

45. www.imi.europa.eu
@IMI_JU
Thank you
Ann Martin • Principal Scientific Manager
ann.martin@imi.europa.eu

46. IMI general presentation 21-10-2014
DKM Project Master
Change History

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