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Ann Martin 14 April 2015 • Pistoia Alliance • Zurich, CH
Innovative Medicines Initiative Update and Opportunities
! What is the Innovative Medicines Initiative? ! IMI achievements ! How does IMI work?
Outline
‘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
IMI – Europe’s partnership for health
> €5 bn
Partnership 2008 - 2024
€2.5 bn
€2.5 bn
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
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
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
IMI achievements
Antimicrobial resistance – a growing threat
25 000 killed
€1.5 billion
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
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
Autism – a common disorder
! Affects 1 in 110 ! Lifelong condition ! Difficulties in social
interaction & communication, unusual repetitive behaviours
! Major impact on families & carers 0
! 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
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
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)
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
IMI – a partner for SMEs 15% of funding recipients 18.4% of budget
135
SMEs
in 4
6 pr
ojec
ts
Funding
Visibility
Knowledge
Access
Networking
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
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!
How does IMI work?
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
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
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!
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
IMI’s flexible intellectual property policy
Support to industry
Freedom of access
Compensation for IP
Dissemination of information
Incentive to participate flexibility
+ trusted party
IMI’s IP policy allows unprecedented levels of sharing
Companies pooling legacy
toxicity data
European platform for antibiotic
development
Companies pooling &
sharing old trial data European
Lead Factory compound collection
Project partners
validate each other’s findings
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
Ann Martin dd.mm.yyyy • Event name • City, Country
Data & Knowledge Management Portfolio
Clinical Trial Simulator -‐ Prototype v.2 Adap9ve Op9mal Designs – prototype V.1
Model Based Drug Development
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
Efforts to Automate clinical research
1DESIGN Feasibility Study
XML XML
Regulators
Clinical Trial Management
System (CTMS)
Document Management
System
2EXECUTION Pa?ent
Recruitment
3EXECUTION
Data Collec?on
FDA-‐EMA SUBMISSION
XML
Case Report Form
(CDISC ODM)
Trial Registry
Clinical Data Management
System (CDMS)
XML
Protocol (CDISC PRM – SDM)
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
" 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
Multiple data types supported
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.
Under Evaluation Call 3, 4
Patient input into drug development Today
Pharma 1 Patients Advocacy Groups Regulators
Pharma 2
Pharma 3
Future
Pharma Patients Advocacy Groups Regulators
Pharma
Pharma
Knowledge Repository
Knowledge repository to enable patient-focus medicine development
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
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)
Current Inidicative Topics
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
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
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.
IMI general presentation 21-10-2014
DKM Project Master
Change History
Stay in touch
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! Sign up to our newsletter bit.ly/IMInewsletter
! Follow us on Twitter @IMI_JU
! Join our LinkedIn group bit.ly/LinkedInIMI
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