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IMI 8th Call
Angela Wittelsberger, PhD Scientific Project Manager
IMI Open Info Day, Bucharest 10 December 2012
Open collaboration in public-private consortia (data
sharing, wide dissemination of results)
“Non-competitive” collaborative research for EFPIA companies
Competitive calls to select partners of
EFPIA companies (IMI beneficiaries)
Key Concepts
IMI Open Info Day, Bucharest 10 December 2012
Innovative Medicines Initiative:Joining Forces in the Healthcare Sector
IMI Open Info Day, Bucharest 10 December 2012
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
IMI Open Info Day, Bucharest 10 December 2012
6
Topics IMI Call 8
Topic Indicative budget EFPIA / IMI JU (in million €)
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
26.0 / 58.9
ND4BB Topic 1C (Innovative trial design & clinical drug development)
25.4 / 26.4
Developing an aetiology based taxonomy of human disease
18.0 / 18.0
European induced pluripotent stem cell bank
up to 30.0 / up to 40.0
IMI Open Info Day, Bucharest 10 December 2012
7
Timelines IMI Call 8
• Launch of Call 8: December 2012
• Submission of EoIs in SOFIA: from shortly after launch until end of February 2013
• Stage 1 evaluation completed: April 2013
• Stage 2 evaluation completed: July 2013
• Indicative start of projects: October 2013
IMI Open Info Day, Bucharest 10 December 2012
NewDrugsForBadBugs (ND4BB) in IMI Call 8
1) ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
2) ND4BB Subtopic 1C: Innovative trial design & clinical drug development
IMI Open Info Day, Bucharest 10 December 2012
9
The ND4BB programme
ND4BB cross-topic collaboration and dissemination(Topic 1 WP1, Topic 2 WP8, Topic 3 WP1, Topic n WPn)
Topic 1: Clinical development Steering Committee
Project level decision making body
Subtopic 1A:Work Packages: 1-4
Subtopic 1B:Work Packages 5A, 5B*, 5C, 5D*, 5E-F
Subtopic 1C:Work Packages 6A, 6B*, 6C*, 6D
ND4BB Information Centre
Topic 2: New drugs into bad bugs
Steering CommitteeProject level decision making body
Work Packages: 1-8
Topic 3: Development of new
drugs combatting Gram-negative infections
Subtopic 3A:Work Packages: 1-3, 5A, 6*, 7*, 8
Subtopic 3B:Work Packages: 4**, 5B
Topic n:
Work packages
1-n
Subject to milestone approval and potentially Call for additional beneficiaries
Potentially subject to Call for additional beneficiaries if needed to provide additional Hit-to-Lead efforts
Topics launched under Call 6
Topics to be launched under Call 8Future topics to be launched
*
**
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
• Focuses on Gram-negative infections only
• Invites public and private partners with Hits and Leads with a novel mechanism of action
• Invites experts and professionals in medicinal chemistry, microbiology, biochemistry, pharmacokinetics
• Aims to combine expertise and knowledge to create a “European Drug Discovery Centre of Excellence for antibiotic resistance”.
• Goal is the delivery of novel Leads and Development Candidates
• Successful Development Candidates can move forward up through Phase 1 clinical trial
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Topic 3: Invitation summary
• Invites public and private partners with Hits and Leads: Novel targets Known targets, novel MoA Mechanism of Action Known targets, known MoAEach can be valuable and each has positives and negatives
• Invites experts and professionals in drug discovery medicinal chemistry, microbiology, biochemistry,
pharmacokinetics, etc. Academics, institutions, SMEs
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
European Drug Discovery Centre of Excellence for
antibiotic resistance
Hit-to-Lead programs novel mechanism of actionfrom public and private partners
medicinal chemistry, microbiology, biochemistry, pharmacokinetics, etc. from academia, SME and EFPIA
Qualified Leads
Qualified Candidates
Phase-1 ready
Phase 1 clinical trial
GSK/Sanofi collaboration
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
European Drug Discovery Centre of Excellence for
antibiotic resistance
Hit-to-Lead programs novel mechanism of actionfrom public and private partners
medicinal chemistry, microbiology, biochemistry, pharmacokinetics, etc. from academia, SME and EFPIA
Qualified Leads
Qualified Candidates
Phase-1 ready
Phase 1 clinical trial
GSK/Sanofi collaboration
Portfolio Management
Committee (50:50 EFPIA:Public)
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
European Drug Discovery Centre of Excellence for
antibiotic resistance
Hit-to-Lead programs novel mechanism of actionfrom public and private partners
medicinal chemistry, microbiology, biochemistry, pharmacokinetics, etc. from academia, SME and EFPIA
Qualified Leads (3)
Qualified Candidates (2)
Phase-1 ready (1-2)
Phase 1 clinical trial (1-2)
GSK/Sanofi collaboration
Portfolio Management
Committee (50:50 EFPIA:Public)
max. 4 hit-to-lead
programs running in
parallel, max. 8 total
ND4BB Topic 3: Objectives
1. Provide a unique platform for collaboration and exchange between private and public partners.
2. Establish a vibrant drug discovery hub across Europe with the resource, skills and expertise to generate a pipeline of “Leads” and “Development Candidates” originating from public or private partners.
3. Discover three novel-mechanism antibacterial Leads.
4. Identify two novel-mechanism Clinical Candidate molecules for the treatment of systemic Gram-negative infections.
5. Progress at least one novel-mechanism Clinical Candidate into preclinical and Phase 1 clinical studies.
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Topic 3: Work packages & Suptopics
WP1: ND4BB Project Management, Collaboration and DisseminationWP2: Portfolio Management CommitteeWP3: Establishment of the ND4BB Drug Discovery PlatformWP4: Delivery of novel “Leads” from public partnersWP5: Delivery of Clinical Candidates
PART A: GSK/Sanofi CollaborationPART B: Public partners
WP6: Delivery of Phase 1-Ready Antibacterials WP7: Clinical Phase 1WP8 : Partnering Outreach
Subtopic 3A
Subtopic 3B
IMI Open Info Day, Bucharest 10 December 2012
EFPIA PARTICIPANTS:
GlaxoSmithKline R&D, Sanofi, AstraZeneca, Basilea
INDICATIVE DURATION OF THE PROJECT:
6 years
INDICATIVE BUDGET
EFPIA in-kind contribution: €26.0MIMI JU contribution: €58.9M
ND4BB Topic 3: Discovery and development of new drugs combatting Gram-negative infections
IMI Open Info Day, Bucharest 10 December 2012
NewDrugsForBadBugs (ND4BB) in IMI Call 8
ND4BB Subtopic 1C (Innovative trial design & clinical drug development)
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Subtopic 1C
WP6: Conduct of clinical trials supporting the development of MEDI4893, a monoclonal antibody targeting S. Aureus alpha toxin.WP6A: Epidemiologic Surveillance of Healthcare-associated infections among surgical and intensive care unit patientsWP6B: Phase 1b/2a study with MEDI4893 for Staph. aureus ventilator associated pneumonia (VAP) WP6C: Phase 1b/2a study with MEDI4893 for prevention of surgical site infections by Staph. aureusWP6D: Project management, dissemination and collaboration
WP7: Conduct of clinical trials supporting the development of AZ9773.
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Subtopic 1C: Invitation summary
• Invites participants with capability for conducting active-surveillance, observational and clinical studies in ICU and surgical patient populations
• Expertise with data handling and standardization• Expertise in clinical project management• Expertise in statistics and PK/PD modeling approaches• Expertise in bacterial, especially S. aureus virulence factors• Proposals for novel diagnostics/biomarkers to be utilized in clinical
trial designs.
IMI Open Info Day, Bucharest 10 December 2012
ND4BB Subtopic 1C
EFPIA PARTICIPANTS:
GlaxoSmithKline, AstraZeneca, Janssen R&D, Sanofi
INDICATIVE DURATION OF THE PROJECT:
Six years
INDICATIVE BUDGET
EFPIA in-kind contribution: €25.4MIMI JU contribution: €26.4M
IMI Open Info Day, Bucharest 10 December 2012
Other topics in IMI Call 8
Developing an aetiology based taxonomy of human disease
IMI Open Info Day, Bucharest 10 December 2012
Developing an aetiology-based taxonomy of human disease
Topic A:Systemic Lupus
Erythematosus (SLE) & related connective tissue disorders & Rheumatoid
Arthritis (RA)
Topic B:Neurodegenerative
disorders with a focus on Alzheimer’s disease and Parkinson’s disease
Chronic Obstructive Pulmonary
Disorders (COPD)
Topic postponed
Taxonomy platform
Coordinated by UCB
EFPIA in-kind commitment: €18 millionIMI JU budget: up to €18 million
New Calls for next disease areas
IMI Open Info Day, Bucharest 10 December 2012
• Expertise in disease classification, taxonomy, molecular aetiologies• Expertise in omics technologies, study of genetic mutations and
polymorphisms, gene expression data, protein modifications and expression patterns, protein interactions, informatics & modeling
• Expertise in clinical research, preclinical research, imaging, epidemiology
• Expertise in data basing, curation, harmonisation, standardisation and sharing (incl. legal and ethical aspects)
Disease Taxonomy – invitation summary
IMI Open Info Day, Bucharest 10 December 2012
Developing an aetiology-based taxonomy of human disease
EFPIA PARTICIPANTS:
UCB, Lundbeck, MerckSerono, Pfizer, Eli Lilly, Bayer
INDICATIVE DURATION OF THE PROJECT:
Five years
INDICATIVE BUDGET
EFPIA in-kind contribution: €18M (add details)IMI JU contribution: €18M
Topic A (SLE + RA)
Topic B (neurodegenerative disorders)
EFPIA in-kind contribution €10M €8M
IMI JU contribution €10M €8M
IMI Open Info Day, Bucharest 10 December 2012
Other topics in IMI Call 8
European induced pluripotent stem cell bank
IMI Open Info Day, Bucharest 10 December 2012
Scientific• Generation of a full complement of geno-
& phenotypic data for key patient cohorts
• Research and implementation of current standard practices for the generation and differentiation of iPS cells
• Development of automatable processes for iPS cell culture and banking
• Application of best practise in cryopreservation & biobanking to develop a ‘commercial standard’ state of the art iPS facility
• Provision of quality protocols and training in iPS cell growth & development
Operational• Set-up of a sustainable, not-for-profit,
specialist production, storage and distribution centre for iPS cells across Europe hosted in appropriate facility
• Provide patient derived iPS cells to a defined quality and within a defined time from placing an order
• Supply an iPS differentiation service during the latter half of the call
• Provide searchable anonymized geno-, phenotypic & clinical data associated with each iPSC line
European induced pluripotent stem cell bank
IMI Open Info Day, Bucharest 10 December 2012
• Applicants that have identified a broad and useful cohort of patient derived iPS cell lines
• Expertise in tissue/somatic cell collection and the generation and differentiation of iPS cells
• Expertise in cell culture, cryopreservation and quantitative analysis in cell biology
• Expertise related to data, security, standards (incl. ethical and confidentiality policies)
• Appropriate infrastructure and laboratory space to support the bank
European induced pluripotent stem cell bank – invitation summary
IMI Open Info Day, Bucharest 10 December 2012
European induced pluripotent stem cell bank
EFPIA PARTICIPANTS:
Pfizer, Sanofi, NovoNordisk, Servier, Lundbeck, AstraZeneca, Novartis, Lilly, UCB
INDICATIVE DURATION OF THE PROJECT:
Six years
INDICATIVE BUDGET
EFPIA in-kind contribution: up to €30MIMI JU contribution: up to €40M
IMI Open Info Day, Bucharest 10 December 2012
IMI Call 8 – upcoming webinars
• European induced pluripotent stem cell bank – Thursday 6 December, 13:00 CET
• Developing an aetiology-based taxonomy of human disease – Wednesday 12 December, 10:30 CET
• ND4BB Subtopic 1C – Tuesday 11 December, 15:00 CET
• ND4BB Topic 3: Discovery and development of new drugs combating Gram – negative infections – Monday 17 December, 15:00 CET
• Webinar on IMI’s rules and procedures on Thursday 13 December at 14:30 CET
IMI Open Info Day, Bucharest 10 December 2012
Future topics
• Development of drug-drug combinations
• Leveraging emerging technology for pharmacovigilance
• Further topics derived from the Scientific Priorities 2013
http://www.imi.europa.eu/content/future-topics
IMI Open Info Day, Bucharest 10 December 2012
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