IMI 8 th Call Angela Wittelsberger, PhD Scientific Project Manager IMI Open Info Day, Bucharest 10...
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Transcript of IMI 8 th Call Angela Wittelsberger, PhD Scientific Project Manager IMI Open Info Day, Bucharest 10...
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