Transcript IMI Call 8

IMI 8th Call
Angela Wittelsberger, PhD
Scientific Project Manager
IMI Open Info Day, Bucharest
10 December 2012
Key Concepts
“Non-competitive” collaborative
research for EFPIA companies
Competitive calls to select partners of
EFPIA companies (IMI beneficiaries)
Open collaboration in public-private consortia (data
sharing, wide dissemination of results)
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
A Typical IMI Consortium
EFPIA
Private
Investment
in kind
(€ 1 billion)
EU Public
Funding
cash
(€ 1 billion)
Pharma 1
Pharma 2
Pharma 3
Pharma 4
Pharma 5
Pharma 6
SMALL AND
MEDIUM-SIZED
ENTERPRISES
ACADEMIA
PATIENTS’
ORGANISATIONS
HOSPITALS
IMI Open Info Day, Bucharest
10 December 2012
REGULATORS
Topics IMI Call 8
5
IMI Open Info Day, Bucharest
10 December 2012
Topics IMI Call 8
Topic
ND4BB Topic 3: Discovery and
development of new drugs combatting
Gram-negative infections
ND4BB Topic 1C (Innovative trial design &
clinical drug development)
Developing an aetiology based taxonomy
of human disease
European induced pluripotent stem cell
bank
6
IMI Open Info Day, Bucharest
10 December 2012
Indicative budget
EFPIA / IMI JU
(in million €)
26.0 / 58.9
25.4 / 26.4
18.0 / 18.0
up to 30.0 / up to 40.0
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
7
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
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
Topic 2:
New drugs into bad bugs
Steering Committee
Project level decision making body
Project level decision making body
Subtopic 1A:
Work Packages: 1-8
Topic 3:
Development of new
drugs combatting Gramnegative infections
Work
packages
1-n
Subtopic 3A:
Work Packages: 1-4
Work Packages: 1-3, 5A, 6*, 7*, 8
Subtopic 1B:
Subtopic 3B:
Work Packages 5A, 5B*, 5C, 5D*, 5E-F
Topic n:
Work Packages: 4**, 5B
Subtopic 1C:
Work Packages 6A, 6B*, 6C*, 6D
ND4BB Information Centre
9
Topics launched under Call 6
Topics to be launched under Call 8
Future topics to be launched
*
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
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 MoA
Each 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
Hit-to-Lead
programs novel
mechanism of
action
from public and private
partners
European Drug
Discovery Centre
of Excellence for
antibiotic
resistance
Qualified Leads
Qualified Candidates
Phase-1 ready
Phase 1 clinical trial
medicinal chemistry,
microbiology,
biochemistry,
pharmacokinetics,
etc.
from academia, SME and
EFPIA
GSK/Sanofi
collaboration
ND4BB Topic 3: Discovery and development of new
drugs combatting Gram-negative infections
Hit-to-Lead
programs novel
mechanism of
action
from public and private
partners
European Drug
Discovery Centre
of Excellence for
antibiotic
resistance
Qualified Leads
Portfolio
Management
Committee
Qualified Candidates
Phase-1 ready
(50:50 EFPIA:Public)
Phase 1 clinical trial
medicinal chemistry,
microbiology,
biochemistry,
pharmacokinetics,
etc.
from academia, SME and
EFPIA
GSK/Sanofi
collaboration
ND4BB Topic 3: Discovery and development of new
drugs combatting Gram-negative infections
Hit-to-Lead
programs novel
mechanism of
action
from public and private
partners
European Drug
Discovery Centre
of Excellence for
antibiotic
resistance
Qualified Leads (3)
Portfolio
Management
Committee
Qualified Candidates (2)
Phase-1 ready (1-2)
(50:50 EFPIA:Public)
Phase 1 clinical trial (1-2)
medicinal chemistry,
microbiology,
biochemistry,
pharmacokinetics,
etc.
from academia, SME and
EFPIA
GSK/Sanofi
collaboration
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 Dissemination
WP2: Portfolio Management Committee
Subtopic 3A
WP3: Establishment of the ND4BB Drug Discovery Platform
WP4: Delivery of novel “Leads” from public partners
WP5: Delivery of Clinical Candidates
Subtopic 3B
PART A: GSK/Sanofi Collaboration
PART B: Public partners
WP6: Delivery of Phase 1-Ready Antibacterials
WP7: Clinical Phase 1
WP8 : Partnering Outreach
IMI Open Info Day, Bucharest
10 December 2012
ND4BB Topic 3: Discovery and development of new
drugs combatting Gram-negative infections
EFPIA PARTICIPANTS:
GlaxoSmithKline R&D, Sanofi, AstraZeneca, Basilea
INDICATIVE DURATION OF THE PROJECT:
6 years
INDICATIVE BUDGET
EFPIA in-kind contribution: €26.0M
IMI JU contribution: €58.9M
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 patients
WP6B: 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. aureus
WP6D: 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: €25.4M
IMI 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
Disease Taxonomy – major objectives
• Initiate a new taxonomy for selected complex diseases, based on aetiological
mechanisms defined by molecular evidence
• The new classification should provide the basis for patient selection and stratification
to facilitate clinical trials and speed up the development of new more effective
medicines
• Provide the rationale for more specific diagnostic tools
• Provide the basis for the identification of novel targets or pathways for future
therapeutic interventions
• Development of cross therapeutic approaches
̶ Clinical classification approaches
̶
Molecular classification approaches
̶
Imaging classification approaches
IMI Open Info Day, Bucharest
10 December 2012
Developing an aetiology-based
taxonomy of human disease
Taxonomy platform
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
EFPIA in-kind commitment: €18 million
IMI JU budget: up to €18 million
Coordinated by UCB
IMI Open Info Day, Bucharest
10 December 2012
New Calls for next
disease areas
Disease Taxonomy – invitation summary
• 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)
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
Topic A
Topic B
EFPIA in-kind contribution:
€18M
(add
details)
(SLE + RA)
(neurodegenerative
disorders)
IMI JU contribution: €18M
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
European induced pluripotent
stem cell bank
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
IMI Open Info Day, Bucharest
10 December 2012
European induced pluripotent stem cell
bank – invitation summary
• 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
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 €30M
IMI 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
IMI – future topics
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
THANK YOU !
www.imi.europa.eu
IMI Open Info Day, Bucharest
10 December 2012