IMI 8 th Call Angela Wittelsberger, PhD Scientific Project Manager IMI Open Info Day, Bucharest 10 December 2012

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


Innovative Medicines Initiative:Joining Forces in the Healthcare Sector


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


5

Topics IMI Call 8


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


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


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


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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

*

**


• 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


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



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






Qualified Leads

Qualified Candidates

Phase-1 ready

Phase 1 clinical trial


Portfolio Management

Committee (50:50 EFPIA:Public)






Qualified Leads (3)

Qualified Candidates (2)

Phase-1 ready (1-2)

Phase 1 clinical trial (1-2)


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.


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


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



NewDrugsForBadBugs (ND4BB) in IMI Call 8

ND4BB Subtopic 1C (Innovative trial design & clinical drug development)


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.


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.


ND4BB Subtopic 1C

EFPIA PARTICIPANTS:

GlaxoSmithKline, AstraZeneca, Janssen R&D, Sanofi


Six years

INDICATIVE BUDGET

EFPIA in-kind contribution: €25.4MIMI JU contribution: €26.4M


Other topics in IMI Call 8

Developing an aetiology based taxonomy of human disease


Disease Taxonomy – major objectives


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


• 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


Developing an aetiology-based taxonomy of human disease

EFPIA PARTICIPANTS:

UCB, Lundbeck, MerckSerono, Pfizer, Eli Lilly, Bayer


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


Other topics in IMI Call 8



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



• 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



EFPIA PARTICIPANTS:

Pfizer, Sanofi, NovoNordisk, Servier, Lundbeck, AstraZeneca, Novartis, Lilly, UCB


Six years

INDICATIVE BUDGET

EFPIA in-kind contribution: up to €30MIMI JU contribution: up to €40M


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 – future topics


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


THANK YOU !THANK YOU !

www.imi.europa.eu


Documents

IMI 8 th Call Angela Wittelsberger, PhD Scientific Project Manager IMI Open Info Day, Bucharest 10 December 2012