The Innovative Medicine Initiative (IMI) has launched the 6th call for proposals.
Publication: The Innovative Medicine Initiative Joint Undertaking (IMI JU) has published on its web the information necessary to submit an Expression of Interest in response to IMI 6th Call-Stage 1
The aim of IMI is to support pre-competitive pharmaceutical research and development to foster the development of safe and more effective medicines for patients throughremoving identified bottlenecks in the drug development process and enhance Europe’s competitiveness by ensuring that its biopharmaceutical sector remains a dynamic hightechnology sector.
The 6th Call 2012 consists of one Theme: Combating Antibiotic Resistance: NewDrugs4BadBugs (ND4BB) and covers the following:
Topic 1: Innovative Trial Design & Clinical Drug Development
- Subtopic 1A: Workpackage 1-4
• WP1 Project Management, Collaboration and Dissemination
• WP2 Establishment & Training of an Investigator Network
• WP3 In vitro microbiology Surveillance and Epidemiology dataset
• WP4 Improvements in data-driven design of Phase 2 and 3 clinical trials
- Subtopic 1B: Workpackage 5
• WP5 Conduct of Clinical Trials supporting the development of GSK1322322:
o WP5A: Evaluation of GSK1322322 in acute bacterial skin and skin structure (ABSSSI) (M1-21);
o WP5B: GSK1322322 Phase III Trial: IV treatment of ABSSSI with oral step down (M18-M38);
o WP5C: Phase 2IIb: GSK Compound GSK1322322 for hospitalised CABP (M1-M21)
o WP5D: GSK1322322 Phase III Pivotal hospitalized CABP Trials (M20-M44)
Topic 2: Learning from success and failure & Getting Drugs into Bad Bugs
Key objectives of topic 2
Improving permeability of drugs into Gram-negative bacteria
Increasing the efficiency of antibiotic R&D through knowledge and data sharing
Duration of the projects
The indicative duration of each project is 5-7 years.
Applicant Consortia are invited to submit expressions of interest to any of the above mentioned (sub)topics (i.e. Topic 1 Subtopic 1A, Topic 1 Subtopic 1B and/or Topic 2), but will not be obliged to apply for the other (sub)topics.
For Topic 1, at the second stage the successful Applicant Consortium for each subtopic will merge with the EFPIA consortium to prepare the full project proposal. All participants working under Topic 1 will be part of the same Grant Agreement.
Funding of the projects
The indicative IMI JU contribution will be divided between the two Topics as follows:
Topic 1: Innovative Trial Design & Clinical drug development: up to EUR 93 million
- Subtopic 1A: WP1-4 (EUR 5M)
- Subtopic 1B: WP5 (EUR 88M)
Topic 2: Learning from success and failure & Getting Drugs into Bad Bugs: up to EUR 16 million
Preparation of the proposal:
Expression of Interest (EoI) to be prepared
by a consortium composed of:
- academic institutions
- non-for-profit organizations
- other entities (not belonging to EFPIA)
Merger of the best EoI consortium with
EFPIA companies interested in the topic.
Preparation of full proposal
Deadline for submission of EoIs: 9 July 2012