David's New Book

Wednesday, July 11, 2012

Innovative Medicines Initiative Explained


GUEST BLOGGERS - DAVID PAYNE AND KIM BROWN of GSK. 


When David sent us an email with ‘does anybody understand IMI ?’ we felt we needed to put this opportunity into better perspective. The New Drugs 4 Bad Bugs (ND4BB) project (6th Call for proposals) came about from high level discussions with the European Commission on how they wanted to do something concrete to address antibiotic resistance  (Press release).  The conclusions of these discussions led us to the Innovative Medicines Initiative (IMI homepage ) as the most immediately available source of funding.  IMI was set up in 2008 to support collaborative research projects between networks of industrial (EFPIA goal and membership) and academic experts to reduce drug discovery bottlenecks, and boost pharmaceutical innovation within Europe.  The effort applied to the project by the EFPIA companies is then matched with funding from IMI; this funding from IMI goes directly to European academics, institutions or small medium enterprises (SME) that have organized themselves into a consortium to address the goals of a research project.  All the EFPIA companies had the opportunity to participate in ND4BB.  The current topic text was the result of discussions amongst those EFPIA companies interested in participating (listed below), and developed in consultation with (and with input from) other stakeholders, such as the European Commission, IMI’s Scientific Committee, and IMI’s States Representatives Group.   

The first project (Topic 1) is focused on creating and enabling an antibiotic clinical trial network for evaluating the clinical efficacy and safety of novel antibacterials, initially from AZ and GSK.  In addition,  Topic 1 has opportunities for  institutions that have not previously run clinical trials to receive training to become compliant clinical trial sites for the future. Sites of particular interest are those in regions of high levels of resistance, or where a specific resistance mechanism predominates. This will create a footprint of compliant clinical trial sites that can be adapted to optimally evaluate new antibacterials against infections resistant to current standard of care antibacterials.

The second project (Topic 2) is focused on improving our understanding of how to design agents that will optimally penetrate Gram negative pathogens – we see the lack of rational approaches to this problem as a major barrier to creating a pipeline of Gram negative antibacterials . Overall, there is €16M available for a consortium of European academics to tackle this problem and EFPIA members will be providing tool compounds and additional support for the various projects. We encourage broad and innovative thinking to address the goals of this project.

So how does the funding work ?  Under IMI individuals can not apply for funding, applications have to be made as a consortium. For example, a consortium of clinical investigators and SMEs with a Principal Investigator need to apply to run the clinical trials in the proposal. Researchers across Europe are encouraged to connect with other interested parties to initiate a consortium and/or communicate their interests and expertise through the IMI Partnering Tool (Link to Partner Search) which can also be the genesis of a consortium. The optimal consortium is then selected by an expert panel consisting of independent academics appointed by IMI.  To ensure a fair application process, EFPIA representatives cannot directly communicate with prospective applicants, so any specific enquires should be emailed to the IMI offices (INFODESK@imi.europa.eu).

Essentially the way this will work for clinical trials is that IMI will provide funding for the European clinical trial sites and the sponsoring EFPIA company will fund an equal share of the cost.  As antibacterial clinical trials have never been run by such a consortium, the risks of added complexity could extend timelines. However, by initiating this project with their compounds, GSK and AZ hope to build confidence around the approach, create an established network of compliant clinical trials sites for future use, and establish Europe as a center of excellence for antibacterial clinical trials.  Those following David’s blog will appreciate that this type of funding support is key to maintaining and encouraging companies to commit to antibacterial R&D.

Finally, a major theme of the proposal will be that the EFPIA members and academic groups participating in ND4BB will share information on antibacterial R&D in a way that we have never done before. This will encompass everything from learnings from clinical trials to past experiences of why particular projects or compounds failed. The hope here is that we will increase the overall efficiency of antibacterial R&D and companies will have broader access to potential liabilities associated with different approaches, targets and novel chemical series to better inform their strategies.

The eagerness of the EC and IMI to play a role here is exemplary and this current proposal is an ambitious first step. Additional funding is available (the total amount could be up to €600M) and we are working on additional projects which will be the subject of future ‘Calls’. We hope ND4BB establishes a framework that will attract additional projects/clinical programs and other EFPIA companies to collaboratively participate in a new way of working collaboratively in antibacterial R&D.

GlaxoSmithKine
AstraZeneca
J&J
Basilea
Sanofi