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
Excellent blog very nice and unique information related to Antibiotics. Thanks for sharing this information.
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