- Europe’s Innovative Medicines Initiative (IMI) entered its second phase (IMI2) last week, with a €3.3 billion budget devoted to “fast-tracking the development of the next generation of medicines.”
- Excitingly, the first call for research proposals includes a €35 million (~$47 million) program devoted to type 1 diabetes research, with participation from JDRF, Sanofi, and other key players.
- One of the strategic goals for the overarching IMI2 (although not specifically for the first call for proposals) is to develop new clinical trial paradigms, including a “conditional approval pathway” for diabetes drugs.
Europe’s Innovative Medicines Initiative (IMI) entered its second phase (IMI2) last week with a call for research proposals focused on type 1 diabetes and retinal diseases; the €3.3 billion (~$4.5 billion) public-private partnership aims to “pave the way for next generation treatments” in areas of unmet medical need. This program represents a massive investment in much-needed research – the budget for the first set of proposals alone is €49 million (~$67 million) – and we are elated to see the high priority given to type 1 diabetes and diabetes-related complications in this first call. The type 1 diabetes program will involve a number of key nonprofit and industry leaders, including Sanofi (named as coordinator), the JDRF (named as a co-coordinator), the Helmsley Charitable Trust, GSK, Novo Nordisk, and Lilly. The type 1 diabetes project, which will focus on characterizing the phenotype and heterogeneity of type 1 diabetes in the at-risk and new onset setting and developing biomarkers for optimizing the design of type 1 diabetes clinical trials, has a total (financial and in-kind) budget of €35.2 million ($47.8 million), including €17.6 million (~$24 million) from the EU’s Horizon 2020 program, €12.6 million (~$17 million) from pharmaceutical companies, €2.8 million (~$4 million) from JDRF, and €2.2 million (~$3 million) from the Helmsley Trust. The IMI’s Strategic Research Agenda lists patient needs and involvement as key priorities, and we were impressed to hear that the type 1 diabetes project will include a patient advisory committee “to ensure the work is in line with patients’ needs.”
The type 1 diabetes call for proposals is one of many programs within the broader IMI2, which will likely include other diabetes programs. The goals outlined in the Strategic Research Agenda for IMI2 diabetes research include “target validation and biomarker development, adoption of innovative clinical trial paradigms, innovative medicines, and patient tailored adherence programs.” Notably, development of a “new, optional conditional approval pathway” for diabetes drugs was listed as one of the priorities with regard to designing new clinical trial paradigms. The current one-size-fits-all regulatory climate for diabetes drugs makes it difficult for relatively high-benefit/high-risk candidates to gain approval. A conditional approval pathway could help get these sorts of therapies into the hands of patients that need them most, and would better reflect the heterogeneity of the diabetes patient population.
- The deadline for preliminary proposal submission for the type 1 diabetes program is November 12, 2014. More information about the submission process can be found here, and the IMI also has an online partner search tool for organizations interested in collaborating on a proposal.
- We had the terrific opportunity to speak with JDRF’s Dr. Richard Insel (JDRF, New York, NY) about IMI2 and the type 1 diabetes program. Dr. Insel said that "JDRF is elated to have type 1 diabetes earmarked for one of the first calls for IMI2" and believes that although Europe is “a bit ahead of the game” with regard to pre-competitive consortia, this type of initiative will be a “trend as we go forward” and that “biomedical research and its translation will be accelerated by these pre-competitive consortia.” In the US, the Foundation for the National Institutes of Health (FNIH) recently announced the launch of the Accelerating Medicines Partnership, a collaboration between the NIH, ten pharmaceutical companies, and several nonprofits that will sponsor three- to five-year pilot projects to identify novel drug targets and biomarkers in specific disease areas (including type 2 diabetes). Additionally, Faster Cures, a nonprofit organization devoted to improving the efficiency of the therapeutic development process, has been championing public-private consortia as an effective means of advancing medical research and will be leading a Congressional briefing on July 22 to discuss this emerging trend.
-- by Emily Regier, Manu Venkat, and Kelly Close