The EU Innovative Medicines Initiative (IMI), the world’s largest public-private partnership in health R&D, is calling for proposals across seven new health care areas.
The areas of focus are linking patients’ data to develop more targeted therapies; using knowledge management of experimental data for translation into drugs for patients; complications of obesity; predicting Alzheimer’s disease and other dementias; drug delivery by nanocarriers; sustainability of chemical drug production; investigating stem cells for drug discovery; and understanding the behavior of drugs in the human body.
The EU has agreed to contribute up to €105 million ($150 million) to this latest step in IMI's evolution, a figure that will be matched by "in kind" contributions – staff, access to databases and research activity and equipment – from the European Federation of Pharmaceutical Industries and Associations.
The new project phase comes weeks after IMI signed a Memorandum of Understanding with the U.S.-based Critical Path Institute, aimed at increasing collaboration between the two bodies. They have agreed to foster increased information sharing regarding each other’s programs and create a mechanism to exchange knowledge and develop scientific consensus regarding research and testing methods.
But, as our European cousins step up to advancing 21st century medicine, wither our own domestic efforts? What’s become of the Critical Path? Where’s the Reagan/Udall Center?
Funding for the FDA’s Critical Path program and the Reagan/Udall Center is generally considered a “Christmas Tree” issue relative to PDUFA V. That’s a mistake. Beyond the agency’s request to fund it’s Advancing Regulatory Science Initiative (ARSI), we are all talk and no action.
For many involved in the reauthorization process, one statement that keeps coming up is -- ”The FDA is broken.” But what does that mean? Rather than making blanket statements that cause friction and promote areas of disagreement, one thing everyone can agree to is that the FDA’s must be both ally and accelerator in the advancement of innovation.
And that must be within the confines of PDUFA V – and it cannot be accomplished without moving forward the FDA’s Critical Path program and funding the Reagan/Udall Center.
