EU IMI and US Critical Path avoid duplication
This article was originally published in Scrip
The EU Innovative Medicines Initiative has signed a memorandum of understanding with the Critical Path Institute (C-Path) in the US to further the shared objective the two public-private organisations have of accelerating the development of safer, more effective medicines.
The IMI was set up by the European Commission and the European pharmaceutical industry federation EFPIA under the 7th Framework Programme, with the aim of overcoming research bottlenecks in drug development. C-Path was created by the US Food and Drug Administration and the University of Arizona, with much the same purpose. Among other things, C-Path's programmes address scientific, safety and educational aspects of medical product development in support of the Critical Path Initiative, which is the FDA's national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated and manufactured.
The MoU indicates the intent of IMI and C-Path to find opportunities to leverage one another's work in order to accelerate progress and prevent duplication of efforts. The expectation is that, by combining their knowledge and expertise in innovative projects, the scientists in these partnerships will be able to tackle challenges "that are too big and complex for individual research teams to handle on their own".
The collaboration, it is expected, will foster increased information sharing regarding each organisation's programmes and will create a mechanism to exchange knowledge and develop scientific consensus regarding research and testing methods.
The MoU also aims to establish a platform to provide oversight and management of databases of non-competitive information to be made available for public use. This will occur under the formal collaborative agreement via joint meetings, shared strategic agendas, streamlined communication and complementary projects.
The IMI points out that in the key area of drug safety, discussions for such knowledge exchange are already under way. The SAFE-T consortium supported by the IMI and the Predictive Safety Testing Consortium (PSTC) led by C-Path are currently working on the development of new biomarkers to predict, diagnose and monitor drug-induced injury to the liver, the kidney and the vascular system in the clinical setting.
IMI executive director Michel Goldman said it was clear that the "IMI is performing a vital role in finding better solutions for patients across Europe, and, via the collaboration with C-Path, the impact will be global". The IMI is currently funding 23 projects; the projects do not aim to develop new medicines as such, but focus on new methods and tools that will enable the entire sector to accelerate the development of safer and more effective treatments for patients. The IMI will launch a new call for proposals later this month.
C-Path president and chief executive Raymond Woosley believes the partnership will benefit patients around the world by making the drug development process more efficient by decreasing the time between discovery and patient access to new therapies.
ePRO consortium
Separately, C-Path announced that it has established an electronic patient reported outcome (ePRO) consortium to develop guidelines for the adaptation of PRO measures into ePRO clinical technologies. The objective is to create better measures of how patients react to drugs taken while in a clinical trial and, in doing so, advance the quality, practicality and acceptability of electronic data collection methods for PRO endpoint assessment in clinical trials.
The founding members of the ePRO Consortium all of which provide electronic data collection technologies for capturing ePRO endpoints in clinical trials – CRF Health, ERT, ICON, invivodata and PH – will work collectively in a non-competitive, neutral environment to develop these guidelines.
The ePRO Consortium will work closely with C-Path's PRO Consortium, a group of 25 pharmaceutical companies working to develop novel PRO measures, to make the new measures available in multiple data collection formats.