Working with industry – developing a consortium to stratify diabetes
This call is now closed for applications and is available for reference purposes only.
The UK academic research base in diabetes, obesity, and related metabolic disorders is, in many areas, world class. They are also areas of increasing importance to the pharmaceutical industry, as evidenced by drug development pipelines, and healthcare providers as over 10% of NHS costs are related to diabetes. While the MRC has longstanding and significant research investments in diabetes, obesity and metabolic disease, there are opportunities for further collaboration between industry and the rich base of academic expertise. To explore these opportunities, MRC held a workshop in March 2011 involving experts from academia and industry. The full report from the workshop can be found here; four main themes were considered ripe for collaborative working:
MRC Strategy Board has considered these recommendations and was impressed by the broad range of opportunities for academics and industry researchers to work together productively. Strategy Board endorsed the research areas and agreed to provide up to £6m to put together an industry-academic consortium, similar to those developed through the MRC/ABPI Inflammation and Immunity initiative, on disease stratification in Type 2 diabetes. MRC Strategy Board agreed the initiative must be fully inclusive of the key academic and industry interests (including the disgnostics and devices sectors), carefully coordinated with the NIHR Office for Clinical Research Infrastructure (NOCRI) and any potential NOCRI Translational Research Partnerships in this area, and also with the Scottish and Welsh Academic Health Sciences Collaborations and Northern Ireland.
To facilitate development of the consortium, MRC Strategy Board identified individuals to work up early plans and MRC is now engaging more widely.
Developing the Consortium
The vision is to incorporate both top-down (for example, advances in disease aetiology informing statification) and bottom-up (for example, developing stratification from analysing drug response of patients) approaches to stratification of Type 2 diabetes. This work will span major UK academic centres and appropriate industry sectors capitalising on the UK’s clinical research infrastructure.
The starting point would be stratifying diabetes which then lends itself to studying obesity and obese phenotypes. Four themes of activity have been suggested:
1. Proof of principle: using therapeutic response (e.g. to sulphonylurea (SU)’s and/or metformin) to identify clinically meaningful strata in the patient population. This could be achieved by pooling individual patient data from completed trials on drugs which are no longer under patent. The consortium would facilitate the analysis of anonymised company and academic trial data.
2. Mechanistic studies: Identifying excellent responders and non-responders to both conventional drugs GLP1 agonists and 5HIAA inhibitors. The initial stages would be to identify clinical characteristics and establish shared bioresources for future biomarker and pharmacogenomic studies (see below). Further work would enable studies to understand the mechanistic basis for variations in response to treatment. Understanding toxic side effects (particularly cardiotoxicity) might also come under this theme.
3. Biomarkers: known and unknown – using shared samples for detailed analysis of mechanisms and pathology, starting with extreme phenotypes.
4. Policy development and methodological innovation: understanding the health econometrics, engaging the regulators and NICE, trial design and the analysis of individual patient data from completed studies.
The consortium should:
- align with UK wide clinical research infrastructure
- align with other lager scale initiatives to add value
- adopt a global view, especially for investigating ethnic differences which were relevant to the UK population (e.g. responses in S. Asian populations).
Investigators are now invited to take part in developing this consortium further. Detailed development will take place throughtout 2011 and early 2012 culminating in a full proposal to MRC. To take part, please contact Dr Des Walsh in the first instance:
Des Walsh
E-mail: desmond.walsh@headoffice.mrc.ac.uk