By any standards, the year 2009 was a challenging one. The severity of the economic downturn and the crisis in the public finances reduced funding for research, for MMI’s academic partners and for health care.

MMI’s Unique Selling Point

MMI responded to this challenge by defining MMI’s strategy. The distillation of the input of many stakeholders and the stimulation of the recession, have resulted in greater coherence about MMI’s ‘unique selling point’. As a result of that process, it is much more obvious that the key challenge facing MMI is to use the strengths and resources of our five partner institutions and their associated hospitals to build that national system for clinical and translational research that everyone agrees is needed. While there is a mountain to climb and funding is required, the MMI Directors and staff are clearer today that building a national system for clinical and translational research is something unique that MMI can contribute to the national agenda for innovation and the smart economy. What did MMI and its partners do in 2009 to build the national system for clinical and translational research?

Dublin Centre for Clinical Research

It is particularly good news that the Wellcome Trust/HRB funded Dublin Centre for Clinical Research (DCCR) is open for business! The DCCR is a key part of the infrastructure for clinical and translational research, linking the clinical research centres associated with UCD (St Vincent’s /Mater), the RCSI CRC in Beaumont Hospital and a new CRC being built by TCD at St James’s Hospital. Four studies are underway across the network; five disease groups have been established or recognised and are conducting and/or planning studies to be conducted through the network. Work on an information system for the network is at an advanced stage. The agreement for the new CRC at St James’s has been signed by TCD, St James’s and Wellcome and the tender for the new CRC went to the selected bidders in December, with tenders to be submitted by end January 2010. 
 

Building National Capacity for Clinical Research

The Irish Clinical Research Infrastructure Network (ICRIN) is putting the structures and processes in place to facilitate the conduct of investigator-led studies in multiple sites across the country and across a range of diseases. ICRIN is funded by the HRB and the HSE and operates as a business unit of MMI. The ICRIN Situation Analysis was published and the Clinical Research Roadmap was circulated for comment to key stakeholders. As a result of this initiative, the Department of Health and Children has invited MMI to publish the Roadmap as a contribution to the implementation of the Government’s Health Research Action Plan and to be a partner in building national clinical research capacity. A single application form for ethical approval of clinical studies, other than of medicinal products, has been agreed and is being piloted by five research ethics committees. As a result of a joint workshop with the State Claims Agency on indemnity of clinical research in April, MMI clarified for the research community many of the issues associated with indemnity and the role of the clinical indemnity scheme.

MMI secured funding from Enterprise Ireland to offer a service to SMEs, indigenous companies and start ups in biotechnology to assist them navigate access to the clinical expertise needed to bring their products to market. Thanks to this initiative, a number of firms have either begun or moved closer to clinical trials. As the year ended, ICRIN was making its expertise in clinical trial organisation, research readiness and sponsorship available to the clinical research community to build capacity and to move to a standardised and harmonised approach to research. ICRIN was actively involved during the year with our European colleagues in building the preparatory phase of the European Clinical Research Infrastructure (ECRIN) and benefiting from their approach to supporting multi-centre clinical studies across Europe.

Training in Clinical and Translational Research

Good work was also done in building the human capital for clinical and translational research. A major gap in GCP training has been filled and over 80 people were trained through the courses offered by ICRIN. MMI coordinated a very successful week long programme and organised the annual scientific meeting for the 22 MMI clinician scientist fellows (CSF) in July in NUI Galway. We commissioned an external review of the CSF programme which was very complementary of what has been achieved and provided useful recommendations for maximising the impact of the programme. The shared curriculum for the CSF programme is currently being mainstreamed as a programme to be available to all medical graduates undertaking PhDs in clinical and translational research. MMI staff worked closely with Professor Larry Egan to prepare a PRTLI 5 proposal for a Clinical and Translational Scholars Programme and a decision is awaited at the time of writing. MMI ran five courses on topics relevant to molecular medicine and translational research, including two new courses, on biostatistics and medical imaging for research. Feedback from all courses has been positive.
 

Supporting Translational Research in Molecular Medicine

Biobanking
MMI had a strong focus on biobanking in 2009. The design phase for GeneLibrary Ireland, an all-island control biobank, was completed and submitted to the funders – the HRB and the Northern Ireland R&D Office  (For a copy of this report please go to: http://www.molecularmedicineireland.ie/page/g/t/4).Unfortunately, the funding agencies did not have the funding to move to the next phase. Responding to the need for a more strategic approach to biobanking, MMI has developed Guidelines for Standardised Biobanking to standardise the collection, processing and storage of biological specimens. The use of harmonised procedures will help to provide the proper safeguards and assurances required for sample quality, consistency and integrity among bio-collections at different sites. MMI is pleased to note that these guidelines have attracted great interest in Europe and are likely to be adopted by the emerging European biobanking infrastructure – BBMRI. MMI has also agreed a position paper on a strategic approach to the development of biobanking on the island of Ireland.

MMI Technology Platform Web-Portal

MMI has developed a Technology Platform Web-Portal with the input of the research community, to promote and showcase the breadth of Technology Platforms and associated expertise that support clinical and translational research in molecular medicine in our partner institutions and collaborators. The Web-Portal also provides details on how these Technology Platforms can be accessed. The MMI Technology Platform Web-Portal can be viewed at the following link: www.molecularmedicineireland.ie/tp_web_portal

Communications and Corporate Governance

MMI also improved its communications. The MMI electronic newsletter was an important initiative in bringing MMI’s messages to a wider audience and four issues were circulated in 2009. The website has been developed in a way that will support the wider engagement of the research community. MMI’s Annual Report 2008 was particularly informative and readable. For a copy of this report please go to: http://www.molecularmedicineireland.ie/page/g/s/81. From the point of view of corporate governance, MMI also had a good year. MMI lived within its budget, agreed a budget for 2009/10 and secured a ‘clean’ audit. All reports to funders were completed to a high standard.

Forward Look - What does 2010 hold?

So MMI faces a new year and the new decade in good shape. As mentioned above, MMI’s unique selling point is its potential to mobilise the strengths of the partner institutions and its associated hospitals, to build a national system for clinical and translational research. This national system is necessary to translate research in molecular medicine into innovative diagnostics, therapies and devices that will improve the health of the population and contribute to economic development. A national system for clinical and translational research can become a virtuous circle for innovation. The good news is that same system can serve the needs of academic researchers, industry-led research and those SMEs and start-ups that need access to clinical resources to bring their prototypes to market.

Over the next few years, MMI’s greatest contribution to the national agenda on innovation will be to integrate the capacity and expertise of the partner institutions and associated hospitals to complete this national system and make it accessible to all who need access to clinical resources. The Government’s Health Research Action Plan and the HRB’s Corporate Strategy emphasise the importance of building national capacity in clinical research, both to improve the health of the nation and to add value to the economy. MMI is committed to playing its part in this major national endeavour and all its activities in 2010 are directed to this end.

Damian O’Connell MD BSc PhD
Chair, Molecular Medicine Ireland