New TRISTAN Project Leverages Potential of Imaging Techniques in Drug Safety Assessment
TRISTAN (Translational Imaging in Drug Safety Assessment) is a public-private partnership supported by the Innovative Medicines Initiative (IMI) and involving 21 organisations including academics centres, research organisations, small and medium-size enterprises (SMEs), imaging and pharmaceutical companies. The objective of the project is to validate or qualify translational imaging methods as potential imaging biomarkers. The imaging biomarker qualification will be specifically addressed in three areas with a high unmet medical need: the assessment of liver toxicity, lung toxicity and the bio-distribution of biologics. The in-kind contributions to the project of around EUR 12 million by the industrial partners are complemented by IMI-funding in a total budget of EUR 24 million. TRISTAN is led by Bayer and coordinated by the European Organisation for Research and Treatment of Cancer (EORTC), who also leads one imaging biomarker qualification study for cancer drug induced interstitial lung disease.
Imaging techniques are firm components of today’s medical practices, just as the use of biomarkers has become commonplace in pre-clinical and clinical research. However, imaging biomarkers are not widely used in the drug discovery process although they could advance drug safety evaluation, both for pre-clinical and clinical development. Imaging biomarkers have the potential to improve translatability of pre-clinical (animal) data to healthy volunteers and patients and thus could help avoid late stage attrition of development programmes. In addition, functional diagnostic imaging methods used as biomarkers would offer the possibility to confirm drug toxicity mechanisms in humans, including the potential to determine drug-drug interactions.
Data relevant for validation of methods addressed in the project and aggregated data will be made publicly available in compliance with data privacy laws. Significant interactions with existing imaging biomarker initiatives as well as with regulatory authorities will have a strong impact on the future value of imaging biomarker procedures. To sustainably offer access to the validated imaging biomarkers, the three project SME partners are planning to offer respective biomarker imaging services commercially.
About Imaging Biomarkers:
An imaging biomarker is a functional radiographic imaging procedure utilising imaging modalities like Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Positron Emission Tomography (PET). In research and development, imaging biomarkers are used as characteristics to objectively measure biological processes, pathological changes, or pharmaceutical responses to a therapeutic intervention. They have the advantage of remaining non-invasive and being spatially and temporally resolved. Imaging biomarkers have the potential to improve translatability of animal data to healthy volunteers and patients, thereby helping to improve our understanding of drug mechanisms, interactions and metabolic processes.
About the Innovative Medicines Initiative (IMI):
The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. IMI is a partnership between the European Union and the European pharmaceutical industries, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of EUR 3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources.
The research leading to these results received funding from the Innovative Medicines Initiatives 2 Joint Undertaking under grant agreement No 116106. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Sheffield’s role in TRISTAN:
Within this consortium the University of Sheffield are playing a leading role in WP3 in the development and evaluation of novel lung imaging methods for the evaluation of drug induced interstitial lung disease. These include hyperpolarised xenon MRI, proton MRI and quantitative CT methods developed in the POLARIS group. Professor Jim Wild is leading the Sheffield team of investigators, which includes: Professor Steve Renshaw, Dr Andy Swift and Dr Jan Wolber (Visiting Chair GE Healthcare). These techniques will be evaluated in a clinical imaging trial performed in Sheffield in a partnership with clinical investigators from Sheffield Teaching Hospitals and clinical collaborators from Manchester and Leeds. The investigators from Sheffield Teaching Hospital NHS Foundation Trust are: Dr Stephen Bianchi (Lead Clinical Investigator), Dr Smitha Rajaram, Dr Mohammed Akil, Prof David Kiely, Dr Jim Lithgow. The project builds on long standing collaborations with GSK and GE Healthcare in the field of lung imaging technology development and its application in drug development.
Partners in TRISTAN
The project is coordinated and led by:
- European Organisation for Research and Treatment of Cancer, EORTC (Coordinator)
- Bayer (Lead)
- Bioxydyn (Co-coordinator)
- GlaxoSmithKline (Co-lead)
- Antaros Medical
- Chalmers University of Technology
- Université de Bourgogne Dijon
- GE Healthcare
- University Medical Center Groningen
- University of Leeds
- Lund University
- University of Manchester
- Radboud University Nijmegen
- Novo Nordisk
- University of Sheffield/Sheffield Teaching Hospitals NHS Trust
- Truly Labs
More info on IMI: www.imi.europa.eu
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