Imaging biomarkers (IBs) for safer drugs: validation of translational imaging methods in drug safety assessment


Start Date
End Date
IMI2 - Call 7
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
12 000 000
EFPIA in kind
10 448 317
192 733
Total Cost
22 641 050


Imaging techniques such as positron emission tomography (PET), computed tomography (CT), and magnetic resonance imaging (MRI) are widely used in medicine to diagnose diseases and track how well a patient is responding to treatment. However, imaging biomarkers based on these techniques are not yet widely used in the drug discovery process, although their non-invasive nature means they offer high-resolution insights into toxicity issues early on in drug development. The TRISTAN project brings together academics, small biotechs, imaging and pharmaceutical companies with the goal of validating the use of imaging biomarkers to assess and predict the toxicity of potential medicines on the liver and lungs. It will also improve the use of imaging to avoid side-effects which arise when certain types of drugs, such as therapeutic antibodies, go to the wrong part of the body. The imaging biomarkers will help translate pre-clinical (animal) findings to healthy volunteers and patients, and clinical trial findings to real-world patients, improving the success of drug development.

Achievements & News

TRISTAN reveals impact of drug side effects in lungs
November 2018

Drugs used to treat a wide range of conditions may carry a higher risk of side effects for the lungs than previously thought. This is the result of a review by IMI’s TRISTAN project published in the Journal of Clinical Medicine. The team notes that while the drugs studied work well for most patients, doctors should be more aware of the potential risks to their patients’ respiratory systems.### They also note that more research is needed in this area. The team arrived at their findings after analysing 156 papers with data on 6 200 patients taking 27 drugs to treat diseases like arthritis, cancer and heart disease. Their focus was on cases of drug-induced interstitial lung disease (DIILD). Interstitial lung disease occurs when lung tissue become scarred, making it hard for patients to breathe. The review showed that around 3-5 % of interstitial lung disease cases are caused by DIILD.

‘Though this area is not well researched, we can say that the side effects of drugs on the lung are much more widespread than previously thought,’ said John Waterton of the University of Manchester. ‘We do know it affects a considerable number of people, which is why we want to develop better imaging tests to pick up any lung problems before they become serious. It’s important to stress that patients can safely continue to take their medication - but it’s also important that doctors monitor and assess them closely for side effects in the lung.’ The lead author of the paper, Nazia Chaudhuri of Manchester University NHS Foundation Trust, added: ‘With newer drugs coming on the market this is an increasing yet under recognised problem and we need better ways of detecting these side effects before they cause harm.’ In conclusion, the authors highlight the areas where further study is needed and point out that the TRISTAN project will work on these.

Participants Show participants on map

EFPIA companies
  • Abbvie Deutschland GMBH & Co Kg, Wiesbaden, Germany
  • Bayer Pharma AG, Berlin, Germany
  • Bruker Biospin Mri GMBH, Ettlingen, Germany
  • Ge Healthcare Limited, Little Chalfont, United Kingdom
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, United States
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Deutschland GMBH, Frankfurt / Main, Germany
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Chalmers Tekniska Hoegskola AB, Goeteborg, Sweden
  • European Organisation For Research And Treatment Of Cancer Aisbl, Brussels, Belgium
  • Lunds Universitet, Lund, Sweden
  • Stichting Katholieke Universiteit, Nijmegen, Netherlands
  • The University Of Manchester, Manchester, United Kingdom
  • The University Of Sheffield, Sheffield, United Kingdom
  • Universite Dijon Bourgogne, Dijon, France
  • University Of Leeds, Leeds, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Antaros Medical AB, Mölndal, Sweden
  • Bioxydyn Limited, Manchester, United Kingdom
  • Truly Labs AB, Lund, Sweden
Third parties
  • Centre National De La Recherche Scientifique Cnrs, Paris, France
  • Manchester University Nhs Foundation Trust, Manchester, United Kingdom
  • Sheffield Teaching Hospitals Nhs Foundation Trust, Sheffield, United Kingdom
  • The Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom


Project coordinator
Stéphane LEJEUNE
Project e-mail
Project leader
Gunnar Schuetz