TRISTAN

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

Summary

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

For small companies, IMI projects can help tap into new markets

Swedish SME Truly Labs specialises in preclinical research and is a partner in IMI’s TRISTAN project, which is investigating how imaging techniques could be used to improve medicines safety. In an interview with the IMI Programme Office, CEO Karin von Wachenfeldt PhD sets out the benefits of IMI for SMEs. ###‘We’ve definitely found it to be a positive experience in terms of networking and meeting new contacts,’ she says. Looking to the future, she explains that TRISTAN will help them offer even more specialised services. ‘The imaging biomarkers are a very niche product and we will be one of the very few centres in the world that can do that,’ she says. ‘That may attract companies that want to study drugs with a certain type of profile.’ More broadly, she concludes that IMI ‘enables work that cannot be performed outside a bigger team effort’.

Read more

TRISTAN reveals impact of drug side effects in lungs

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

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EFPIA companies
  • Abbvie Deutschland GMBH & Co Kg, Wiesbaden, Germany
  • Bayer Aktiengesellschaft, Leverkusen, 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 Hogskola AB, Goeteborg, Sweden
  • European Organisation For Research And Treatment Of Cancer Aisbl, Brussels, Belgium
  • Lunds Universitet, Lund, Sweden
  • Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
  • Stichting Vumc, Amsterdam, 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

Participants
NameIHI funding in €
Academisch Ziekenhuis Groningen1 010 313
Antaros Medical AB566 025
Bioxydyn Limited1 958 392
Chalmers Tekniska Hogskola AB563 003
European Organisation For Research And Treatment Of Cancer Aisbl691 479
Lunds Universitet716 015
Stichting Radboud Universitair Medisch Centrum1 310 232
Stichting Vumc75 000
The University Of Manchester1 140 882
The University Of Sheffield1 564 036
Truly Labs AB792 146
Universite Dijon Bourgogne204 864
University Of Leeds818 243
 
Third parties
NameFunding in €
Centre National De La Recherche Scientifique Cnrs45 136
Manchester University Nhs Foundation Trust220 140
Sheffield Teaching Hospitals Nhs Foundation Trust313 000
The Leeds Teaching Hospitals National Health Service Trust11 094
 
Total Cost12 000 000