Biomarkers European Special Interest Group (SIG)

Objectives

When we restarted the Biomarkers ESIG in 2022, we set some ambitious objectives.
After two years of significant progress to push biomarkers and precision medicine in our field, we decided it was time to sharpen the overarching mission, which is split in three pillars:

1️⃣ We advance Precision Medicine. 
We are on a mission to bring precision medicine to life. We identify innovative approaches, discuss the latest research, and share best practices. We use them to promote the use of biomarkers in clinical development. 
 
2️⃣ We enhance Biomarker Insights. 
We provide solutions on practical topics related to biomarker modeling. We develop and contribute to hands-on guidance, discuss the challenges that we face, and share experiences. This enables the community to generate meaningful biomarker insights for the various stages of clinical development. 

3️⃣ We foster Collaborative Learning.
We build a collaborative and interactive learning community on biomarker topics. We enable active discussions, knowledge sharing, and problem-solving – for the benefit of the wider community, not only for the Biomarkers ESIG members. We offer regular meetings, workshops, case studies, and collaborative projects. 
The definition of these pillars led to the creation of three substreams in the Biomarkers ESIG:

✨ Deciphering one kind of biomarker data at a time 
This substream is being led by Holly Tovey. 

✨ Advancing the application of Machine Learning (ML) & Artificial Intelligence (AI) to Biomarkers 
This substream is being led by Nils Ternès and Karl Köchert. 

✨ Identifying strategic actions necessary to continue advancing precision medicine within our field, ensuring we make it a reality. 

This substream is being led by Achilleas Livieratos.


Upcoming Events

In June 2025, the ML/AI substream will showcase their latest work in a poster at the PSI Conference 2025.
Stay tuned for more exciting events! 😉

Latest achievements!

Here are our latest achievements:

  • 2023
    • PSI/EFSPI Webinar: Biomarker-based design for early phase and Machine Learning, November 2023 (recording & slides)
    • Poster presentation @ EFSPI Regulatory Statistics Workshop 2023, September 2023
    • 90' session @ PSI Conference 2023, June 2023
    • PSI/EFSPI Webinar: Biomarkers in Clinical Development, January 2023 (recording & slides)
    • Review of the FDA Discussion Paper: Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products
    • Review of the EMA Reflection Paper: Use of artificial intelligence in the lifecycle of medicines
    • See 2023 round-up here!

  • 2022
    • Poster presentation at the PSI Conference 2022, June 2022
    • The Effective Statistician podcast episode about the Biomarkers European SIG, led by Alexander Schacht: Biomarkers - essentials to get you started, May 2022
    • See our 2022 round-up here!

     

 

Topics of interest 2024-2025

Here are our 3 current topics of interest:

  • Deciphering one kind of biomarker data at a time
  • Advancing the application of Machine Learning (ML) & Artificial Intelligence (AI) to Biomarkers
  • Identifying strategic actions necessary to continue advancing precision medicine within our field


Topics of interest 2022-2023

Here were our 3 topics of interest across 2022 and 2023:

  • Biomarker-based designs
  • Machine Learning for Biomarker Analysis, led by Nils Ternès and Karl Köchert
  • Identification of publicly-available datasets to create a data repository, led by Guillaume Desachy
    👉 A Shiny App can be found here.


How to get in touch

Interested in joining the Biomarkers SIG?
Please send an email to Nicole (nicole_2.kraemer@boehringer-ingelheim.com ; LinkedIn) or Guillaume (guillaume.desachy@pierre-fabre.com ; LinkedIn).

 

Who we are (as of May 26th, 2025)

The Biomarkers European SIG is co-led by Nicole Krämer and Guillaume Desachy.
The full list of members of the Biomarkers ESIG can be found below:

    NameCompany/Institution
    Abhishek SinghAlmirall
    Achilleas Livieratos-
    Alexander OhnmachtRoche
    Ali FarnoudBoehringer-Ingelheim
    Andreas GustavssonAstraZeneca
    Antigoni ElefsiniotiBayer
    Corinna ElzerStaburo
    Dan LinGSK
    Dana BotesteanuCytel
    Debasree PurkayasthaAstraZeneca
    Deepak ParasharUniversity of Warwick
    Denis EngemannRoche
    Dimitrios DoudesisUniversity of Edinburgh
    Duleek RanatungaPearBio
    Eliana Garcia CossioBayer
    Florian LipsmeierRoche
    Gaëlle Saint-HilarySaryga
    Gilles GuillotCSL Behring
    Graham HealeyOncimmune
    Guillaume Desachy (co-chair)Pierre Fabre
    Gunther JansenNovartis
    Hoda SharifianMolecular Partners
    Holly ToveyInstitute of Cancer Research
    Hugo HadjurSaryga
    Inoncent AgueusopSanofi
    Ivan KryukovBayer
    Jan WiemerSanofi
    Jinesh ShahCSL Behring
    Karl KöchertBayer
    Kevin YarBiognosys
    Kostas SechidisNovartis
    Laura GoeaBayer
    Laura SchliekerStaburo
    Lidia SacchettoBayer
    Lucas ThorntonParexel
    Marco SalvatoreAbzu
    Marie Holst MørchGenmab
    Marie-Karelle RivièreSaryga
    Marie-Lise GrisoniLabcorp Drug Development
    Marzia ScelsiRoche
    Mathias CardnerAstraZeneca
    Mathilde SaccareauPierre Fabre
    Nicole Krämer (co-chair)Boehringer-Ingelheim
    Nils TernèsSanofi
    Nohaila BazineSanofi
    Onyeka ObuayaUniversity of Edinburgh
    Perrine SoretServier
    Pok LoUniversity of Edinburgh
    Rebecca FreudlingStaburo
    Samantha ThompsonAstraZeneca
    Sandra Gonzalez MaldonadoBoehringer-Ingelheim
    Saskia LesererChrestos
    Sébastien MarqueHoriana
    Shreyan BanerjeeGSK
    Stephan BischofbergerStaburo
    Vivek DasNovoNordisk

     

    Meeting Minutes

    Here are the round-ups of our activities since the re-launch of the Biomarkers ESIG:



    The PSI / EFSPI Biomarkers Special Interest Group has been formed with the aim of developing knowledge and opinions within the statisticians about biomarker usage and the related statistical and study design techniques that are involved. We hope to provide a forum for discussion and the sharing of experiences regarding the use of biomarker data across all stages of pharmaceutical development, in topics such as:

    • Developments in Biomarker Statistical Metholodology related to the pharmaceutical development
    • Statistical issues involving the Translation of biomarkers from pre-clinical in-vivo and in-vitro models
    • The development of the statistical expertise on the  use of Omics (genomics, proteomics, metabonomics  and other multiplexed molecular assay systems) as a means for identifying potential biomarkers
    • Statistical issues relating to Biomarkers of safety and toxicity
    • Statistical Validation  and qualification of biomarkers
    • Biomarkers in clinical development, biomarker clinical study designs, stratification of patient populations, prediction of clinical response, diagnostics and related statistical issues in personalised healthcare 
    • The statistical assessment of benefits and costs of using biomarkers

    If you have experience in one of these other areas, or in biomarker usage in general and would like to participate in the SIG, its committee or a future meeting then please contact Athula Herath ( heratha@medimmune.com). Similarly if you would just like to be kept informed of our activities then please get in touch. More info can be found on our pages in the resources section of psiweb.

    Mailing list and LinkedIn Group

    To keep up to date with the activities of the SIG, contact us to join the mailing list. This will keep you up to date with our events and other interesting pieces of news. Similarly, we have a LinkedIn group where you can start and participate in discussions on biomarker related statistical topics.

    Paper - A Statistician's Perspective on Biomarkers in Drug Development

    The SIG's thoughts and advice have been summarised in a review paper in the 10th anniversary edition of Pharmaceutical Statistics (November/December 2011, Volume 10, issue 6). This paper entitled "A Statistician's Perspective on Biomarkers in Drug Development" provides practical advice to statisticians working in the field. It can be found on the journal website here

    In addition an overview of the publication was also presented at the PSI Journal Club in September 2012. Slides and a recording of the presentation can be found from the PSI Journal Club webpage here.

    A list of biomarker related references from the scientific literature can be found here. This includes many references from the review article, but with further additions too. Weblinks are included in the document.

    Omics Web Resources

    A list of web based resources for those new to 'omics work, including genomics, mass-spec etc is being established. This list can be found here in our resource folders.

    Upcoming Events

    PSI Introduction to Industry Training (ITIT) Course - 2025/2026

    An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

    Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

    Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

    Urgent Meeting: Medical Statistician Apprenticeship Scheme

    The UK government have recently announced that level 7 apprenticeships must be fully funded by the employer from January 2026, for any apprentice over the age of 21. With funding for MSc's at an all time low, and universities courses facing closures, the apprenticeship scheme remains as important as ever, as a tool to encourage new statisticians into our industry. In this dedicated meeting, Valerie Millar (chair of the apprenticeship scheme) will provide full updates on the government changes and seek feedback and ideas from employers, universities and apprentices on how to keep this scheme successfully running for many years to come.

    PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

    This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

    One-day Event: Change Management for Moving to R/Open-Source

    This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.