Biomarkers European Special Interest Group (ESIG)

Objectives

When we restarted the Biomarkers European Special Interest Group (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 and is currently focusing on ctDNA. 

✨ 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.

Mathias Cardner and Laura Schlieker co-lead the Biomarkers  ESIG since summer 2025.

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:

  • 2025
    • The poster presentation by the ML substream at the PSI Conference in London was amongst four recipients of the Best Poster Award
    • In-depth literature review explored how circulating tumour DNA (ctDNA) is used in clinical trials and surveyed key analytical methods for ctDNA data
    • Knowledge sharing through regular presentations from team members on ML-based topic
    • A collaborative space (GitHub) was created enabling members to work together on practical ML projects
    • Establish a preliminary benchmark for simulating realistic biomarker datasets, supporting evaluation of predictive biomarker detection and treatment effect heterogeneity (TEH) estimation methods
    • Submission of a white paper on non-oncology biomarkers in precision medicine
    • We initiated a collaboration with the WHO and engaged in dialogue with the EMA
    • See 2025 round-up here!
    • 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

    Are you interested in joining the Biomarkers ESIG?
    Please send an email to Laura (schlieker@staburo.de; LinkedIn) or Mathias (mathias.cardner1@astrazeneca.com; LinkedIn).

     

    Who we are (as of 21 November 2025)

    The Biomarkers ESIG is co-led by Laura Schlieker and Mathias Cardner, who took over from Nicole Krämer and Guillaume Desachy in Q3 2025.
    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
      Aslihan Gerhold-AyMerck
      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 DesachyPierre 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 Schlieker (co-chair)Staburo
      Lidia SacchettoBayer
      Lucas ThorntonParexel
      Maike AhrensEvidenze Germany GmbH
      Marco SalvatoreAbzu
      Marie Holst MørchGenmab
      Marie-Karelle RivièreSaryga
      Marie-Lise GrisoniLabcorp Drug Development
      Marzia ScelsiRoche
      Mathias Cardner (co-chair)AstraZeneca
      Mathilde SaccareauPierre Fabre
      Nicole KrämerBoehringer-Ingelheim
      Nils TernèsSanofi
      Nohaila BazineSanofi
      Onyeka ObuayaUniversity of Edinburgh
      Perrine SoretServier
      Pok LoUniversity of Edinburgh
      Rebecca FreudlingStaburo
      Ruben Sethi 
      Samantha ThompsonAstraZeneca
      Sandra Gonzalez MaldonadoBoehringer-Ingelheim
      Sarantis ChlamydasOlink
      Saskia StändlerEvidenze Germany GmbH
      Sebastian VoßEvidenze Germany GmbH
      Sébastien MarqueHoriana
      Shreyan BanerjeeGSK
      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

      AIMS SIG - Open-Source Lunch Bites

      Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry.

      PSI Mentoring 2026

      Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

      PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence

      If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.

      PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities

      This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.

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