Biomarkers SIG


  • Establish advanced analytical methods to analyse biomarkers for clinical development
  • Increase interaction with other disciplines (medicine, biology, academic research)
  • Connect with other SIGs

Latest achievements!

The Leads of the PSI Biomarkers SIG recently recorded an episode of The Effective Statistician, led by Alexander Schacht:
Biomarkers - essentials to get you started

Topics of interest for 2022

  • Biomarker-based designs
  • Machine Learning for Biomarker Analysis
  • Identification of publicly-available datasets to create a data repository

Potential future topics

  • Incorporating prior biological knowledge and real-world evidence
    • Bioinformatics tools (pathway analysis, network based stratification etc)
    • Signature development and validation
    • Using real-world data as priors in high-dimensional biomarker analysis
  • Machine learning / deep learning and advanced analytical methods in general
    • Methods
    • Software
  • Digital biomarkers and imaging biomarkers
    • Statistical challenges
    • Applications
  • Decision making based on biomarkers
    • Away from exploration only to identification and validation of biomarker effects
    • Joint modeling of biomarker effects and clinical endpoints
    • Biomarkers as surrogate endpoints
    • Adaptive designs
    • Regulatory implications
  • Biomarkers and estimands


Who we are

The PSI Biomarkers SIG members can be found below:

    Andreas KrauseIdorsia
    Azra KurbasicLeo Pharma
    Bie VerbistJanssen
    Boris HejblumInserm Bordeaux Population Health research center
    Dana BotesteanuCytel
    Deepak ParasharUniversity of Warwick
    Duleek RanatungaPearBio
    Graham HealeyOncimmune
    Guillaume Desachy (co-chair)AstraZeneca
    Holly ToveyInstitute of Cancer Research
    Jakob VowinckelBiognosys
    Kostas SechidisNovartis
    Lidia SacchettoBayer
    Louise BaschetHoriana
    Marie-Lise GrisoniLabcorp Drug Development
    Mathilde SaccareauEnterome
    Mickaël GuedjNanobiotix
    Milan GeybelsNovo Nordisk
    Nicole Krämer (co-chair)Boehringer-Ingelheim
    Nils TernèsSanofi
    Perrine SoretServier
    Sébastien MarqueHoriana
    Stevenn VolantPasteur Institute


    How to get in touch

    Interested in joining the Biomarkers SIG?
    Please send an email to Nicole ( or Guillaume (


    Meeting Minutes

    2022-07-20: Minutes of Biomarkers SIG July 2022 meeting


    We had a lively July meeting, with 12 participants joining the discussion despite the summer break.

    After introducing several new members to the group, we planned

    • a joint meeting with the Subgroup SIG on subgroup identification and predictive methods for biomarker data.
    • a collaboration with the Visualization SIG and their Wonderful Wednesdays session. To identify an exciting visualization challenge, our sub stream “Data repository of publicly available biomarker data” will be very helpful.

    We plan to have presentations from SIG members on the two other sub streams “Machine Learning for Biomarker Analysis” and “Biomarker-based Designs” in the upcoming meetings.

    The PSI Biomarkers SIG will meet on a monthly basis the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for August 17th.

    Please contact us if you would like to join the SIG!

    2022-06-22: Minutes of Biomarkers SIG June 2022 meeting

    We had our third meeting of the Biomarkers SIG, with 15 participants discussing biomarker-related topics.

    One of the members of the Biomarkers SIG shared an overview of subgroup identifications methods and how these can be used in the context of biomarkers, be they prognostic or predictive.

    The Biomarkers SIG also debriefed on the PSI Conference 2022 and is grateful for the support coming from PSI, EFSPI and the whole community.

    The Biomarkers SIG is now organizing itself in sub-working groups, focusing on the following topics:

    1. Machine Learning for Biomarker Analysis
    2. Biomarkers-based designs
    3. Building a data repository of publicly-available biomarker data

    The PSI Biomarkers SIG will meet on a monthly basis the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for July 20th.

    Please contact us if you would like to join the SIG!

    2022-05-19: Minutes of Biomarkers SIG May 2022 meeting

    We had our second meeting of the Biomarkers SIG, with 14 participants discussing biomarker-related topics.

    Based on our brainstorming session during the kick-off, we identified three areas that we want to focus on during the next months:

    (1)    Machine Learning for Biomarker Analysis

    (2)    Biomarker-based designs

    (3)    Identification of publicly-available datasets to create a data repository

    Our goal for this year is to organize a webinar later this year.

    Further, we plan to work on a data repository with biomarker data. This can be used for benchmarking and evaluation of statistical methods.

    The PSI Biomarkers SIG will meet on a monthly basis the third Wednesday of each month from 9AM CET to 10AM CET. Due to PSI, the next is however postponed to June 22nd.

    Please contact us if you would like to join the SIG!

    2022-04-20: Minutes of kick-off meeting

    We kicked off the PSI Biomarkers SIG on April 20th with 12 enthusiastic participants, coming from both academia and the private sector.

    After brief introductions, we collectively brainstormed on subjects of interest for this SIG, using a virtual board.  

    To give all SIG members the possibility to contribute, the virtual board will remain open until May 4th and we will then send a poll to PSI Biomarkers SIG members to choose specific topics to be explored in the months to come.

    The group discussed short-term and mid-term goals. These include a poster presentation at PSI 2022 in June 2022 and the possibility to organize a PSI webinar with 2 to 3 biomarkers-related topics in Q3/Q4 2022.

    The PSI Biomarkers SIG will meet on a monthly basis the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for May 18th.
    Please contact us if you would like to join the SIG!


    Upcoming Events

    To be announced

    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 ( 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.

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