Biomarkers European Special Interest Group (SIG)

Objectives

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

 

Upcoming Events

In February 2024, we will be collaborating with the Data Visualization ESIG, as part of a Wonderful Wednesday edition leveraging a vaginal microbiome dataset, led by Mathilde Saccareau.
In June 2024, for the second year in a row, we will be hosting a 90'-session on the topic of biomarkers at the PSI Conference 2024!

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)
    • See you 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 for 2023

Here are our 3 topics of interest for the year:

  • Biomarker-based designs
  • Machine Learning for Biomarker Analysis
  • Identification of publicly-available datasets to create a data repository
    👉 The data repository 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@astrazeneca.com ; LinkedIn).

 

Who we are

The members of the Biomarkers European SIG can be found below:

    NameCompany/Institution
    Ali FarnoudBoehringer-Ingelheim
    Andreas GustavssonAstraZeneca
    Azra KurbasicLeo Pharma
    Corinna ElzerStaburo
    Dana BotesteanuCytel
    Debasree PurkayasthaAstraZeneca
    Deepak ParasharUniversity of Warwick
    Denis EngemannRoche
    Dimitrios DoudesisUniversity of Edinburgh
    Duleek RanatungaPearBio
    Eliana Garcia CossioBayer
    Esha MohamedAstraZeneca
    Federico AgostinisEvotec
    Florian LipsmeierRoche
    Gaëlle Saint-HilarySaryga
    Gilles GuillotCSL Behring
    Graham HealeyOncimmune
    Guillaume Desachy (co-chair)AstraZeneca
    Gunther JansenNovartis
    Hoda SharifianAstraZeneca
    Holly ToveyInstitute of Cancer Research
    Inoncent AgueusopSanofi
    Ivan KryukovBayer
    Jakob VowinckelBiognosys
    Jan WiemerThermo Fisher Scientific
    Jinesh ShahCSL Behring
    Karl KöchertBayer
    Kevin YarBiognosys
    Kostas SechidisNovartis
    Laura GoeaBayer
    Laura SchliekerStaburo
    Lidia SacchettoBayer
    Louise BaschetHoriana
    Lucas ThorntonParexel
    Marco SalvatoreAbzu
    Marie-Karelle RiviereSaryga
    Marie-Lise GrisoniLabcorp Drug Development
    Marzia ScelsiRoche
    Mathilde SaccareauPierre Fabre
    Nicole Krämer (co-chair)Boehringer-Ingelheim
    Nils TernèsSanofi
    Nohaila BazineSanofi
    Onyeka ObuayaUniversity of Edinburgh
    Perrine SoretServier
    Pok LoUniversity of Edinburgh
    Samantha ThompsonAstraZeneca
    Sandra Gonzalez MaldonadoBoehringer-Ingelheim
    Sébastien MarqueHoriana
    Shreyan BanerjeeGSK

     

    Meeting Minutes

    2023-04-19: Minutes of Biomarkers SIG April 2023 meeting - A new molecular classification in primary Sjögren’s syndrome

    Another month, another great monthly meeting! 🤩
    This time, Perrine Soret shared with us some of her work at Servier (PMID: 34112769) to implement a new molecular classification to drive precision treatment strategies in primary Sjögren’s syndrome, using a methodology developed by Mickael Guedj some years ago.
    A very interesting paper leveraging the power of the IMI-PreciseSADS consortium.


    We also caught up on our three priorities for the year:

    1. Biomarker-based designs
    2. Machine Learning for Biomarkers, co-led by Kostas Sechidis & Nils Ternès
    3. Identification of publicly available biomarker datasets, led by Guillaume Desachy

     

    ⏩ Up next?
    The SIG is working hard on the session at the PSI Conference later this year!

    📅 Next meeting: May 17th 10AM CET. If you want to join us, reach out to @nicole or me.


    2023-03-15: Minutes of Biomarkers SIG March 2023 meeting - Digital Biomarkers

    At this month’s meeting of the European Biomarker SIG, Kostas Sechidis gave a presentation on “Developing digital biomarkers for neurological conditions”. The group discussed different machine learning approaches for digital biomarkers. The topic fits perfectly into the current priorities of the European SIG. These are

    • Biomarker-based designs
    • Machine Learning for Biomarkers
    • Identification of publicly available biomarker datasets

    The group is also busy organizing a dedicated session at the PSI conference later this year!


    The European Biomarkers SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET.  The next meeting is scheduled for April 19th.

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

     

     

    2023-02-15: Minutes of Biomarkers SIG February 2023 meeting - Designing a precision medicine trial

    The theme of the February meeting of the European Biomarker SIG was biomarker-based designs. Guillaume Desachy presented a case study on “From a PhIIa to a seamless 2-part PhII: the journey of designing a precision-medicine early phase trial.” The 20+ participants discussed about adaptive designs combining proof of concept, dose optimization and cut-off detection.

    The European Biomarkers SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET.
    Please contact us if you would like to join the ESIG!

     

    2023-01-18: Minutes of Biomarkers SIG January 2023 meeting

    Happy new year, looking forward to 2023!


    After a busy 2022, the Biomarkers European SIG is very excited about 2023. 🤩
    2023 kicked off with a great webinar and we will also be at the PSI conference later this year! 😍

    In the coming months, we will be focusing on our three priorities:

    • Biomarker-based designs
    • Machine Learning for Biomarkers
    • Identification of publicly available biomarker datasets


    The PSI Biomarkers SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for February 15th.

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

     

    2022-11-16: Minutes of Biomarkers SIG November 2022 meeting

    We had a very productive November meeting, and 15 SIG members joined the call.

    Pok Lo provided a great overview on “Surrogate Endpoints: Practical Implications and Call for International Research Network”. This top is very relevant for biomarkers, and we discussed implications and potential collaborations.  

    We are getting ready for the PSI Biomarkers Webinar in January 2023 – please look out for more details to be posted soon.

    Our group contributes to many other PSI activities, and we plan a PSI Biomarkers SIG session at PSI 2023!  

    The PSI Biomarkers SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for December 21st.


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



    2022-10-19: Minutes of Biomarkers SIG October 2022 meeting

    We had a very productive October meeting, and 18 SIG members joined the call.

    Deepak Parashar gave a great presentation about “Predictive biomarker enrichment designs in Phase II clinical trials”. This started with a nice introduction on the topic and was followed by the latest on state-of-the-art research on that topic.

    The next few months are going to be busy for the Biomarkers European SIG as Nicole Krämer and Guillaume Desachy will be attending the PSI Strategy Day 2022 in November and the whole group is getting ready for our January 2023 Webinar as well as for a Biomarkers European SIG session at the PSI conference in June 2023!

    The Biomarkers European SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for November 16th.


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


    2022-09-21: Minutes of Biomarkers SIG September 2022 meeting

    We had a very productive September meeting, and 16 SIG members joined the call.

    How to use interpretable AI to generate biomarker features from multi-modal data? This was the topic of a presentation by one of the participants, followed by a lively discussion.

    Our first PSI/EFSPI Webinar on Biomarkers will take place in Q1 2023!
    You can look forward to three presentations on our current priority topics:

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

      The Biomarkers European SIG meets monthly, on the third Wednesday of each month from 9AM CET to 10AM CET. The next meeting is scheduled for October 19th.


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


      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 Biomarkers European 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 Biomarkers European 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 Biomarkers European 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 Biomarkers European 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 Biomarkers European 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 Biomarkers European 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!

       

      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


      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