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 November 2024, Antigoni Elefsinioti, Eliana Garcia Cossio and Sandra González-Maldonado will be leading a ML-oriented workshop on behalf of the Biomarkers ESIG at The Effective Statistician Conference.

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 PaperUse 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

We are currently updating them, stay tuned!

Topics of interest 2022-2023

Here are our 3 topics of interest for the year:

  • 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 Aug. 9th, 2024)

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
    Achilleas Livieratos-
    Ali FarnoudBoehringer-Ingelheim
    Andreas GustavssonAstraZeneca
    Antigoni ElefsiniotiBayer
    Azra KurbasicGenmab
    Corinna ElzerStaburo
    Dana BotesteanuCytel
    Debasree PurkayasthaAstraZeneca
    Deepak ParasharUniversity of Warwick
    Denis EngemannRoche
    Dimitrios DoudesisUniversity of Edinburgh
    Duleek RanatungaPearBio
    Eliana Garcia CossioBayer
    Federico AgostinisEvotec
    Florian LipsmeierRoche
    Gaëlle Saint-HilarySaryga
    Gilles GuillotCSL Behring
    Graham HealeyOncimmune
    Guillaume Desachy (co-chair)Pierre Fabre
    Gunther JansenNovartis
    Hoda SharifianAstraZeneca
    Holly ToveyInstitute of Cancer Research
    Hugo HadjurSaryga
    Inoncent AgueusopSanofi
    Ivan KryukovBayer
    Jakob VowinckelBiognosys
    Jan WiemerSanofi
    Jinesh ShahCSL Behring
    Josua BoeserChrestos
    Karl KöchertBayer
    Kevin YarBiognosys
    Kostas SechidisNovartis
    Laura GoeaBayer
    Laura SchliekerStaburo
    Lea ZittlauChrestos
    Lidia SacchettoBayer
    Louise BaschetHoriana
    Lucas ThorntonParexel
    Marco SalvatoreAbzu
    Marie Holst MørchGenmab
    Marie-Karelle RivièreSaryga
    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
    Saskia LesererChrestos
    Sébastien MarqueHoriana
    Shreyan BanerjeeGSK
    Susanne MesslerRoche

     

    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.

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