Biomarkers SIG

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.

Recent Activity

Biomarker Validation - Case Studies and Approaches

by System Administrator | Oct 10, 2012

The SIG's most recent face to face meeting was held on the 10th October 2012 at MedImmune in Cambridge on the topic of biomarker validation and qualification. Various scenarios for biomarker validation were considered and it was discussed how the burden of proof that needs to be demonstrated varies in each instance. Technical aspects of analytical assay validation were also described. This was a successful meeting with some very informative talks and around 40 attendees.

The following topics were discussed:

  • An Overview of Scenarios for Biomarker Validation

  • The Burden of Proof required to validate a pharmacogenetic biomarker for adverse events

  • A Phase III Alzheimer’s Disease Programme based on Pharmacogenetic markers

  • Difficulties in translation from animal to man: some examples from neuroscience research

  • Biomarker method validation: Fit-for-purpose - statistical considerations

  • Developing Companion Invitro Diagnostic Tests

For details and to see selected slide sets please click here.

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