“Biomarker Exchange Standards”

This is another Pistoia Alliance teleconference – to present and discuss in more depth topics emanating from the Hannover Information Ecosystem Workshop – which will take place on Wednesday 18th January 2012 at:

(07:00 to 08:00 -PST), (10:00 to 11:00 -EST), (15:00 to 16:00 -GMT), (16:00 to 17:00 -CET)

Sandor Szalma, Head of External Innovation, R&D IT at Janssen Research and Development will lead a teleconference presentation / discussion on Topic #31 "Biomarker Exchange Standards".

Pharmaceutical companies already registered for this event include: AstraZeneca, Bayer, Boehringer-Ingelheim, GSK, Janssen, Merck, Merck-Serono, Roche, Sanofi. 

Pharmaceutical and biotechnology companies increasingly rely on a network of collaborators for bringing drug ideas through the research and development stages to the market. Typically, these collaborators include academic labs, specialty service providers, CROs and even other pharma and biotech companies.  

The complexity of these networks is increasing and thus the management of data and meta-data is becoming more complex. Exchanging orders and data with these collaborators is in the majority of cases reliant on primitive vehicles such as moving around doc, PDF and XLS files with no apparent standards.  

As one of the first steps, the proposed workgroup – “Biomarkers Exchange Standards” – will develop requirements and use cases to foster the eventual development and adoption of data and meta-data exchange standards for biomarker assays enabling collaboration between pharma/biotech and collaborators.  

Since many assays in the biomarker domain are similar (or the same) to assays in the target validation domain the output of this workgroup should be applicable to the target validation domain and thus target validation stakeholders should be involved from day one. 

Many other domains of the R&D continuum will have to be addressed in separate workstreams such as screening, target identification, toxicity, etc. During the development of these standards attention will be paid to specific challenges such as: 

• Secured real-time information exchange
• IP Protection & infringement
• Process & Data harmonization
• Lack of standard data formats
• Lack of regulatory guidelines around collaboration & networking