Working Group 1

Selection and analytical validation
of
biomarker detection technique(s)

Working group 1 will develop a consensus on what biomarker detection technique should be used for specific biomarkers in COPD and biomarkers in general. In addition, it will develop a consensus on how detection techniques should be validated to achieve reproducible detection of biomarkers. Ultimately, Working Group 1 will produce a development plan for biomarkers in COPD and a BBP whitepaper on the selection and analytical validation of biomarker detection techniques to ensure standardized and reproducible biomarker detections for each class of biomarker throughout Europe.

Objectives

To establish a development plan
for biomarkers in COPD

To establish a BBP whitepaper
for selection and analytical validation
of detection techniques.

Tasks

1

To evaluate and select types of mass spectrometry techniques, protein multiplex techniques and high-throughput immune-based techniques that are used to measure protein biomarkers, and of different types of source material that are used for analytical validation of the detection techniques, including evaluation of existing guidelines.

2

To evaluate and select read-out parameters used as criteria for analytical validation of detection techniques for each ranked biomarker (e.g. detection limit, variability, duration of test, high-throughput potential, cost), including evaluation of existing guidelines.

3

To integrate considerations, including FDA and EMA guidelines for eventual market approval, and identified hurdles and solutions for biomarker detection tests and technical validation to define a BBP guideline for:

3.1

Selection of detection technique and source material for each class of protein biomarker

3.2

Selection and analytical validation of biomarker detection techniques for each class of protein biomarker.

4

To develop a whitepaper for BBP for selection and analytical validation of biomarker detection techniques.

5

To identify technical bottlenecks in the methods that will be included in the BBP whitepaper.

6

To set up new research proposals to develop solutions for the technical bottlenecks in the BBP.

Activities

These tasks will be organized through video conferences

  • Tasks 1-8

    WG meeting

  • Tasks 2 & 3

    Short-Term Scientific Missions (STSM)

  • Tasks 4 & 6

    a scientific symposium

  • Tasks 4 & 6

    development of dissemination material and scientific publications

Major deliverables

BBP guidelines on biomarker detection techniques.

New research proposals to develop solutions for technical bottlenecks.

Milestones

publication of bbp white paper on biomarker detection techniques