The Pistoia Alliance has been looking at the area of Companion/Complementary Diagnostics* (CDx) and considering how data standards could be aligned better between the research and regulatory environments to reduce time and costs for the development of CDx – especially when using large data sets that have been generated in the clinic using NGS technology.

The Pistoia Alliance is looking at the challenges of regulatory compliant development of Companion/Complementary Diagnostics* (CDx) using Next Generation Sequencing (NGS). Can data standards used in the research environment be aligned better with data standards used in the regulated environments? If so, the time and cost of developing CDx could be reduced – especially when using large NGS data sets that have been generated from exploratory studies.

  * Companion Diagnostic: A companion diagnostic is a medical device, often an in vitro device (IVD), which provides information that is essential for the safe and effective use of a corresponding drug or biological product.
  * Complementary Diagnostic: A complementary diagnostic is a test that aids in the benefit–risk decision–making about the use of the therapeutic product, where the difference in benefit–risk is clinically meaningful. Complementary IVD information is included in the therapeutic product labelling.

* 1. What is your role in the Life Science R&D & Healthcare ecosystem?

* 2. How would you define your area of work? (you may select more than one answer)

* 3. What sort of data do you work with? (you may choose more than one answer)

* 4. Do you work with biomarkers or CDx?
(Biomarker = a biologic feature that can be used to measure the presence or progress of disease or the effects of treatment)

* 5. What do you see as the key issues for progressing biomarker/CDx? (you may choose more than one answer)

* 6. What differences do you see between the Discovery and the Clinical Research and Development environments? (you may choose more than one answer)

* 7. What would enable you to re-use Discovery or Clinical Research and Development data as part of a regulatory filing?

* 8. What degree of experience does your organisation have in using NGS data for regulated purposes?

* 9. Are there any other comments you would like to make?

* 10. Please enter your contact details: