Precision Medicine: Aligning Research Standards with Clinical Standards

This Pistoia Alliance symposium, sponsored by ThermoFisher Scientific, is the fourth in the series of activities organised by the Pistoia Alliance community of interest on the theme of “CDx / NGS & Regulation – Precision Medicine”

The EU IVDR came into force in May 2017 and will come into effect in May 2022. There is much work to be done to realign CDx R&D processes from the requirements of the old Directive 98/79/EC to the rigours of the new Regulation (EU) 2017/746 and its enhanced demands for CE Marking.

This symposium will address the need to align CDx research processes with best practices in CDx development such that CDx certification by notified bodies might be achieved with minimal re-work leading to substantially improved efficiencies.

Speakers will be drawn from the regulatory, notified body and EMQN domains along with speakers from the biopharmaceutical industry, healthcare delivery and service companies.

Speakers from:

Almac, EMBL-EBI, GA4GH, GSK, MHRA, European Molecular Genetics Quality Network, Genomics England, Notified Bodies, Thermo Fisher Scientific...

Free to Pistoia Alliance Members - $300 for non-members

Background:

In April 2018, the Pistoia Alliance hosted a workshop at the Royal Society of Chemistry in London on the topic of “NGS, CDx and Regulation”.

The objective of the workshop was to identify opportunities better to align CDx data standards and working practices in the research domain and the clinical domain thereby speeding the development, certification and deployment of safe and effective CDx to support precision medicine.

Speakers from GSK research, MHRA, BSI (a Notified Body), EMQN and Almac Diagnostics presented their different perspectives of the opportunities and challenges facing the use of NGS in CDx (the slides and notes can be found here).

One of the key outcomes of the workshop was the realisation that there were several specialist areas which were not as well understood by the practitioners (e.g., regulators, notified bodies, management in biopharma, clinicians and other specialists in related areas) as was desirable. As such, the workshop delegates suggested it would be helpful to create a forum where a basic level of understanding of these different NGS technologies could be considered along with presentations of different use cases demonstrating their different applicabilities.

Three key educational themes were identified:

• NGS Technologies

• Clinical Bioinformatics

• Regulations and standards

The first of these themes, NGS Technologies, was addressed at a Symposium in September 2018. The second at a symposium aligned with the Pistoia Alliance Annual European Conference in March 2019. This symposium on 1st July 2019 will bring together the key actors who will provide an overview of the CDx research practices, the relevant CDx regulations, and the best practices to achieve conformance with those regulations in support of CDx and Precision Medicine.