Pistoia Alliance CDx, NGS & Regulation Workshop

Pistoia Alliance CDx, NGS & Regulation Workshop, Wednesday 11th April 2018

Royal Society of Chemistry, Burlington House, Piccadilly, London W1J 0BA

AGENDA

09.00           Registration and Coffee

10.00            Overview of the day and planned outcomes

(Mike Furness, Pistoia Alliance)

10.30            Overview of current large-scale NGS data projects

(John Whittaker, VP Target Discovery, GSK)

11.00            Coffee

11.30            What are CDx and the regulatory requirements around them?

(Stephen Lee, Senior Regulatory Policy Manager – IVD Devices Division, MHRA)

12.00            How good is your Next Generation Sequencing?

(Simon Patton, European Molecular Genetics Quality Network (EMQN))

12.30            Notified Bodies – what are they and what do they do? (Liz Harrison, Technical Team Manager, BSI Group)

13:00             Lunch

14:00            Industry Regulatory – Perspectives. Challenges of NGS Companion Diagnostics Development

(Stewart McWilliams, VP Quality & Regulatory Affairs, Almac)

14.30             Cross-Expertise Breakout Groups to discuss:

  • What benefits could aligning the data requirements and standards bring?
  • What needs to be achieved to facilitate this?
  • Identify possible next steps.

(chair: Nadia Anwar, Translational Research Solution Consultant, Oracle)

15.15             Coffee

15:45             Plenary session: Collect ideas, identify next steps and define targeted outcomes

16:30            Networking reception

17:00            Close