Global Regulatory Working Group

Elaine Katrivanos

Vice President, Regulatory Affairs

Tempus AI

Co-Chairs

Jennifer Dickey, PhD

Head of Regulatory and Quality

PGDx

Current Projects

  • Exploring the possibility of hosting an in-person meeting in Brussels to engage with several European organizations and formalize a project.

  • The Global Regulatory WG is collaborating with the Data Science working group in writing a manuscript to showcase how BLOODPAC’s standardization efforts in the US could also make an impact in the EU.

    • Qualitative analysis through survey with US and EU BLOODPAC members on MTDE and AV protocol usage.

Participating Organizations

AstraZeneca, Bristol Myers Squibb (BMS), Cancer Patients Europe, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), European Liquid Biopsy Society (ELBS), European Organisation for Research and Treatment of Cancer (EORTC), Exact Sciences, Friends of Cancer Research (FOCR), GlaxoSmithKline (GSK), International Quality Network for Pathology (IQN Path), International Society of Liquid Biopsy (ISLB), Johnson & Johnson, Labcorp, MDx CRO, Merck, Natera, Personalis, Tecan, Tempus AI, Thermo Fisher Scientific

Past Deliverables

Meetings

This working group meets on zoom every other Tuesday from 11:00 - 12:00 PM EST.

Special workshops and sessions:

Not applicable at this time.