Panel Discussion: Grey Zones & Growing Pains: The Realities of Pharma–Dx Collaboration

• At what stage should the diagnostic partner ideally be involved to ensure technical and regulatory alignment without slowing drug development?
• What does an ideal collaboration model look like under IVDR, balancing innovation speed with compliance?
• Can pharma use any IVD within its drug trial framework?
• Who should take the lead, and the regulatory accountability, in a combined study?

Speakers:

Kirsten Van Garsse

Director Authorised Representative Services & Manager IVD - Regulatory Affairs

QbD Group

Nicole Chaves Petronzi

Senior Director, Global Regulatory Affairs Diagnostics

Eli Lilly & Co.

Jules Petit

Project Manager, Companion Diagnostics

GenDx