Panel Discussion: Innovating Global Rx-Dx Trial Pathways Through Strategic & Compliant Co-Development Partnerships to Deliver Harmonized Precision Medicine Solutions

• When should biomarker evidence trigger CDx development, and how can strategies align with therapeutic goals, clinical endpoints, and regulatory requirements?
• How can organizations build adaptable CDx strategies that support clinical development while addressing regional differences in regulation, testing infrastructure, and clinical practice?
• What partnerships, operating models, and data strategies are needed to embed CDx development across the drug lifecycle and enable coordinated evidence generation and assay readiness?

Speakers:

Adriana Racolta

Senior Director, Global Regulatory Leader, IVD

Bayer

Diarmuid Moran

Head of Precision Medicine & Diagnostics (R&D)

Astellas Pharma

Wendy Valenius

Director, Global Regulatory Strategy, Companion Diagnostics

Pfizer

Zhen Mahoney

Director, Companion Diagnostics Business Development

Agilent Technologies