Navigating Grey Zones & Growing Pains: Developments in the Regulatory CDx Space

About this webinar

The tremendous advances in the Precision Medicine field are shifting the focus of treatment towards more precise and targeted treatments that leverage intrinsic features of the immune system. As the genetic background of the patient and/or disease determines the efficacy of such therapies, there is a growing need for companion diagnostics (CDx).

The co-development of a CDx between Pharma and IVD manufacturers comes with its own Grey Zones and Growing Pains, with differing regulations, submission processes, and different understanding of the roles and responsibilities. These challenges also offer opportunities to improve the ways of working and increase partnership effectiveness.

What you will learn

During this webinar, Kirsten van Garsse (QbD Group) and Jules Petit (GenDx) will discuss key elements of their joint panel discussion at the 16th World Clinical Biomarkers & Companion Diagnostics Summit Europe and dive deeper into the regulatory impact of current developments and trends in the Companion Diagnostics space.

• Key regulatory developments shaping the CDx landscape
• Grey zones in the co-development of CDx between Pharma and IVD manufacturers
• How differing regulations and submission processes impact partnerships
• Opportunities to improve collaboration and partnership effectiveness

Interactive Q&A

During the live webinar, we would like to answer your questions regarding the regulatory CDx space. You are invited to submit questions during registration or live during the session.