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Companion diagnostics (CDx) facilitate the use of more targeted treatment options for patients. However, developing and getting them approved can be a complex process. Effective development must follow a strategically sound pathway from biomarker identification to regulatory approval.

In this webinar, experts from Precision for Medicine will discuss the key stages in CDx development, as well as what to consider and plan for at each stage of the process. They will also share recommended best practices for biomarker development, assay selection and validation; the alignment of CDx development and therapeutic timelines; and optimal global regulatory strategies.

This webinar will answer the following questions:

  • How do I select an assay for my registrational study?
  • What do I need to consider if I plan to register for accelerated approval with Phase II data?
  • What regulatory work is required for clinical trials and marketing approval of my companion diagnostic?
  • How do I translate my U.S. regulatory strategy to other regions?

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelists.

Maggie Curnutte
Maggie Curnutte, PhD
Senior Director, IVD Regulatory 
& Quality Consulting
Precision for Medicine
Kennon Daniels
Kennon Daniels, PhD
VP, IVD Regulatory Consulting
Precision for Medicine