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Webinar - On Demand

Companion Diagnostics: Strategies for Effective Co-Development with Therapeutics

Date: August 1, 2023

Duration: 47 Minutes

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.
 
Questions addressed:

  • 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?

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Speakers

Margaret Curnutte_Square_260px

Magaret Curnutte
Precision for Medicine

More than 10 years of research and regulatory affairs experience focused on in vitro diagnostics (IVDs). She has held regulatory positions at both device and pharmaceutical companies, during which she led seven U.S. and ex-U.S. companion diagnostic registrations. She has extensive expertise in CDx development and clinical trial integration, IVD product development, next-generation sequencing technologies, and translation of U.S. regulatory strategy to major markets.

Kennon Daniels

Kennon Daniels PhD
Precision for Medicine

Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.