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Margaret Curnutte

Dr. Curnutte has more than ten 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.

• Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

  Translational Research - Regulatory

  Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

  Apr 17, ‘24 | 4 min read

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  • Kennon D.

    Margaret C.

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• Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

  Translational Research - Regulatory - Gene Therapies

  Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

  Feb 12, ‘24 | 5 min read

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  • Kennon D.

    Margaret C.

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