Kennon Daniels

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.

Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies

Translational Research - Biomarkers - Assays

Optimizing Immunohistochemistry Validation and Regulatory Strategies

Nov 15, ‘24 | 8 min read
- Kennon D.
- Christie .
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Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

Translational Research

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

Apr 17, ‘24 | 4 min read
- Kennon D.
- Margaret C.
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Read: Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies

Translational Research - Gene Therapies

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

Feb 12, ‘24 | 5 min read
- Kennon D.
- Margaret C.
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Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

Translational Research - Gene Therapies

8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

Feb 05, ‘24 | 6 min read
- Kennon D.
  
  Travis H.
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Read: Going Beyond Viral Detection: COVID-19 Diagnostics

Biospecimens

Going Beyond Viral Detection: COVID-19 Diagnostics

Feb 17, ‘21 | 3 min read
- Kennon Daniels
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Read: Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics

Translational Research

Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics

Feb 04, ‘21 | 2 min read
- Kennon Daniels
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