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.
Optimizing Immunohistochemistry Validation and Regulatory Strategies
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Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics
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Companion Diagnostics: Strategies for Biomarker Development and Early Phase Clinical Studies
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8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy
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Choosing the Right Partner: Special Sample Needs For In Vitro Diagnostics
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