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Xtalks, Online
2025-01-30
In oncology, companion diagnostics (CDx) are crucial for identifying patients who are most likely to benefit from a particular cancer therapy based on their biomarker status. This personalized approach enhances targeted patient selection, treatment efficacy, minimizes adverse effects, and contributes to more efficient clinical trials by focusing on defined patient populations.
With the increase in the application of CDx in oncology therapeutic development, regulatory scrutiny has intensified. Beginning May of 2025, manufacturers will face more stringent requirements for analytical and clinical validation of laboratory-developed tests (LDTs), including CDx. This shift in regulatory requirements may demand additional resources, lengthen development timelines, and increase operational complexity.
In this webinar, the expert speakers will explore the shifting landscape of CDx in oncology, highlighting key regulatory, assay development and study design considerations for biomarker-guided clinical trials.
Keywords: Clinical Trials, Drug Development, Clinical Research, Oncology, Medical Devices, Diagnostics, Medical Device Regulation, Therapeutic Areas, MDR, Clinical Trial Regulation
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Organized by:
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Xtalks |
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Invited Speakers:
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Meera Belur, Executive Director, Program Strategy, Oncology, Premier Research
Charlie Chrisawn, Executive Director, Program Strategy, Diagnostics, Premier Research
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Deadline for Abstracts:
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2025-01-30
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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