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Clinical Trial Assay & CDx Development in the Era of Precision Medicine – Planning for Success

Dr. Jude O’Donnell discusses Clinicial Trial Assay & CDx Development in the era of Precision Medicine.

 

Synopsis

  • Regulatory considerations for assay development, validation & commercialization
  • Choosing the right diagnostic partner: experience, ability to deliver, transparency & trust
  • Biomarker-led clinical trial assay and companion diagnostic development & validation challenges
  • Case study showcasing a recent Almac Biomarker Program with a large global pharma partner
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