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