Developing Standards for Cell and Gene Therapy Product Monitoring

Join CDISC and Embleema as we share our plans to develop new standards for experimental assays and bioinformatics protocols to facilitate monitoring the activity of Cell and Gene Therapy Products (CGTP). Initial projects will focus on the following three areas:

• Protocols for experimental assays and bioinformatics pipelines for evidence generation and submission to the regulation bodies
• Provenance and privacy with relation to the patient CGTP datasets
• Longitudinal data linkage and patient engagement

The new standards are intended to create opportunities to accelerate drug development and regulatory approvals in personalized medicine and bring associated costs down.