Clinical enablement

As the regenerative therapies sector grows, pathways for clinical enablement need to be developed, optimised and implemented.

To address this growing sector need, this program focuses on streamlining access to pre-clinical models, establishing quality metrics and analyses that reflect mechanism of action, and designing and coordinating clinical trials.

Indicative outcomes include:

• Improved in vitro and ex vivo preclinical models to accelerate clinical impact
• Pathways to translate therapies into clinical products
• Use of biomarkers for clinical decision making and the establishment of quality assays
• Improved clinical trial design, optimisation, enrolment and data analysis
• Alignment with regulatory requirements to accelerate translation