Validation is a crucial part of the journey in the development of a drug delivery technology from the laboratory to the clinic. The key challenge is to ensure consistency between the technical approach and real-world delivery. To address this challenge and to de-risk the process, our approach secures integration, collaboration and communication throughout the programme, including early engagement with end-users to inform technology development and design. Our programme enables engineers access to real-world scenarios, making the operating room and clinic an extension of the lab, delivering regular interdisciplinary workshops, and providing seamless access to the clinical environment to evaluate prototype technologies rapidly and efficiently.
The programme integrates cross-cutting validation through focusing on solutions that are disease-specific, measurable, achievable, relevant and time-bound. Our validation process includes the following scenarios:
- Implantable devices to treat inoperable brain tumours
- Injectable gels to fill cavity after brain tumour resection
- Locally applied supramolecular vehicle suspensions and gels for mesothelioma
- Systemically administered supramolecular vehicles for pancreatic cancer.
This delivery model is designed for maximum health impact and brings ability to fast-track regulatory approval of first-in-human trials.
