UCL supports towards commercial adoption and NHS uptake of translational small molecules projects.
REVIEW, EVALUATION AND FDA/MHRA APPROVAL:
Once the drugs is effective in clinical trials, the data is gathered and NDA is submitted to the MHRA/FDA for approve the licence of the drug.
The regulating body will review and evaluate the safety and efficacy from all the data provided. If the benefited of the drug out weights an risk that arise, the drug will be approved.
MANUFACTURING AND POST-RELEASE MONITORING:
The Pharmaceutical company will produce the drug in large quantities and available for patient use. Marketing approval needs to be obtained. The drug is given to the patients and they are monitored to look for any adverse effect that may not have occurred in the clinic trails.
Key tips to facilitate adoption - Continuously undertake internal and external stakeholder review of the small molecules:
- The Steering Committee should meet regularly (at least every 6 months)
- Ensure the identification and measurement of tangible data that will support adoption (e.g. outcomes meaningful to ward managers, hospital laboratory managers)
Be mindful of the key ‘facets’ developed for successfully adopted:
- FISCAL OPPORTUNITY: Clearly defined & attractive market potential
- SYSTEM OPERATIONS: Awareness & solutions to operational challenges of delivering the healthcare
- COMMUNICATION: Effective publicity of the biologic throughout its lifetime
- HUMAN FACTORS: Minimized use-related hazards, risks & inconvenience wherever practically possible
- PROOF: Provision of ‘work as done’ evidence (i.e. in both clinical & laboratory scenarios)
- IPR: Secure intellectual property rights as early as possible, then drive for market adoption as soon as possible
UCL’s Translational Research Office (TRO) builds on an increasingly vibrant translational culture across the wider university community by providing integrated support for translational research and industrial partnerships.
UCL has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of therapeutics into the NHS.