Periodic Reporting for period 1 - StableVax (Commercialisation of a world changing invention for the stabilisation and delivery of vaccines)
Période du rapport: 2015-09-01 au 2015-10-31
Stablepharma have developed a revolutionary vaccine stabilisation process incorporating an autodestruct syringe delivery system that has the capacity to make a significant contribution to world health by eliminating the costly and wasteful cold chain that is currently required to keep vaccines viable. The vaccine cold chain currently costs approximately €1m each day and can fail at any stage resulting in the wastage of over 50% of vaccines and more seriously, the potential for administration of ineffective vaccines.
The full economic and health consequences of such failures are significant and the Stablevax system will be a game-changing solution to this global problem.
We have undertaken a range of activities as part of our successful Phase 1 project and are now in a position to begin the final phase of work in readiness for product launch. Our process is fully patent protected in Africa and we have determined that we have full freedom to operate in this area. We have also reviewed the full specification of the process and the product required for protection. We have already begun an accelerated programme to ensure full protection in eleven international territories. As part of our regulatory obligations, we have contracted an expert, Dr Anil Chawla from Chimera Gentec, to direct our regulatory and commercialisation activities. He has many years’ experience in this field and in engaging with the World Health Organisation which will be one of our first customers. We have demonstrated that we have an acceptable yield rate of vaccine (>90%) after it has undergone the stabilisation process. This finding has been replicated in independent laboratories showing the consistency and reliability of our novel technology.
We have undertaken a range of activities as part of our successful Phase 1 project and are now in a position to begin the final phase of work in readiness for product launch. Our process is fully patent protected in Africa and we have determined that we have full freedom to operate in this area. We have also reviewed the full specification of the process and the product required for protection. We have already begun an accelerated programme to ensure full protection in eleven international territories. As part of our regulatory obligations, we have contracted an expert, Dr Anil Chawla from Chimera Gentec, to direct our regulatory and commercialisation activities. He has many years’ experience in this field and in engaging with the World Health Organisation which will be one of our first customers. We have demonstrated that we have an acceptable yield rate of vaccine (>90%) after it has undergone the stabilisation process. This finding has been replicated in independent laboratories showing the consistency and reliability of our novel technology.
As part of our Phase 2 project, we will progress up to 10 vaccines into pre-clinical testing to demonstrate the safety and efficacy of the stabilisation process. This will be rapidly followed by a clinical trial in human subjects. A plan for manufacture has also been developed as part of our Phase 1 project and we have draft design plans of the machinery required along with estimated costings. A full Business Plan has been prepared incorporating the outputs of the Phase 1 project outlined above, and details both technical and commercial goals including our best routes to market and a robust publicity strategy to ensure there is global awareness and uptake out the Stablevax system.