Replies to post #814824 on NorthWest Biotherapeutics Inc (NWBO)

[Baxers]

I dont believe there would be any need for this hire to oversee privately run clinics too. There is no regulation in the UK (under the ATMP framework) that forbids companies from using third-parties for cell collection so I dont reckon the MHRA would mandate that NWBO have to have QMS oversight of privately run clinics simply for Leukapheresis.

Having said that, there is a nuance here. A leukapheresis centre must hold a Human Tissue Authority (HTA) Licence as the HTA regulates the collection of human cells intended for human application. Now a satellite facility of Advent can piggyback on Advent's existing HTA licence having had due inspections. But a satellite facility would also require an entirely new CQC (Care Quality Commission) certification, which must be obtained before the first patient can be treated. Furthermore, - and herein lies a substantial hurdle to servicing NHS England patients with this facility, - the facility would also require an entirely new JACIE certification, which cannot be obtained until the facility has been operational for at least 12 months (and is mandatory in order to begin servicing NHS patients).

So, based on this, this satellite would only be able to service private patients (and compassionate use & I suppose new trial patients) once the HTA and CQC are received. Thereafter 12 months of private collections would be needed to generate the SOP required to apply for the JACIE Certification. Once received, then the facility can service NHS patients. So, it seems the timeline looks something like this:

Phase 1 (Months 0-6): Fit out the clinic. Secure CQC registration & HTA Satellite status.
Phase 2 (Month 6-18): Open for Private patients & Compassionate Use/ Trial participants only. Use these patients to generate the data and SOP proof required for JACIE.
Phase 3 (Month 18+): Apply for and achieve JACIE accreditation. Once achieved begin servicing NHS-funded patients efficiently.

From what I have read this JACIE certification unfortunately cannot be sidestepped or fast-tracked if the intended end use of this facility is to include NHS patients.