CAR-Ts again are very peculiar class of medicinal products. They are living drugs, they are made and manufactured from living hematopoietic cells, collected from patients and in the future, maybe from cells collected from donors. So again, the supply chain is very specific. One product is produced for one patient. There is no batch. There are some specific rules for the management of manufacturing failures, and out of specification products...
CAR-Ts again are very peculiar class of medicinal products. They are living drugs, they are made and manufactured from living hematopoietic cells, collected from patients and in the future, maybe from cells collected from donors. So again, the supply chain is very specific. One product is produced for one patient. There is no batch. There are some specific rules for the management of manufacturing failures, and out of specification products. So, all of that is very different from the use and administration of conventional drugs. And on top of that, as already mentioned, these are extremely expensive medicinal products.
For all these reasons, there are a number of issues that need to be tackled or improved in the near future. And that will go along with the improvement of the regulatory framework. So, what’s being discussed in the multi-stakeholder forum is the likelihood of changes in regulations for cell procurement, with the view to manufacture medicinal products. And this is important to stress that there is a switch in regulatory status between the collection step and the manufacturing and distribution step.
What’s being discussed is alternatives to the central manufacturing organization process. There are still many academic centers that develop point of care manufacturing. So, how do we ensure in these conditions that the compliance with good manufacturing practices is met, that ensure safety and efficacy of the medicine product to be administered to the patient.
And finally what’s being discussed is, how can we improve the success rate and the speed when working to transfer innovative CAR-Ts from preclinical or early clinical phases to the commercial phase? And in particular in Europe, how can we help the building of public private partnerships in order to ensure that European centers and European industries are competitive in comparison to activities taking place in the USA or China or in other parts of the world?
This is a session that tries to bring together all interested parties, whether from the public or the private sector and in this particular field, it is even maybe more important than in other fields, looking at the development of other categories of drugs.