Operator: Thank you. We are now going to take our last question. And the questions come from the line of Manos Mastorakis from Deutsche Bank. Please ask your question.
Manos Mastorakis: Hi, thank you for taking my question. So, there is a lot of enthusiasm and promise on the centralized model, but I’m wondering whether you expect to see any pushback or hurdles in your effort to roll out a broad network of decentralized machines producing autologous products locally. And I’m coming from a standardization or quality control point of view here. Are there any mouth regards discussions with the FDA, and potential green light from the FDA on this aspect until you get…
Paul Stoffels: So, the start of a platform is one of where we highly automate and highly standardize work towards a fully closed loop system, fully closed system to produce CAR-Ts. And we are very far advanced to that, that after administering the apheresis, the white blood cells, and the selected white blood cells and the vector, there is no interaction anymore between that and administering to the patient. So it’s about highly automated, highly standardized way of producing, followed by a highly standardized and automated way of doing the quality release. And that is pulled together in a very expert way at the moment. And we are using that today in our clinical trials in Europe. So we’re delivering CAR-Ts as we speak in the hospital with local release.
A lot of work goes into the standardization of the quality release, also push the button type of testing rather than any manual handling of the testing. And that’s the basis of it. The process also allows to start sterility early in the process, because you have a fully closed system, which allows us at the moment, what we do is to release on day seven when the cells come off the machine. And that has yielded a very good clinical result. We interact extensively so far with the European authorities as we are doing our clinical trials and with multiple local authorities in Europe. And so far so good. We have been able to progress everything with technology as well as with the clinical applications. Our team has had discussions with the FDA as pre-IND and we’re part of the global consultation on this.
Those activities are ongoing. As part of this consultation, they asked us to have a first site up and running in the US, fully validated to be part of the IND. And that is the work we are doing in the first half of this year to make sure we can submit INDs around mid-year, one after the other, NHL and CLL. So out of those discussions, we’ll learn again a lot. But we are anticipating that we will be able to bring these systems. The benefit now of going to the largest sites close to the hospital, like for example, Thermo Fisher and Landmark Bio in Boston allows us to transfer once to highly specialized technical teams which can serve a whole region. So a landmark bio site will be able to serve the whole Boston area. With one to two hour drive, you can reach every hospital in the vicinity and the same in the Bay area with the Thermo Fisher site on the UCSF campus.
And there you can use the whole Bay Area with fresh cells from that site. So it makes our life simpler, probably much more effective, and much less risk if we do the system which we are building now in the U.S. than going to many, many hospitals in the same region. So we are derisking by automating, derisking by standardizing, derisking by standard operations and training, but also by bringing this together into verified express sites.
Manos Mastorakis: Thank you.
Sofie Van Gijsel: Thank you. This concludes today’s call. Please feel free to reach out to the IR team if you still have questions. Our next financial results call will be our first quarter 2024 call on May 3. Thank you all for participating and have a great rest of your day.
Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect your lines. Thank you.
