Interview with network coordinator Lilian Walther Jallow
Lilian Walther Jallow, PhD, is a research coordinator for the BOOSTB4 clinical trial at Karolinska Institutet. She is also the coordinator of the Flemingsberg ATMP network, co-founder of the Swedish Network for Advanced Therapies (NAT) and acting member of the ISCT EU LRA regulatory network.
Back in the day…. around 2006, during my second postdoc, the autologous T cell based HIV vaccine project that I was working on moved from an academic project to a newly formed company called Avaris. At the time we started the Network for Advanced Therapies (NAT) to learn from each other and were actually sitting together with the MPA people discussing issues. Here, I learned how to develop pharmaceuticals and what it takes to develop an ATMP from scratch. I have since worked with other ATMPs; NK-cells to treat Multiple Myeloma and more recently fetal Mesenchymal Stem Cells to treat Osteogenesis Imperfecta in unborn and small children (the BOOSTB4 project). I have specialized in drug development and the necessary documentation needed for an approved clinical trial.
ATMPs are, in my opinion, the absolute contrast to the traditional “low hanging fruits” in drug development. They are developed with the aim of treating the, so far, incurable and are often aiming at complex diseases and conditions. In the field there is the feeling of breaking new ground, since there are not that many approved ATMPs out there. I find it stimulating to see that national initiatives such as CAMP/Swelife-ATMP and recently Vision Driven Health are actually bearing fruit, getting people to work together to actually achieve progress. We are doing this for the patients and I finally start to feel that we are moving in the right direction!
I see the need for a new type of platform, where efforts and financing is focussed on the “software” of ATMP development. Necessary endeavors have established facilities, laboratories, infrastructures, equipment etc (the “hardware”) but I think it is high time to step up and finance a platform built on knowledge e.g. providing coaches that can guide people from the academy and small companies through the veritable jungle of documents, agreements and regulations involved in ATMP development and GMP manufacturing. I am convinced that this would save time, money and frustration in the long run. Been there done that, sort of, and I guess now we who went through it can help others.
Another big challenge is financing possibilities for the “next step”, beyond academic grants. As it is now it is possible to finance maybe a Phase I study, but to take the next step is resource consuming and the hope of attracting Venture Capital is scarce in most cases.
The aim of the Flemingsberg ATMP network is to connect available resources with researchers and clinicians and to share our collected knowledge and experience, with the aim of facilitating clinical translation and research. The hope is that the network will assist in spreading information that will make the process of ATMP development from research to patient delivery more effective, and to act as a forum for discussion and assistance in development of practical solutions. So actually very much in line with my “ATMP software platform of dreams”.
I think that people have realized that they do not have to struggle alone. There are colleagues to contact and to help solve difficult problems. One nice thing is that the word appears to be spreading and that we actually seem to reach out with information relevant to many people. The rings on the water effect so to speak.
Working with ATMP in Flemingsberg is great since we have everything close by and a lot of competence is gathered here. We have the University Hospital with interested clinicians and specialized clinics and Vecura that are experts in manufacturing of ATMPs. We further have the newly built pre-GMP laboratory, designed to help people develop their products. We further have many academic groups and small companies working on cell- and gene therapy. Everything is close by, providing an excellent milieu to move the field forward.
…..For the next 3 questions of course we know the answer is BOOSTB4 but humour us….
Oh, I am of course a bit biased here working in the BOOSTB4 project. However, it is actually a project that we as an academic group have managed to navigate through the regulatory landscape out there and the study is now open and recruiting patients. This project is a pioneer in ATMP in Sweden and to be able to navigate and generate this competence within academia is truly something to be proud of.
However there are so many interesting ATMP initiatives here in Flemingsberg; The NextGen NK platform, NextCell Pharma (MSC for diabetes), Fredrik Lanner and Anna Falk (GMP grade, feeder free, xeno free pluripotent stem cells), Samir El Andaloussi (Extracellular vesicles for gene therapy delivery, what a rock star!). Stephan Mielke/CAST/CAR-T, Vecura, the list goes on and on….
I would say; watch out for the Flemingsberg ATMP network satellite meeting on April 1, just before the ATMP 2020 Conference inauguration. There you will get a taste of what is going on here in Flemingsberg- don’t miss out on that opportunity! Rula Zain, Mathias Svahn, Michael Uhlin, Bo-Göran Ericzon, Hans Grönlund, Cecilia Götherström and Marc Willuhn, all great examples of Flemingsberg born and bred ATMP research.
I think that I must mention the company CellProtect here, aiming at treating Multiple Myeloma with in-vitro expanded NK-cells. That project has gone from a pure academic finding (by Evren Alici et al), taken through a successful Phase I clinical trial (lead by Hareth Nahi at the clinic) under the wings of CellProtect, and is now planning a phase II trial. I think here the Flemingsberg milieu has worked wonders to achieve all this.
I want to see ATMPs being used to treat patients in need. For that to happen we will have to work hard and focused, joining forces as we go. My own dream scenario would be to contribute by being able to set up the ATMP software platform in Flemingsberg. I know that I am rubbing this in a bit, but it is really important for good progress!
Check out the ATMP map for more info on Flemingsberg ATMP activities!