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Testimonials from JACIE Inspectors Grant Recipients

JACIE Committee
Inspector Committee

JACIE Inspectors were invited to apply for a grant to attend the 50th Annual Meeting of the EBMT in-person in Glasgow or virtually. Two winners, Korinne Di Leo and Valentino Granero, share their experiences of this year special Anniversary congress:

Korinne Di Leo

LabTCS, UOC Oncoematologia Pediatrica, Azienda Ospedale - Università di Padova, Italy

Coming to the Annual Meeting of the EBMT is always great: four days full of sessions for all professionals working on this field. I gained new insights on advanced therapies and also on the ethical aspects to make sure all patients can benefit from them. Focus had also been given on supportive care demonstrating to have an impact on outcome.

EBMT inspires research, provides education, and creates real networks of relationships via a worldwide approach to clinical studies. This is the result of 50 years of community. JACIE is part of this “Project” and the whole team was present in the main exhibition area, available for any question.

I really appreciated meeting face-to-face and getting to hug some of the Inspector Coordinators and Accreditation Coordinators, who constantly support our activity by email. I met with such pleasure other inspectors and inspected colleagues with whom I shared some time being a JACIE Inspector.

Of course, it was not possible to miss the Quality Management Sessions on Tuesday, which had very interesting presentations about services provided thanks to the JACIE Board, the JACIE Committee and groups supporting Inspections and working on Standards: the 9th Edition is ready!

Some take-home messages were:

See you again in Florence in 2025!

Valentino Granero

Director of Tissue Establishment – Transplant Program A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy

The EBMT hosted its 50th Annual Meeting in 2024 in Glasgow, Scotland. This conference brought together doctors and researchers in the field of stem cell transplantation and gene therapy.

This report explores the most important notions of the conference in terms of educational impact and scientific training. The scientific committee organised the event collaborating with the JACIE committee, giving the opportunity to take part in the meeting through the provision of a grant, being the main recipients of this presentation. The document recounts the experience lived by the author during the participation at the congress through a personal evaluation of the programs, the scientific talks and the different work experiences narrated by the participants. A conference full of novelties: innovative, inclusive and has laid the foundations for important future developments in the field of transplants and gene therapy.

Since its conception in 1974, the EBMT has remained a leading non-profit organisation promoting innovative scientific research and has improved outcomes in stem cell transplantation and gene therapy. This year's Annual Meeting of the EBMT, held in Glasgow, United Kingdom, stood out by introducing all the latest communications technologies to facilitate personalised usability for attendees.

With this congress the EBMT wanted to celebrate its 50 years and retraced its history through a splendid "timeline". This path demonstrates once again the commitment, passion and perseverance of all the people who over time have promoted the progress of knowledge in the field of stem cell transplants and cell therapies.
This article will provide a personal evaluation related to the experience of the Congress.

The EBMT conference attempted to offer talks on all four days focused on all areas of scientific research on cell and gene therapies. The programme consisted of a rigorous series of workshops and training seminars that were specifically thought of, for novice researchers to more experienced professionals, including all professional figures and involving both patient and donor associations. Many of the sessions I attended provided in-depth information to comprehend emerging trends, developments and challenges in the field of stem cell transplantation and gene therapy: through poster sessions, educational symposia and encounters with companies, I had the possibility of creating a job network, with whom I laid the foundations for the development of future scientific work.

In my opinion, the most significant expected outcome from this conference was that healthcare professionals and researchers were able to update themselves on the latest knowledge on cell and gene therapies. The conference provided valuable job networking opportunities between all the professionals involved in these activities, encouraging the exchange of ideas and projects that could help us face the future of transplants in a compelling and safe way.
Surely, there are still many challenges but through being united by sharing and being guided by the scientific community, we will be able to fight neoplastic diseases and obtain the desired results.

This document provides the author's personal resume of the EBMT Meeting which was held in Glasgow, Scotland, in April 2024. The conference enabled the training and scientific updating of healthcare professionals working in the field of stem cell transplants and gene therapies. The same meeting promoted research among the participants by cooperating in networks and bringing together the world's leading experts.

To conclude, the experience was fantastic and I want to thank personally for the work of the organisers:
✓ covered and updated on useful topics for my specific work activities;
✓ proved to be inclusive and respectful of everyone;
✓ stood out in the technological field and in social communications thanks to apps, notifications, messages, possibility to rewatch on-demand recorded sessions.

Annual Meeting 2024 JACIE
Xiu Li Tan, Bruno Di Liscia, Norelys Borrego (JACIE Inspectors and Accreditation Coordinators) with Valentino Granero.

Dimitrios Bourantas

Haematology Consultant, Quality Manager of Hematopoietic Stem Cell Transplant Program, University Hospital of San Sebastian, Spain

My name is Dimitrios Bourantas and I am a Haematology Consultant and the Quality Manager of the Hematopoietic Stem Cell Transplant and CAR-T Cell Program of the Donostia University Hospital at San Sebastian, Spain. I am also a JACIE inspector since November 2022 and I would like to thank JACIE for giving me the opportunity to attend virtually the 50th Annual Meeting of the EBMT, between the 14th and 17th of April 2024, after being awarded with the JACIE Inspectors Grant.

My virtual attendance at the EBMT Meeting was a highly didactic experience on the fields of hematopoietic stem cell transplant and advanced cellular therapies. The Scientific Program was outstanding and I attended various sessions related to my daily job assignments including stem cell transplant complications, CAR-T cell therapies, JACIE accreditation and data management.

On the first Meeting Day, Sunday 14th of April, I attended various interesting sessions where up-to-date information and data of haploidentical transplant, transplant related microangiopathy, hepatic veno-occlusive disease and management of CMV and EBV reactivation were presented. On the second Meeting Day, Monday, 15th of April, I was excited to attend presentations related to immune effector cell therapies. Data of CAR-T cell therapies in new indications like neuroblastoma and autoimmune diseases as well as quality and regulatory processes used to control and monitor these new revolutionary treatments where excellently presented in all talks.

I dedicated the third Meeting Day, Tuesday 16th of April, to sessions related to Quality Management and the Accreditation Process. The talks extensively analyzed important topics related to the JACIE inspection, both from the Center´s and the Inspectors´ perspective. The fourth and last day of the Meeting, Wednesday 17th of April, was an opportunity to review the most recent updates and information regarding the EBMT Benchmarking project and its future strategies.

In conclusion, as the field of stem cell transplant and cellular therapies is rapidly expanding, my recent EBMT Meeting virtual attendance has been an excellent opportunity to keep up to date with all the recent advances in the field. I consider all the knowledge and information I acquired during the Meeting essential in order to keep offering high-quality care to our patients.

Finally, I would strongly recommend to all colleagues working in the field to attend the future EBMT Meetings virtually in case they cannot attend on site. I am looking forward to seeing you all (on site or virtually) at the next, 51st EBMT Annual Meeting in Florence, Italy!

Richard Olaussen

Consultant at the Oslo University Hospital, Clinic for Oncology in Oslo, Norway

"An unforgettable experience"

As I ventured from Oslo to Glasgow to join the 50th Annual Meeting of the EBMT in April 2024, I was full of excitement about what was going to come.  I had already studied the programme in detail, and I knew it was going to be a joyous journey into the past, the present and the future, both personally, as I had visited Glasgow some decades ago, and professionally, as the scent of time, this fulfilling and omnipresent fragrance of jubilant history filled the air of the conference from beginning to end. This proud nation of the Caledonian Heights, which hosted the conference, had always attracted me with its friendly people and its exciting rugged and spiky landscape, which reminded me of home, and allegorically, of how science itself progresses. I also knew how treacherous the trade winds from the North Atlantic could be at that time of the year, so I was prepared for an unpredictable weather. And the location by the river Clyde waterfront emphasized the historical context of the conference even more. It was like the tall ships of the Clyde Heritage came back to life and reminded me that the industrious and inventive Scots were hand in glove with the spirit of the EBMT. It was indeed a love that wouldn’t go.

The programme was incredibly versatile and contained something for absolutely everyone from learners to experts, including patients and donors with their families to every aspect of all subjects, both for professionals of all sorts and for the industry. A multitude of diverse parallel sessions covering a range of typical EBMT topics made it impossible to describe everything in a brief summary. For my own part I prioritized subjects like CAR-Ts, cell- and immune therapies, ATMPs, technology developments, quality sessions, cell collection and a number of joint sessions, certainly including the Opening Ceremony, “50 years of Cellular Therapy” and the Presidential Symposium. I felt like a child in a candy shop given to complete gluttony, eating far too much and feeling exhausted afterwards. Fortunately, it was possible to re-watch the programme afterwards as there were far too many subjects I missed out of. Every day was a joy, and I felt a bit empty when the whole thing was over. Perhaps it could be likened to a scientific party frenzy if something like that exists.

I had received a grant from JACIE to take part at the conference, an organisation at the heart of the EBMT itself, which I profoundly respected and had come to appreciate more and more for its importance in developing and conveying the expected timely standards and level of services provided by the professional bodies of the EBMT. A long career had though me that high quality doesn’t suddenly jump out of a black box by itself. Like in so many walks of life, the pound does not look after itself if you ignore the penny. Trustworthiness comes from paying meticulous attention to details which often can prevent disastrous results, and JACIE is armed with exactly those tools that provide cell therapy facilities with the necessary means to achieve this high level of quality. From the first EBMT start-up to our present day services, there has been an almost unprecedented increase in the complexity of services provided, with successive historical landmarks competing to supersede each other. I dare to claim that presently, it is virtually impossible to maintain a reasonable level of quality for cell therapy services with no quality management system at all. So let me dip vaguely into this notion as there are various views on this.

During a Q&A-session, there was a very interesting “interpellation” by a moderator who suggested that perhaps we didn’t need standards at all, and in fact that such an approach would facilitate further development due to increasing variable practices which eventually (and perhaps magically) would provide comparative advantages that we all could learn from. I have encountered this claim before, but does it really reflect reality, or is it merely a shallow dish with no deeper substance? I’m aware that too much regulation can indeed be counterproductive, and I know of cases where strict regulation seem to prevents good services and flexible solutions. Thus, there is always a need to be critical also about this field. But let me refer to some examples from the EBMT conference itself.

One lecturer on CAR-T-cells showed a slide where patients who received products that were out of specification (OOS) fare much worse than patients receiving products in accordance with expected results. When asked about the details of the OOS production failures, no information was provided as they were company secrets. Whether it was due to failed transfections, low cell number and viability or any other possible reason, was not available for the professional body to assess and learn from. Would it have been possible to amend the outcome for the unfortunate patients? And shouldn’t this have been included in a careful examination by the professional society which is the overseer of this kind of practice? Obviously, a state regulation that provided a certain level of transparency would be helpful.

Another example is how the vein-to-vein time seem to be important for the clinical outcome of certain patient groups. Shouldn’t we expect centres and cell therapy programmes to provide statistics on this as it seems to be so important (just as we do for engraftments)? Quality management is also about e.g. making sure that product labels don’t fall off in the freezer or that products are not mixed up in other ways. Thus, it is clear that many kinds of regulation obviously does not prevent people from “doing different things in different ways and thus accelerating our common knowledge”. To the contrary, the right kind of quality management system provide a real booster to the safety of our practices both for the patients and for us, and this goes hand in hand with the progression of cell therapy science and services. We need to be bound by some constraints to make sure that we do the right things. And it is this attitude and formal quality leadership that gives us all the confidence that patients and the greater society expects from us. Recently, Britain has memorized the blood scandals from the late twentieth century. And this is a reminder of how we all need to watch our steps as well as having an eye for the fantastic opportunities that lie ahead.

Lastly, I would encourage everyone to visit the EBMTs own FACT/JACIE stand at every future conference. Don’t just pass by, but make a sharp U-turn and head for the stand to share a cup of coffee (or whatever) and have a chat with the people there. It is a friendly and welcoming lot, and you will certainly not regret the visit. It is one of the most important visits for my own sake. In a way, it’s like coming home. I am deeply grateful for the JACIE grant, and I’m looking forward to future years of enjoyment and cooperation with this great organisation. See you all inn Florence next year.