Hyllner and Gidlund report from the ATMP group

Johan Hyllner, Head of Cell Therapy, BioPharmaceuticals R&D at AstraZeneca and Eva-Karin Gidlund, Collaboration Development Manager at Cobra Biologics - a Charles River Company are chair and vice chair respectively of the SwedenBIO reference group that contributes to the life science office's work on precision medicine and ATMP.

ATMP has become very hot in Sweden in recent years, why?

– Sweden is an innovation- and research-driven country that currently also has a strategic goal of becoming a “leader in advanced therapies by 2030”. These therapies can not only alleviate and treat severe disease but, in some cases, even cure diseases that are currently untreatable. These new treatments have the potential to become part of standard practice in advanced healthcare in the near future.

Globally, the field is on the verge of a breakthrough. The first ATMP products with proven efficacy and commercial viability have reached the market.

Intriguingly, the Alliance for Regenerative Medicine’s latest report from 2020 showed that there are close to 1100 companies developing advanced therapies for a wide range of diseases and over a thousand ongoing clinical trials of which more than 150 are in phase III.

– Many companies in Sweden are currently making strong progress in the ATMP area and the Swedish government is clearly focusing on this area and has already made important investments through initiatives such as the Center for Advanced Medical Products (CAMP). To some extent, the rapid development of ATMPs can be compared to the previous boom in monoclonal antibodies. It’s fast, not only technically and in terms of production, but also economically and for the benefit of patients. It’s all about keeping up!

You both participated in the ATMP Sweden World Tour, which took place for the first time this May on a global basis. Can you summarize?

– The meeting was arranged under ATMP Sweden’s organization – a national network that brings together a palette of diversified actors and initiatives, all with Advanced Therapy Medicinal Products (ATMP) as a common denominator.

As representatives of SwedenBIO, can you mention some key points to pass on to our members from the ATMP World Tour?

– Yes, the conference gave a clear picture that everyone seems to have the same problems, although the severity of these sometimes differs. Manufacturing competence and skills supply was a recurring issue in almost all sessions. This is a question that we in SwedenBIO’s working group for process development and production have discussed intensively over the past two years as we are many company representatives who see that the businesses are expanding more and at a faster pace than the proportion of trained people does.

– We also believe that it is extremely important that Sweden starts working now (preferably yesterday) to ensure access to competent people. We see clear problems in how academia is currently building new courses, which is usually based on existing courses. This approach often takes too long and can be very costly.

Eva-Karin and Johan believe that when areas are rapidly adapting and changing, such as in the life sciences, it is necessary to find simpler, more effective ways of resource management in order to be able to keep pace not only at a national level but also in the international arena.

– Many of the presenters representing other countries experienced similar skills supply problems, but were also able to describe concrete examples of how education systems have been redesigned to be more responsive to demand. As an example, the UK is currently very advanced in terms of training across the spectrum from basic education to leadership training, but to get there the price tag and government funding has been very high.

Other key points that permeated the entire conference and were reflected globally for the ATMP field were the high cost of manufacturing and goods, partly the lack of a sustainable global supply chain, lack of established assays/animal models and biomarkers of efficacy/potency. But also some gaps in product development and commercialization skills in academia, lack of ability for hospitals to implement ATMP and lack of appropriate payment models for reimbursement, which has long been a problem in Sweden.

– Many also highlighted the problem of getting an innovation all the way to a commercial product, which is of course not ATMP specific, but clearly recurring for ATMP products such as the high maintenance costs, material costs and being able to hire and maintain skilled staff.

– As hospitals usually do not have the opportunity or want to be associated with commercial risks, the healthcare system must work together with industry to collaborate more than ever if ATMPs in Sweden and internationally are to be successful, i.e.. reach out to our patients.

– But apart from the shortcomings highlighted, we think we can see clear areas where Sweden really excels. These areas include our world-leading research in ATMP and our healthcare, both of which are of extremely high quality. In addition, we can pride ourselves on our solid experience in GMP and pharmaceutical manufacturing and the national collaborations already mentioned such as ATMP Sweden. In the field of cell therapy, we are definitely already a world leader in NK cells, MSC cells, hPSCs, and we were very early in CAR-T therapies just to name a few.

Short info about ATMP Sweden

The network aims to accelerate ATMP-based technologies and initiatives in Sweden. ATMP Sweden also provides coordination and communication support between ongoing ATMP activities and works to include all stakeholders and to maintain a comprehensive and updated fact base where also gaps and needs in the Swedish ATMP chain are highlighted. ATMP Sweden runs the website atmpsweden.se where project information and reports from various ATMP initiatives are published. ATMP Sweden works to support and develop national ATMP projects such as Swelife-ATMP, CAMP and ATMP Innovation Milieu (part of Vinnova’s program Vision Driven Health).

ATMP Sweden has an annual national conference which will be organized 18-19 November 2021, but now 26-30 April the first international conference was arranged.