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The BioRegion of Catalonia has top-notch science in emerging and advanced therapies; a network of first-rate R+I institutes and hospitals, centers like Hospital Clinic and Hospital de la Santa Creu i Sant Pau (pioneers in Spain in developing their own CAR-T with promising results), a good and growing number of startups, spinoffs and scaleups, and investment firms focusing on biomedicine, making it one of the top health innovation ecosystems in Europe. Catalonia is currently home to 60% of all research in this field in Spain and half of all the global benchmark hospitals. 

In November 2022, the Government of Catalonia named Biocat the coordinator of the future Advanced Therapies Hub, which will have the Center for Advanced Therapies of Catalonia as its core facility, located at the Band de Sang I Teixits. “The goal is to apply research, for it to be transformed into healthcare products so it can improve people’s health,” explained Catalan Minister of Health Manel Balcells at the presentation. In this regard, the project will work to guarantee the much-needed transfer, clinical validation, adoption and implementation of these technologies in the healthcare system.

This past February, Biocat held the first meeting of the group of promoters of the hub, with representatives from throughout the value chain (R&D system, industrial and entrepreneurial fabric, venture capitalists and the public administration). The group conducted a primary diagnosis to identify the main challenges to tackle and prepare a three-year action plan, with responsibilities assigned to each of the system stakeholders. The resulting report will be submitted to the Government of Catalonia this October. 

According to Biocat CEO Robert Fabregat, “The top priority for all stakeholders in the value chain, public and private, is to democratize access to these new therapies and make them sustainable for the healthcare systems. To tackle this challenge, we have to rigorously analyze the main barriers and difficulties in carrying it out, as well as reaching a consensus among players with a variety of interests and visions, all of which are essential. The report we are drafting together lays out the specific actions and measures to take in order to advance in promoting and consolidating the hub with guarantees of success.”

An opportunity for the ecosystem

This project is the Government’s clear commitment to positioning Catalonia in an area that has attracted interest from the international community given the positive impact it is expected to have. Among others, the hub will substantially grow the pipeline in clinical advanced therapies, boost Catalan hospitals’ capacity to carry out trials in advanced therapies, generate talent trained in these technologies and develop a local industry in advanced therapies and bioengineering of great strategic interest.

“A countrywide advanced therapies strategy will allow Catalonia to lead innovation in this emerging field,” sums up Lluís Pareras, founding partner of InVivo Capital and member of the group promoting the Advanced Therapies Hub. “It will promote research and scientific development, as well as attracting talent and investment to the sector.” Pareras noted that advanced therapies can be used to transform the treatment of chronic and serious diseases. “With a countrywide strategy, we can promote and facilitate access to these innovative therapies, improving the health and quality of life of the citizens,” highlights Lluís Pareras. “We can’t be left behind. Patients must continue having access to one of the best health systems in the world.”

For Esteve Trias, technical director for Advanced Therapies at Hospital Clinic, executive medical director at Leitat and member of the group promoting the hub, “There is a now or never aspect, because this field is moving quickly and if we don’t hurry, coordinate resources and work together with all the structures and organizations that have these capacities, we could be left behind in a field where we are currently leaders.” This coordination of capacities, warns Esteve Trias, “Doesn’t mean centralizing or mechanizing control. It means accelerating all capacities to advance faster.” Isabel Amat, global head of Innovation and Pipeline Management at Reig Jofre and member of the group promoting the hub, agrees: “It is important for all the stakeholders involved to have a united strategy: we don’t have to stop our individual initiatives, like each hospital’s CAR-T, but we do need to align them and see what role private companies can play, beyond funding these therapies,” noted Amat. 

Need for public-private partnership

The new hub requires coordination among all the stakeholders in the ecosystem. “One of the main focal points has to be encouraging collaboration among companies, universities, research centers, hospitals and other key stakeholders in the field of advanced therapies, and that can include setting up collaboration networks, carrying out joint projects and sharing knowledge and resources to speed up innovation and technology transfer,” explains Lluís Pareras.

Coordination between public and private stakeholders is one of the biggest challenges facing the hub. “Advanced therapies can’t be developed only in an academic setting because it is impossible to get the financial and technological capacity needed for all the therapeutic opportunities. But it can’t be done solely in the private sector either, because we need research and needs analysis from academia to fuel this ecosystem,” notes Esteve Trias. This is why Trias stresses the importance of “creating a public-private partnership system where the public system can fuel the private with guarantees that the returns would not only be channeled into the development of the ecosystem but also ensure access to these therapies through the public healthcare system.”

Hospitals like Hospital Sant Joan de Déu and Hospital Clinic have taken advantage of the hospital exemption pathway for regulatory approval to administer their own CAR-T to patients, but scaling up these treatments systemwide will take the whole industry. “It’s always more controversial to help companies than help research or hospitals, but we have to be brave politically and build public-private consortia so this opportunity doesn’t pass us by because we weren’t able to build a business fabric that can make advanced therapies work outside of research,” warns Isabel Amat.

The funding challenge 

Advanced therapies are expensive to develop, manufacture and administer. “Being well funded and attracting investment to advance is one of the inherent challenges of the hub. If we don’t have the funding, we can build a structure, but it won’t be enough,” warns Esteve Trias, technical director for Advanced Therapies at Hospital Clinic and executive medical director at Leitat.

To this end, €60 million has been earmarked for the Center for Advanced Therapies over the coming three years. However, as part of the hub project, it will also apply for competitive grants and other calls for strategic projects to develop and implement advanced therapies, providing access to other sources of funding (e.g., PERTE Health, ERDF, etc.). It will also work to promote the strategic initiatives the system needs, searching for the funding necessary to carry them out (e.g., current ISCIII and CDTI calls) while promoting and ramping up a public-private partnership to reach deals with pharmaceutical companies on industrial development.

Talent, an essential piece of the puzzle

The lack of specialized professionals is one of the needs found throughout the value chain of the future Advanced Therapies Hub. “When we set up white rooms, we’ll need lots of people trained in quality, regulatory issues, manufacturing regulations, etc. because manufacturing the same drug in several locations takes a level of oversight and quality management that you don’t see in other therapies,” explains Isabel Amat.

In this regard, Lluís Pareras proposes promoting specialized educational and training programs in advanced therapies to attract and develop the talent we need in this arena. “That includes collaborating with universities and research centers to offer masters and PhD programs, research grants and other initiatives to attract and retain qualified professionals,” notes Pareras.

As Robert Fabregat points out, a report will be presented in October that will set out the actions to be carried out in the future. "We have the capacities, the opportunities are there, we just need to generate the necessary connections to take advantage of them and extract the maximum performance", says the head of Biocat.

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