2CA Braga – A Model to Follow

Portugal’s most important clinical trial hub is indisputably the Clinical Academic Center of Braga (2CA-Braga), established by Dr Nuno Sousa and his team in 2012 as a clinical research facility for the University of Minho. This marked the first step on the journey to bring Portugal’s clinical research capabilities up to par with its strong footprint in basic biomedical research.

 

Our focus is on replicating [2CA-Braga’s] success and building a network across the country for greater impact

Nuno Sousa, 2CA-Braga

 

The results thus far have been impressive, as Sousa explains. “Leveraging an innovative public-private framework, we transitioned from having almost no clinical trials to conducting over 250 clinical studies, recruiting more than 1000 participants, and employing over 30 full-time professionals dedicated to clinical research.” He continues, “We have rapid recruitment, feasibility responses within 24 hours, recruitment rates consistently above 100 percent, and the first patient recruited in less than 15 days.”

The next stage will be using this model elsewhere in the country and bolstering the overall ecosystem. “A single centre, no matter how strong, might not attract complex trials from major pharmaceutical companies,” admits Sousa. “Therefore, our focus is on replicating this success and building a network across the country for greater impact.”

 

Fundamentals for Growth

Building this network and establishing Portugal as a more prominent clinical trial destination in Europe (the country currently sits behind the likes of Hungary, Finland, and Greece in terms of trial numbers) will take time.

However, as Sousa expands, many of the fundamentals to assume as greater share of continental clinical research are already in place. “Here in Portugal, we have a commitment to regulatory excellence and excel in specific areas, such as clinical neurosciences, imaging, and the associated infrastructure like imaging biobanks. This specialisation allows us to stand out and compete effectively with larger nations in these domains.”

He continues, “additionally, our clinical trial network operates within a national system, which simplifies the regulatory alignment and approval process. We do not have to redo protocols when moving between hospitals. The national system allows for a streamlined approach, eliminating unnecessary costs and the bureaucracy associated with regional disparities that you can find in some other European countries.”

 

Increased Openness to Industry

Portugal’s scientific community is also more open to collaborating with the pharmaceutical industry than ever before, paving the way for greater numbers of private sector-sponsored clinical research initiatives. The Gulbenkian Institute of Science (IGC), one of the country’s leading foundational biomedical research institutions, for its part has long benefited from a partnership with the German firm Merck and has the appetite for more such deals.

 

The institute is becoming more open to engaging with the pharmaceutical sector, recognizing the value of such collaborations, and with potentially significant knock-on effects on clinical trials in Portugal

Monica Bettencourt-Dias, IGC

 

As the IGC’s Principal Investigator & Former Director Dr Monica Bettencourt-Dias explains, “In recent years, the IGC has extended its collaborations with the pharmaceutical industry through its innovation office. Engagements include partnerships with Medinfar and other pharma companies, with a specific focus on developing diagnostic tests, such as during the COVID-19 pandemic.”

Bettencourt Dias admits that “While there may still be some resistance within the IGC community to industry collaborations, the innovation office is actively working to address this. Efforts include encouraging open-mindedness among researchers and facilitating discussions about the potential significance of their ideas in collaboration with companies. The institute is becoming more open to engaging with the pharmaceutical sector, recognizing the value of such collaborations, and with potentially significant knock-on effects on clinical trials in Portugal.”

Companies such as Bayer are already making positive noises around Portugal’s prospectiveness as a clinical trial destination. “Bayer is making a significant investment in clinical trials in Portugal, with approximately 20 clinical trials underway, involving 80 centres, over 800 healthcare professionals and more than 400 patients,” says Marco Dietrich, the company’s managing director and country division head. “We view Portugal as a strategic hub for conducting groundbreaking clinical research and the country even boasted the best recruiting centre globally for one of our Phase III trials.”

 

Tapping the New EU Database

Regulatory upgrades at the European Union level are also positively impacting Portugal. “The recent establishment of a centralised database for clinical trials presents significant opportunities for Sanofi Portugal,” explains Helena Freitas, the French giant’s country lead. “We see this as a positive development that can streamline and expedite the clinical trial process in terms of patient recruitment and trial initiation, making it more efficient and accessible.” Sanofi already has 22 ongoing clinical trials in the country, with ambitious plans to scale up to 78 by 2026.

For Simão Soares, president of national biotech industry association P-BIO, this new database “levels the playing field among countries involved in clinical trials.” He adds that “countries like Belgium that have traditionally been European leaders in clinical trials now find themselves in competition with Portugal and some Eastern European nations, where costs are lower. Portugal has already been engaging in clinical trials and there is certainly a substantial opportunity to expand these efforts further.”

 

Overcoming Hurdles

The main barriers standing in the way of greater numbers of Portuguese clinical trials are bureaucracy and delays. “While our low costs and high level of professional infrastructure are potential advantages, bureaucracy poses a hurdle to the efficiency and speed of conducting clinical trials in Portugal,” explains Mario Martins, general manager at IQVIA. “Currently, Portugal captures around EUR 150 million directly from clinical trials, a considerably lower figure than a country like Belgium, which is a similar size.” He continues, “to be competitive in clinical trials, Portugal needs to address the political and organizational aspects of the process and leverage our prime site network globally.”

 

While Portugal has demonstrated quality, our shortfall lies in timing and living up to our commitments

Filipa Mota e Costa, J&J Innovative Medicine

 

Filipa Mota e Costa of Johnson & Johnson Innovative Medicine – which has enrolled more than 800 patients in multicentre trials in Portugal over the past five years – agrees that bureaucracy is an inhibitor to further investment. “Clinical trials operate independently of national boundaries, and site locations are chosen based on guaranteed quality, commitment, and timely delivery,” she outlines. “While Portugal has demonstrated quality, our shortfall lies in timing and living up to our commitments. Often, clinical trials commence with projections for enrolling a certain number of patients, but actual recruitment falls short due to organisational and healthcare system issues.”

2CA-Braga’s Sousa adds that the “cumbersome bureaucratic processes” in place often prevent a challenge to conducting clinical trials, but that the aforementioned streamlined approach his centre is now taking has reduced their burden significantly.

 

Engaging the HCPs

Making clinical trials a viable and attractive proposition for doctors working in Portugal will be a crucial piece of the puzzle. As Pfizer Country Manager Paulo Teixeira laments, “Clinical trials in Portugal have significant untapped potential and it’s disheartening to observe repeated delays in harnessing this opportunity. The challenge lies in hospitals’ incapacity to establish appealing conditions for healthcare professionals, hindering their active participation and dedication to clinical trials. This issue necessitates political will and commitment to instigate the necessary changes.”

IQVIA’s Martins agrees. “Aligning the incentives for healthcare professionals, particularly those involved in the execution of clinical trials, is crucial,” he says. “There is currently a disconnect where the money often stays at the hospital board and does not directly benefit the professionals conducting the trials, which they see as additional work. Therefore, doctors are not motivated to participate.”

In addition to a lack of financial incentives, many of Portugal’s overworked healthcare practitioners simply do not have the time to engage in activities outside of their core caregiving work. J&J’s Mota e Costa asserts that “doctors involved in clinical trials need dedicated time, or at least a portion of their time, for patient follow-ups and identification.” Bettencourt-Dias of the IGC adds that “providing medical professionals with the necessary time for research remains crucial for fostering a more conducive environment for clinical trials in Portugal.”

 

The Innovation Ecosystem

More broadly, clinical trial numbers in a country are just one metric of a well-functioning overall innovation ecosystem alongside strong basic research, opportunities for biotech start-ups to develop, advanced manufacturing, and market access to innovative therapies. This is still a way off in Portugal, as Pfizer’s Teixeira explains. “The government must prioritize creating attractive conditions not only for clinical trials and digitalisation but also for manufacturing and R&D,” he states.

“This involves showcasing Portugal as a viable option for companies to establish even small-scale production sites. The success of such endeavours may serve as a catalyst, opening doors for more substantial investments, and the government, alongside regulatory agencies, must actively contribute to creating an innovation-friendly environment, ensuring stability and predictability for potential investors.”

Maria Mota

 

We need higher standards and world class levels of management to attract the attention of international partners, pushing our centre and others to flourish further

Maria Mota, iMM

 

J&J’s Mota e Costa adds that “there has been positive momentum in the last five years towards recognising the potential of clinical trials and The Portuguese Agency for Clinical Research (AICIB) was created to expedite research and clinical investigation in the biomedical field. The challenge now lies in translating intent into action. Infrastructure and human resources are in place, but the systems need refinement. The creation of a conducive environment where clinical trials are efficiently approved and executed is the next frontier.”

Dr Maria Mota, executive director of the Lisbon-based Institute of Molecular Medicine (iMM), concludes that “The good news is that Portugal has a little bit of everything, but the bad news is we are not world class players in any one area. At times, we lack the resources and funds are really stretched to the limits, but the main change we need is cultural.”

Developing this point, she proclaims that “People here tend to be quite comfortable but taking on a greater role in the innovation chain requires a push and for people to be ambitious. We need higher standards and world class levels of management to attract the attention of international partners, pushing our centre and others to flourish further.”

 

Learning From Others

Taking lessons from other countries already succeeding in clinical trials is perhaps the most logical move for Portugal. “Instead of reinventing the wheel, Portugal can learn from the experiences of countries like Belgium and adapt them to the local context,” says P-BIO’s Soares. “This process would involve aligning regulatory frameworks, streamlining bureaucracy, and creating a unified entry point, providing international partners with access to the relevant communities and patients without having to navigate the specificities of the country on their own.”

J&J’s Mota has an example even closer to home. “Our neighbour, Spain has made remarkable progress in embracing clinical trials as a significant opportunity,” she notes. “The country has strategically recognised clinical trials as a priority, with the Health Minister behind this. A cultural shift has been achieved by incorporating awareness and training on clinical trials from an early stage in physicians’ education. This recognition by authorities has allowed Spain to establish a system that nurtures the ecosystem, demonstrating a commitment to clinical investigation and creating a mindset where clinical trials are viewed as a crucial component of the therapeutic arsenal to treat patients.”

 

Instead of reinventing the wheel, Portugal can learn from the experiences of countries like Belgium and adapt them to the local context

Simão Soares, P-BIO

 

Spain will also be a touchstone for 2CA-Braga in expanding its network across the country. “The discussions about unifying a connected clinical trial network beyond our centre in Braga are in progress at a national level,” explains Sousa. “The objective is to enhance the autonomy of clinical research centres in Portugal. The current model, where research centres operate as departments within hospitals, lacks the agility needed to meet the deadlines set by clinical research promoters. The goal is to create more flexibility in management and establish a one-stop entry system that facilitates collaboration between different healthcare institutions. While this initiative is still in the conceptual stage, the aim is to replicate successful models implemented by other countries, such as Spain, with the potential to significantly impact and elevate the entire clinical research system in Portugal.”

He concludes, “To attract sponsors effectively, the crucial selling point is not just the excellence of a single centre but the vision of creating a network of strong research centres. Rather than aiming for one or two, the objective is to have four, five, or six robust centres that collectively form a powerful ecosystem. The goal is to empower these emerging centres to achieve a similar position, fostering a collaborative environment that can potentially position Portugal on par with Spain in the clinical research landscape within the next five years.”