#BIOSPAIN2023 Interview | "Spain has become a global benchmark in clinical trials in recent years"

Spain is solidifying its position as one of the world leaders in clinical research. According to data published by the Spanish Clinical Trials Registry (REEC), coordinated by the Spanish Agency of Medicines and Medical Devices (Aemps), Spain concluded 2022 with more than 900 ongoing clinical trials. In recent years, Spain has climbed the ranks among European countries with the best conditions for the development of clinical trials.

The research conducted in both research centers and biotechnology companies in the healthcare sector is built on promising foundations in terms of business development, thanks to the high scientific level of researchers and entrepreneurs.

Despite the positive outlook we see in clinical research and Spain's strong international standing in basic research, there is a need for a significant push in translating that knowledge and overcoming the substantial barriers that exist for the final development of a treatment that ultimately benefits patients.

This scenario also presents other challenges, such as the need to promote public-private collaboration and make the most of digitalization, challenges well-known to Farmaindustria, the National Business Association of the Pharmaceutical Industry, and Bronze Sponsor of BIOSPAIN 2023, an international reference event in the biotechnology sector. We discuss the challenges of translating scientific knowledge into tangible benefits for patients with Amelia Martín Uranga, Director of Clinical and Translational Research at Farmaindustria.

AseBio: What is the current landscape of clinical trials in Spain?

Amelia Martín Uranga. Spain authorized 924 clinical trials with drugs last year, according to the Spanish Clinical Trials Registry (REEC), coordinated by the Spanish Agency of Medicines and Medical Devices (Aemps). This number is higher than the figures recorded in 2018 and 2019, the years before the pandemic, when 800 and 833 clinical trials were authorized, respectively. 86% of these trials were initiated by pharmaceutical companies.

Another significant statistic for our country is related to rare diseases, which accounted for 25% of the clinical trials conducted last year, totaling 230 trials. This data has seen significant growth in recent years, with 73 studies aimed at testing orphan drugs in 2018 and 117 in 2019. Despite advances, rare diseases remain an important area of development for biomedical research, as only 5% of these conditions have an available treatment.

Furthermore, a total of 166 clinical trials involved children or adolescents as patients. The pediatric field has also experienced substantial growth in Spain in recent years, with an increasing number of studies since 2016 when there were 108 pediatric drug trials, a 35% increase from last year. In fact, Farmaindustria has been working in collaboration with the Spanish Network of Pediatric Clinical Trials (Reclip) and the Hospital Sant Joan de Déu, an international reference in this field.

AseBio: What are the differences in the Spanish research ecosystem compared to our European neighbors?

Amelia Martín Uranga. In recent years, Spain has become a global leader in clinical trials, thanks to the commitment of the pharmaceutical industry, which finances nearly nine out of ten studies conducted in our country (86%), and the successful model of public-private collaboration. This model, which we have been working on for years with authorities, regulators, research centers, hospitals, healthcare professionals, and patients, is what has set us apart from other countries in our region and made us a global reference in clinical research.

In Spain, we are also well positioned in basic research, although greater funding for science would undoubtedly be needed. Where we have more shortcomings - and here our European neighbors outperform us - is in bridging the so-called "valley of death," which is the gap between the point projects usually reach in the academic realm and the level of maturity typically required by pharmaceutical companies. Although steps are being taken in the right direction, there is still much room for improvement.

Spain can leverage its leadership in clinical research and extend it to preclinical and translational research to become a global hub for biomedical innovation and the discovery of new drugs, within an exemplary public-private collaboration framework and with the support of various instruments such as the PERTE Vanguard Health.

The future of biomedical innovation in Spain will require the creation of a true national ecosystem to promote biotechs and facilities for the production of biological drugs and advanced therapies.

AseBio: What is the role of the biopharmaceutical industry in the development of this ecosystem?

Amelia Martín Uranga. As I mentioned, 86% of clinical trials initiated in this country are sponsored by the pharmaceutical industry. The companies established in Spain possess the right structure, experience, results, and willingness to continue growing and solidify our country's leading position.

Perhaps the most significant factor in understanding their role in the innovation ecosystem is the investment made by this sector in Spain in R&D. The innovative pharmaceutical industry based in our country reached its highest level of research investment in history, as reflected in the latest R&D Activities Survey conducted by Farmaindustria among its members. In 2021, it exceeded €1.267 billion, representing a 9.2% increase compared to the previous year, 2020. The consistent commitment of this sector to R&D is evident as it now accounts for nearly 20% of all industrial R&D conducted in our country. This represents over 9% of the total R&D carried out by the entire business sector in Spain and 6.1% of the overall research in the Spanish economy, including both public and private sectors.

The leading role played by our sector in research activities, crucial for drug development, is an opportunity to attract international investment to the healthcare system and therefore to the country. It is also an opportunity for patients and society as a whole, as participation in a clinical trial can be the only alternative for certain seriously ill patients. In this regard, I would like to highlight that the allocation for clinical research has been increasing in recent years to €789 million, which is 60% of the total R&D investment in the sector in Spain.

Undoubtedly, we are at a moment of opportunity, as we have presented to the government in the Strategic Plan for the Pharmaceutical Industry, which includes sector objectives of a total investment of over €8 billion in Spain over three years. In terms of areas, biomedical research will account for more than half of this investment effort, with €4.3 billion, to strengthen Spain's leadership in clinical trials and enhance translational and preclinical research.

AseBio: What are the main barriers we encounter when translating the generated knowledge into tangible benefits for patients?

Amelia Martín Uranga. It is true that there is still a significant challenge in transferring knowledge in the early stages of biomedical research. Therefore, it is necessary to incentivize public-private collaborations specifically focused on crossing the "valley of death." This would involve more precisely targeting existing public funds to significantly reduce the inherent risk in early biomedical research.

Here, I would like to emphasize that the research and development of new treatments, until they reach patients, is a long, complex, and costly process. It takes between 10 and 12 years to develop and deliver a new drug or vaccine to patients; only one out of every 10,000 compounds investigated ultimately makes it to the market, and developing a new drug requires an average investment of €2.4 billion.

It is also important to note that the research efforts of so many people, including healthcare professionals and patients, are of no use if they cannot benefit from the use of innovation to improve healthcare provision and, in the case of patients, their lives. With a reform of the national pricing and reimbursement procedure, greater clarity in funding criteria, an early access mechanism for innovations, coordination mechanisms to ensure equitable access among autonomous communities, and a more agile and efficient drug procurement framework, we must ensure that new drugs reach patients who need them as soon as possible.

AseBio: Farmaindustria has a program called Farma-Biotech, an initiative that was launched 10 years ago to promote biomedical research in Spain. How does it work?

Amelia Martín Uranga. The major challenge in drug research is to identify knowledge wherever it may be and assume the high cost of developing that potentiality, with a high risk of failure. Farma-Biotech, which was established in 2011, helps connect research teams and small companies that generate knowledge with pharmaceutical companies that, in addition to generating their own knowledge, have the experience, leadership, organizational capacity, and investment capability to demonstrate that this option can truly become a therapeutic solution.

The pharmaceutical industry's interest in finding new biologically derived drugs is increasing and needs to do so while maintaining affordable costs, which encourages the approach of finding products in development in research centers or small start-ups with which effective collaboration agreements can be reached. This way, economic benefits can be generated for both the pharmaceutical company and the biotechnology company or research center, which, without the impetus provided by such an agreement, would face enormous difficulties in advancing the project to advanced stages of clinical research.

Ten years later, it can be said that the initiative is on the right track as a bridge to connect both worlds. Since 2011, Farma-Biotech has analyzed a total of 733 biomedical research projects, of which 139 projects have been selected. A total of 51 companies and 36 research centers and hospitals have participated in the events, presenting the selected advanced research projects for their innovation potential, along with 48 different pharmaceutical companies. In total, more than a hundred stakeholders from the public and private sectors.

AseBio: How has biomedical research evolved in Spain over the last decade?

Amelia Martín Uranga. It has clearly been a success story that has allowed us to achieve the prominent position we are in now, as I mentioned earlier, thanks to the public-private collaboration model.

We have done well in Spain, and we must persevere in collaboration to adapt to the new European environment. The new European Clinical Trials Regulation, fully applicable since January 2022, harmonizes and coordinates the evaluation of a clinical trial at the European level and also provides a more competitive framework. If we want to continue gaining ground and consolidate our leadership, we must continue improving infrastructure and increasing resources dedicated to research. It is an opportune time for this, and as a country, we must all work towards achieving it.

AseBio: What does Farmaindustria expect from BIOSPAIN 2023?

Amelia Martín Uranga. This edition of BIOSPAIN in Barcelona continues to be a reference for anyone involved in the research system both within and beyond our borders. At Farmaindustria, we are convinced that it will serve to continue taking steps forward and building bridges to propel biomedical research in Spain. In fact, we are organizing a panel discussion on Wednesday, September 27, starting at 5:30 PM, on the importance of ensuring knowledge transfer.

Addressing some of the bottlenecks surrounding preclinical research and the deficiencies in Spanish public research systems to bring the results of their efforts from basic research to a point that is attractive to the pharmaceutical industry will be one of the objectives of the panel, with the participation of various stakeholders and discussions on successful initiatives in the field of public-private collaboration in preclinical research. I invite everyone not to miss it.