Madrid, September 12, 2024.
Spain has unique conditions for the development of innovative medicines and a leading role, not only in Europe but globally, due to the excellence of its healthcare system, the ability to recruit patients, and the quality of the data generated by clinical trials.” This description by Luis Nudelman, Medical Director of AbbVie Spain, was agreed upon by participants at the roundtable on Spain’s Role in Research, held during the Challenges and Opportunities of the Innovative Pharmaceutical Industry event. Nudelman highlighted the dual function of trials, “for the savings they generate in the healthcare system—around 200,000 patients participate annually in Spain—and because they allow patients to receive treatments that are not yet available on the market.” Another “critical and differentiating” element in the field of clinical research “that happens in Spain and not in neighboring countries is the co-creation and collaboration with all involved stakeholders, such as healthcare administrations, patients, and researchers,” explained Reyes Boceta, Director of Clinical Development at GSK Spain. She also pointed to the importance of this activity as a “generator of science, productivity, and investment in infrastructure.” It should be noted that clinical research “is a long process, which consumes a lot of resources, and less than 10% of molecules in Phase I reach the market,” stated Ana Peiró, Medical Director of Oncology at AstraZeneca Spain. “It is everyone’s responsibility to promote innovation from the earliest stages to shorten the timeframes for access to medicines,” she added. These timelines can be reduced by “conducting research in parallel in some stages of drug development, instead of the traditional sequential stages,” Nudelman pointed out.
Public-private research is another differentiating factor in clinical development in Spain, as highlighted by María Perelló, Medical Director of the Oncology Unit at Daiichi Sankyo Spain. Through it, “we all benefit from the exchange of capabilities, innovation, knowledge, and learning, both in the public sector—universities, research centers, and hospitals—and in the private sector, which includes the pharmaceutical, biotech, and technology industries. Public-private collaboration has shown that we can be much more agile, as seen during the pandemic with the record time for vaccine development and commercialization. We must continue to strengthen this; we are at a point of growth, but there is much work to be done, and we need to focus on projects that are disruptive in terms of innovation to stay at the forefront, remain competitive, and face countries like the United States and China,” she added.
The forefront of R&D also comes with new tools like artificial intelligence (AI) and big data. Carlos Galmarini, CEO of Topazium, pointed out that when using these technologies, “first and foremost, we must not lose sight of the goal; the tools are not an end in themselves. The important thing is to have a clear and specific question about the problem to solve based on the available data. AI is not a magic box where we input data and it spits out a result that solves any type of problem. Once we have the data and a well-defined question, we can determine the mathematical model to develop to answer that question. Ultimately, it’s a more sophisticated statistical tool.”
“Then,” Galmarini said, “we need to communicate that result, and for that, interdisciplinary language is essential because the problem to be solved is medical, not engineering, so it’s important to understand the problem from the ground up, the available data, and the semantics of medical data to develop the right mathematical model.” His company, which works in virtual drug discovery and clinical trials, is made up of a multidisciplinary team where “engineers are learning medicine, and MDs are learning engineering.”
Reyes Boceta added that “it is human intelligence that is behind everything. If we are not clear about the question and what we want to solve, we generate completely erroneous outputs; we must differentiate well between technology, digitalization, and innovation.”
To testify to the role that research in the sector plays in Spain, the spokespersons provided examples of their companies’ activities. Nudelman recalled that “AbbVie conducts nearly 100 clinical trials in the country, not only in late phases—10% are in Phase I—and more than 200 people work in R&D in Spain.” The role of GSK’s Spanish subsidiary “is unique,” according to Boceta, because it houses the multinational’s laboratory for the R&D of third-world diseases, such as malaria and tuberculosis, where “we generate the molecules that will move into the clinical phase, covering from their invention to the final phase.” AstraZeneca is carrying out “research partnerships from the earliest stages, where we co-create clinical development strategies for the molecules. An example is the global initiative Partners of Choice, which in Spain collaborates with two centers,” said Peiró. Lastly, Perelló noted that Daiichi Sankyo invests more than 24% of its annual revenue in R&D in Spain. The subsidiary is the company’s second-largest in clinical trials, behind the United States, and one of its most important projects is a lung cancer screening initiative in several Spanish hospitals to detect incidental nodules or previous lung pathology and use AI predictive patterns to identify whether a nodule could be cancerous.”
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