"The way to investigate is changing by the convergence of a series of facts. First, the sequencing of the human genome, which has thrown something more light on genetic diseases and, on the other hand, the way of working in health with data . Based on digital tools and the ability to transform raw data into intelligent data, "said Federico Plaza, Director of Corporate Affairs of Roche Farma, during the day the new biomedical research and access to innovation in Spain: challenges and opportunities that It took place on Thursday.
During the act, organized by the world and medical daily in collaboration with Roche Farma and opened by Miguel González Corral, director of the Editorial Unity Health Area, several experts discussed how research can ensure that drugs arrive earlier to patients. A new biomedical research linked to access to innovation, which feels the foundations of a future development for the benefit of patients, the health system and the whole of the population.
As for the investigation, it does not end when a medication has already been approved by regulatory agencies and begins to be used. The data of this 'real' use are a complement and cause the product to continue investigating, thus knowing elements linked to the safety and efficiency of the medication.
From Roche, the challenge of duplicating investment in research and development has been proposed in the next ten years, regardless of the evolution of its sales. In addition, they have also acquired the commitment to triple and even quintuplicate the benefits for patients in access to new medications.
The research model is changing from a model based on commercial networks to one whose base are knowledge networks and scientists, thus working with system agents involved in research and treatment from the clinical and assistance perspective.
"A sample of trust between the parties has been how access to classical drugs has been managed but essential as therapeutic innovations, such as vaccines and treatments at the time of the pandemic. This opportunity that has been generated with this new relationship of I can not lose it, we have to amplify it, "concluded Plaza.
"I think we are aware, both on the part of regulatory agencies and from the pharmaceutical industry, that at this moment we have an opportunity for change and transformation to make the development of medicines more agile. That we have more effective medications, from Fort and accessible for citizens, "said María Jesús Lamas, director of the Spanish Agency for Medicines and Health Products (AEMPS), during his online intervention.
During his shift, Lamas pointed out that it is inevitable to make some balance of what the health crisis has meant and their management in order to decide from here in the future. "The Spanish Agency for Medicines and Health Products has authorized 172 clinical trials related to Covid treatment, some of the drugs that have most been used, which have been more frequently repeated in trials, have been hydroxychloroquine (23 trials); 11 With Remdesivir, an antiviral; Other 11 trials with Tocilizumab and five trials have proven dexamethasone and other molecules, "explained the agency director.
For example, thanks to these trials, it has been shown that hydroxychloroquine does not have any active roles in the treatment of COVID-19, it could even have an unfavorable profile in terms of safety, especially when combined with azithromycin. Therefore, "70% of studies have been repositioning of classical molecules, which had other indications for which another orientation is sought within the Covid. While 62% have been of non-commercial promoter, promoted by researchers from the National Health System, by the University, but above all health professionals ".
This has converted Spain into the second country, after the US, in the number of clinical trials in Covid, although Lamas pointed out that this is not necessarily good. He explained that it is true that we are a leading country in biomedical research and usually occupy the fourth position. In oncology we are well positioned, something very important because it is a way to contribute from our health system, with the active participation of our professionals, in the development of medicines.
This aspect is also positive because it generates value, the Spanish subsidiaries of multinational companies gain prominence and visibility against other subsidiaries from other countries, something that ends up impact on health and the economy of Spain. "However, so many clinical trials in Covid illustrated another thing about what we were direct witnesses and tried to control it from the agency and it was not possible, the reality is that there has been much more competition than collaboration," said the Director of the AEMP.
Ideally, it would have been that many of these trials that checked the same molecule were made within the same master protocol, with adaptive modalities of clinical models, which are perfectly accepted and that have regulatory utility, but it was not possible, this being the reason Why it is not necessarily good to have a number of trials so high. "It would have been very interesting that these essays would have been multicentric and international, not only an umbrella in Spain that hangs the rest of the trials," said Lamas.
The WHO Initiative of Solidarity trials was intended to cover this need, picked up what I was using in real practice, but submitted to the scientific method in order to extract conclusions. "These essays have been made with some of these molecules that she cited previously and, nevertheless, we were not able to be adhered to Solidarity," added the expert.
Currently, there is only one essay with a vaccine developed in Spain that is active. There is another that is now being valued by the agency, but there is only one at this time that has been authorized and is the vaccine of the veterinary company Hippra, a company with a lot of experience in the manufacture of vaccines in veterinary and with A lot of experience in regulatory procedure.
Another of the conclusions referred to by the Director of the AEMPS is the high potential of the National Health System. It is not only an ecosystem that provides health services to patients, is an ecosystem generating knowledge with a very important number of highly qualified professionals, capable of doing interesting projects and generating scientific evidence.
Since the pandemic, Lamas mentioned how the European Commission has launched at ambitious legislative initiatives such as the European pharmaceutical strategy, which prioritizes the aspects that have been necessary before a crisis. He also noted that it is necessary to have an interoperability of all health data, for which the European health data space will be created with the purpose of primary use of data to give the best cross-border healthcare.
During the first colloquium of the day, Humberto Arnaés, General Director of Farmaindustry, Pilar Garrido, Head of Medical Oncology Section at the Ramón and Cajal University Hospital and President of the Federation of Spanish Medical Medical Associations (FACME), and Cristóbal Belda, Director of the Carlos III Health Institute.
"Spain, in the field of clinical research, is an international reference. We have been the fourth country worldwide in Treatment Testing against Covid-19 and the first European country, which is very significant," harness explained. He also pointed out the key role of administrations, being pioneers in adapting a regulation that facilitates clinical research. Also the strength of our national health system and excellent scientific training that our professionals have, also highlighting patients' involvement and industry commitment.
"I would kill that we are very good in clinical research led by the pharmaceutical industry, that is, clinical trials that want to answer questions that are also important for the industry," said Garrido. "We have shown not only that we are able to include many patients, but that the quality of the data is good," he added. Oncologist also indicated that while in trials in the topic of Covid, many with very small groups have been done, in oncology there are very powerful research groups.
For its part, Belda stressed that "on the one hand, the Institute promotes protecting translational science, which is a science that needs the State support and support. For example, since the summer of 2018 it has increased its capacity for funding until you reach At the time the general budgets of the State are being discussed for 2022. In these, we practically duplicate our budget and therefore we are going to achieve unknown financing rates throughout history, "said the principal of the Institute.
"At this time oncology has advanced by precision medicine, which represents the individualization of the diagnostic processes and treatment of each of the patients. This has been thanks to the investigation," explained Enriqueta Felip, president of Spanish society of Medical Oncology (SEOM). In recent years, it has been known more what was the molecular basis of each tumor and through genomics, which allows analyzing the genetic profile of tumors, allows them to classify and guide treatments.
This genetic analysis has also allowed designing more specific treatments, designed to interfere with the mechanisms responsible for the malignant genotype. This achieves great therapeutic efficiency with a lower toxicity, such as the one with chemotherapy. "Although this implies a paradigm shift," the President of SEOM said. Both in research and application, because to make personalized medicine are needed biomarkers in real time, very tight in order to treat patients with quality controls.
"We have a very clear goal that is to be able to offer society more effective approaches against cancer with individualized attention as a way to achieve it. This not only applied to treatment, but probably also in prevention and early diagnosis," concluded Felip .
During the second colloquium of the day, Antonio González, head of the Medical Oncology Service of the University of Navarra Clinic (CUN) Madrid; Aleix Prat, head of the Medical Oncology Service of the Hospital Clíric de Barcelona; Luisa María Villar, Head of the Immunology Service of the Ramón and Cajal University Hospital; and Beatriz Pérez, Medical Director of Roche Farma. Together they addressed the challenges of the new clinical research.
Villar insisted on the importance of sharing tools, such as the discovery of biomarkers, and making networks that help to use these resources in clinical practice. During the round table it was pointed out that there is a lot of potential in the data, also supporting themselves in other profiles not only from the health sector, as computer or mathematics, highlighting that there are more and more actors that contribute to the evolution of biomedical research.
During the day it was also discussed from other points of view as that of medication assessment trends and its challenges, with experts such as César Hernández, Head of Human Use Medications of the AEMPS; Felix Lobo, Professor Emeritus of the Carlos III University of Madrid; and Fernando Gutiérrez, Director of Applied Research of the Spanish Society of Hospital Pharmacy (SEFH). In this talk it was concluded that there are problems and not only in relation to the data, but in relation to scientific evidence, with the evidence in which we have to base us to make an economic evaluation. That is, the evaluation only makes sense if we know the effectiveness or effectiveness of a drug or a sanitary technology.
To conclude, during the last round table they shared their experience Fidela Mirón Torrente, Vice President of the Spanish Federation of Rare Diseases (ERDF) and María Gálvez, General Director of the Patient Organizations (POP).
During this last part of the day, the vision of the patients was treated in terms of the future of biomedical investigations. The speakers agreed that research is the future, although in the case of rare or rare diseases have perceived little support on research issues, highlighting that only 5% of rare pathologies have treatment.
They also assured that from patients living with great expectation everything that has to do with new investigations and essays. "I believe that this pandemic is making us see the need and the importance of investigating health, I think science has to be a clear bet and so we have been claiming from patient organizations for a long time. Many more investment is needed and In addition, more structural, that is not at a timely time, "the Vice President of ERDR finishes.Updated Date: 07 November 2021, 17:04