The future of pharmacological research

Compilation
pharmacological studies It is the process of discovering and developing new drugs to treat various pathologies affecting humans. Over the years, this process has aimed to produce the same medicine for all people, following the approach one size fits all. However, since the 1990s, the field has been revolutionized by all the technological advances available within pharmacology in personalized precision medicine, such as genome sequencing, the use of knowledge gained from analyzing massive data, and artificial intelligence tools. .

In this sense, thanks to advances in omics and computational technologies, based on the genomic profile and pharmacological stratification markers, it is possible to identify not only genetic predisposition to diseases, but also individual response to pharmacological treatment. facilitate the personalization of medications, minimizing side effects and optimizing their effectiveness.

The report details some of the major trends that are changing the discovery and development of new drugs.

In this line Roche Institute Foundation published a new one Expected reportMade of Observatory of Trends in Future Medicine, on pharmacological research in the era of personalized precision medicine. This report details some of the major trends that are changing the drug discovery and development process at all stages. It also highlights the need to address various issues with a view to incorporating them into clinical practice, with the ultimate goal of providing new and better treatments to the population in a more effective manner through personalized precision medicine.

Evolution of the traditional approach

The pharmacological research process, including the preclinical research and clinical development phases, as well as subsequent monitoring of drugs approved for marketing, is extensive and complex; Of the thousands of molecules being studied, only a few drugs make it through clinical phases. Therefore, a paradigm shift in research is necessary in order to reduce the time and optimize the processes for obtaining new, more effective and safe drugs, taking into account the needs and individual characteristics of patients, within the framework of precision personalized medicine.

“Pharmacology research is evolving from the traditional approach of discovering and developing drugs for patient populations around the world.”

According to the Managing Director of the Roche Institute Foundation: Consuelo Martin de Dios, “Pharmacology research is evolving from a traditional approach focused on drug discovery and development for global patient populations to a research model targeting specific subpopulations stratified based on biomarkers, in which new innovative and adaptive clinical trial designs allow possible improvements in the efficiency of drug development and research “

The development of precision translational pharmacology aims to address the challenges of translating basic and preclinical research into the clinic to achieve greater efficiency throughout the drug discovery and development process and ultimately the proper implementation of personalized precision medicine.

“The convergence of omics developments together with technological and computational advances makes it possible to generate large volumes of information”

According to the coordinator of the report, professor of pharmacology at the University of Santiago de Compostela and coordinator of the BioFarma research group, Dr. Mabel Loza, “The convergence of omics development, together with technological and computational advances, is enabling the generation of large amounts of information about diseases and the factors influencing their development and evolution.” These advances contribute significantly to important changes in the way pharmacological research is conducted, he said. “from the initial identification of a therapeutic target to the generation and use of real-life data.”

Specifically in preclinical studies, as Dr. Loza points out: “Omics sciences are defining a new paradigm for identifying new therapeutic targets and mechanisms of pharmacological action for unmet medical needs; also to avoid possible adverse reactions.” In addition, new strategies such as high-throughput screening, drug repositioning, organoids or studies in silica facilitate the identification of new and more effective compounds, as well as more effective optimization of existing compounds..

“Omics sciences define a new paradigm for identifying new therapeutic targets”

Clinical Research Trends

On the other hand, regarding trends in clinical research, applications for stratification and companion diagnostics can be developed, new clinical trial designs can be proposed, and new assessment pathways such as surrogate response variables or patient-reported outcome measures (PROMs) can be proposed. adjust designs based on the specific profiles of patients who have certain biomarkers present in order to optimize their inclusion in studies and improve response rates. Digitization and, in particular, the integration of artificial intelligence to collect, manage and process patient data are facilitating patient access to innovative treatments, reducing the time to recruit patients for studies or continuously monitor the study population.

New clinical trial designs enable the adequate evaluation of new treatments and interventions in the field of personalized precision medicine, accelerate the development and approval of new drugs, and improve the efficiency of research. The report coordinator highlights the value of some of these new projects, such as basket clinical trials or basket tests. As he explains, these medical studies involve populations that share the same biomarker or molecular alteration, where they are treated with a single therapy to evaluate its effect on multiple pathologies that share a common target. “This provides greater efficacy in future drug use, as it could be useful in treating a variety of the pathologies mentioned.”– he points out.

The pharmacological research process is extensive and complex.

Likewise, the pharmacology professor highlights other new developments such as umbrella studies or umbrella tests, where multiple treatments are evaluated in different groups of patients with the same disease but different molecular characteristics; platform type testing or platform testing, targeting patient populations with the same disease but different biomarkers, studying different treatments within the same protocol; in addition to patient-centered or research studies N-of-1where the effectiveness and safety of therapy in a specific patient is assessed to determine the optimal intervention on an individual basis.

Real data and real evidence

After passing the clinical trial phase and obtaining marketing authorization, the research is not completed, but will continue throughout the entire life cycle of the drug. To do this, it is necessary to collect real-world evidence of the effects of drugs, also known as Evidence from the real world (RWE) and thus monitor the assessment of risks and benefits. RWE uses real data or Real data (RWD), that is, all data related to a patient’s health or health care that is routinely collected from various sources, such as an electronic health record (EHR).

“RWE and RWD are increasingly used in research to evaluate the effectiveness and safety of treatments in real patients,”

Although randomized clinical trials are the reference method for clinical research, their results cannot always be replicated in healthcare settings. Because of this, according to Dr. Loza, “RWE and RWD are increasingly being used in research to evaluate the effectiveness and safety of treatments in real-life patients, as well as other aspects that may be of interest in evaluating treatments and making health decisions, such as quality of life.”

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In this context, although biotechnological and computational advances are leading to changes in pharmacological research, they are still in the early stages of research, making their translation into practice and, as a consequence, the approval and use of new drugs difficult. shop. In this regard, the expert co-authors of the Anticipando Report consider it necessary to solve problems of a different nature to optimize pharmacological research, with the ultimate goal of providing the population with new and more effective treatments within the framework of personalized precision medicine.

“It is recommended to encourage interdisciplinary and collaborative work throughout the process.”

Among them, special attention is paid to technical problems such as understanding the mechanisms of drug resistance; implementation, given the high bureaucratic complexity of clinical trials and the lack of standards; while being mindful of regulatory, ethical and legal issues such as inequalities in access to clinical trials and investigational drugs. Faced with these challenges, a number of recommendations have been developed to implement and consolidate new advances and trends in pharmacological research. “It is recommended to encourage interdisciplinary and collaborative work throughout the process, and to structure public-private, basic, preclinical and clinical research in an inclusive manner, taking into account the vision and needs of patients.”– Dr. Loza summarizes.