Section: "The Role of Relevant Models and Quality Test Systems in Preclinical Research"

As part of the business program of the second day of the IPhEB 2026 forum, the V All-Russian Scientific and Practical Conference with International Participation "Pharmaceutical Science: Challenges and Solutions in the 21st Century" was held.

The section "The Role of Relevant Models and Quality Test Systems in Preclinical Research" was moderated by Dmitry Ivkin, Head of the Center for Experimental Pharmacology at SPHFA of the Ministry of Health of Russia, Candidate of Biological Sciences, Associate Professor.

During the section, speakers presented the results of their own preclinical research in various scientific fields.

In his presentation on modeling pathological conditions, Dmitry noted that the choice of an experimental model is always a compromise between three key parameters: clinical validity (how well the model corresponds to the disease in terms of symptoms, markers, and pathogenesis), reproducibility (standardization and inter-operator consistency), and practical feasibility (ethics, cost, labor intensity, equipment availability). The optimal model is not the most complex one, but rather one in which a balance is achieved among these criteria in relation to the specific scientific task.

The evolutionary trajectory of models is progressive: from monofactorial models that reproduce an isolated effect, to functional models that account for dynamics and remodeling, and further to comorbid models that are as close as possible to the real clinical profile of a patient with multiple concomitant pathologies.

The development of new drugs cannot be limited to evaluation using a single model. A clinically significant result requires testing on several models that reflect different pathogenetic mechanisms and effects on various target organs. Such a multimodel approach makes it possible to predict the systemic efficacy of a pharmacological compound, identify potential organ-specific effects, and reasonably transition to clinical trials.

It was noted that a test system is always a combination of a model, an experimental design, and a set of endpoints. Data can only be meaningfully evaluated by taking all three components into account.

One of the main problems of the modern oncology drug market is the high time and financial costs associated with drug development, preclinical studies, and clinical trials.

In a report by Kirill Krysheń, Candidate of Biological Sciences, Deputy Director for Science at the Research and Production Association "DOM PHARMACY" JSC, it was noted that a wide variety of animal species are used in preclinical research. Regulatory requirements mandate the use of two animal species in long-term toxicological experiments, one of which must be a non-rodent. The choice is influenced by ethical aspects, cost, and animal availability, but most importantly by the scientific validity of the choice.