Clinical and Preclinical Studies Centre

Address: 14 Studencheskaya Street, 308007 Belgorod, Russia Phone/fax: +7 4722 301859 Head of the Centre Professor Mikhail Pokrovksy, Doctor of Medicine

The BelSU Clinical and Preclinical Studies Centre was established as University’s structural department in 2011.

In 2011, the Centre entered the Federal Service on Surveillance in Healthcare’s list of organisations and institutions certified to conduct preclinical studies for medical drugs.

The Centre fulfils the requirements of the ISO 9001-2008 standard (certificate issued on 29.12.2011).

According to the Ministry of Public Health of the Russian Federation Decree No 274 of 27.04.2012, Belgorod State National Research University is accredited for conducting clinical studies.

Research team’s key accomplishments

The Centre has conducted over 50 preclinical studies on general toxic action, specific activity, pharmacokinetic properties and bioequivalence of medicinal drugs on order of large Russian and worldwide pharmaceutical companies, among them are the following:

• TEVA Pharmaceutical Industries LTD (Israel)
• Pharmstandard-Leksredstva, JSC (Kursk, Russia)
• Pharmstandard-Tomskhimpharm, JSC (Tomsk, Russia)
• Pharmstandard-UfaVita JSC (Ufa, Russia)
• Valenta Pharmaceuticals, JSC (Moscow, Russia)
• Pharmaceutical Company Obolensky, CJSC
• Akvion, CJSC
• Rafarma, CJSC
• R-Pharm, CJSC
• National Scientific Centre for Bioactive Substances Safety, OJSC
• N.F. Gamaleya Research Institute of Epidemiology and Microbiology

Research support

Much of the research funding at the Centre comes from the government, councils and funds:

• Russian Federation President Grant No МК-905.2012.4
• Russian Federation President Grant No МК-3136.2014.4
• Government Procurement Contract No 13411.1008799.13.129 of June, 27 2013 within the framework of “Pharma 2020” on “Preclinical studies on pharmaceutical drug based on small molecule the Arginase-2 inhibitors for treating arterial and pulmonary hypertension”
• Government Procurement Contract No 13411.1008799.13.218 of December, 16 2013 within the framework of “Pharma 2020” on “Preclinical Studies of pharmaceutical pain management drug based on non-opioid analgesic TRPA-1 channel suppressor”
• Government Assignment for conducting works for Ministry of Education and Science of the Russian Federation (Government Procurement Contract No 4.913.2011)
• 3 grants from Foundation for Assistance to Small Innovative Enterprises in Science and Technology (FASIE / У.М.Н.И.К)
• a grant from Russian Foundation for Basic Research

The BelSU Clinical and Preclinical Studies Centre conducts research and development in most pressing problems of modern Experimental Pharmacology. Among main focuses of scientific effort of Centre’s laboratories are experimental Cardiac Pharmacology, Experimental Osteology, pharmacological correction of epithelial dysfunction during cardiovascular diseases, diabetes, gestational toxicosis and other nosologies, pharmacological correction of chronic limb ischemia, studying the possibilities for using distant pharmacological and ischemic preconditioning in surgery, obstetrics & gynaecology, and cardiology.

Based on research conducted, a detailed and comprehensive concept of the role of endothelium in course and regulation of a number of diseases. The Centre’s researcher formed approaches to pharmacological correction of endothelium-associated pathologies in cardiology, osteology, obstetrics & gynaecology. At present, the Centre’s staff together with scientists and researchers from Lomonosov Moscow State University and ChemRar High-Tech Centre applies joint effort to search and develop new molecules for aimed correction of endothelial dysfunction and pulmonary hypertension, as well as developing novel analgesics aimed at new biological target involved in noxious response.

All studies and research are conducted in partnership with Saint Ioasaph Belgorod Regional Clinical Hospital, the BelSU Medical and Preventive Clinic, Applied Immunomorphology and Cytogenetics Scientific and Education Centre, Immunochemical Laboratory of regional anatomic pathology bureau.

The Centre’s research groups

• General Toxicology,
• Cardiac Pharmacology,
• Isolated Organ Pharmacology,
• Behavioral Pharmacology,
• Electrophysiology,
• Control Clinical Study,
• Pharmacokinetics.

General Toxicology research group conducts research into toxicological safety of pharmaceutical drugs. The research is conducted with due regard to latest standards of lab animals keeping and assessment of the influence of the pharmaceutical drugs under research on their life parameters.

Among research areas are:

• Acute toxicity
• Chronic toxicity
• Chronic toxicity in the immature animals
• Chronic maternal toxicity in animals
• Fertility research
• Allergic action

Cardiac Pharmacology research group works on research into CVS drugs pharmacological activity and searches for new remedies and ways for pharmacological correction of endothelium-derived pathology. Research is conducted by high-qualified staff on the Biopac System equipment (USA). Among their research focuses are:

• Antihypertensive action,
• Antidysrhythmic action,
• Cardioprotective action (coronary occlusion (heart attack),
• Endothelium protective action,
• Thrombolytic action,
• Factors, influencing neo-vasculogenesis,

Isolated Organ Pharmacology research group conducts studies:

• Ischemia/reperfusion-induced injury of Langendorf-perfused rat hearts,
• Mechanical activity in isolated segments of blood vessels (hepatic portal vein and aorta),
• Mechanical activity in isolated segments of intestinal wall,
• Mechanical activity in isolated uterine horn.

Behavioural Pharmacology research group covers entire spectrum of studies of pharmaceutical drugs influence on integrity of physiological responses:

Electrophysiology research group conducts the following kinds of research:

• Electrocardiogram tracing (ECG)
• Electroencephalography (EEG)
• Electromyography (EMG)
• Event-related potential (ERP)
• Impedance resistography.

Pharmacokinetics and Bioequivalence research group works on:

• Studying Pharmacokinetics of well-known pharmaceutical drugs and pharmacologically active compounds in experiment;
• Studying clinical pharmacokinetics of pharmaceutical drugs;
• Studying drug biotransformation and pharmacologically active compounds, identifying active metabolites;
• Biopharmaceutical research;
• Research on pharmacokinetics and pharmacodynamics;
• Drug interaction studies.

Prospects for the BelSU Clinical and Preclinical Studies Centre within the Belgorod Biopharmaceutical cluster

Clinical and Preclinical Studies Centre is a milestone for forming the infrastructure of the regional pharmaceutical cluster. The Centre provides facilities for studying effectiveness of various pharmaceutical drugs and their forms at cellular, organ and organism levels in laboratory animals.

Main ambitions of the BelSU Clinical and Preclinical Studies Centre are:

• to create at BelSU a scientific and educational infrastructure to develop research into living systems pharmacology,
• to found a state-of-art preclinical translational research centre to unite laboratories of pharmacokinetics, pharmacogenetics, cell technologies, modern vivarium, and other divisions,
• to form an innovative scientific and educational environment to arrange effective interaction and co-operation between the BelSU Clinical and Preclinical Studies Centre and University’s departments, large local pharmaceutical enterprises, smaller innovative enterprises of BelSU and other universities,
• to coordinate live systems research aimed at identifying biomedical targets and ways to affect them with drugs, composite medical materials, devices and diagnostic systems,
• to integrate and promote such research projects to the Medicine of the Future technology platform – live systems research development is an issue of pressing importance for prevention, diagnosis and disease treatment, using newest scientific approaches: genome sequencing, molecule- and cellular-level therapeutic interventions; model building in silico (Bioinformatics), microelectronics–pharma–biotechnology; technology convergence (bio-nano-info),
• to set an innovative scientific and educational environment providing for effective co-operation between modern biomedical and pharmaceutical technologies for development and production liquid, solid, and semisolid dosage forms of drugs,
• to develop the University’s information resources and employ them for pharmaceutical market research and analysis, elaboration of marketing plans, promotion of import-substituting innovative pharmaceutical drugs, composite materials, medical devices, diagnosticums, etc.
• to ensure effective and efficient use of scientific and technological equipment through creating common use centres, integrating university’s own and other universities’ possibilities for consolidating with production, scientific, engineering and technological laboratories in order to optimize the live systems and drug discovery developments,
• in cooperation with chairs and departments of the BelSU Institute of Medicine, to conduct joint experimental and clinical research into employing methods of regenerative cell treatment, cell immunotherapy, and into using cell technology products for disease prevention and treatment:
  • post-infarct heart failure,
  • cardiac muscle and limb soft tissues ischemia resulting from systemic atherosclerosis - and inflammation of blood vessels,
  • cancerous diseases,
  • severe injuries or traumas to skeleton and soft tissues,
  • traumatic and ischemic injuries to the central nervous system, including birth traumas and infantile cerebral paralysis (ICP),
  • liver failure caused by hepatitides and cirrhosis of different origin,
  • autoimmune and allergenic diseases,
  • congenital diseases and genetic disorders.
• in cooperation with the BelSU Faculty of Biology and Chemistry, to discover and prepare for production growth mediums for cell, tissue and organ culture for import substitution and commercialization of original techniques,
• in cooperation with the BelSU Faculty of Pharmacy, to develop and study nanoparticulated drug formulations for pharmacologic follow-up of cell treatment (hyaluronidase, colonie-stimulating factor, endothelial growth factor, fibroblast growth factor, etc.).

Information was given by Mikhail Pokrovksy,
Head of the Clinical and Preclinical Studies Centre,
on 31.01.2017

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