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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/1991-2919-2025-15-3-248-251</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-791</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ДОКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ: КУРС НА ТРАНСЛЯЦИОННОСТЬ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PRECLINICAL TRIALS: A COURSE TOWARDS TRANSLATIONALITY</subject></subj-group></article-categories><title-group><article-title>Трансляционный кризис биомедицинских разработок: анализ причин и пути преодоления</article-title><trans-title-group xml:lang="en"><trans-title>Translational Crisis in Biomedical Research: Analysis of Causes and Ways to Overcome It</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Галагудза</surname><given-names>М. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Galagudza</surname><given-names>M. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Галагудза Михаил Михайлович</p><p>ул. Аккуратова, д. 2, Санкт-Петербург, 197341</p></bio><bio xml:lang="en"><p>Mikhail M. Galagudza</p><p>2 Akkuratova St., St. Petersburg 197341</p></bio><email xlink:type="simple">galagudza@almazovcentre.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение&#13;
«Национальный медицинский исследовательский центр им. В.А. Алмазова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Medical Research Center named after V.A. Almazov</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>02</day><month>07</month><year>2025</year></pub-date><volume>15</volume><issue>3</issue><elocation-id>248–251</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Галагудза М.М., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Галагудза М.М.</copyright-holder><copyright-holder xml:lang="en">Galagudza M.M.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.vedomostincesmp.ru/jour/article/view/791">https://www.vedomostincesmp.ru/jour/article/view/791</self-uri><abstract><p>Понятие трансляционного разрыва заключается в том, что интенсивное развитие фундаментальных биомедицинских исследований на рубеже ХХ и ХХI вв. до последнего времени не сопровождалось пропорциональным увеличением количества инновационных лекарственных препаратов, а также диагностических и лечебных технологий, нашедших применение в клинической практике. Своими мыслями о причинах трансляционного кризиса и путях выхода из него делится директор Института экспериментальной медицины ФГБУ «НМИЦ им. В.А.  Алмазова» Минздрава России доктор медицинских наук, профессор, член-корреспондент РАН Михаил Михайлович Галагудза.</p></abstract><trans-abstract xml:lang="en"><p>The concept of translational gap implies that the intensive development of basic biomedical research at the turn of the 20th and 21st centuries has not, until recently, been accompanied by a proportional increase in the number of innovative drugs, as well as diagnostic and therapeutic technologies that have found application in clinical practice. Mikhail M. Galagudza, Director of the Institute of Experimental Medicine at the Almazov National Medical Research Center of the Russian Ministry of Healthcare, Doctor of Medical Sciences, Professor and Corresponding Member of the Russian Academy of Sciences, shares his thoughts on the causes of the translational crisis and ways of its resolution.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>биомедицина</kwd><kwd>разработки</kwd><kwd>трансляционные исследования</kwd><kwd>трансляционный кризис</kwd><kwd>воспроизводимость данных</kwd><kwd>доклинические исследования</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biomedicine</kwd><kwd>development</kwd><kwd>translational research</kwd><kwd>translational crisis</kwd><kwd>data reproducibility</kwd><kwd>preclinical studies</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
