<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<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">persmed</journal-id><journal-title-group><journal-title xml:lang="ru">Российский журнал персонализированной медицины</journal-title><trans-title-group xml:lang="en"><trans-title>Russian Journal for Personalized Medicine</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2782-3806</issn><issn pub-type="epub">2782-3814</issn><publisher><publisher-name>ФОНД АЛМАЗОВА</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">615.1</article-id><article-id custom-type="elpub" pub-id-type="custom">persmed-5</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>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWERS</subject></subj-group></article-categories><title-group><article-title>Фабрика фармакогенетических биомаркеров: как это работает?</article-title><trans-title-group xml:lang="en"><trans-title>Pharmacogenetic biomarker factory: how does it work?</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>Сычев</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sychev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сычев Дмитрий Алексеевич, д.м.н., профессор, профессор РАН, чл.-корр. РАН, заведующий кафедрой клинической фармакологии и терапии имени академика Б. Е. Вотчала, ректор</p><p>Москва</p></bio><bio xml:lang="en"><p>Sychev Dmitry A., MD, PhD, Professor, Professor of the Russian Academy of Sciences (RAS), Corresponding Member of RAS, Head of B. E. Votchal Department of Clinical Pharmacology and Therapy</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мирзаев</surname><given-names>К. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Mirzaev</surname><given-names>K. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мирзаев Карин Бадавиевич, к.м.н., доцент кафедры клинической фармакологии и терапии имени академика Б. Е. Вотчала, заведующий НИЛ геномных предикторов нежелательных лекарственных реакций НИИ молекулярной и персонализированной медицины</p><p>Москва</p></bio><bio xml:lang="en"><p>Mirzaev Karin B., MD, PhD, Assistant Professor of B. E. Votchal Department of Clinical Pharmacology and Therapy, Head of Adverse Drug Reactions Genomic Predictors Research Laboratory in Research Institute of Molecular and Personalized Medicine</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Денисенко</surname><given-names>Н. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Denisenko</surname><given-names>N. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Денисенко Наталья Павловна, к.м.н., доцент кафедры клинической фармакологии и терапии имени академика Б. Е. Вотчала, заведующий отделом персонализированной медицины НИИ молекулярной и персонализированной медицины</p><p>ул. Баррикадная, д. 2/1, стр. 1, Москва, Россия, 125993</p></bio><bio xml:lang="en"><p>Denisenko Natalia P., MD, PhD, Assistant Professor of B. E. Votchal Department of Clinical Pharmacology and Therapy, Head of the Department of Personalized Medicine in Research Institute of Molecular and Personalized Medicine</p><p>st. Barrikadnaya, 2/1, str. 1, Moscow, Russia, 125993</p></bio><email xlink:type="simple">natalypilipenko3990@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Абдуллаев</surname><given-names>Ш. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Abdullaev</surname><given-names>S. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Абдуллаев Шерзод Пардабоевич, к.б.н., заведующий отделом молекулярной медицины НИИ молекулярной и персонализированной медицины</p><p>Москва</p></bio><bio xml:lang="en"><p>Abdullaev Sherzod P., PhD (Biol.), Head of the Department of Molecular Medicine in Research Institute of Molecular and Personalized Medicine</p><p>st. Barrikadnaya, 2/1, str. 1, Moscow, Russia, 125993</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гришина</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Grishina</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гришина Елена Анатольевна, д.б.н., доцент, директор НИИ молекулярной и персонализированной медицины</p><p>Москва</p></bio><bio xml:lang="en"><p>Grishina Elena A., PhD (Biol.), Assistant Professor, Director of the Research Institute of Molecular and Personalized Medicine</p><p>st. Barrikadnaya, 2/1, str. 1, Moscow, Russia, 125993</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение дополнительного профессионального образования «Российская медицинская академия непрерывного профессионального образования» Министерства здравоохранения России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Medical Academy of Continuous Professional Education</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>28</day><month>12</month><year>2021</year></pub-date><volume>1</volume><issue>1</issue><fpage>33</fpage><lpage>42</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Сычев Д.А., Мирзаев К.Б., Денисенко Н.П., Абдуллаев Ш.П., Гришина Е.А., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Сычев Д.А., Мирзаев К.Б., Денисенко Н.П., Абдуллаев Ш.П., Гришина Е.А.</copyright-holder><copyright-holder xml:lang="en">Sychev D.A., Mirzaev K.V., Denisenko N.P., Abdullaev S.P., Grishina E.A.</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://persmed.elpub.ru/jour/article/view/5">https://persmed.elpub.ru/jour/article/view/5</self-uri><abstract><p>Несмотря на успехи в области изучения омиксных данных, в том числе фармакогеномных, до сих пор имеется нехватка надежных, воспроизводимых, чувствительных, специфичных и, главное, клинически полезных биомаркеров прогнозирования ответа на медикаментозное лечение в реальной клинической практике. Важнейшую роль в разработке и внедрении новых фармакогенетических биомаркеров может сыграть создание соответствующей экосистемы вокруг биомаркеров путем объединения в консорциумы академических и научных центров, биомедицинских лабораторий и фармацевтических компаний, компаний сферы IT-разработки и искусственного интеллекта. В статье представлен обзор так называемой «фабрики биомаркеров», позволяющей выстроить и систематизировать процесс внедрения фармакогеномного биомаркера в клиническую практику.</p></abstract><trans-abstract xml:lang="en"><p>Despite the strides made in the study of -omics data, including pharmacogenomic data, there is still a lack of reliable, reproducible, sensitive, specific and, most importantly, clinically useful biomarkers for predicting response to drug treatment in real clinical practice. An important impact in the development and implementation of new pharmacogenetic biomarkers can be made by the creation of an appropriate ecosystem around biomarkers by uniting capacities of academic and research centers, biomedical laboratories and pharmaceutical companies, IT and artificial intelligence companies into consortiums. The article provides an overview of the so-called “biomarker factory”, which allows to build and systematize the process of introducing a pharmacogenomic biomarker into clinical practice.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>биомаркеры</kwd><kwd>консорциумы</kwd><kwd>научные группы</kwd><kwd>омиксные технологии</kwd><kwd>персонализированная медицина</kwd><kwd>фармакогенетика</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biomarkers</kwd><kwd>consortiums</kwd><kwd>omics technologies</kwd><kwd>personalized medicine</kwd><kwd>pharmacogenetics</kwd><kwd>scientific groups</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Приказ Минздрава России от 01.02.2019 г. № 42 (ред. от 24.08.2020) «Об утверждении ведомственной целевой программы “Развитие фундаментальной, трансляционной и персонализированной медицины”» https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/042/771/original/Приказ_№_42_ВЦП.pdf?1549880974 (12.09.2021).</mixed-citation><mixed-citation xml:lang="en">Order of the Ministry of Health of Russia dated 01.02.2019 No. 42 (revised from 24.08.2020) “On approval of the departmental program” Development of fundamental, translational and personalized medicine”. https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/042/771/original/Приказ_№_42_ВЦП. pdf?1549880974 (12 September 2021). In Russian</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Постановление Правительства России от 21 мая 2013 г. № 426 «О федеральной целевой программе «Исследования и разработки по приоритетным направлениям развития научно-технологического комплекса России на 2014-2021 годы». https://fcpir.ru/business/prioritety-nauchno-tekhnologicheskogorazvitiya/ (12.09.2021).</mixed-citation><mixed-citation xml:lang="en">Decree of the Government of Russia dated May 21, 2013 No. 426 “On the federal target program” Research and development in priority areas of development of the scientific and technological complex of Russia for 2014-2021”. https://fcpir.ru/business/prioritety-nauchnotekhnologicheskogo-razvitiya/ (12 September 2021). In Russian [Постановление Правительства России от 21 мая 2013 г. № 426 «О федеральной целевой программе «Исследования и разработки по приоритетным направлениям развития научно-технологического комплекса России на 2014-2021 годы». https://fcpir.ru/business/prioritety-nauchno-tekhnologicheskogorazvitiya/ (12.09.2021)].</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">The precision medicine initiative. https://obamawhitehouse.archives.gov/precision-medicine (13 September 2021).</mixed-citation><mixed-citation xml:lang="en">The precision medicine initiative. https://obamawhitehouse.archives.gov/precision-medicine (13 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">The 100,000 Genomes Project. https://www.genomicsengland.co.uk/about-genomics-england/the-100000-genomes-project (13 September 2021).</mixed-citation><mixed-citation xml:lang="en">The 100,000 Genomes Project. https://www.genomicsengland.co.uk/about-genomics-england/the-100000-genomes-project (13 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Health research and innovation of European Commission. Personalised medicine. https://ec.europa.eu/info/research-and-innovation/research-area/healthresearch-and-innovation/personalised-medicine_en (13 September 2021).</mixed-citation><mixed-citation xml:lang="en">Health research and innovation of European Commission. Personalised medicine. https://ec.europa.eu/info/research-and-innovation/research-area/healthresearch-and-innovation/personalised-medicine_en (13 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">The project Clinical Implementation of Personalized Medicine in Health Services (Personalized Medicine Applied-MedeA). https://www.proyectomedea.es/en/home/ (13 September 2021).</mixed-citation><mixed-citation xml:lang="en">The project Clinical Implementation of Personalized Medicine in Health Services (Personalized Medicine Applied-MedeA). https://www.proyectomedea.es/en/home/ (13 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Прикладная фармакогенетика: монография / под ред. Д. А. Сычева. М. Тверь: Издательство «Триада», 2021. с. 496.</mixed-citation><mixed-citation xml:lang="en">Sychev DA. Applied pharmacogenetics. Tver: Izdatel’stvo Triada, 2021. p. 496. In Russian</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Whitcomb DC. Barriers and research priorities for implementing precision medicine. Pancreas. 2019;48(10):1246-1249. DOI: 10.1097/MPA.0000000000001415.</mixed-citation><mixed-citation xml:lang="en">Whitcomb DC. Barriers and research priorities for implementing precision medicine. Pancreas. 2019;48(10):1246-1249. DOI: 10.1097/MPA.0000000000001415.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">BEST (Biomarkers, EndpointS, and other Tools) Resource. https://www.ncbi.nlm.nih.gov/books/NBK326791/ (14 September 2021).</mixed-citation><mixed-citation xml:lang="en">BEST (Biomarkers, EndpointS, and other Tools) Resource. https://www.ncbi.nlm.nih.gov/books/NBK326791/ (14 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Davis KD, Aghaeepour N, Ahn AH, et al. Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities. Nat Rev Neurol. 2020;16(7):381–400. DOI: 10.1038/s41582-020-0362-2.</mixed-citation><mixed-citation xml:lang="en">Davis KD, Aghaeepour N, Ahn AH, et al. Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities. Nat Rev Neurol. 2020;16(7):381–400. DOI: 10.1038/s41582-020-0362-2.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Silva PJ, Schaibley VM, Ramos KS. Academic medical centers as innovation ecosystems to address population — omics challenges in precision medicine. J Transl Med. 2018;16(1):28. DOI: 10.1186/s12967-018-1401-2.</mixed-citation><mixed-citation xml:lang="en">Silva PJ, Schaibley VM, Ramos KS. Academic medical centers as innovation ecosystems to address population — omics challenges in precision medicine. J Transl Med. 2018;16(1):28. DOI: 10.1186/s12967-018-1401-2.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Vandenbroeck K, Comabella M, Tolosa E, et al. United Europeans for development of pharmacogenomics in multiple sclerosis network. Pharmacogenomics. 2009;10(5):885-894. DOI: 10.2217/pgs.09.33.</mixed-citation><mixed-citation xml:lang="en">Vandenbroeck K, Comabella M, Tolosa E, et al. United Europeans for development of pharmacogenomics in multiple sclerosis network. Pharmacogenomics. 2009;10(5):885-894. DOI: 10.2217/pgs.09.33.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Sobocki P, Pugliatti M, Lauer K, et al. Estimation of the cost of MS in Europe: extrapolations from a multinational cost study. Mult Scler. 2007;13(8):1054–1064. DOI: 10.1177/1352458507077941.</mixed-citation><mixed-citation xml:lang="en">Sobocki P, Pugliatti M, Lauer K, et al. Estimation of the cost of MS in Europe: extrapolations from a multinational cost study. Mult Scler. 2007;13(8):1054–1064. DOI: 10.1177/1352458507077941.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes Project (U-BIOPRED). https://europeanlung.org/en/projects-and-campaigns/past-projects/u-biopred (14 September 2021).</mixed-citation><mixed-citation xml:lang="en">Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes Project (U-BIOPRED). https://europeanlung.org/en/projects-and-campaigns/past-projects/u-biopred (14 September 2021).</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Craig BM, Han G, Munkin MK, et al. Simulating the contribution of a biospecimen and clinical data repository in a phase II clinical trial: a value of information analysis. Statistical methods in medical research. 2016;25(4):1303–1312. DOI: 10.1177/0962280213480282.</mixed-citation><mixed-citation xml:lang="en">Craig BM, Han G, Munkin MK, et al. Simulating the contribution of a biospecimen and clinical data repository in a phase II clinical trial: a value of information analysis. Statistical methods in medical research. 2016;25(4):1303–1312. DOI: 10.1177/0962280213480282.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Консорциум «Генетика cердечно-сосудистых заболеваний». https://cardiogenetics.ru (14.09.2021)</mixed-citation><mixed-citation xml:lang="en">Consortium “Genetics of Cardiovascular Diseases”. https://cardiogenetics.ru (14 September 2021). In Russian</mixed-citation></citation-alternatives></ref></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>
