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Educational modules for innovational drug development researchers M.V.Lomonosov Moscow State University - Faculty of bioengineering and bioinformatics - Faculty of fundamental medicine Educational modules • Preclinical safety assessment of innovational biosimilars 15 credits • Mitochondriatargeted drugs development 15 credits Preclinical safety assessment of innovational biosimilars Laboratory of Biological Testing Aaalac license since 2005 GLP compliance certificate since 2013 Staff includes more than 40 exceptionally dedicated professionals: 16 research scientists (2 D.Sci., 7 Ph.D.), 6 engineers, and 16 technicians. Research staff members are educated in physiology, veterinary surgery, biochemistry, pharmacology and pharmaceutics. Possibility to use SPF animals. All research protocols involving animals are reviewed by Institutional Animal Care and Use Committee. 17 laboratory rooms, 13 animal rooms. Controlled conditions of animal housing and management. Module elements • Laboratory animals in biomedical research • Medical safety trials • Good Laboratory Practice (GLP) principles • Experimental research basic principles Mitochondria-targeted drugs development Mitochondrion Cell Aging Cancer Programmed cell death Mitochondrial diseases Metabolic disorders Inflammation Oxidative stress Belozersky Institute, Moscow State University - One of the major research and educational units of the Lomonosov Moscow State University -50 years of mitochondrial research - Excellent modern equipment Faculty of bioengineering and bioinformatics, Moscow State University • Innovational educational program • Special focus on: - mathematics - research - biology of mitochondria Practical implementation New type of mitochondriatargeted antioxidants: SkQ Antioxidant (plastoquinone) «Skulachev Ion» triphenylphosphonium Fluorescent SkQ specifically stains mitochondria in HeLa cells SkQ1 prevents accelerated aging in mutant mice B.Cannon, Stockholm SkQ1 cures eye disease in rats N.G. Kolosova, Novosibirsk Clinical trials (dry eye syndrom) of SkQ1 eye drops. Percent of patients reporting complete recovery 60% 60% *** Tears SkQ1 naturale "слеза натуральная" 50% 40% SkQ1 30% 20% 20% 15% 15% 10% 0% 0% 0% 0% 0% 0% 3% 0% 3% 5% 0% 0 1 2 3 Days of treatment *** p<0,001 7 14 21 2012: first approved and marketed mitochondria-targeted drug • Eye drops 155 ng SkQ1 per ml Registration number: ЛП-001355, 13 December 2011 г. Module elements • Molecular biology of mitochondria • Structure and function of mitochondria • Mitochondria in programmed cell death • Mitochondria-targeted drugs: development principles