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 Mitochondria- targeted 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

Programmed cell death Mitochondrial diseases Cancer Aging Metabolic disorders Oxidative stress Inflammation

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 mitochondria- targeted 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 *** *** p<0,001 Tears naturale SkQ1

2012: first approved and marketed mitochondria-targeted drug Eye drops 155 ng SkQ1 per ml Registration number: ЛП , 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