"MEDICAL ENGINEERING" CLUSTER Project annotation 1. Project goal Creation of innovative diagnostic and therapeutic equipment for medical radiology. 2. Description The project is aimed at achievement of international recognition and improvement of competitive ability of the university in the field of medical engineering on the basis of an international platform creation that will integrate all outstanding methods for training of highly qualified researchers and engineers, creation and transfer of resource-effective technologies for improvement of quality and duration of the planet inhabitants' life. The project's goal is identified by creation of new, internationally competitive radiopharmaceuticals, devices and methods for medical radiology intended for diagnostics and therapy of oncological and cardiovascular diseases, creation of international-level educational programmes in the field of medical physics, training of internationally competitive specialists for national and international medical centers. The project is characterized by a high social significance and substantial commercial potential, since the cardiovascular and oncological diseases still hold the top positions in mortality statistics and cause severe labor disability of population. Such pathologies cause over 50 percent of deaths of working age people. Implementation of radionuclide diagnostics with the use of short-living and ultra-short-living radionuclides allows improvement of the treatment efficiency by 40% for patients with oncological diseases and by 35% for patients that survived a myocardial infarction. At the time, radiotherapy is considered the most economic and effective method for definitive and palliative therapy of oncology patients. The estimated size of market of medical radiology services and goods in USA reaches USD 2,000,000,000. 3. Project performers On TPU behalf: Institute of Physics and Technology, Institute of Non-destructive Testing, Institute of High Technology Physics. External performers: Institute of Cardiology, Siberian Branch, Russian Academy of Medical Sciences (Tomsk, Russia), Heidelberg University (Germany), Johns Hopkins Medicine, Division of Nuclear Medicine (USA), PET Center (USA). 4. Partners University of Minnesota Duluth (USA), Isotope JSC (Russia), Calgary University (Canada), Albany Medical College (USA), Muenster University (Germany), Siberian State Medical University (Russia), Open University Skolkovo (Russia), Humboldt-Universität (Germany), Far Eastern Federal University (Russia), KEK (Japan), DESY (Germany), LNF (Italy). 5. Amount of funding Year 2014: RUR 48,000,000 from subsidy allocated for the Leading Research University. Co-financing Year 2014: RUR 20,000,000; Year 2015: RUR 30,000,000; Year 2016: RUR 100,000,000. Page 1 from 3 7. Calendar plan and project deliveries Year 2014 Fundamental basics of 186Re synthesis with high specific activity. Experimental sample of zero waste automatic 99mTc-module. Results of pre-clinical tests of radiopharmaceuticals for inflammation diagnostics and identification of sentinel lymph nodes on the basis of labeled nanocolloids. Methods for chemical modification of glucose derivatives for creation of oncotropic radiopharmaceuticals Dosimetric and radiobiological support of neutron and intraoperative therapy. Hardware-software complex on the basis of betatrons for intraoperative radiotherapy of malignant neoplasms. Certification of 123I-based pharmaceutical. Development of technology for synthesis of 111In-based radiopharmaceuticals. Creation of the laboratory entitled "Radionuclide therapy and diagnostics" in collaboration with Russian Academy of Sciences. Publications in top-rated journals, defense of theses, applications for patents. International-level graduate programme entitled "Biomedical engineering" (Appendix 1). 2015 Fundamental basics of chemical modification of oncotropic antibiotics and creation of liposomes on their basis. Fundamental basics of synthesis of 188Re-labeled oncotropic antibiotics for radiotherapy. Preproduction lot of radiopharmaceuticals on the basis of 99mTc-labeled glucose derivatives and oncotropic antibiotics for diagnosis of malignant neoplasms. Production line for radiopharmaceuticals that are used for inflammation diagnosis and identification of sentinel lymph nodes. Pre-clinical tests and certification of the hardware-software complex for the intraoperative therapy. Organization of production and delivery of waste-free automatic 99mTc-module. Launch of production line and delivery of the following radiopharmaceuticals to consumers: 199 Tl, tallium chloride, 199Tl, dimethylthiocarbamate, 123I, sodium iodo-o-hippurate, 123I, metaiodobenzylguanidine, 123I, iodophen. Certification of 111In-based pharmaceutical. Creation of the laboratory entitled "Advanced methods of diagnostics, status monitoring and visualization of biological objects". Publications in top-rated journals, defense of theses, applications for patents. Enrollment into a programme for graduate students. Year 2016 Pre-clinical tests and preproduction lot of 188Re-based radiopharmaceuticals for radionuclide therapy in the field of arthrology. A line for production and supply of radiopharmaceuticals based on 99mTc-labeled antitumor antibiotics and glucose derivatives. Licensing, production and delivery of a hardware-software complex for intraoperative therapy. Launch of production and delivery of 111In-based radiopharmaceuticals to consumers. Page 2 from 3 Attraction of extra funds for the project performance within the programme of the Leading Research University in 2014 will enable additional activities on creation of a research and technological background for development of precursor synthesis methods, production of ultrashort-living radiopharmaceuticals and synthesis modules for Positron Emission Tomography (PET) diagnostics. Development of experimental sample of X-ray emission source on the basis of small-scale pulsed betatrons for early-diagnosis systems (mammography, angiography, xradiography) and radiological (Photon Capture) therapy. Development of terahertz electromagnetic emission sources for study of its interaction mechanisms with biological objects at cellular level. Creation of software for 3D-visualization of biological and artificial structures on the basis of SAFT-method with the use of matrix acoustic arrays. Attraction of investments for purchase of a new cyclotron will enable expansion of the megaproject deliveries in terms of development of technologies and production of Ge-68/Ga-68 generators for synthesis of diagnostic radiopharmaceuticals for PET, CT, Ac-225/Bi-213 alphaemitting radionuclides and mono- and polyclonal antibodies labeled by them, synthetic polypeptides for radio-immunotherapy of malignant neoplasms with the economic capacity of USD 200,000,000. Page 3 from 3