Transcript of "Yury scherbak development of scientific technical platfroms in a firald of biomedicine"
Development of the scientific-technical platforms in a field of biomedicineAuthor:Academician Genrikh SofronovSpeakers:Prof. Anton OrlovProf. Youry Scherbuk 1
Scientific-technical platforms as mainstream approach for effective innovative development Ideology: •Approaches Single product development alternative Scientific-research centers - Invention & development • Complex vehicle Education centers - Education Experimental-industrial - Test output production Clinical centers - Clinical studies Healthcare system - Implementation Developing Platforms: Nosological Technological group group Oncology Recombinant vaccines Autoimmune diseasesDevelopment of founded platforms will lead to wide-front breakthrough intechnologies creation and implementation 2
Institute of Experimental Medicine (IEM)of the North-West Branchof Russian Academy of the Medical Sciences• Over 120-years history (since 1890)• The most authoritative center of the biomedical science in Russian FederationMajor goal of the studies An investigation of molecular mechanisms ofconducted in IEM: dysfunctions of the human organs and systems and search of the ways for their correction Staff: more than 600 employees, including: • 7 academicians, members of RAMS; • 24 professors; • 53 doctors of sciences (Dr.Sc); • 102 PhDs. 3
Institute of Experimental Medicine (IEM)of the North-West Branchof Russian Academy of the Medical Sciences Structure include: 11 research Clinic Scientific- Educational departments practical centers unit - diagnosis, study, treatment and prophylaxis of human diseases • Mass-spectrometers, Research • Real time PCR equipment, • Confocal microscopy, facilities • Microarray systems, • Sequencers, • Cytofluorymeters, etc. International cooperation: USA, Sweden, Slovakia, Vietnam, Germany, Australia, Italy, Poland, Hungary, China, Czech Republic, Japan and others 4
Modern Clinical facilities of Saint-Petersburg Saint-Petersburg State Healthcare complex• Sustainable development of new clinical capacities• Sustainable city Expenses on top-class equipment Outstandingly equipped RAMS clinical complexes Scientific • oncology; capacity • cardiology; • infections; • • multi profile; International • others Scientific capacity Bases to implement breakthrough technologies and methodicsUnique facilities for initial founding of scientific-technological platforms of aState/Federal value 5
Modern Clinical facilities of Saint-Petersburg Saint-Petersburg clinical scientific & practical center (oncological) Launched – feb 2010 Properties: 78 000 sq.m. area Bright example of one of nosological 23 units platform Participant 14 surgeries GMP laminar coatings Personnel – 1 200 employees. Clinical capacity – 600 beds Technical capacity: Diagnostics Beam therapy• Multispiral computed tomography 128 14 beam therapy complexes, including:• combined PET-CT,• MRT 3Tesla, • LEA 20 MeV complexes,• Intraoperational MRT, • Brahitherapy complexes,• Dual-head CT gamma camera, • Intraoperational X-Ray complexes.• Dual-source CT angiograph,• US complexes of expert and premium class,• Digital X-Ray complexes.Clinical complex of a top level in Russia relevant to a worldwide level 6
Scientific-technical platform #1 Research & Development of the facilities for personified diagnostics and treatment of oncological diseases 7
Project Participants SPbSU Saint-Petersburg State University IEM Institute of Experimental Medicine of the North - West Branch of the Russian Academy of the Medical Sciences CSPC Saint-Petersburg clinical scientific & practical center (oncological) 8
Research & Development tools for personified diagnostics and treatment of oncological diseases Project structure: • The risk group identification, via genetic diagnostics of the oncology predisposition • General diagnostics of oncology • Noninvasive extracting of tumor cells • Differential diagnostics with optimal for therapy tumor cell surface antigens recognizing • R&D and production of medicines made of genetically engineered complexes • Target therapy of multiple origin tumorsFirst case in Russia of full-stages united system to be created: from diagnostics topersonified therapy 9
Project actuality 1 Russia: the disease rate increase Annually Annual Under monitoring detected new cases deaths 2,5 mln 490 000 new 290 000 Статистика онкологических заболеваний в РФ patients cases patients Вестник РОНЦ им. Н.Н. Блохина, 2009 г. 29 % growth 11 % growth 0 % growth in 10 years in 5 years • Cancer– the second in value cause of country population mortality • While peoples life length is growing the following growth of disease rate is estimated 2 Low medicine consumption rate in Russia 65-70% of cancer patients need to be treated with medicines on multiple desease stages Medicine therapy Medicine Deathes due to the required therapy absence of medicine provided therapy Lung tumor 65% 10% >50% Breast tumor 95% >50% >30% Ovary tumor 95% >50% >30% • Indexes show medicines demand unavoidable growth in close future 10
1 Risk groups identification Genetical diagnostics of hereditary cancer predisposition Researches held The predisposition to breast and ovary cancer was explored • The risk of hereditary cancer development is near 90%.IEM researches • The hereditary breast cancer occurs mostly due to genes BRCA1 and BRCA2 mutations. • Most frequently noted is the 5382 ins C mutation, which is responsible for breast cancer cases and 40% ovary cancer cases. Also were found some other mutations associated with tumors of several types development. • The risk of cancer development in young aged mutations holders is 10 times higher. • It is reasonable to run tests on mutations presence (PCR, sequenation, restriction analysis) firstly for women of families with breast or ovary cancer, and for all women from 20 to 50 years old, as routine healthcare campaign. Over 90% of patients with determined tumors of breast in due time are able to run a valid life. Original Methodics 2012-2013 г. 11
2 General diagnostics via tumor markersMethods • PCR with reverse transcription (cDNA, detection on transcriptase level); • ELISA (detection on proteomics level).Base Universal tumor genes are found which are proposed as base for diagnostics. Start-up №1 Reverse transcription PCR analysis of these markers (cDNA) original methodics shows sensibility up to 95% and specificity – 95%. 2012-2013 ELISA with purified proteins for antibodies used in blood Registration of medicines, certification of methodics, detection shows sensibility up to 94%, specificity – 98% launch on market 12
3 Extraction of tumor cells via non-invasive techniqueMethod • The fraction of tumor cells in blood determination via stream cytologic fluorimetry • Concentration of tumor cells via monoclonal antibodies based sorter • Test of tumor cells RNA function of specific surface antigen encoding Advantages: • Biopsy avoidance Original methodic • High promptness 2012-2013 13
4 Differential diagnosticsAntigens specification – as targets for each individual case • for monoclonal antibodies (МАb) and target-medicines created on their base • for medicine resistance determination and its neutralization vehicles switching on • for immunotherapy efficiency increasing Method: Reverse transcription – real time PCR Start-up №2 original methodics 2012-2013 Medicines registration, Methodics sertification, Product launch 14
5 Developing of biotechnological medicines based on genetically engineered complexes - Monoclonal antibodies (MAb)• Specified linking to the transmembrane antigenes, expressed on the surfaces of tumor cells (onco-markers)• Initiate a cascade of immunological reactions of the humans organism which leads to a lysis of onco-markersexpressing cells• Fundamental difference of MAb opposite to chemo-medicines is its specificity of damage action on target-cells causingminimal harmful influence on normal tissues and organs of host• Nowadays in Russia some of himeric and humanized monoclonal antibodies (MAb) medicines which are totally foreignmade are approved for clinical implementation MAb Conventional MAb action illustration: receptor Start-up №3 Invention 2 original MAb worldwide exclusive MAb pharmaceuticals IEM Particularly based on stage №4 achievements 2013 г. (Definition of universal tumor markers) Therapeutic efficiency studies using cell-models and Clinical studies, clinical samples Pharmaceuticals registration, Methodics certification, 15 Methodics of application studies Product launch
5 Developing of biotechnological medicines based on genetically engineered complexes - Single-chain antibodies (mini-MAb)• Single-chains are genetically engineered atnibodies consisting of only Fv and Sc fragments of ordinary monoclonal antibodies. Their size is 5 times less than that of ordinary antibodies (up to 20nm).• Action mechanism is equivalent to one of ordinary MAb• Small size allows it to penetrate the areas unreachable for МАb Start-up №3 single-chain MAb pharmaceuticals 2013 Clinical studies, Pharmaceutical registration, Methodics certification, Product launch 16
5 Developing of biotechnological medicines based on genetically engineered complexes - MAb conjugated with cytostatic agents (A-MAb) • Complexes of MAb molecules (as nano carrier) conjugated with chemotherapy cytostatic molecules • Action principles based on MAb’s ability to specifically conjugate with onco-markers expressed on tumor cells surface • Due to implementation of MAb as nano-carrier it allows to deliver cytostatic agents directly to cells expressing onco-markers. Clathrine-banded vesicle Clathrine Start-up №3 conjugated MAb pharmaceuticals 2013 Nucleus Clinical studies, Pharmaceutical registration, Methodics certification, Product launch 17
Targeted R&D achievements Field Matter Target1. Risk groups identification Investigation of additional reasonable Original methodics; mutations; Base for diagnosticums development Population studies and commercialization Extended studies of proposed Base for unified diagnosticums for2. General diagnostics tumor-specified genes onco-markers development and commercialization. Start- Studies of additional reliable tumor- up specified genes Original methodics Extended studies and proving the3. Non-invasive tumor cells Original methodics; precision of proposed method , extraction relevant to all types of tumors Base for unified diagnosticums Start-4. Differential diagnostics Extended studies and proving the development and up precision of proposed method relevant to all types of tumors commercialization/ Original methodics Developing new 4 genetically-5. Development of genetically- Technologies of synthesis engineered medicines: technology Start- egineered pharmaceuticals of synthesis, therapeutic efficiency of 4 original pharmaceuticals. up studies Lab Protocols of efficiency studies6. Developed pharmaceuticals In framework of following start-up appliance to cancer therapy development 18
Project resultWithin 5 years following aims will be reached:Creation of technologies and tools for Russia’s first united full-stagesystem in treatment of oncological diseases: from risk groupsidentification to personified diagnostics and therapy, relevant to topworldwide classCreation of technologies for national innovative pharmindustry ofgeneral and differential diagnostics facilities and target-therapypharmaceuticals for treatment of oncological diseases. Creation oforiginal treatment methodics.This will lead to competence for developing start-ups purchased withmore than 7 original oncologic medicines of top worldwide levelCreation of scientific-technological platform aimed to facilitate quickspinoff of start-ups for development and to put into healthcarepractice a new highly innovative pharmaceuticals and treatmentmethodics in a field of oncology 19
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