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Interdisciplinary 
consortium collaboration 
for the development of 
radiopharmaceutical 
approach for effective 
diagnostics and therapy of 
prostate cancer in Russia 
K. German1,2, O. Vlasova3, V. Petriev4, V. Skvortsov4, G. 
Kodina5, A. Maruk5, N. Airapetova6, N. Epshtein6, N. Nerozin3, 
A. Safonov1,2, V. Lebedev1, Ya. Obruchnikova1,2, Yu. Shevko3 
1 - A.N. Frumkin Institute of Physical Chemistry and Electrochemistry RAS, Moscow 
2 - Medical Institute Reaviz, Moscow branch, Russia 
3 - A. I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Russia 
4 - Medical Radiological Research Center of Ministry of Health of Russia, Obninsk, 
Russia 
5 - Burnazyan Federal Medical Biological Center of FMBA, Moscow, Russia 
6 - National Research Nuclear University MEPhI, Obninsk, Russia
Consortium organigram 
Direсtorate 
A.N. Frumkin 
Institute of Physical 
Chemistry and 
Electrochemistry RAS, 
Moscow 
Medical 
Institute Reaviz, 
Moscow branch, 
Russia 
Burnazyan Federal 
Medical Biological 
Center of FMBA, 
Moscow, Russia 
A. I. Leipunsky Institute for 
Physics and Power 
Engineering, Obninsk, 
Medical Radiological 
Research Center of 
Ministry of Health of 
Russia, Obninsk, Russia 
National Research 
Nuclear University 
MEPhI, Obninsk, 
Russia 
Russia 
Tc-99m for 
prostate cancer 
diagnostics and 
Re-188 for treatment
A.N. Frumkin Institute of Physical 
Chemistry and Electrochemistry RAS, 
Moscow 
Technetium chemistry laboratory 
• K. German, Project CEO, Head of Tc 
laboratory, PhD , Doc., Prof. 
• A. Safonov, Deputy head of Tc laboratory, PhD 
• Ya. Obruchnikova, PhD 
• V. Tregubova, PhD student 
• M. Glazkova 
Innovation department 
• V. Lebedev, General manager for innovations 
Laboratory of new physical-chemical problems 
• A. Tsivadze, Director of IPCE RAS, Academician 
• A. Filyanin, liquid extraction group, PhD 
• V. Tarasov, NMR analysis, Professor 
Laboratory of substance radiation chemistry 
• B. Ershov, Head of laboratory, corr. member 
RAS, Professor 
• E. Abkhalimov, PhD 
• R. Solovov, PhD student 
Laboratory of interphase boundaries and 
electocatalysis 
• V. Andreev, Head of laboratory, Professor 
Laboratory of radioactive material analysis 
• M. Grigoriev, Head of laboratory, Professor
• The main purpose of the Institute is to carry 
out fundamental and applied scientific 
research in various fields of physical chemistry, 
electrochemistry, chemical resistance of 
materials, radiochemistry and radiation 
chemistry.
A. I. Leipunsky Institute for Physics and 
Power Engineering, Obninsk, Russia 
• O. Vlasova, N. Nerozin, Yu. Shevko, I. Zhuk 
• multidisciplinary scientific organization, 
conducting complex investigations of physical 
and technical problems of nuclear science and 
technology.
Medical Radiological Research Center 
of Ministry of Health of Russia, 
Obninsk, Russia 
• V. Skvortsov, V. Petriev 
• Mission: Development of concepts, regulatory 
documents related to radiation safety of a human 
and the environment, health security and 
reduction of socioeconomic prejudice caused by 
radiation. 
• The Institute was founded in 1962 to develop and 
improve methods of radiation diagnostics and 
radiation therapy, prevention and treatment of 
radiation injury, the study of the biological and 
medical effects of ionizing radiation.
National Research Nuclear University 
MEPhI, Obninsk, Russia 
• N. Airapetova, N. Epshtein 
• Development of analytical procedures 
for quality control of 
radiopharmaceuticals and staff training 
• Mission: to generate, disseminate the use and to 
preserve scientific knowledge aiming to address 
global challenges of the XXI century, as well as to 
provide innovative transformations in Russia 
accompanying development of the country 
competitiveness in the global energy and non-energy 
high-tech markets.
Burnazyan Federal Medical Biological 
Center of FMBA, Moscow, Russia 
• G. Kodina, PhD, Department head 
• A. Maruk, PhD, Laboratory Head 
• Production of Tc-99m (for radiodiagnostics) 
and Re-188 (for radiotherapy) isotopes and 
preclinical medicine tests 
• Fundamental and applied research in the field of radiation 
medicine, radiobiology and radiation protection; 
• Research in the field of biomedical technologies, radiopharmacy; 
• Development of new radiation technologies (including photon 
and neutron capture therapy); 
• Research in the field of chemical and radiation safety in the use 
of technology for special applications.
Medical Institute Reaviz, 
Moscow branch, Russia 
• K. German, Chair of Natural science, Professor 
• A. Safonov, docent, PhD 
• Ya. Obruchnikova, assistant prof., PhD 
• V. Tregubova, PhD student 
• Training of medical staff for modern medicine 
“The main aim of Reaviz is the training of health care staff, of young people 
who should become highly professional physicians in the nearest future. The 
most important quality for these professionals should be the integration of the 
greatest responsibility and the inner freedom of this profession, of scientific 
research and practical achievements.” Rector of Samara Medical Institute 
“REAVIZ”, Doctor of Medical Science, professor Nikolay A. Lyssov
What we intend to obtain 
In the course of this project should be developed 
• production technologies of 99mTc generators and high-value 
188Re generators with reduced transport index, 
• technologies of 188Re concentration, development of 
analytical methods for detection of radioactive and 
chemical impurities in the 188Re preparation, 
• quality assurance of 99mTc and 188Re generator eluates 
in accordance with the requirements of potential 
radiopharmaceuticals based on them, specifically binds 
to the receptor tissue of prostate cancer.
What we already have 
for radionuclide imaging 
• 2-18F-fluoro-2-deoxy-D-glucose (FDG); 
• 111In-7E11 antibody (ProstaScint); 
• 18F-fluorodihydrotestosterone (18F-FDHT); 
• radioacetate analogs; 
• radiocholine analogs; 
• anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic 
acid (anti-[18F]FACBC) 
Production of Tc-99m (for radiodiagnostics) and Re-188 
(for radiotherapy) isotopes were improved with 
optimized generator design aimed to high specific activity 
production.
• Potential consumer of radiopharmaceuticals 
(RPh): medical institutions at various levels, 
cancer medical centers, cancer clinics, licensed to 
work with sources of ionizing radiation and 
equipped with diagnostic equipment, SPECT or 
PET. 
• Objects of RPh application: patients with the 
disease of prostate cancer (about 30 thousand 
pers. / year). 
• Over the past few years in Russia approximately 
40,000 new cases of prostate cancer per year 
were recorded, and only for 30% of them 
brachytherapy is performed with an efficiency of 
75%
Effective diagnostics and therapy of 
prostate cancer is an important issue 
for Russia due to constantly increasing 
number of decease cases herein. 
Rational development of new radiopharmaceuticals 
for the management of advanced and metastatic 
prostate cancer requires an improved cooperation 
of the organization thus involved. For this reason an 
interdisciplinary consortium collaboration for the 
development of radiopharmaceutical approach is 
established with principle aim to improve the 
situation within the 3 coming years.
The development of new radiopharmaceuticals 
and generators for the management of 
advanced prostate cancer will help to improve 
the treatment of this disease in Russia.
• Special educational interdisciplinary program for 
specialist training for technetium application to 
prostate radiodiagnostics is elaborated. 
• The development of new radiopharmaceuticals 
and generators for the management of advanced 
prostate cancer will help to improve the treatment 
of this disease in Russia. 
• Innovative character of this project requires special 
attention on staff training. 
• New technologies worked out by Igor Zhuk and 
Yury Shevko (A.I. Leipunsky Institute for Physics 
and Power Engineering, Obninsk, Russian 
Federation) are to be used in this project
A new approach to 
form a competent team of 
specialists
What makes a good specialist? 
Interest Competence 
Objectivity Creativity 
Self-criticism 
Efficiency
Many issues written by leading scientists state 
that the expert is endowed mainly the 
following qualities, namely: 
1) has a degree in the subject area; 
2) has a positive experience with previous 
expertise in the subject area; 
3) must work at least 10 years; 
4) objective; 
5) must constantly improve their knowledge and 
so on.
Is it true? 
In our opinion, these qualities are of a formal 
nature and do not meet the full competencies 
that have been proposed by the European 
community as one of the core competences for 
professionals of the twenty-first century.
Five basic EU competencies were chosen as the most 
necessary for the Expert of the XXI century : 
1. Communication in the mother tongue. 
2. Communication in foreign languages. 
3. Mathematics skills and core competencies 
(skills) in science and technology. 
4. Information technology competence. 
5. The ability to find new information and 
produce new knowledge for expert’s 
professional area.
Ask yourself: “Are you sure that You 
have all this basic competencies?” 
Or Do You think that the expert and specialist of 
technetium application to prostate 
radiodiagnostics do not need 
this competencies? 
Unfortunately, it is not a simple question. 
Please, think about quantity of the wrong 
diagnosis in different countries
Thank you 
for the attention !
• The PSMA markers are focus selection of the project 
due to their ability not only for cancer but also for 
methastatic object detection. Draw investigation 
indicated that the prostate-specific membrane antigen 
(PSMA) based markers could be the key substrate 
matter for the solution of the problem. PSMA is highly 
expressed in prostate cancer, and small-molecule 
radiopharma-ceuticals targeting PSMA helps to rapidly 
detect the location and extent of disease. Comparative 
study provided with a selected row of substrates 
including several MIP derivatives and some others. 
Synthetic procedures were optimized for better yields, 
purities and prices.
Expert assessments in Russia 
• Expert assessments are applied with success 
in various fields of human activity and find 
their reflection in the works of such Russian 
scientists as Azgaldov G.G., Beshelev S.D., 
Evlanov L.G., Gurvich F.G., Larichev O.I., Litvak 
B.G., Novikov, D. A., Orlov, A.I., Raichman I.P., 
Sidelnikov Y.V., and many other authors 
involved in problem of expert assessments. 
24
Evlanov L.G. thought that the expert 
has the following requirements: 
1) Competence; 
2) Creativity; 
3) Respect to the examination; 
4) Conformism; 
5) Constructive thinking; 
6) Teamwork; 
7) Self-criticism. 
25
In the work of Raichman A.P. and Azgldov G.G. the 
quality of the expert has the following requirements: 
1) Competence; 
2) Interest; 
3) Efficiency; 
4) Objectivity. 
The competence of the expert should be applied 
to the object quality assessment (professional 
competence) and methodology (qualitative 
competence).
Data about the authors 
• Zhuk Igor Aleksandrovich, PHD, 
• Shevko Yuri Viktorovich, 
e-mail: zz-38@yandex.ru 
• (A. I. Leipunsky Institute for Physics and Power 
Engineering, Obninsk, Russia)
2014 german-vlasova-obruchnikova-istr

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2014 german-vlasova-obruchnikova-istr

  • 1. Interdisciplinary consortium collaboration for the development of radiopharmaceutical approach for effective diagnostics and therapy of prostate cancer in Russia K. German1,2, O. Vlasova3, V. Petriev4, V. Skvortsov4, G. Kodina5, A. Maruk5, N. Airapetova6, N. Epshtein6, N. Nerozin3, A. Safonov1,2, V. Lebedev1, Ya. Obruchnikova1,2, Yu. Shevko3 1 - A.N. Frumkin Institute of Physical Chemistry and Electrochemistry RAS, Moscow 2 - Medical Institute Reaviz, Moscow branch, Russia 3 - A. I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Russia 4 - Medical Radiological Research Center of Ministry of Health of Russia, Obninsk, Russia 5 - Burnazyan Federal Medical Biological Center of FMBA, Moscow, Russia 6 - National Research Nuclear University MEPhI, Obninsk, Russia
  • 2. Consortium organigram Direсtorate A.N. Frumkin Institute of Physical Chemistry and Electrochemistry RAS, Moscow Medical Institute Reaviz, Moscow branch, Russia Burnazyan Federal Medical Biological Center of FMBA, Moscow, Russia A. I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Medical Radiological Research Center of Ministry of Health of Russia, Obninsk, Russia National Research Nuclear University MEPhI, Obninsk, Russia Russia Tc-99m for prostate cancer diagnostics and Re-188 for treatment
  • 3. A.N. Frumkin Institute of Physical Chemistry and Electrochemistry RAS, Moscow Technetium chemistry laboratory • K. German, Project CEO, Head of Tc laboratory, PhD , Doc., Prof. • A. Safonov, Deputy head of Tc laboratory, PhD • Ya. Obruchnikova, PhD • V. Tregubova, PhD student • M. Glazkova Innovation department • V. Lebedev, General manager for innovations Laboratory of new physical-chemical problems • A. Tsivadze, Director of IPCE RAS, Academician • A. Filyanin, liquid extraction group, PhD • V. Tarasov, NMR analysis, Professor Laboratory of substance radiation chemistry • B. Ershov, Head of laboratory, corr. member RAS, Professor • E. Abkhalimov, PhD • R. Solovov, PhD student Laboratory of interphase boundaries and electocatalysis • V. Andreev, Head of laboratory, Professor Laboratory of radioactive material analysis • M. Grigoriev, Head of laboratory, Professor
  • 4. • The main purpose of the Institute is to carry out fundamental and applied scientific research in various fields of physical chemistry, electrochemistry, chemical resistance of materials, radiochemistry and radiation chemistry.
  • 5. A. I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Russia • O. Vlasova, N. Nerozin, Yu. Shevko, I. Zhuk • multidisciplinary scientific organization, conducting complex investigations of physical and technical problems of nuclear science and technology.
  • 6. Medical Radiological Research Center of Ministry of Health of Russia, Obninsk, Russia • V. Skvortsov, V. Petriev • Mission: Development of concepts, regulatory documents related to radiation safety of a human and the environment, health security and reduction of socioeconomic prejudice caused by radiation. • The Institute was founded in 1962 to develop and improve methods of radiation diagnostics and radiation therapy, prevention and treatment of radiation injury, the study of the biological and medical effects of ionizing radiation.
  • 7. National Research Nuclear University MEPhI, Obninsk, Russia • N. Airapetova, N. Epshtein • Development of analytical procedures for quality control of radiopharmaceuticals and staff training • Mission: to generate, disseminate the use and to preserve scientific knowledge aiming to address global challenges of the XXI century, as well as to provide innovative transformations in Russia accompanying development of the country competitiveness in the global energy and non-energy high-tech markets.
  • 8. Burnazyan Federal Medical Biological Center of FMBA, Moscow, Russia • G. Kodina, PhD, Department head • A. Maruk, PhD, Laboratory Head • Production of Tc-99m (for radiodiagnostics) and Re-188 (for radiotherapy) isotopes and preclinical medicine tests • Fundamental and applied research in the field of radiation medicine, radiobiology and radiation protection; • Research in the field of biomedical technologies, radiopharmacy; • Development of new radiation technologies (including photon and neutron capture therapy); • Research in the field of chemical and radiation safety in the use of technology for special applications.
  • 9. Medical Institute Reaviz, Moscow branch, Russia • K. German, Chair of Natural science, Professor • A. Safonov, docent, PhD • Ya. Obruchnikova, assistant prof., PhD • V. Tregubova, PhD student • Training of medical staff for modern medicine “The main aim of Reaviz is the training of health care staff, of young people who should become highly professional physicians in the nearest future. The most important quality for these professionals should be the integration of the greatest responsibility and the inner freedom of this profession, of scientific research and practical achievements.” Rector of Samara Medical Institute “REAVIZ”, Doctor of Medical Science, professor Nikolay A. Lyssov
  • 10. What we intend to obtain In the course of this project should be developed • production technologies of 99mTc generators and high-value 188Re generators with reduced transport index, • technologies of 188Re concentration, development of analytical methods for detection of radioactive and chemical impurities in the 188Re preparation, • quality assurance of 99mTc and 188Re generator eluates in accordance with the requirements of potential radiopharmaceuticals based on them, specifically binds to the receptor tissue of prostate cancer.
  • 11. What we already have for radionuclide imaging • 2-18F-fluoro-2-deoxy-D-glucose (FDG); • 111In-7E11 antibody (ProstaScint); • 18F-fluorodihydrotestosterone (18F-FDHT); • radioacetate analogs; • radiocholine analogs; • anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid (anti-[18F]FACBC) Production of Tc-99m (for radiodiagnostics) and Re-188 (for radiotherapy) isotopes were improved with optimized generator design aimed to high specific activity production.
  • 12. • Potential consumer of radiopharmaceuticals (RPh): medical institutions at various levels, cancer medical centers, cancer clinics, licensed to work with sources of ionizing radiation and equipped with diagnostic equipment, SPECT or PET. • Objects of RPh application: patients with the disease of prostate cancer (about 30 thousand pers. / year). • Over the past few years in Russia approximately 40,000 new cases of prostate cancer per year were recorded, and only for 30% of them brachytherapy is performed with an efficiency of 75%
  • 13. Effective diagnostics and therapy of prostate cancer is an important issue for Russia due to constantly increasing number of decease cases herein. Rational development of new radiopharmaceuticals for the management of advanced and metastatic prostate cancer requires an improved cooperation of the organization thus involved. For this reason an interdisciplinary consortium collaboration for the development of radiopharmaceutical approach is established with principle aim to improve the situation within the 3 coming years.
  • 14. The development of new radiopharmaceuticals and generators for the management of advanced prostate cancer will help to improve the treatment of this disease in Russia.
  • 15. • Special educational interdisciplinary program for specialist training for technetium application to prostate radiodiagnostics is elaborated. • The development of new radiopharmaceuticals and generators for the management of advanced prostate cancer will help to improve the treatment of this disease in Russia. • Innovative character of this project requires special attention on staff training. • New technologies worked out by Igor Zhuk and Yury Shevko (A.I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Russian Federation) are to be used in this project
  • 16. A new approach to form a competent team of specialists
  • 17. What makes a good specialist? Interest Competence Objectivity Creativity Self-criticism Efficiency
  • 18. Many issues written by leading scientists state that the expert is endowed mainly the following qualities, namely: 1) has a degree in the subject area; 2) has a positive experience with previous expertise in the subject area; 3) must work at least 10 years; 4) objective; 5) must constantly improve their knowledge and so on.
  • 19. Is it true? In our opinion, these qualities are of a formal nature and do not meet the full competencies that have been proposed by the European community as one of the core competences for professionals of the twenty-first century.
  • 20. Five basic EU competencies were chosen as the most necessary for the Expert of the XXI century : 1. Communication in the mother tongue. 2. Communication in foreign languages. 3. Mathematics skills and core competencies (skills) in science and technology. 4. Information technology competence. 5. The ability to find new information and produce new knowledge for expert’s professional area.
  • 21. Ask yourself: “Are you sure that You have all this basic competencies?” Or Do You think that the expert and specialist of technetium application to prostate radiodiagnostics do not need this competencies? Unfortunately, it is not a simple question. Please, think about quantity of the wrong diagnosis in different countries
  • 22. Thank you for the attention !
  • 23. • The PSMA markers are focus selection of the project due to their ability not only for cancer but also for methastatic object detection. Draw investigation indicated that the prostate-specific membrane antigen (PSMA) based markers could be the key substrate matter for the solution of the problem. PSMA is highly expressed in prostate cancer, and small-molecule radiopharma-ceuticals targeting PSMA helps to rapidly detect the location and extent of disease. Comparative study provided with a selected row of substrates including several MIP derivatives and some others. Synthetic procedures were optimized for better yields, purities and prices.
  • 24. Expert assessments in Russia • Expert assessments are applied with success in various fields of human activity and find their reflection in the works of such Russian scientists as Azgaldov G.G., Beshelev S.D., Evlanov L.G., Gurvich F.G., Larichev O.I., Litvak B.G., Novikov, D. A., Orlov, A.I., Raichman I.P., Sidelnikov Y.V., and many other authors involved in problem of expert assessments. 24
  • 25. Evlanov L.G. thought that the expert has the following requirements: 1) Competence; 2) Creativity; 3) Respect to the examination; 4) Conformism; 5) Constructive thinking; 6) Teamwork; 7) Self-criticism. 25
  • 26. In the work of Raichman A.P. and Azgldov G.G. the quality of the expert has the following requirements: 1) Competence; 2) Interest; 3) Efficiency; 4) Objectivity. The competence of the expert should be applied to the object quality assessment (professional competence) and methodology (qualitative competence).
  • 27. Data about the authors • Zhuk Igor Aleksandrovich, PHD, • Shevko Yuri Viktorovich, e-mail: zz-38@yandex.ru • (A. I. Leipunsky Institute for Physics and Power Engineering, Obninsk, Russia)