Drug Security Forum

Patients with rare diseases around the world face significant challenges in ensuring early and accurate diagnosis and access to life-saving treatment. Orphan diseases place a heavy burden on the healthcare system due to the limited availability of pathogenic therapies and their high cost. The development of new drugs is a knowledge-intensive and costly process. The feasibility of investment in it by pharmaceutical companies depends on the size of the potential market. In addition, the limited number of patients makes it difficult to conduct full-scale clinical trials in one country. Cross-country collaboration at all stages of making treatment of patients with orphan diseasesavailable, from development, clinical trials, collection, and analysis of real-world clinical practice data to consolidation of demand for procurement, is of particular importance in this context. What strategies for ensuring the availability of orphan drugs are being implemented in the Russian Federation and in foreign countries? What approaches are most appropriate for molecular genetic research for orphan diseases? What solutions can contribute to the creation of rare disease patient registries? What obstacles do pharmaceutical companies encounter when introducing orphan drugs to the Russian and foreign markets? What approaches exist in Russian and international practice to increase the effectiveness of financing innovative orphan drugs? Should the experience of the Circle of Kindness Foundation be extended to the provision of drugs for adult patients? How to ensure the availability of unregistered orphan drugs? What platforms are needed to build a cross-country dialogue on drug development and improve the regulatory environment for market access?

Moderator
Sergey Kutsev, Director of the Federal State Budgetary Scientific Institution “Medical Genetic Research Center named after A.I. Academician N.P. Bochkov"; Chief Freelance Specialist in Medical Genetics of the Ministry of Health of Russia

Sergey Kutsev

Director of the Federal State Budgetary Scientific Institution “Medical Genetic Research Center named after A.I. Academician N.P. Bochkov"; Chief Freelance Specialist in Medical Genetics of the Ministry of Health of Russia

In 1988, he graduated from the Medical Faculty of the Rostov Order of Peoples' Friendship Medical Institute (RODNMI). Upon graduation from the institute in 1988, he was left for postgraduate studies. In his main position from 1991 to 2000. - Assistant, from 2000 to 2006 - Associate Professor, and from 2006 to August 2011 - Head of the Laboratory of Medical Genetics at the Rostov State Medical University (RostSMU). From 2006, he was concurrently an associate professor and then professor of the course in genetics and laboratory genetics at the Faculty of Advanced Medical Education of the Rostov State Medical University.
After moving to Moscow in 2011 - as the head of the department at the Pirogov Russian National Research Medical University. From 2012 to 2015 - Deputy Head of the Mutagenesis Laboratory (part-time) at the Medical Genetics Research Center of the Russian Academy of Medical Sciences. From 2012 to 2015 - Deputy Director for Scientific Work of the Federal State Budgetary Scientific Institution "Moscow Research Center". From May 20, 2015 - Acting Director and then Director of the Federal State Budgetary Institution "Medical Genetics Research Center" (since 2019 - Federal State Budgetary Institution "Academician N.P. Bochkov Medical Genetics Research Center").
His scientific interests include clinic, diagnosis and treatment of inherited diseases, genetics of oncohematological diseases, the role of viruses in carcinogenesis, neonatal screening, and organization of medical genetic services. He is the author of more than 300 publications, 17 manuals and guidelines.

Panellists
Hesa Sabah Al Doseri, Chief, Health Facilities Regulation, National Health Regulatory Authority of the Kingdom of Bahrain (NHRA)
Yury Zhulev, President, Russian Hemophilia Society
Elena Maksimkina, Director, "Federal Center for Planning and Regulation of Medical Supply Circulation" of the Ministry of Health of the Russian Federation
Inga Nizharadze, General Director, Skopinfarm
Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Aleksandr Rumyantsev, Scientific Director, Dmitry Rogachev National Research Centre (online)
Aleksandr Tkachenko, Archipiest; Chairman of the Committee of Charity and Social Work of the Civic Chamber of the Russian Federation; Chairman of the Board, Circle of Kindness Foundation
Oleg Ergashev, Vice-Governor of Saint Petersburg

Hesa Sabah Al Doseri

Chief, Health Facilities Regulation, National Health Regulatory Authority of the Kingdom of Bahrain (NHRA)

Yury Zhulev

President, Russian Hemophilia Society

In 1985, graduated from the school number 856 (Moscow).
In 1991, graduated from the Moscow State Law University.
In 1989, he was elected Vice President of Hemophilia Association (later renamed Hemophilia Society) that was established the same year.
Since 1993, he was the President of the Hemophilia Society.
In 2000, at the founding congress of the Russian Hemophilia Society he was elected its President, and he still holds this position.
In 2002–2004, he was a board member of the European Hemophilia Consortium and member of the World Federation of Hemophilia. He was named ‘Best volunteer’ of the World Federation of Hemophilia for his active work in CIS countries.
At present, he also holds the following positions:
• Co-chairman of the Russian Union of Patients Public Societies;
• Member of Commission for the Disabled under President of the Russian Federation;
• Head of the working group for improvement of the state sociomedical assessment system and monitoring of implementation of decisions made for the Commission for the Disabled under President of the Russian Federation;
• Co-chair of the Council of public agencies for patients’ rights for the Ministry of Health of the Russian Federation;
• Deputy Chairman of the Public Council of the Ministry of Health of the Russian Federation;
• Member of Council of public agencies for patients’ rights for Federal Service for Surveillance in Healthcare;
• Member of Moscow’s regional department of All-Russia People's Front.
Yury Zhulyov was awarded with an honorary certificate by the Ministry of Health of the Russian Federation, an honorary certificate by the Federal Service for Surveillance in Healthcare and Social Development.

Elena Maksimkina

Director, "Federal Center for Planning and Regulation of Medical Supply Circulation" of the Ministry of Health of the Russian Federation

She was born in Moscow in 1961.

In 1984, she graduated from the Faculty of Pharmacy of the First Moscow Medical Institute (First Moscow State Medical University named after I.M. Sechenov). Since 1984, she graduated from the Faculty of Pharmacy at the I.M. Sechenov First Moscow State Medical University, where she subsequently held the positions of senior laboratory assistant (1984-1986), assistant (1986-1989), senior lecturer (1989-1993), associate professor (1993-2005), professor of the Department of Pharmacy Management and Economics of the Faculty of Pharmacy (2005-2006), head of the Department of Pharmacy Management and Economics (since 2007), dean of the Faculty of Postgraduate Professional Education for pharmacists (since 2005).
Expert in the field of management and economics of pharmacy, Doctor of Pharmacy, Professor.
She is the author of the first dissertation in marketing research on the pharmaceutical market in Russia, one of the founders and chief editors of a professional pharmaceutical magazine "LadyVita" (2003-2004).
Since 2005 she has been the editor-in-chief of the professional pharmaceutical magazine Pervy Stol.
Since 2007 she has been a member of the international pharmaceutical organization FIP.
By order of the Minister of Health of the Russian Federation, she was appointed Director of the Department of State Regulation of Circulation of Medicines.
In July 2013, she was appointed Assistant Minister of Health of the Russian Federation.
In October 2013, she was appointed Director of the Department of Drug Provision and Regulation of Circulation of Medical Products of the Russian Ministry of Health.
In 2020, she was appointed Head of the Federal State Institution "Federal Center for Planning and Organization of Drug Provision to Citizens".

Vitaliy Omelyanovskiy

General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation

Born July 27, 1964 in Obninsk, Kaluga Oblast.
In 1987, he graduated from the Pirogov Russian National Research Medical University with a degree in General Medicine. After graduation he stayed in the university, where he rose from postgraduate to professor of the department of clinical pharmacology.
In 1998 he graduated from the Russian Presidential Academy of National Economy and Public Administration of the Russian Federation with a degree in state and municipal management, with the qualification of economist-financier.
In 2002, he defended the first doctoral dissertation in the Russian Federation on clinical and economic analysis and pharmacoeconomics.
From 2009 to 2012 he was. - Vladimir Potanin was Director of the Research Institute for Clinical and Economic Expertise and Pharmacoeconomics at the N.I. Pirogov Russian National Research Medical University, Federal State Autonomous Educational Institution of Higher Professional Education, Ministry of Health Care of the Russian Federation.
From 2012 to 2020, she was Head of the Research Laboratory of the N.I. Pirogov Russian National Research Medical University. - Head of the Research Laboratory for Technology Assessment in Healthcare at the Institute of Applied Economic Research of the Russian Presidential Academy of National Economy and Public Administration, a federal state budget-funded educational institution of higher education.
Since 2014. - Head of the Healthcare Finance Center of the Federal State Budgetary Institution "Research Financial Institute" of the Ministry of Finance of the Russian Federation. Ministry of Finance of the Russian Federation.
Since 2015. - General Director of the Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation.
Since 2020. - Head of the Department of Economics, Management and Assessment of Healthcare Technologies of the Federal State Budgetary Educational Institution of Additional Professional Education "Russian Medical Academy of Continuing Professional Education" of the Ministry of Healthcare of the Russian Federation.

Member of the Dissertation Council D 208.088.01.
Head of the Expert Council on Health Care of the Federation Council Committee on Social Policy, Expert of the Analytical Centre for the Government of the Russian Federation.
Chief Clinical Pharmacologist, Ministry of Health, Moscow Region.
Chief editor of scientific journals, Pharmacoeconomics. Modern Pharmacoeconomics and Pharmacoepidemiology" and "Medical Technology. Evaluation and Choice".
She is an author of three patents of the Russian Federation, two monographs, educational and methodical manuals for physicians, and more than 140 scientific papers published in Russian and foreign medical journals.
Doctor of Medicine (2002), Professor (2007). Under his supervision V.V. Omelyanovsky defended one doctoral thesis and seven Ph. Currently supervises the theses of two doctoral students and two doctoral candidates.
He is the President of the Russian branch of the International Society for Pharmacoeconomic Research and Outcome Evaluation (ISPOR).
He is a laureate of the Russian Federation Government Award in Science and Technology, has certificates of merit from the President of the Russian Federation and the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, and has received commendations from the Chairman of the Federation Council of the Federal Assembly of the Russian Federation, the Analytical Center of the Russian Federation Government, the Russian Academy of National Economy and Public Administration under the President of the Russian Federation, and the Sverdlovsk Oblast Government.

Aleksandr Rumyantsev

Scientific Director, Dmitry Rogachev National Research Centre

Alexander Rumyantsev, born in 1947, is a Russian Doctor of Medical Sciences, professor, member of the Russian Academy of Sciences, General Director of the Dmitry Rogachev National Research Centre of Pediatric Hematology, Oncology and Immunology, member of the Board of the ‘Doctors, Innovation and Science for Children’ Foundation that supports the development of Pediatric Hematology, Oncology and Immunology, chief consulting pediatric hematologist of the Ministry of Health of Russia, President of the National Society of Pediatric Hematologists and Oncologists, Chairman of the Board of the National Association of Experts in Primary Immunodeficiency, Vice President of the National Medical Chamber, Honorary Professor of the Department of Oncology and Hematology of the School of Pediatrics of Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation. Graduated with honours from the Russian National Research Medical University named after N.I. Pirogov in 1971.
Alexander Rumyantsev is an active facilitator of medical science and practice. For years he headed the RSMU scientific programmes on leukemia in humans and animals of the USSR Committee for Science and Technology and research on rectifying the consequences of Chernobyl disaster, was a member of the Academic Council of the Academy of Medical Sciences and the Ministry of Health of the USSR on pediatrics, hematology and oncology. From 1989 to the present day he has been a Chairman of the hematology section of the Moscow Society of Pediatric Physicians. He is a participant of the Chernobyl nuclear disaster elimination team (1986–1987), ‘Children of Chernobyl’ research programme facilitator in the USSR (1990–1991) and in Russia (1991–1995). Rumyantsev for twenty five years has led pediatric hematology/oncology services in Russia, the process of preparation and adoption of the industry development and financing programme, successful treatment of leukemia, malignant lymphomas, brain tumours, other neoplasms in children and adolescents, setting up a course on pediatric hematology/oncology in the School of Continuing Medical Education in RSMU (the Department of Clinical Hematology/Oncology and Immunology of the School of Continuing Medical Education in RSMU since 2004, and the Department of Oncology and Hematology of the School of Pediatrics of the RSMU), the groundwork for academic programme, the training and certification of pediatric hematologists/oncologists in the Russian Federation.
As a researcher, Alexander Rumyantsev is known for his works in pediatric hematology and immunology, medical ecology, intensive and outpatient pediatrics, adolescent medicine and organization of public health, clinical physiology and pathophysiology of blood, regulation of hematopoiesis and immune response, pathogenesis and treatment of hereditary and evoked blood diseases in children, intensive polychemotherapy and immunotherapy of leukemia. Alexander Rumyantsev is the author of more than 650 scientific papers, including 45 monographs and manuals. He is a member of the Scientific Council and the head of the scientific platform ‘Oncology’ of the Ministry of Health of the Russian Federation, the editor-in-chief of the Bulletin of Blood Service in Russia journal, a member of editorial boards of the following journals: Pediatrics, Russian Pediatric Journal, Issues of Practical Pediatrics, Issues of Dietary Therapy In Pediatrics, Issues of Hematology/Oncology And Immunopathology In Pediatrics, Hematology And Transfusiology, Russian Journal of Pediatric Hematology and Oncology, School of Health, Russian Journal of Immunology; member of the Pharmaceutical Committee of the Russian Federation; member of the National Council of Experts on Rare Diseases, advised 70 doctors and 128 candidates of medical sciences. Honourable Laureate of the Russian National Research Medical University awards (1978, 1983, 1994, 2007), of the Maslov Academy of Medical Sciences of the USSR (1978), of the Moscow Komsomol (1979) for the research in hematology and immunology. He was awarded with a participant’s diploma and a silver medal of the VDNKh (All-Union Exhibition of Achievements of National Economy) (1989) for development of diagnostics and immunotherapy of blood diseases in children, and with an honorary medal of the University of Montpellier (France, 1990). In 1994 he was awarded the Order of Friendship of Peoples for his scientific and academic work, in 2002 – the Honorary Diplomas of the State Duma of the Russian Federation and the Moscow City Duma, in 2003 and 2015 – ‘The Calling’ Award for the best doctors in Russia, in 2004 – the medal ‘For Merits in Healthcare’, in 2007 – Excellent Worker of Public Health badge. In 2008 and 2011 he received the medical awards from the Moscow government, in 2013 – the International Galien Award. In 2015 he was awarded the Glory of Ossetia Order and the Russian Emergencies Ministry (EMERCOM) medal ‘Cooperation for Salvation’.
Married with two children and five grandchildren.

Aleksandr Tkachenko

Archipiest; Chairman of the Committee of Charity and Social Work of the Civic Chamber of the Russian Federation; Chairman of the Board, Circle of Kindness Foundation

Oleg Ergashev

Vice-Governor of Saint Petersburg

Front row participants
Darya Kryuchko, Head of the Department of Translational Medicine and Innovative Technologies, Federal Medical and Biological Agency (FMBA of Russia)
Oleg Lapochkin, Committee on Health Care and Health-Saving Technologies, Business Center for Economic Development of the CIS

Darya Kryuchko

Head of the Department of Translational Medicine and Innovative Technologies, Federal Medical and Biological Agency (FMBA of Russia)