Ensuring Drug Security Forum

Orphan diseases are a heavy medical and social burden for any state. Roughly 70% of orphan diseases are genetic, progressive, and lead to either disability or early mortality. Moreover, the rarity of such diseases is what causes problems with their diagnosis. Insufficient data about them prevents us from determining their prevalence and, as such, does not provide pharmaceutical companies with the opportunity to forecast the potential market and the efficiency of investments. Some countries struggle to conduct local clinical trials due to their low number of patients with orphan diseases. These factors limit the ability to provide drugs to patients with orphan diseases. To expand such opportunities and jumpstart the market for innovative orphan drugs, it is crucial to strengthen tools for international cooperation, from developing therapies, conducting full-scale clinical studies, collecting and analysing data from real clinical practice, and creating common registries, to consolidating demand and developing mechanisms for joint international procurements. Given the economic sanctions in Russia, the problem of access to innovative pharmaceutical technologies must be solved by improving national technological sovereignty. How can we ensure the creation of domestic developments for molecular genetic research into orphan diseases? How can we promote the creation of patient registries? What regulatory and financial practices could stimulate the development of innovative orphan drugs? How can we ensure the availability of orphan drugs, including for adult patients? What effective tools to support the provision of orphan drugs can be borrowed from international experience?

Moderators
Sergey Kutsev, Director, Academician N.P. Bochkov Medical Genetic Research Center; Chief Freelance Specialist in Medical Genetics of the Ministry of Health of Russia
Tatyana Pervunina, Director of the Institute of Perinatology and Pediatrics, V.A. Almazov National Medical Research Center of the Ministry of Health of the Russian Federation

Sergey Kutsev

Director, Academician N.P. Bochkov Medical Genetic Research Center; 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
Dmitriy Galkin, Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation
Yury Zhulev, President, Russian Hemophilia Society
Guvenc Kockaya, General Director, Econix Research, Analysis and Consulting Inc.
Igor Korobko, Head of Science and Innovative Development of Health Department, Ministry of Health of the Russian Federation (online)
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, Skopinpharm
Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
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

Dmitriy Galkin

Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation

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.

Igor Korobko

Head of Science and Innovative Development of Health Department, Ministry of Health of the Russian Federation

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".

Inga Nizharadze

General Director, Skopinpharm

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 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 participant
Alexey Kosolapov, Commercial Director, Alexion Pharmaceuticals

Alexey Kosolapov

Commercial Director, Alexion Pharmaceuticals