Uncertainty analysis and risk assessment of the creation of a joint Russian-Nicaraguan biotechnology enterprise


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The authors have analyzed the current programs and projects of the World Health Organization and found that special attention is paid to immunization, vaccines, and biotechnological preparations. To date, global manufacturers of immunobiological preparations face a number of problems in continuing to design, manufacture, and supply innovative and high-quality vaccines that meet the needs of countries, as well as in creating new production capacities in the countries and regions where this potential was previously absent. Today, the Russian Federation has been established to be an active participant in the assistance and development of the resources of a number of countries in the field of immunobiotechnology. The project to create a joint Russian-Nicaraguan biotechnology enterprise will be able to introduce Russian immunobiological preparations and technologies for their production on the markets of Central and Latin America. The authors provide a rationale for selecting key parameters to assess project risks. A risk situations classification has been developed; approaches and measures to minimize risks have been substantiated.

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作者简介

Victor Trukhin

Saint Petersburg Research Institute of Vaccines and Sera and Enterprise for the Production of Bacterial Preparations, Federal Biomedical Agency; Saint Petersburg State Chemical-Pharmaceutical University

Email: truhin64@gmail.com
Director of the Saint-Petersburg scientific research institute of vaccines and serums and the enterprise for the production of bacterial preparations, Professor of the Department of Immunobiotechnology, SaintPetersburg State Chemical and Pharmaceutical University (SPbSChPhU) Saint Petersburg, Russian Federation

Igor Narkevich

Saint Petersburg State Chemical-Pharmaceutical University

Email: igor.narkevich@pharminnotech.com
Rector, Head of the Department of Management and Economy of Pharmacy , Doctor of Pharmaceutical Sciences, Professor Saint Petersburg, Russian Federation

Elena Nacharova

Saint Petersburg State Chemical-Pharmaceutical University; Latin American Institute for Biotechnology Mechnikov

Email: e.nacharova@mecnikov.org
Medical Director of Latin-American Institute for biotechnology Mechnikov, Associate Professor of the Department of Immunobiotechnology SPbSChPhU, PhD Medicine Saint Petersburg, Russian Federation

Stanislav Uiba

Latin American Institute for Biotechnology Mechnikov

Email: s.uiba@mechnikov.org
Director General Saint Petersburg, Russian Federation

Irina Basakina

Saint Petersburg State Chemical-Pharmaceutical University

Email: irina.basakina@pharminnotech.com
Associate Professor of the Department of Management and Economy of Pharmacy Saint Petersburg, Russian Federation

参考

  1. World Health Organization, Programmes and projects. Access mode: http:// www.who.int/entity/en/ (circulation date 25 February, 2019).
  2. World Health Organization, Miloud Kaddar «Global Vaccine Market Features and Trends». Access mode: http://who. int/influenza_vaccines_plan/-resources/session_10_kaddar.pdf (circulation date 25 February, 2019).
  3. Трухин В.П., Наркевич И.А., Начарова Е.П. и др. Потенциал Российской Федерации в экспорте противогриппозных вакцин в страны Латино-американского региона. Разработка и регистрация лекарственных средств. 2018; 2 (2з): 156-62.
  4. Басакина И.И., Наркевич И.А., Трухин В.П. и др. Роль базовой кафедры иммунобиотехнологии СПХФА в стратегии отечественного и международного трансфера знаний в области биофармацевтической промышленности. Биотехнология: состояние и перспективы развития. Материалы I Международного конгресса. 2017: 534-6.
  5. World Health Organization, Report of the second WHO consultation on the global action plan for influenza vaccines. (GAP), Geneva, Switzerland, 12-14 July 2011. Access mode: http://www.who.int/influenza_vaccines_plan/resources/gap-2consultationreport.pdf (circulation date 25 February, 2019).
  6. Трухин В.П., Наркевич И.А., Начарова Е.П. и др. Оценка перспектив экспорта отечественных противогриппозных вакцин в страны Латинской Америки и Карибского бассейна. Ремедиум. 2018; 11: 49-54. DOI: http://dx.doi. org/10.21518/1561-5936-2018-11-49-54
  7. Palache A., Oriol-Mathieu V., Abelin A. et al. Seasonal influenza vaccine dose distribution in 157 countries (2004-2011). Vaccine. 2014, 32 (48): 6369-76. doi: 10.1016/j.vac-cine.2014.07.012. Epub 2014 Nov 1

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