Litvinova O. Theoretical and practical approaches to intellectual resources management of drug developers and manufacturers under conditions of innovative development

The dissertation is devoted to the development of theoretical, methodological and scientific-practical principles of intellectual resource management of drug developers and manufacturers in the context of building an innovative development. It has substantiated the essence and methodological principles of building a level system of intellectual resource management in pharmacy. It has identified directions for improving the regulatory and legal framework regarding the exclusivity regime of clinical research data, which in Ukraine today does not take into account the specifics of certain groups of drugs (pediatric drugs, orphan drugs, etc.). It has developed the methodology for intellectual resources evaluating in pharmacy. It has developed methodical approaches to the management of specific intellectual resources in pharmacy: intellectual property objects are related to the development, implementation and patenting biosimilars, nanotechnology-based drugs, orphan drugs and antiretroviral drugs. It has developed the methodical approaches to patent researches of drug development. It has carried out the classification of risks faced by the subjects of the pharmaceutical market in the process of intellectual property commercialization. It has developed scientific and practical approaches to designing a patent-innovation strategy for the creation and organization of production of domestic drugs (on the example of preparations for treatment of the cardiovascular system, urology, immune system). It has developed the methodical principles for constructing a process model of commercialization of intellectual property objects in pharmacy.