Development and Introduction into Clinical Practice of Personalized Selection and Monitoring of Pharmaceuticals for Socially Significant Diseases

Project tasks

The key tasks for the given project are the following:

1.     Developing the techniques of quantification of pharmaceuticals using the method of HPLC in the human blood serum;

2.     Obtaining approvals and introducing the developed techniques into the practices of the medical institutions at the federal level;

3.     Developing the algorithms of generating pharmacokinetic test reports aimed at optimal monitoring of pharmaceutical treatment;

4.     Creating an electronic textbook for the students of medical schools, clinical pharmacologists, and workers of clinical pharmacokinetics and chemical toxicology laboratories;

5.     Publications of scientific papers and theses for conferences and symposia on the results of the research conducted.

 

Project participants

• Khromatografia research and education center, Novosibirsk State University;
• Closed joint-stock company EcoNova Chromatography Institute;
• Novosibirsk State Medical University under the Russian Ministry of Health;
• Limnological Institute, Siberian branch of the Russian Academy of Sciences.

 

Market potential

The recommendations developed relating to equipment and methodological support required for a complete laboratory plant for pharmaceutical treatment monitoring will allow optimization of the costs of equipping clinical-diagnostic and clinical pharmacokinetics laboratories in medical institutions.  

The possibility of raising the quality of medical care provided to the people will ensure a steadfast demand for such laboratory plants. In the nearest 2-3 years of the project implementation, it is planned to equip 250 medical institutions with the said complete laboratory plants for pharmaceutical treatment monitoring in the territory of Russia and then to export the Milikhrom A-02 liquid chromatographs to the CIS countries.

The computer simulator "Liquid Chromatograph", being developed in accordance with the third-generation standards, will allow training in the HPLC method without wasting expensive eluents and significantly saving time. There are about 70 medical schools, advanced medical learning institutes and military medical schools in Russia, which are potential customers for the educational product being developed.

 

Topicality

The number of organizations in Russia exercising monitoring of pharmaceutical treatment is limited. The high price of imported high-performance liquid chromatographs is one of the obstacles on the way of introducing complete laboratory plants into the medical testing practice.

Project phase

The project is now in the implementation phase.

Currently a list of patients suffering from specific diseases is being generated (tuberculosis, chronic myeloleukemia, Crohn’s disease, ulcerative colitis), staff members are being trained, reagents and materials are being procured, and equipment is being put into operation.

The implementation and funding plan

Project phase	Implementation period	Results	Funding, thousand rubles
Developing the techniques of quantification of pharmaceuticals using the method of HPLC in the human blood serum, obtaining approvals and registration	2013-2016	The techniques of quantification of pharmaceuticals using the method of HPLC in the human blood serum, registered with the Russian Ministry of Health	15,500
Developing an electronic textbook	2015	An electronic textbook	1,000
Total			16,500

 

Required support of the cluster infrastructure

• Provision of consulting services;
• Expert examination of documents required for registration of medical techniques;
• Project lobbying;
• Search for off-budget funding sources (regional- and federal-level grants);
• Preparation of documents required for obtaining federal and municipal co-funding support.