Realisation period: 1. 7. 2017 – 30. 6. 2021
The main objective of the project is in line with the substantive focus monitored challenges, ie. The project goal is mainly to support the construction, upgrade, modernization and research activities of the research infrastructure of CZECRIN (structure set out in the Travel map of Czech Republic of large infrastructures for research, experimental development and innovation for the years 2016-2022). The specific objective of the project is to support and increase international quality of research and its results.
The main research goal of the project is the development, manufacture and clinical evaluation of innovative medicine ATMP focusing on rare diseases. Partial objectives of the project are divided into three core research areas that are further developed infrastructure CZECRIN:
1) Research and development ATMP and its preparation for clinical use
Partial aim is validation process isolation of mesenchymal cells from bone marrow and adipose tissue and its application in clinical practice in clinical trials of the product ATMP.
2) Monitoring and clinical pharmacological interpretations of plasma concentrations of innovative modern drugs in the treatment of rare diseases with an emphasis on paediatric oncological diseases
Partial aim is development and establishment of methods for qualitative and quantitative detection of analytes of innovative targeted drugs based on monoclonal antibodies and tyrosine kinase inhibitors using LC-MS/MS, their reproduction and applications into clinical practice within a clinical trial, along with comprehensive pharmacological interpretations seeking to establish biologically optimal dose and length therapy.
3) Design and methodological support for preparation of clinical trials protocol on rare diseases
The partial aim of the draft protocol and study design to the above mentioned clinical trials on rare diseases.