European Regional Development Fund Operational Program “Growth and Employment” 1.2.1. specific aid objective “Increase private sector investment in R&D” 1.2.1.1. activity “Support for the development of new products and technologies within the competence centers” within the project No. 1.2.1.1/18/A/005 “Pharmaceutical, Biomedical, and Medical Technology Competence Center” on March 1, 2019, JSC Olainfarm started the implementation of the research project “Pre-clinical and clinical trials of medicines”.

As part of the project, preclinical studies of medicinal substances are planned to be performed in accordance with the principles of Good Laboratory Practice and clinical trials of 5 pharmaceutical forms in accordance with the principles of Good Clinical Practice. Data from studies will be used for the development of registration files for medicinal products, which are necessary for the registration of medicinal products.

The implementation time of the research project is from March 1, 2019, to June 30, 2022.

The total cost of the project is planned to be EUR 3 529 925.00, including EUR 941 622.25 ERDF funding.

Chronology of works implemented within the project:

1. On February 25, 2019, a procurement procedure was announced for the performance of a contract study “Full-service pharmacokinetic and bioavailability study of medicines OF_NEIR”. On March 26, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/573617. An agreement on the implementation of the study has been concluded. A study has been conducted. The final report of the research has been received.

2. On March 4, 2019, procurement procedures were announced for the performance of contract research “In vivo micronucleus studies in rats” and “In vitro human lymphocyte chromosome aberration studies”. On April 1, 2019, the result within the procurement “In vitro human lymphocyte chromosome aberration studies” was announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/574324. An agreement on the implementation of the study has been concluded. Within the framework of the research, five research plans were prepared and coordinated. Final study reports received (5 substances).

3. On April 1, 2019, the termination of the procurement “In vivo micronucleus studies in rats” was announced, taking into account the need to specify the technical specification (study design), the publication on the termination of the procurement is available at https://pvs.iub.gov.lv/show/574325.

4. On April 18, 2019, the procurement procedure for the contract study “Full-service pharmacokinetic study for the medicinal products OF_FEN” was announced. On May 21, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/579299. An agreement on the implementation of the study has been concluded. Within the framework of the research, the draft of the research protocol was coordinated, the development of the bioanalytical method was started. Within the framework of the research, the research protocol was developed and agreed upon and the permits of the Competent Authority and the Independent Ethics Committee were received. Taking into account the limitations of COVID-19, the clinical part of the study is planned for the third quarter of 2021.

5. On April 30, 2019, the procurement procedure for the contract study “Full-service pharmacokinetic study for the medicinal products OF_FUM” was announced. On May 24, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/579807. An agreement on the implementation of the study has been concluded. Within the framework of the research, a research protocol has been developed and agreed upon, documentation has been prepared for obtaining the permits of the Competent Authority and the Independent Ethics Committee, which have been received. The clinical part of the study was performed. The final report of the research has been received.

6. On 23 May 2019, a procurement procedure was announced for the contract study “Full-service pharmacokinetic study for medicinal products OF_ADA”. On June 17, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/582419. An agreement on the implementation of the study has been concluded. Within the framework of the research, a research protocol has been developed and agreed upon, documentation has been prepared for obtaining the permits of the Competent Authority and the Independent Ethics Committee, which have been received. The clinical part of the study was performed. The final report of the research has been received.

7. On 23 May 2019, a procurement procedure was announced for the contract study “In vivo micronucleus studies in rats with five medicinal substances”. On July 15, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/585312. An agreement on the implementation of the study has been concluded. Within the framework of the research, five research plans were prepared and coordinated. Implementation of research has started. Final study reports for three medicinal substances have been received.

8. On 2 August 2019, a procurement procedure was announced for the contract study “Full-service pharmacokinetic study for the medicinal product OF_NOF”. On September 3, 2019, the result within the procurement has been announced, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/587093. An agreement on the implementation of the study has been concluded. Within the framework of the research, a research protocol has been developed and agreed upon, documentation has been prepared for obtaining the permits of the Competent Authority and the Independent Ethics Committee, which have been received. The clinical part of the study was performed. The final report of the research has been received.

9. On 17 October 2019, a procurement procedure was announced for the contract study “Clinical trial (Phase 3) with investigational medicinal products vs. placebo for the treatment of peripheral nervous system diseases ”, with the deadline for submission of tenders November 15, 2019. 2 tenders were received within the deadline set by the procurement procedure. On December 21, 2019, a decision was made and the result was announced within the procurement, the publication on the procurement results is available at https://pvs.iub.gov.lv/show/603924. In February 2020, an agreement on the implementation of a clinical trial was concluded. Development and submission of research documents for obtaining permits to the Competent Institutions and Ethics Commissions. Permits for research have been received in the Czech Republic and Poland.