18.Apr.2012

OCT gives an interview to a distinguished biotechnology portal

OCT has given an interview dedicated to the topic of clinical trials conduct in Central and Eastern Europe. The discussion covers several issues and touches upon social and healthcare, scientific, as well as some financial aspects.

OCT has given an interview dedicated to the topic of clinical trials conduct in Central and Eastern Europe. The discussion covers several issues and touches upon social and healthcare, scientific, as well as some financial aspects.

The discussion started with the overview of the overall picture, including the range of companies, which come to the CEE region.

"Most of our clients and sponsors are companies coming from either WE or the USA but we also can observe a constant increase in the number of Russian and CIS sponsors. I would not say that there are a lot of sponsors exactly from the countries, where we operate, which include mainly Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria . To a high degree, our customers are from western countries (Germany, Switzerland, the UK, Italy, etc. and also the USA)." (.) An ever-increasing number of Russian companies may to a certain extent be also explained by the favorable legislative conditions. There has been a boom in the Russian pharma industry. There are a lot of start-up biotech pharmaceutical companies, which produce original as well as generic drugs. Naturally, before entering the market, these drugs have to be tested and their safety and effectiveness analyzed, the process being strictly controlled by the competent regulatory authorities (the Ministry of Health and Social Development of the Russian Federation). To encompass all the needed activities, companies address OCT to assist them in this essential matter

The interview touched upon the issue of certain key advantages of the CEE market, which is one of the most widely discussed at the moment. "Among the financial ones we could name the following" - says Ms. Salamova - the overall costs. We could say that the overall cost for conducting clinical trials in Russia, Ukraine and Belarus would be less as compared to those in the USA or WE (however, surely depending on a therapeutic area and the scope and design of the study). What factors stipulate this?

For instance, principle investigator's grants are usually lower than those in the USA and WE, and this is also connected with the fact that, generally speaking, this way physicians can gain additional source of payment. Yet, naturally, this is not the prime reason. Important is also that the investigators participating in clinical trials have an access to new therapies, latest, up-to-date drugs. At the same time, patients are eager to participate in clinical trials because of the access to these new drugs. It is also connected with the fact that there are a lot of patients in this region that have not yet been exposed to new drugs. This enables researchers to include patients into the trials.

Another thing is the timelines, which influence the general price as well as the pace of the trial. This is also one of the key strategic factors for sponsors. Timelines for RA approval and patients` enrollment (which sometimes turns into a crucial point) are quite favourable in this region.

The choice of analyzing laboratories, warehouses and other vendors is pretty extensive. The pharmaceutical industry has been booming in these countries during the last 5-10 years, which imposed other service providers to deal their businesses. It constantly gives us more and more options. Even speaking about the number of clinical trials compared to those from the last year it has grown, especially in case of phase 3 and 4 trials," - clarifies Ms. Salamova.

The question of the current existing intricacies, which some companies face, was in place, too. "One of the existing complexities is connected with generic drugs. For generic drugs, companies still have to repeat the earlier-conducted trials (bioequivalence) in Russia, as well. . Foreign Companies have to organize additional money for an additional trial to register their generic drug. This is how it works now." - says Natala.

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