Central and Eastern Europe region for execution of bio-similar and bio-equivalent studies.

Central and Eastern Europe is very promising for the development of life science sector, especially medicine and biotechnology. Majority of newest trends concentrate on innovative medicinal substances which are Biosimilars and Bioequivalent Drugs. During 13^th edition of BioForum Anna Baran, Chief Medical Officer, KCR and Mike Jagielski, CEO, KCR have presented lectures concerning advantages and challenges associated with the execution of biosimilars and clinical endpoint bioequivalence studies.

According to PhD Anna Baran, there are two major steps for optimization path for development of biosimilars and bioequivalent drugs in Central and Eastern Europe. The first one is interpretation and understanding the difference in definitions for a biosimilar and a generic. The second step is the evolution of European Union regulation. Both in Poland and in CEE the biosimilar pathway is well‑defined as it follows the approach represented by EU authorities. Therefore, Poland does not have its own approach in biosimilars and bioequivalent drugs studies. Moreover, the more effort of United States in studies is undertaken, the higher impact of US on our own studies is observed. The solution for overcoming the two-side study impact is to meet the approval of both Food and Drug Association (FDA) and European Medicines Agency (EMA) together with designing a scientific program that will satisfy all the stakeholders. In addition, to retarget to both markets, reference methods and products are also important.

 “Our challenge at CRO company is that biosimilar development is closer to innovative development than to generic development” says Anna Baran. At the end of her speech PhD Baran draw the attention of the audience to two conclusions over optimization of biosimilars and bioequivalent drugs pathway:

• CEE region is and still will remain supportive for biosimilars and bioequivalent drugs researches. The only effort that is needed is to bring all the stakeholders to the parallel level of awareness
• biosimilars and bioequivalent drugs studies are still a challenge not only for the industry but also for the standard classification of research.

The second part of the session was hosted by Mike Jagielski, CEO, KCR and considered cost effective execution of bio-similar and bio-equivalent clinical trials applying new technologies and processes. Biosimilars are well-known and easy products, however, they must follow the Food and Drug Association (FDA) guidelines and quality standards. According to KCR CEO, “the quality matters and the cost matters. The execution of quality very much affects the result of a study”. But apart from the quality, the way of production of medical products also affects researches. “Technology plays the larger role to achieve efficiency”, says Mike Jagielski. The efficiency of production process, as well as the division of clinical trial drivers, determine the time and costs. The current drivers of KCR company are CRO/service fees and investigator fees respectively.

It is estimated statistically that CRO and services fees are about 50-60% of all cost drivers which include monitoring, drug supply and central lab. The rest share are investigator payments and out patients clinical. A tendency which might be noticed is that the more pressure is laid on CRO fees while almost no pressure on investigators, therefore, an overall optimization and solutions should be incorporated. The best solution seem to be technology advances which reduce partial costs. CEO Mike Jagielski has presented ways for cost reduction which involves technology advances. The very basic one is creation of patient recruitment portals which will be commercially accessible and will facilitate direct patient engagement. Additionally, designing of specific sensors should also improve the cost, in particular the ones dealing with travelling. The sensors could be in a form of an application available on smart-phones or normal phones. Such solutions will be beneficial both for the investigators and patients as it simplify the communication between patients and a clinical trial centre.

KCR is a European Contract Research Organization (CRO) and a provider with strategic solutions for companies looking for a reliable alternative to global CROs.

KCR also operates as a Functional Service Provider with strategic and tactical solutions in Clinical Operations, Data Management and Expert Sourcing.

by Agnieszka Tyfa