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The CEE region rising importance in bio-similar and bio-equivalent studies - KCR experts st

The CEE region rising importance in bio-similar and bio-equivalent studies - KCR experts statements

Publish date: 2014-02-05

The region of Central & Eastern Europe (CEE) has been growing dynamically as a life science market since mid-1990s. With high productivity and quality standards, the CEE market attracts more and more companies looking for reliable partners. KCR will lead a panel on clinical research in CEE during the upcoming BioForum 2014 in Poland.

Tags: medicine , clinical trials , CRO , drug development

Clinical trials are necessary to ensure efficacy and safety of newly developed medicine. Currently, there might be a trend observed for sponsors to seek for increased operational (and cost) efficiency primary by outsourcing trials to CROs and considering new locations for research projects, for example, based in CEE. This location is attractive due to constant developments in pharmaceutical industry, such as declining productivity of R&D spent caused among others by upcoming patent expiry of blockbusters as well as expected shortening of drug development. At this moment, Poland remains the largest clinical trials market in CEE region.

During BioForum 2014, KCR, European Clinical Research Organization (CRO), will lead a panel titled “Advantages of execution of bio-similar and bio-equivalent studies in the CEE region”, scheduled on May, 28th.. The discussion will cover the impact of regulatory and public healthcare environment on the clinical studies’ timelines, as well as patient recruitment and retention. Topics will be presented by CEO, KCR, Mike Jagielski and Chief Medical Officer, KCR, Anna Baran. The panel will be moderated by KCR founder and Chairman of the Supervisory Board, Marek Kiecana.

“The CEE region along with Russia and Ukraine seems to remain an undiscovered land when it comes to clinical endpoint bioequivalence studies. This region, however, offers a significant potential to be tapped into. With other regions’ reliability being currently questioned by FDA, CEE turns out to be a very promising market that might play a crucial role in the near future,” says Anna Baran.

The panel session will outline advantages and challenges associated with the execution of bio-similar studies as well as clinical endpoint bio-equivalent studies in the EU and non EU-regulated countries. Panel lecturers will explore how including both those regions into one program can most efficiently contribute to the overall success of large scale bio-similar or bio-equivalent projects.

“Thanks to KCR experience on the CEE market, the company has gained a remarkable knowledge on all the key influencing factors that drive research in the region. This includes a complete understanding of the regulatory nuances, healthcare policies and standards. Therefore KCR is well placed to help partners resolve any hurdles and mitigate risks when operating on the CEE market,” adds Mike Jagielski.

Upcoming BioForum 2014 will be a place to exchange information on trends and market prospects of bio-business. The cooperation opportunities between CEE and other regions will be discussed. BioForum will be held on 28-29 May 2014 in Łódź at Double Tree by Hilton hotel.

More information on BioForum and presenters can be found at www.cebioforum.com. If you would like to learn more about KCR, there is the opportunity to meet with representatives of the BioForum 2014 in Łódź.

 

Joanna Lewandowska

PR & Marketing Manager, KCR

 

Tomasz Domagała

Bio-Tech Consulting

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