RVC Biofund’s portfolio company opens Russia’s first commercial center for early clinical trials

On March 21, BioEq, Russia’s first commercial R&D center for early phase studies has been opened in St. Petersburg. The research and development complex is a joint project of Biofund of the Russian Venture Company (RVC) and the BioEq company. The center operation is aimed at Russian and foreign pharmaceutical companies, which develop original drugs and generics.

BioEq clinical pharmacology center has the equipment and necessary infrastructure for clinical research of product bioequivalence (the degree of equivalence of a generic product to the original product ) and for phase I clinical studies in accordance with international standards. The center provides a clinical research site (equipment and premises, 40 beds for volunteers/patients). In addition, the leading partner of the center provides supporting services: medical writing, regulatory support, logistics support, project management, clinical monitoring, data management, statistics, CSR, etc.

‘BioEq joined the Biofund’s portfolio in 2012. Our decision to participate in the project was driven by the then situation on the Russian market of medical services, which was characterized by a shortage of specialized research centers under the conditions of high demand for such services. It is sufficient to say that the size of the local market of bioequivalence studies amounts to $50 million and, its growth potential is up to $100 million’, comments Yegor Beketov, Director of RVC Biofund. ‘Today, we can claim a new structure has been created from scratch, which is operating in compliance with international standards and is very important for the development of the Russian pharmaceutical market’.

Nowadays, the Russian market of clinical studies is represented by clinical centers established on the premises of medical institutions within the system of the Russian Academy of Medical Sciences and mostly specialized in phase II and III studies. These sites do not have the infrastructure for studies in big groups of volunteers, as well as conducting several studies in parallel.

“The major goal of BioEq is to facilitate the launch of high-quality innovative and generic products on the Russian market. In 2013, over 30 phase I studies and 250 bioequivalence studies were initiated in Russia. BioEq capacities afford high-quality performance of approximately 1/5 of those’, says Ivan Sardaryan, General director and co-founder of BioEq.

The new clinical center will operate in full compliance with European standards, GCP (Good Clinical Practice), SOPs (standard operating procedures), and applicable legislation.