«BioEq» team has announced an official opening of the unit on March 21, 2014.
The first commercial dedicated R&D center for early phase studies has been established with the support of Biofund of the Russian Venture Company (BioFund RVC).
The unit operation is aimed at Russian and foreign pharmaceutical companies, which develop own original products or generic products (analogues of already existing patented original products).
Nowadays, the Russian market of clinical studies is to a large extent represented by clinical centers established on the premises of medical institutions within the system of the Russian Academy of Medical Sciences, and are mostly specialized in phase II and III studies. «BioEq» is the first commercial clinical site, which has the infrastructure for studies in big groups of volunteers, as well as for conducting several studies in parallel.
The opening event has attracted pharmaceutical companies, contract research organisations, regulatory bodies.
Welcoming speeches were delivered by «BioEq» General Director Ivan Sardaryan and BioFund RVC General Director Yegor Beketov. Congratulations on the opening and wishes of success were made by the Assistant Officer of Deputy Minister of Industry and Trade of the Russian Federation Aleksej Alekhin, Head of the Investment Policy and Innovation Directorate under the Committee on Industrial Policy and Innovation of St. Petersburg government Rimma Sachunova.
Scientific presentations dedicated to the topic of early phase clinical studies were delivered to the event participants. The sessions were chaired by «BioEq» partners - Smooth Drug Development, ChromoLab, Flex Databases. The experts have shared valued information on such clinical research aspects as project management, bioequivalence studies planning, statistics in clinical studies, data management, bioanalytics, and other.
The guests had an opportunity to communicate with «BioEq» management and team, as well as their counter-partners and colleagues from the pharmaceutical sphere. Visits to the clinical unit were organized afterwards, and «BioEq» operation principles were discussed with the guests.
«BioEq» clinical pharmacology center has the equipment and necessary infrastructure for bioequivalence and phase I clinical studies in accordance with international standards. Volunteers` wards, blood collection, processing, and storage rooms, emergency room, surgery room, doctors` rooms, catered meal room, pharmacy, server room, archive, etc. – this is a part of infrastructure that has been located on the territory of 2, 000 square meters. Clinic equipment includes infusion pumps, 12-lead ECG machines, cold centrifuges, refrigerators (-20…-80), alarm bracelets, crash carts, master clock with synchronization to the official atomic time, alarm buttons, vide-recording, and other.
The leading partner of the center – Smooth Drug Development – 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 $20 million and, its growth potential is up to $60 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’.
`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.
The Open Joint-Stock Company RVC is the state fund of funds, the development institution of the Russian Federation, one of the key tools of the state in building the national innovation system. The registered capital of the Open Joint-Stock Company RVC amounts to more than 30 billion rubles. Hundred percent of capital of RVC is held by the Russian Federation represented by the Federal Property Management Agency (Rosimushchestvo). The total number of funds formed by the Open Joint-Stock Company RVC has amounted to 13, their total size is 25.3 billion rubles. The share of the Open Joint-Stock Company RVC is more than 15.7 billion rubles. The number of innovation campaigns financed by RVC funds amounted to 146. Total amount of invested resources is 13.4 billion rubles.
About the RVC Biofund
In early 2010, the Board of Directors of the Open Joint-Stock Company RVC approved the concept of RVC Biofund. In early 2011, the fund has started its activities. The investment focus of RVC Biofund covers innovational biopharmaceutical companies and service companies which provide contractual laboratory services, as well as analytical and consulting services to biotechnological, pharmaceutical and medical companies.
In 2012, the Open Joint-Stock Company «BioEq» has been established. Company operational profile includes early phase studies, thus providing support to Russian and foreign pharmaceutical and biotechnological companies for the development of medicinal products and its launch on the Russian market.