OCT and Skolkovo Foundation have organized a seminar devoted to pre-clinical and early-phase clinical studies, which took place in Skolkovo Hypercube on March, 19th.
The event has been attended by more than 100 participants - from research institutes and hospitals to well-known pharmaceutical companies and smaller start-ups and biotechnology companies who were especially interested to get to know the peculiarities of animal studies and preclinical research and their influence on the design of the subsequent clinical research program.
The seminar was opened by Kirill Kaem, vice-President of Skolkovo Foundation and Chief Executive of Skolkovo Biomed Claster, who has marked the particular importance and topicality of the seminar subjects both for Skolkovo participants and start-ups and other market players.
Maria Zaytseva, Pre-clinical Manager, auditor and Head of OCT QA department, was the first speaker and started with the concept of multi-centre pre-clinical trials organization as well as harmonization of the Russian regulatory framework with the international standards. Maria told about the process of pre-clinical centers accreditation for GLP (the pre-clinical center Maria represents is about to receive GLP certificate beginning of summer this year).
OCT was also represented by Vladimir Chistyakov, Medical Writer and expert in clinical studies design. Vladimir provided valuable advice with regards to the selection of dose in the first clinical trial on the example of an anticancer drug.
The audience were impressed by the high level of speakers' and their expertise.
This is not the first seminar conducted by OCT in joint with Skolkovo: such events are a great opportunity to provide start-up and early stage companies with the precious information and share our practical experience, which is hard to overestimate at the level of pre-clinical and early phase clinical studies planning and organization.
As a full-service CRO, OCT is always ready to help our clients bring their compounds to the market,no matter which stage they are on - planning their pre-clinical program or thinking about the design of the phase I study of their compound.