This event was attended by representatives of pharmaceutical and biotech companies, regulatory departments, startups engaged in the development of new medicines and medical devices, and investors interested in biomedical research projects.
The attendees were invited to take part in two parallel speaking sessions. Six agenda items covered the widest range of issues and went beyond the conduct, technical and regulatory aspects of clinical trials. This year’s conference also covered the issues that might help pharmaceutical project developers in implementing their ideas.
– Irina Bondareva, Biostatistician, Federal Medical & Biological Agency of Russia, Scientific Research Institute of Physical-Chemical Medicine;
– Mikhail Samsonov, Chief Medical Officer, R-Pharm;
– Kristina Khodova, Head of Oncology/Immunology Projects, BMT Cluster, Skolkovo Foundation;
– Dmitry Golikov, CEO, IVIX;
– Kirill Volynchik, Chief Development Officer, “Northern” BioPharmCluster.
One of the conference reports touched upon changes in regulatory aspects of clinical trials and drug registration. ReCon managing partners Anna Astakhova and Andrei Kozhanov shared their vision on these changes and their effect on the R&D sector in the upcoming years. “The review of these changes was followed by a lively discussion focusing on the most critical drug approval issues ranging from the content of the clinical trial application dossier to drug compatibility aspects. We’ve invited industry expert Mikhail Samsonov to gain insight from a different perspective. We hope that the dialogue and exchange of opinions will help the conference participants to be fully prepared for the changes introduced by Federal Law #61,” says Andrei Kozhanov.
Primer Capital venture fund has arranged a panel discussion on strategic partnerships and pharmaceutical projects that featured representatives of venture market, pharma companies and startups. “The panelists provided their views from different perspectives about what to concentrate on when applying for investments and what stages require the most preparatory work. Such an active discussion allowed the developers’ representatives to interact directly with investors and partners. I believe this will help the developers to avoid many mistakes in the future,” says Primer Capital CEO Ekaterina Teplukhina. The panel participants raised another important issue, the lack of expert industry advise that is becoming a major market entry barrier for new companies: “Financing is not the only concern of developers. What they need more often are experienced consultants capable of providing expert advice at every stage of project development. All this requires a well-organized structure of R&D and manufacturing organizations,” points out Primer Capital COO Elizaveta Rozhdestvenskaya.
Like in previous OCT conferences, this year's most attention-gabbing workshops were those related to quality assurance, drug efficacy criteria and biostatistics. Kristina Leus (Data MATRIX) presented her report on cloud-based applications for clinical trials: “Cloud solutions are becoming more and more popular in Russia every year. This conference is yet another opportunity to clarify all details related to such solutions and address the questions raised by the audience.”
“Clinical Trials In And Outside Russia-2015” is the third annual conference held by OCT. This year’s event hosted more than 150 attendees.
“We’re very pleased that this year we’ve managed to expand the conference’s focus and invite a wide range of industry experts. This conference gave us a chance to share the most recent updates with our colleagues and contribute to the field’s development. First of all, it is a platform for discussions and an opportunity for industry representatives to share their views on important issues,” says OCT CEO Dmitry Sharov.