26.Dec.2016

2016 for clinical trials

The end of December marks the time when we traditionally sum up outgoing year’s results for the clinical trials industry.

This time, OCT President Dmitry Sharov shares with Pharmvestnik his view on the company’s challenges and achievements, legislative changes and their impact on the business sector, and main trends in biotech industry in 2016.

The full version of the interview is available at the Pharmvestnik website

—  Is there a particular global trend in the clinical research development that has a notable impact on the local industry?

— OCT team welcomes the EMA’s initiative on transparency of clinical trial data and sees it as one of the most important market events. This is a great step for everyone concerned —regulators, manufacturers, doctors, subjects, CROs, and all those who use medicinal products. The clinical trial industry is quite complicated for non-specialists, the people who are most affected by the industry’s performance. Thus, the mission to make clinical trials more transparent and clear to everyone involved marks an important stage for the development of the whole pharmaceutical industry. This will undoubtedly contribute to more efficient and reliable drug development. For now, there are a number of issues in the Russian clinical research that still remain unclear for the general public. Nevertheless, the public interest in biotech projects has increased remarkably. More and more talented developers are beginning to offer their attractive solutions to users thus sparking their interest and passion for learning more details about the industry and, in particular, about drug development.

— This year we have seen the increase of attention to biotechnology projects both from the industry participants and wide-ranging investors. Why did it happen?

— In USA, biotech investments grow by 20-25% every year. In Russia, according to Biotech 2020 government program, the budget allocates RUB 106 bln investments in biopharmaceutics and RUB 150 bln investments in biomedicine. In 2016, our group’s venture fund Primer Capital invested in four projects. All of them provide technological solutions in medicine. The synergy of IT and pharmaceutical sectors provides a variety of opportunities: from automation of many complicated processes and big data analysis (Data MATRIX solutions) to implementation of the P4 approach, and first of all of its personalized and predictive healthcare models (solutions of Atlas Biomed Group are a great example).

We see unique potential in the development of medical device sector. In 2015, the size of this market reached RUB 270 bln. Of the 35 thousand medical devices marketed in Russia 30% were produced by Russian companies, and everything seems to indicate that this number will only increase. There is also a number of interesting projects in medical diagnostics that are managed by our regulatory consulting team ReCon.