Time to move away from universal approaches

December has marked the end of the year with the traditional message of the President to the Federal Assembly. The streets of the cities are adorned with decorations and Christmas trees. This year is not over yet, but it’s a good time to sum it up.

R&D industry is now faced with a new global trend focusing on the efficiency of implemented projects. There is no place for big budgets with vague prospects of good results, which is not surprising. Market analysts believe that focusing on the speed of development and research, costs and other research related factors may increase internal rates of return up to 13-15%, and up to 20% in case of collaboration with experienced strategic partner.  The last year turned out to be difficult for pharmaceutical market players bringing economic recession, legislative changes, and rising uncertainties over new regulatory requirements. Yet Pharma-2020 remains to be the main objective focusing on the creation of special economic zones, implementation of pharmaceutical industry development programs, benefits for local players in state procurement legislation, etc. This is what makes the industry players to believe in potential of the Russian pharma market and take import substitution strategies seriously. Recent years showed a considerable and significant increase in the number of requests and clinical trials from Russian companies. As of today, we do business with more than 70 partners. The key element of profitable growth for companies in this environment is a combination of long-term development strategy and rapid response to changes. The most relevant objective for today is to benefit from the current market opportunities. The boom of pharmaceutical startups now reached Russia. We see an increasing number of projects applying information technologies for medical purposes, whether it be for health services, or for software solutions for healthcare professionals.

The majority of the sector specialists agree that the main focus for the upcoming years will be the launch of new medicines to the Russian market. Today the attention is shifting to R&D investments, which are considered as a factor of success, with more scrupulous selection of a strategic partner whose qualification and expertise are crucial for profitable results. While most market analysts have negative views on R&D project productivity, there have been no rejections of OCT’s clinical trial applications on the part of regulatory authorities throughout the entire period of the company’s operation. We also actively cooperate with all institutions playing an important role in the development of the pharma industry, such as RUSNANO, Skolkovo, RVC, North-West Technology Transfer Center (NWTTC), Federal Target Program (FTP) “Pharma 2020”.

Once we all understand that the strategy of approaching any research task universally no longer works in this environment, we’ll again see global positive changes in companies’ R&D activities. In this background, the increase of clinical-trial-data transparency becomes a particularly important target for the industry. This initiative can be achieved with advanced data management tools and brand-new pharmacovigilance software solutions.

The focus on finding more effective solutions is the main driver of dynamic growth in the clinical research market. However, many major global CROs have reduced their presence in the Russian market this year. To the contrary, we have managed to achieve a 20% increase in growth rates and improve our employees’ skills by completing 30 training programs. We have also arranged three professional development workshops which provided a good opportunity for the speakers to share their experience and knowledge that might help all our industry colleagues in their daily practice.

During these workshops much attention was given to state registration of medical products, which has become an issue of utmost importance for generic manufacturers this year. The migration to GxP standards and enactment of a pharmacovigilance procedure gradually harmonize Russian and international rules and regulations, which is good both in terms of quality and strategic partnerships. It becomes more and more evident for foreign developers and investors that Russia can provide the basis for conducting high-quality studies for adequate prices. We also feel these changes bringing a 100% increase of our Asian customer base mainly composed of sponsors from Korea and Japan. 

Yet this year turned out to be challenging for the whole Russian pharmaceutical industry, especially for clinical research field, but definitely brought its benefits. The year of 2016 promises to be no less interesting and informative as 2015. We expect to expand our geographic coverage to Europe and the EurAsEC, launch new service products and conduct regular workshops for our industry colleagues. There is a high probability that the productivity of R&D activities will continue to be the main focus of the market. As for now, the industry is somewhat perplexed, as it is still unclear what to expect or which will be the business environment. We hope that the year of 2016 will bring long awaited answers from the regulators, thus increasing the number of new medical products.

See you soon in 2016! We wish all our industry colleagues success in implementation of the most ambitious projects! 

Dmitry Sharov, OCT President

Source article: Pharmvestnik, December 23, 2015