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June 11, 2009
On June 11, 2009 Synergy Research Group (SynRG), a Russia-based CRO and the author of SynRG Orange Paper, issued the report about the recent clinical trial conference Emerging Superpowers in Clinical Research. Russia, India, China which took place in Amsterdam on 28-29 May 2009. The formation of a civilized clinical trial market in modern Russia, and further improvement of the country’s research attractiveness for foreign study sponsors are among other number one strategic SynRG priorities.
There are two major conclusions we’ve took away from the conference: 1) there’s no competition between Russia, India and China on the international clinical trial arena and 2) Russia is not an emerging market anymore, it’s rather a growing potential Superpower in the changing landscape of worldwide clinical trials.
It also looks like the crisis did not yet affect the clinical trial industry. From our viewpoint, the reason is twofold: firstly, the development cycle of a new drug is much longer than any crisis, and, secondly, the elasticity of a medicine is low enough to stand the chaotic fluctuations of the world stock market.
According to the Frost & Sullivan analytics, the worldwide financial warming is expected to happen somewhere in June 2009. The forecast is as dependable as any other, moreover, we fully share their view at the crisis as an additional growth opportunity for the Russian clinical trial market. By the way the Chinese hieroglyph “crisis” consists of two symbols: the first ( , wei) means “danger”, and the second ( , ji) means “chance”.
"Best-in-class companies don't view a downturn as a period in which to simply survive. They see opportunity in the uncertainty and navigate through the storm with investments in growth strategies that not only help them carry on, but also prepare them to move quickly once the economy recovers,” says David Frigstad, Chairman of Frost & Sullivan. “To catapult ahead of the competition, companies should continue to invest in growth strategy development and seek insights and guidance from trusted sources," adds Frigstad. "After all, if they don't, their competitors will."
This is also true for countries. We believe that under the current global circumstances Russia as clinical trial market becomes even more attractive, and there is a good chance for small and mid-size international pharmaceutical and biotechnological companies to utilize the country’s advantages to shorten the time to market for the drugs in their pipelines. This is one of the most critical success factors in today’s challenging environment, and for some companies becomes the question of life and death.
The conference was opened by the excellent presentation of Mikhail Samsonov MD, Executive Director Regional Clinical Operations Asia Pacific and EMEA, Global Development and Medical Affairs. Mikhail gave a bird-eye view on Russia, India and China, as well as greater details on each of the market, highlighting coutry’s advantages and disadvantages in terms of clinical trial conduct. The information is unique and priceless, since it the first-hand information from a person with broad expertise in all three markets and his feet on the ground.
The second day also started under Russia’s umbrella. The session was opened by Anita Kasper, Regional Director Clinical Operations CEE. Anita was so enthusiastic when presenting her report about the site saturation in Russia, that you couldn’t wish a better adept for clinical trials in Russia. She’s a kind of independent source of information – Austrian living and working in Belgium, a scientist with a very high reputation among the European R&D community. In conclusion Anita shared a secret that she rehearses piano with the Russian teacher Natasha.
Then Mikhail Putilovskiy, Clinical Operations Manager, Lilly Russia shared his company’s experience in managing study contracts with sites and investigators. He overviewed three different options which now exist in Russia, and compared them to each other. The information rose audience’s interest, and Mikhail answered a lot of questions.
After the short coffee-break the word was given to Yuri Afonchikov, Deputy Head of Department of Registration (Drugs) of the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (alias RosZdravNadzor, RZN). Yuri explained in great details the current legislation state and general regulatory environment in Russia, including the timing for passing a study application through the Russian regulatory bodies, as well as useful practical tips for sponsors to speed-up the approval time.
Then Dr. Evgeny Rogov, MD, JD, PhD, a member of Federal Ethic Committee of the Russian Federation presented the Ethics Committee perspective. The presentation covered various aspects of the ethical expertise in Russia, from approval time and SOPs, to the delegation of duties from local ethics committees to the Federal Ethics Committee. At the end of the presentation Evgeny answered the questions from the audience.
Besides the speakers the conference was attended by Russian Pharma and CRO representatives: Oleg Milenin and Anna Dontsenko from GSK Russia, Elena Karelina, Pfizer Clinical Country Manager, and representatives from Crocusmedical, Cromos, CCCP è Synergy Research Group.
Summarizing the above, we can say confidently that the conference became the real triumph of Russia which de facto can apply to the title of the emerging Superpower in the worldwide clinical trial market, and has the potential and positive momentum to become it. Thanks to the organizers of the event, Next Level Pharma crew and all Pharma and CRO representatives, speakers and the second day Chair Mikhail Samsonov for such an excellent clinical Russian Seasons in Amsterdam.
Synergy Research Group (SynRG™) is a Russian contract research organization, which has been successfully operating in Russia since 2002. SynRG™ offers a broad range of services for conducting clinical trials for Russian and foreign pharmaceutical and biotechnological companies – from registration of the studies in regulatory authorities to pharmaco-economic surveys. The company has its own clinical depot in Moscow, with the total area of 180 square meters. Today, Synergy Research Group is represented in Moscow, Saint-Petersburg, Novosibirsk, Yekaterinburg, Perm and Almaty (Kazakhstan). The company’s headquarters are in Moscow.
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