With patient recruitment rates up to twenty times faster than the West, the biopharmaceutical industry is embracing the undeniable benefits of conductin
g clinical trials in emerging markets such as Russia. In fact, 33% of all drugs approved by the FDA and 48% of all drugs approved by the EMEA in 2011 included data from clinical trial research conducted in this region.
Yet with benefits like this, why isn’t this number closer to 100%? Unfortunately, many organizations still have negative perceptions of working in this region due to fear of prolonged study start-up times and unknown regulatory and logistics requirements. For logistics alone, Sponsors may have a number of questions or uncertainties, including:
- How will the study drug be imported into the country?
- Where will it be stored?
- How will it get to the remote locations of trial sites?
- How can I ensure there will be no temperature deviations along the way?
- What happens to the unused drug supply?
During the webinar, ClinStar CEO David Passov will begin the presentation with a discussion about the benefits of conducting clinical trials in Russia and parts of Eastern Europe compared to other emerging markets. ClinStar/IMP Logistics VP & General Counsel Leon Dzivinsky will follow and address many of the questions and concerns Sponsors have about logistics and introduce five keys to successfully managing clinical trial logistics in this region.
David Passov, CEO, ClinStar
David Passov was born in Estonia when it was part of the former Soviet Union. He attended Tartu University Medical School in Estonia prior to moving to the US in 1993. He received a degree in biology from Boston College and following a short basic science research tenure at Massachusetts General Hospital’s neuroscience department entered the biopharmaceutical industry in 1996.
Since that time, Mr. Passov has held positions in clinical operations, project management, market research, business development and commercial operations at various small and large US-based CROs. He also received an MBA from the Executive MBA Program at Northeastern University (Boston, MA) in 2002. Mr. Passov joined ClinStar in 2005. He is a native Russian speaker and spends the majority of his time residing in Moscow managing ClinStar’s offices in Russia and Ukraine.
Leon Dzivinsky, ClinStar’s Vice President and General Counsel, was born in a Former Soviet Union and moved to US in 1995. Mr. Dzivinsky received his B.S. degree in 1999 from St. John’s University in New York and J.D. degree in 2002 from Hofstra University School of Law, where he was a Founder and Editor-in-Chief of International Law Digest, a joint publication between Hofstra University School of Law and Hofstra Business School.
After receiving admission in New York and Connecticut, Mr. Dzivinsky practiced law in private firms, specializing in corporate and commercial litigation, employment and business law. In 2006 Mr. Dzivinsky joined ClinStar and is currently one of the top managers of the company, with responsibilities ranging from heading an internal legal department to managing ClinStar’s warehousing division, IMP Logistics. Mr. Dzivinsky is a Member of the Board of Association of Clinical Trial Organizations (“ACTO”), representing ClinStar.
Who Should Attend?
Pharma and Biotech staff, more specifically anyone within these organizations who are clinical outsourcing or procurement decision makers or a part of clinical teams such as Sr. Clinical Project Managers and heads of clinical operations.
ClinStar is a Western managed CRO with local operations in Russia, Ukraine, Belarus and the Baltics. We have 12 years of experience in Phase I-IV clinical trials across multiple therapeutic areas. Unlike many global CROs, we offer a substantial local presence across all areas of operations, providing us with unique local knowledge and personal relationships that benefit your clinical trial.
From regulatory submissions and clinical affairs to medical monitoring, drug storage and distribution, we offer fully integrated services for managing your trials in Russia, Ukraine and other regions of Eastern Europe. We are best known as a Western CRO in Eastern Europe providing faster patient recruitment and higher quality data than that provided in the West.