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September 13, 2012

Study Start-up: A Comparison Across Emerging Markets

Speakers for this Event:
  • Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics     Learn More
  • Richard Koenig, Vice President of Operations, ClinStar     Learn More
  • Study Start-up: A Comparison Across Emerging Markets

    The biopharmaceutical industry continues to rebound from the largest patent cliff in drug development history. The industry also faces unprecedented pressure to innovate and replenish depleted pipelines while operating under record low R&D budgets and extreme cost-containment measures by payers. Unfortunately, these surmounting demands are occurring at a time when Western markets are saturated with clinical trials and patient enrollment and retention is more challenging than ever.

    With the lure of large, untapped patient populations, faster enrollment rates and lower drop-out rates, the industry is embracing the benefits of conducting clinical trials in emerging markets such as Brazil, Russia, China, and India. But are faster enrollment rates really worth jumping through the hoops for up to a year of study start-up timelines?

    During the webinar, ClinStar/IMP Logistics Senior VP & General Counsel Leon Dzivinsky will kick-off the session with an overview of the advantages of conducting clinical trials in emerging markets. Richard Koenig, vice president of business operations for ClinStar, will draw upon his years of global clinical operations experience to present an analysis of the importance of start-up timelines in the decision-making process when selecting geographies for a global clinical trial. Mr. Dzivinsky will close out the discussion with a review of the regulatory challenges that can be anticipated when starting up a trial in Russia, such as:

    • Clock stoppages
    • Import/export Licensing
    • Legal representation
    • Contract negotiations

    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.


    Leon Dzivinsky, Senior Vice President & General Counsel, ClinStar, LLC / IMP Logistics

    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 to the state bar in New York and Connecticut, Mr. Dzivinsky practiced, 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.

    Richard Koenig, Vice President of Operations, ClinStar

    Richard Koenig, ClinStar’s Vice President for Operations, has spent the last 12 years working in clinical research for major CROs. He has worked in a variety of different positions including data management, clinical project management, and clinical operations management. His recent CRO experience includes serving as the Vice President for Global Information Technology and as an Executive Director of Clinical Development, managing key sponsors and clinical trials. His current responsibilities include development of project reports and metrics, ERP implementation and management of proposals and change orders.

    Prior to working in clinical research, Mr. Koenig spent 15 years working for the US Government in Northern Virginia in IT project management. He has a Masters in Health Care/Public Administration from Long Island University and was selected for a Presidential Management Internship upon graduation. Mr. Koenig is based in ClinStar’s offices in Durham, North Carolina.


    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.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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