Kendle, a global clinical research organization, appointed Thomas B. Smith, MD, as vice president, medical affairs. Dr. Smith will develop and lead the company’s new global medical affairs organization, which will enhance delivery of Phase II-IV services to customers worldwide. This team will serve as medical and therapeutic advisors to customers in such areas as protocol design, endpoint selection and inclusion/exclusion criteria, providing resources across the clinical development process to build efficiencies and maximize pull-through opportunities as a compound progresses through study and its lifecycle. Candace Kendle, chairman and chief executive officer, said: “With an increasing focus on novel drugs like TNF blockers and the multiple therapeutic possibilities these proteins bring, Kendle’s Medical Affairs organization will provide a competitive advantage by offering expertise across the full therapeutic spectrum.”

While speaking with Outsourcing-Pharma on its clinical research experiences in the emerging Latin America market, Parexel points out that Brazil, Argentina, Mexico and Columbia, have become the most popular clinical trial locations in Latin America, and Columbia is expected to undergo a period of rapid growth over the next few years, along with Peru and Chile. Cost savings is not the only driving factor, Graciela Racaro, Parexel’s director of clinical & regulatory in Latin America, told Outsourcing-Pharma at the recent Drug Information Association (DIA) conference in Atlanta. “Many of these countries have now put internationally-acceptable legislation and regulations in place in regard to clinical research and have good facilities, infrastructure, and access to large patient populations.” However, according to a presentation by Dan McDonald, vice president of Strategic and product development for consultancy firm D. Anderson & Company, Argentina now runs 32% of Latin America’s clinical trials, while Brazil runs 29%. The two countries are close in terms of the number of clinical trials currently in progress, and may switch between positions one and two from year to year.

Synergy Research Group (SynRG), a Russian CRO, presented its regular analytical report on the market of clinical trials in Russia, called the “Orange Paper.” According to the report, in Q2 2007, the Federal Agency for Health Care and Social Development (Roszdravnadzor, or RZN) issued 114 permits to conduct clinical trials in Russia. This is 13% lower than in Q2 2006; the number of international multi-center clinical trials dropped by 25 percent. But the number of local and bioequivalence studies grew inconsiderably. As a result, the contribution made by Russian sponsors grew by 7 percent as compared to Q2 2006, and made up 35 percent of the total volume of the trials in Russia.

INC Research, an expanding contract research organization that helps drug makers test new treatments in humans, agreed to double its space in North Raleigh to a total of about 58,000 square feet.

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