Aug 2011

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The Middle East is forecasted to be one of the fastest growing markets for clinical research outsourcing based on availability of the required infrastructure, access to necessary patients, faster timelines and lower costs compared to other markets. Global pharmaceutical companies are currently seeking emerging markets to conduct clinical trials due to the increase in drug development costs and the demand to advance drugs faster.

FDA has issued draft guidance on "Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring."  The new draft guidance is being issued to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical investigations of human drug and biological products, medical devices, and combinations thereof. This guidance is intended to make clear that sponsors can use a variety of approaches to meet their monitoring responsibilities during clinical investigations. This guidance describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies on a combination of monitoring activities to effectively oversee a study.

Venture capitalists are taking exception to recent comments by the FDA Administration Commissioner Margaret Hamburg, who said in an Aug. 1 Wall Street Journal guest column that the agency’s cautious approach to approving new medical treatments boosts consumer confidence in products on the market, and stimulates economic growth.

US investment bank Morgan Stanley today raised its growth forecast for Israel to 4.8% growth in both 2011 and 2012. Without doubt the Israeli economy remains one of the robust and well managed among both the developed and the emerging market economies.Having shown an excellent track record in weathering the most recent crisis via timely monetary and fiscal policy responses, the country earned well deserved respect and confidence among global investors.

Foreign direct investment (FDI) in Israel totaled $500 million in June, rising above the monthly average of $410 million for the first half of 2011. The majority of investments were made in the high tech sector.

Social media and online networks could be of particular value in initiating, and recruiting patients for, studies of sometimes neglected rare medical conditions, US-based non-profit Mayo Clinic has found, according to PharmaTimes.

As medium-sized and large CROs continue their quest to get bigger and get acquired, smaller CROs are on the march around the globe, expanding as best they can to attract contracts from smaller pharmaceutical companies and biotechs seeking something approximating worldwide reach.