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UpFront Milestones Almac turns 20 Dr. Robert Dunlop, president and managing director of Almac Clinical Services (left), and Sir Allen McClay, chairman of Almac Group, celebrate the division’s 20th anniversary. Almac Clinical Services, one of the key divisions at Almac Group, has grown to become the largest and one of the most successful parts of the Almac family. Originally operating with two employees in one location in Craigavon, U.K., the company now employs 1,100 skilled individuals across three main operational centers — Craigavon, Audubon (Pa.), and Durham (N.C.) in the United States. As Almac Clinical Services enters its third decade of operations, the company is now firmly established as one of the market leaders in world-class clinical services. Almac has recently announced further expansion with a new $110 million North American headquarters in the United States, which when completed in 2010 will create hundreds of new jobs in Pennsylvania as well as further opportunities for existing staff For more information, visit almacgroup.com. Administrative issues Healthcare Reform Over Next 10 Years As the White House changes guard, a new series of reports released by the Deloitte Center for Health Solutions identifies $530 billion in opportunities to reduce costs while improving the U.S. healthcare system over the next 10 years. “Reducing Costs While Improving Care in the U.S. Health System: The Health Reform Pyramid (deloitte.com/us/healthreformpyramid), outlines the impact on investment and potential savings that might be realized by key reforms based on four interdependent areas of focus: healthcare information technology; comparative effectiveness; coordination of care; and consumerism. Taken together, these four areas provide the opportunity to achieve $530 billion in savings opportunity based on a $220 billion up front investment over three years, with net savings realized beginning in year six. Thereafter, compound annual growth rate health costs may decline to 4% if implementation of the plan proceeds without delay, with adequate investment and proper oversight. n Two in three respondents say healthcare is an important policy consideration in the new president’s first term. n Only one in five gives the system an above-average report-card grade, and more than half of respondents say 50% or more of the amount spent on healthcare in the United States is wasted. n 75% of respondents outright oppose or are lukewarm to tax increases to cover the uninsured, and 63% express concern about forcing individuals to have health insurance. Requiring employers to provide insurance for employees wins more support (53% are in favor). Development Timeline Eight-Year Average, Still New drug development still takes eight years despite faster FDA review, according to Tufts Center for the Study of Drug Development. While the FDA has quickened the review and approval of new medicines, the complex nature of diseases for which new therapeutics are being developed has resulted in longer clinical development times. The average time for the FDA to approve new drugs declinced to 1.1 years in the 2005 to 2007 period, but longer average clinical phase times means combined clinical and approval time continues to hover around eight years. Drug companies have taken steps to speed development, including improving project management, expanding use of partnerships and licensing arrangements, and increasing surrogate endpoints and adaptive clincial trials. Among the trends cited in the Tufts CSDD’s Outlook 2009 report are: n Firms will continue globalization of their preclinical and clinical development activities to overcome local capacity constraints, increase speed to market, and expand their presence in emerging markets. n Demand for services from CROs is expected to grow by more than 15% annually, as sponsors face capacity contraints and a rising volume of large, complex global clinical trials. Tuning in… Featured Podcasts and Weblinx Pharmaceutical Forecasting Models Featured Thought Leader: Todd Johnson, The Mattson Jack Group Log onto: www.pharmavoice.com/podcasts Oncology Market Access Europe: Bridging the Gap Between Regulatory Approval and Product Adoption Featured Thought Leaders: Pierre Anhoury, M.D., Senior VP, MattsonJack Europe, Rhoda Dunn, Senior Director, Oncology Market Access Europe, and Anne-Pierre Pickaert, Consultant, Oncology Market Access Europe Register: www.pharmavoice.com/omaeurope