According to the most recent report from the Tufts Center for the Study of Drug Development, it takes about 10 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing, and of these five, only one is approved. On average, it costs a company $1 billion to get one new medicine from the lab to the hands of consumers; in 2003, the cost was $897 million. And once the product reaches the market, myriad factors impact adoption and use — from proposed changes to patent life to a changing consumer world. There are hundreds, if not thousands, of points of contact along the development continuum. For the purposes of this special issue, we have divided the process into three broad categories — drug discovery, early development, and full development — and then by seven areas of focus: target identification and validation, HIT finding, and lead optimization; early clinical safety and efficacy; Phase I trials; Phase II trials; Phase III trials; registration… Sidebar: Drug Companies Still Under Pressure Molecule to Market: Plan for Success Experts on this topic Stephen Cutler, Ph.D., senior VP and chief operating officer at Kendle Jens Oliver Funk, M.D., senior VP and global head of TA oncology, EMD Serono Jean-Jacques Garaud, M.D., global head, pharmaceutical research and early development at Roche James DeSanti, founder and CEO of PharmaVigilant Paul Boni, chief research officer at Grail Research William Crown, Ph.D., president of i3 Innovus Troy McCall, Ph.D., CEO of Cetero Research Kevin Hrusovsky, president and CEO of Caliper Life Sciences Michael Naimoli, U.S. life sciences industry solutions director at Microsoft Corp. Scott Treiber, executive VP, clinical development solutions, at inVentiv Clinical Solutions Jeff Trotter, executive VP, Phase IV development, at PharmaNet Nagaraja Srivatsan, VP and head of life sciences, North America, at Cognizant Robert Norris, founder and president of Complete Healthcare Communications Patricia Bassett, VP sales EMEA at Unithink Patrick Chassaigne, director, late phase solutions, at Medidata Solutions Mark Goldberg, M.D., chief operating officer of Parexel International John Andrews, Ph.D., director of regulatory affairs, Americas, at Chiltern
