Life Science Leader Magazine

JAN 2012

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Research Development & Clinical Trials Bringing A Billion-Dollar Drug To Market By Cindy Dubin, contributing editor A report by Deloitte on the world's 12 largest drugmakers shows that the average cost of bringing a product to market rose by more than 25% to greater than $1 billion in 2011, from $830 million in 2010. And, for new drugs, it typically averages 10 to 15 years from discovery to enter the market- place. With the time and monetary invest- ment, it is no wonder that the number of late-stage drugs in development dropped to 18 from 23, on average, per company, from 2010. And, 10 of the 12 firms actually saw a decline in investment returns from R&D;, resulting in an overall drop to 8.4% from 11.8% last year. But there are success stories: 35 new medi- cations were approved during the FDA's 2011 fiscal year, the second-highest number in a decade. Industry pros say that those who have received FDA approval were careful to dot all their "i"s and cross all their "t"s during clinical studies, communicate with regulatory bodies, and choose the right sales and marketing team. BEGIN WITH THE END IN MIND According to Gene Haley, CEO and found- er of Wilmington Pharmaceuticals (which develops and out-licenses fast-dissolving for- mulations for established medicines), a suc- cessful process begins with the end in mind. "Bringing a drug to market is not an exercise in imagination but a process that aims to satisfy an unmet need within the market for patients, physicians, and managed care and brings with it economic value." Haley says when you start with the end in mind, it is much easier to communicate the goal and gather a team that has the capability to carry out that goal. The team should represent a variety of skill sets — formulation, clinical design and trial, 32 LifeScienceLeader.com regulatory, and manufacturing. "Any drug approval process is more than one person deep," agrees Jim Hauske, Ph.D., president and founder of Sensor Pharmaceuticals, a virtual drug discovery and development organization focused on molecules affect- ing the nexus of inflammation and meta- bolic disease. Hauske is not a novice when it comes to bringing a drug to market; he was part of the team associated with discovering and developing Zithromax. "Bringing a drug to market is a team sport that requires all the skills of a highly diversified team." CLINICAL TRIALS: WHEN TO STOP To promote the development of inno- vative new therapies, the FDA has made advances in regulatory science a top prior- ity. For example, the agency is working to improve the science behind certain clinical trial designs. It has issued a draft guidance document on "adaptive trial designs" that makes use of early results of a trial to modify the design, making the study more likely to detect whether a drug works. The FDA also is working on a guidance document on "enrichment designs," studies that make use of patient characteristics to identify people for whom the drug is likely to be effec- tive. These designs allow smaller studies to be successful and target the treatment to patients who will benefit the most. About 50% of drugs entering Phase 3 trials fail because of lack of benefit and some- times because of unacceptable side effects that were not seen in Phase 2. "That fact is January 2012 just amazing to me," says Robert Temple, M.D., CDER's (Center for Drug Evaluation and Research's) deputy center director for clinical science. "The FDA understands that when the drug is exposed to more people during a Phase 3 trial, this opens the possi- bility to see more adverse events, but a large failure rate for effectiveness suggests inad- equate Phase 2 trials. I encourage pharma to take a close look at their Phase 3 failures to identify why a failure occurred." One area Temple says requires a closer study during Phase 3 is dose response. While no one wants to give more drug than necessary to do the job, studying a range of doses can mean the difference between success and failure. "There was one drug, Alosetron for diarrhea caused by irritable bowel syndrome, that caused severe con- stipation, which sometimes needed to be treated surgically, as well as ischemic colitis," relays Temple. "During the course of clinical trials, patients were dropping out because of the constipation. One would have thought the drug company would have tried a lower- ing of the dose study, but no." The International Conference on Harmonization (ICH) urges that different dosing regimens be evaluated dur- ing Phase 3. Often companies study a few dosing regimens in Phase 2 and then study only one dose in Phase 3, which Temple says is often a "terrible mistake." In addition to studies of more doses, Temple recommends that clinical trials

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