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A summary of the top news impacting the pharma industry. October 20, 2010             Spotlight  Better market data improves new drug development planning   Darien T. Kadens Senior Director Market Intelligence i3 Pharma Informatics Bringing a new drug to market in the United States costs roughly $1 billion and takes more than seven years from the onset of clinical trials, according to the Tufts Center for the Study of Drug Development. With the stakes this high and the Food and Drug Administration increasing scrutiny of the body of evidence required for product approval, the pharmaceutical industry cannot afford missteps regarding which product development opportunities it will pursue. New approaches and better forecasting tools should empower the industry to make development efforts more successful. "At the end of the day, all companies are scrambling for good data to help inform their decision-making in the new product development arena," said Darien T. Kadens, senior director of Market Intelligence for i3 Pharma Informatics. "Companies have to transform the manner in which they assess products and determine where to place their bets," he added. "They need to take into account all of the different forces -- more complex industry dynamics, consolidation and a restructured health care system pursuant to reform measures -- that can affect the future of a given product." Click here to continue reading this article online. Understanding the Dynamics of Patient Adherence Webinar: Oct. 28 at noon EST Join us for this free webinar on developing compliance programs that really work by understanding "total" patient behavior. Traditional persistency analyses have always focused solely on undertaking one brand at a time. Incorporating a patient's behavior across all markets can lead to a more comprehensive and effective patient compliance program. Presenters: Louis Brooks, Jr., Vice President, Consulting, i3 Pharma Informatics Matthew Sulzicki, Senior Consulting Analyst, i3 Pharma Informatics     In Development  Experts use E. coli to boost production of a cancer drug compound Scientists at the Massachusetts Institute of Technology and Tufts University were able to yield taxadiene, a compound derived from the Pacific yew tree that is used in manufacturing cancer drug Taxol, in a large amount using a technique involving E. coli. The lead researcher said the process might cut drug-development costs and pave the way for additional treatments for hypertension and other conditions. Mass High Tech (Boston) (10/1) Researchers formulate a dual vaccine against anthrax and smallpox U.S. scientists added a protein from anthrax bacteria to an altered form of Wyeth's smallpox vaccine DryVax to produce a single treatment that is safer and more effective than licensed vaccines. "We believe our dual vaccine, Wyeth/IL-15/PA, which is effective against two of the most deadly pathogens, will help consolidate and simplify our national bioterror counterefforts by streamlining the manufacture, stockpiling, and swift deployment of such vaccines should the need arise," the researchers wrote. Reuters (10/4) Novartis signs a 3-year deal to speed up flu vaccine development Novartis and Synthetic Genomics Vaccines agreed to a three-year collaboration aimed at speeding up the development of flu vaccines. The companies will create seed viruses needed in vaccine production using a technology from Synthetic Genomic Vaccines. The process is expected to cut production time by two months, Novartis said. Bloomberg (10/7) Inviragen and PharmaJet receive NIH grant for dengue vaccine The NIH's National Institute of Allergy and Infectious Diseases awarded a five-year, $15.5 million grant to Inviragen and PharmaJet to develop a needleless vaccine that can offer protection against all four strains of dengue virus. Inviragen's DENVax vaccine can be administered using PharmaJet's injector that uses pressurized liquid in drug delivery. American City Business Journals/Denver (10/8) Profectus secures federal funding for a chronic-disease vaccine The NIH's AIDS division gave a $3.1 million grant to Profectus BioSciences to work on a vaccine against chronic diseases. The National Cancer Institute and other groups also awarded $1.3 million to the biotech firm. American City Business Journals/Baltimore (10/6)   In Market  Report: Global drug sales will increase as much as 7% next year Worldwide sales of prescription drugs are expected to climb between 5% and 7% to as much as $890 billion next year, driven by continued growth in China and other emerging markets, according to data from IMS Health. The U.S. will remain the world's biggest market for pharmaceutical products, with sales estimated at $320 billion to $330 billion next year. Reuters (10/7) NIH funds an initiative to test adult drugs for use in children A seven-year NIH initiative, the Pediatric Trials Network, will include more than a dozen clinical studies of existing pharmaceuticals such as anti-hypertension drugs in an effort to find the ideal doses for use in pediatric patients. Study results will be available to the public. The Wall Street Journal (tiered subscription model)/Health Blog (10/1) Indian market attracts Japan's top drugmakers Japan's major drugmakers have expressed interest in expanding in the Indian market through partnerships or acquisitions, after Daiichi Sankyo acquired Ranbaxy Laboratories in 2008. India is expected to become one of the world's top 10 pharmaceutical markets during the next decade, according to a report from PricewaterhouseCoopers. Business Standard (India) (10/4) Scientists work to find additional therapeutic uses of Botox U.K. scientists used a so-called clipping method to refine molecules in Botox, Allergan's anti-wrinkle treatment, that might improve the drug's use for treating chronic migraine, cerebral palsy and Parkinson's disease. "This is the first time we have been able to treat protein molecules like Lego building blocks, mixing and matching them to create the basis for treatments that would not previously have been possible," the lead researcher said. Reuters (10/4) Study: PPIs are safe and effective in use with blood thinners A randomized study of more than 3,700 patients showed that those who took blood thinners plus a proton pump inhibitor had a lower risk of experiencing gastrointestinal bleeding and cardiovascular events compared with those who received blood thinners and a placebo. The finding contradicts previous studies suggesting that heartburn drugs can weaken the efficacy of anti-clotting medications. The Boston Globe/White Coat Notes blog (free registration) (10/7)   Technology & Informatics  NHLBI allots $65M for nanotech-based diagnostics and treatments NIH's National Heart, Lung and Blood Institute is allotting $65 million to revive its Programs for Nanotechnology Research project, which was started in 2005. The initiative aims to advance the development of nanotechnology that can be used to improve the diagnosis and treatment of heart, lung and blood diseases. The funds will be given out to four interdisciplinary teams across the country during a five-year period. Genetic Engineering & Biotechnology News (9/29) Study: Nanoparticle holds promise for prostate cancer U.S. scientists have created a nanoparticle that can accurately deliver as many as two treatments to prostate cancer cells. The study suggests the nanoparticle, which has a "drug-polymer blending" capability, might also be used in the treatment of other forms of cancer or in other therapy. Mass High Tech (Boston) (10/7) Researchers develop a nanoneedle for live-cell imaging Researchers have developed a nanoneedle that can precisely deliver nanoparticles called quantum dots to targeted areas in living cells. The quantum dots are capable of functioning as molecular imaging agents. The researchers employed an external electrical application for a faster and more accurate release of quantum dots from the nanoneedle. HealthImaging.com (10/1) Microfluidics chip can spot rare cancer cells in blood Scientists at Massachusetts General Hospital have devised a plastic-based microfluidics chip that has the ability to detect groups of rare tumor cells in a patient's blood sample. The technique could help improve research into cancer metastasis and spare patients from undergoing invasive procedures used for collecting tumor samples. MIT Technology Review (10/2010) Sharecare.com offers health info from experts and the industry Sharecare.com is a website offering a question-and-answer format for providing consumers with health information, with some answers coming from experts and some from marketers. "Knowledge partners" will pay from $1 million to $7 million to sponsor the site and include Colgate-Palmolive, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, Unilever and UnitedHealthcare. The New York Times (tiered subscription model) (10/6)   Regulatory Affairs  Flurry of activity from the FDA is likely to continue The FDA's Center for Drug Evaluation and Research issued 103 warning letters in 2009 for misleading labeling and other violations, up from 21 in 2006, and the agency is seeking the authority to issue mandatory product recalls. "I think the general approach has clearly been more warning letters, more regulatory activity, a much more rigorous approach to regulating products on the market," said Kenneth Kaitin, director of the nonprofit Tufts Center for the Study of Drug Development. Los Angeles Times (10/9) High court struggles with whether vaccine makers can be sued Supreme Court justices appeared divided on whether a 1986 law gives families of children hurt by vaccines the right to sue companies if the adverse reaction could have been avoided. The court is looking into the case of a Pennsylvania girl who allegedly experienced seizures after getting the third dose of a vaccine made by Wyeth, which was purchased by Pfizer last year. Bloomberg (10/12) FDA looks to bolster regulatory science The FDA aims to invest millions of dollars in science and technology in an effort to develop methods for evaluating medical products and create tests for identifying food contaminants. The agency expects the investment to strengthen regulatory science and give a boost to "creative approaches to product development and safety for both food and medical products." Reuters (10/6) EU agency prepares to issue guidelines on biosimilar antibodies The European Medicines Agency will publish requirements for biosimilar monoclonal antibodies after a review by an advisory committee next month, said Executive Director Thomas Lonngren. The agency expects to receive two or three biosimilar applications annually, reflecting the difficulty of producing such treatments, Lonngren said. Reuters (10/1) Survey: Embryonic stem cell research has strong public support A Harris Interactive/HealthDay survey of 2,113 adults across different demographic groups, including Catholics and Republicans, found that 72% favor use of embryonic stem cells that were left unused from in vitro fertilization techniques in biomedical research. "This [poll] shows that the public still believes that stem cells could lead to important therapeutics," said Paul Sanberg, a neurosurgery professor. U.S. News & World Report/HealthDay News (10/7)   i3 News  Upcoming i3 events 32nd Annual Meeting of the Society for Medical Decision Making "Evidence, Economics and Ethics: The Future of Health Technology Assessment" Oct. 24 to 27 in Toronto i3 Presenters: Rebecca Hancock, Ph.D., i3 Innovus, and Deborah Marshall, Ph.D., Principal Consultant, i3 Innovus 2010 Regulatory Affairs Professionals Society Annual Conference & Exhibition Oct. 24 to 27 in San Jose, Calif. i3 Presenters: Bernard Chiasson, Ph.D., Vice President, U.S. Regulatory Affairs, i3 (Moderator) William Jacobson, Ph.D., Executive Director, U.S. Regulatory Affairs, i3 (Speaker) Anne Tomalin, President, Strategic Regulatory Services, i3 BioNetwork West 2010 Oct. 25 to 27 in Laguna Niguel, Calif. 7th Drug Information Association Japan Annual Meeting Oct. 28 and 29 in Tokyo i3 Presenter: K. Arnold Chan, M.D., Sc.D., FISPE Oct. 28 presentation: "Actual Use of Safety Databases" in global clinical trials 16th Japanese Society for Pharmacoepidemiology and 5th Asian Conference on Pharmacoepidemiology joint meeting Oct. 29 to 31 in Tokyo i3 Presenter: K. Arnold Chan, M.D., Sc.D., FISPE International Society for Pharmacoeconomics and Outcomes Research 13th Annual European Congress Nov. 6 to 9 in Prague Stand 69-72 Review i3's entire schedule of contributions, including workshops, plenary sessions, podium addresses and more than two dozen poster presentations.   SmartQuote  Everyone has a fair turn to be as great as he pleases." --Jeremy Collier, British theater critic and theologian Subscriber Tools       Web version |  Search past news |  Archive |  Privacy policy   About i3 i3 is a global pharmaceutical services company that brings together the leading minds in specialized areas of expertise. Together, we apply rigorous science to deliver integrated strategies and solutions of the highest quality throughout the product lifecycle. And we're backed by the unmatched health care intelligence and resources of UnitedHealth Group, one of the largest health and well-being companies in the world. To gain sharper insights that lead to better patient care, look to i3. Learn more at i3global.com.       Recent i3 InLine Issues: Wednesday, October 06, 2010 Thursday, September 16, 2010 Wednesday, September 01, 2010 Wednesday, August 18, 2010 Wednesday, August 04, 2010     Lead Editor:  Elizabeth Collins       Distributed by: SmartBrief, Inc.®, 1100 H ST NW, Suite 1000, Washington, DC 20005     © 1999-2011 SmartBrief, Inc.® Legal Information