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A summary of the top news impacting the pharma industry.
December 5, 2007
  • Stepping up risk management efforts is sound prescription for pharma
    Stepping up risk management efforts is sound prescription for pharma  
    Terri Madison President, i3 Drug Safety
    Pharmaceutical companies seeking to ensure robust risk management strategies need to take another look at their drug safety policies and procedures. The goal: to transition these processes to a more proactive approach. "Generally, all products have risks; the challenge is to develop and implement strategies that maximize patient benefit while minimizing patient risk," according to Terri Madison, president, i3 Drug Safety. "The level of tolerance for risk depends on the product's use; higher risk for a life-saving treatment is more acceptable than even minimal risk for a product that treats cold symptoms. These principles are the foundation of risk management, and the industry must evolve to incorporate these principles into their routine product development and maintenance strategies," she said. Continue reading this article online. Email this Story
  In Development 
  • Benchmarks needed for outsourced clinical trials
    To ensure patient safety and public confidence, outsourced clinical trials must have benchmarks for quality and incentives for adherence to best practices, according to life science legal experts. The authors of this analysis cite the Global Technology Transactions Organization as a model for creating international standards and incentives for biopharmaceutical companies conducting trials in emerging markets. PharmAsia News/FDC Reports (11/26) Email this Story
  • Critics raise concerns over diversity in drug, device trials
    Critics argue that a lack of diversity among patients in early clinical trials has led to an increase in adverse events from commercial medical devices and drugs when used in larger populations. Experts say the reasons behind the small number of women, minorities, older patients and children in clinical trials include the susceptibility of older patients to age-related diseases and concerns about the possible effects of a treatment on the fetus of expectant mothers. The Sun (Baltimore) (11/18) Email this Story
  • Genzyme among fans of Waban Software
    Waban Software says its technology platform allows for more efficient clinical data management, analysis and reporting, and Genzyme is one biopharmaceutical company that claims the system has improved the quality and efficiency of its drug-development processes. Bio-IT World (11/28) Email this Story
  • Pharmacogenetics slowly becoming reality, drugmakers say
    It will likely take 20 years before medicines designed specifically for an individual's genetic profile can transform the pharmaceutical industry, GlaxoSmithKline CEO Jean-Pierre Garnier said at the Reuters Health Summit. Some companies have treatments in clinical trials, and many experts say pharmacogenetics will revolutionize patient care. Reuters (11/15) Email this Story
  • Other News
  In Market 
  • Process improvement key to Pfizer's success
    A Pfizer executive recently said the company was uniquely positioned to tackle industrywide problems in clinical development because of its large size, which requires efficiency and effectiveness in all processes. Managing data repositories, streamlining clinical trials, consolidating processes and working effectively with two CROs at the same time are key elements in the continued success of Pfizer, VP of development operations Mike Collins said. ClinPage (11/27) Email this Story
  • Genetic tests benefit cancer patients
    Genetic tests have broad implications for the diagnosis and treatment of various diseases, but especially cancer, where they have been instrumental in personalizing traditional cancer care. One example is the Oncotype DX test, which has helped oncologists determine the clinical characteristics of tumors and develop appropriate treatment plans. The Plain Dealer (Cleveland) (11/19) Email this Story
  • Data storage firm offers cheaper option for smaller companies
    San Jose, Calif.-based BlueArc, a data storage company with customers in the life science and education fields, has come out with a leaner and less expensive product. The Titan 1100 includes support for two-node clustering and up to 128 terabytes of storage capacity, but has only four Ethernet ports and less processing power and memory than previous models. Bio-IT World (11/27) Email this Story
  • Singapore biopharm decline pulls down region's performance
    Singapore's biopharmaceutical manufacturing output shrank by 15.3% in October, compared to the same month last year, according to figures released by the country's Economic Development Board. However, biomedical manufacturing grew 8.7% in the first 10 months of the year, compared to 2006, mainly due to growth in the medical technology sector. In-Pharma Technologist (11/26) Email this Story
  • Biotech startups launch human liver models
    Biotech firms TE-bio and Hepregen are planning to market liver cell cultures they developed that would help drugmakers identify toxicity problems of drug candidates. The microstructured liver cells can mimic the functions of the human liver, retain gene-expression profiles for four to six weeks and form significant transport systems known as bile ducts. M.I.T. Technology Review (11/29) Email this Story
  Technology & Informatics 
  • Survey reveals impact of HIPAA on medical research
    A U.S. survey of more than 1,500 epidemiologists found that two-thirds of respondents experienced difficulties recruiting patients and accessing their health records for medical research because of HIPAA privacy rules. One privacy advocate, however, said most Americans support the rule because they want to be asked for their consent before their medical records are used for research. Forbes/Associated Press (11/13) Email this Story
  • Q-and-A: CDISC chief discusses adoption of global e-data standards
    Becky Kush, the president and CEO of the Clinical Data Interchange Standards Consortium, says the consortium is working on several fronts to help manage the growing demand for electronic data submission. It is training FDA staff on the study data tabulation model, leading the Clinical Data Acquisition Standards Harmonization initiative and working with user networks across Europe and the U.S. Bio-IT World (11/28) Email this Story
  • Experts optimistic over promise of nanotechnology, despite possible risks
    Its fans say nanotechnology will bring significant benefits to science, the environment and health, but early studies suggest some of the tiny particles may cause cancer in animals. The FDA says there is no scientific evidence that products manufactured with nanotechnology pose any major safety risks. Materials company DuPont has taken on this issue by developing a system for evaluating whether to proceed with nanotechnology projects. Reuters (11/14) Email this Story
  • New technology lets developing countries create biobanks
    India and other countries in the developing world are now able to establish biobanks of human tissue and blood samples, thanks to technological advances, such as the use of dried blood spots instead of serum for biobank storage, according to an article in the journal Science. The trend could allow for an "imaginative search for common and rare genetic and other biological correlates of global diseases," the authors say. Science and Development Network/Science (11/16) Email this Story
  Regulatory Affairs 
  • Ex-FDA head heralds new drug-safety bill
    Former FDA commissioner Mark McClellan commended the recently enacted drug-safety bill, saying it would pave the way for the creation of a vast new drug-patient database by 2012. The database could help prevent problems like those posed by Merck & Co.'s Vioxx, he said. CNNMoney (11/28) Email this Story
  • U.S., Europe loosen orphan-drug approval rules
    The European Commission, the European Medicines Agency and the FDA announced that they are implementing a common process for orphan-drug status application in a bid to promote the development of medicines for rare diseases. The more-lenient rules allow drug firms to seek orphan designation from both the EC and the FDA at the same time and with one application. Reuters (11/26) Email this Story
  • J&J, Genzyme execs have seats on board of FDA foundation
    Executives from Johnson & Johnson and Genzyme Corp. were selected, along with officials from other sectors, to oversee the FDA's Reagan-Udall Foundation, an alliance created to improve product handling and safety as well as speed up the development of drugs and medical devices. The drug sector representatives join officials from academic institutions and nonprofit groups on the foundation's 14-member board. MSNBC/Associated Press (11/20) Email this Story
  • FDA addresses conflicts of interest among advisers
    The FDA has proposed a system to reduce potential conflicts of interest among members of its advisory committees on product approvals. The new rules, aimed at making the regulatory process more transparent, would require advisory board members to fill out a form disclosing any industry ties. If the FDA decides to allow them to sit anyway, the disclosure form would be posted on the agency's Web site. Google/Associated Press (11/15) Email this Story
  • Other News
  i3 News 
  • The American Society of Hematology Annual Meeting Dec. 8 to 11, 2007
    i3 will be exhibiting at the 49th annual meeting of ASH in Atlanta. The Society's annual meeting provides hematologists from around the world a forum for discussing critical issues in hematology. The four-day meeting offers many educational programs and cutting-edge scientific sessions dealing with the latest and most exciting developments in scientific research. Learn more here. Email this Story
Imagination will often carry us to worlds that never were. But without it, we go nowhere."
--Carl Sagan,
astronomer and Pulitzer Prize-winning author

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