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| i3 InLine |
| December 5, 2007 |
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Spotlight
Stepping up risk management efforts is sound prescription for pharma
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. Blank (12/5)
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)
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)
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)
Researchers discover way to produce cancer vaccine
Canadian researchers have produced a potent cancer vaccine from a patient's own tumor cells through a technique called photo-dynamic therapy. The process uses ultraviolet light to trigger the vaccine when it reaches its target, allowing large doses of the drug to be administered without the risk of toxic effects in other parts of the body. The Independent (London) (tiered subscription model) (11/14)
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)
Other News
In Market
Explosive growth predicted in children's vaccine market
A new report from Datamonitor says the market for children's vaccines will grow fourfold in the next decade, due in large part to Wyeth's pneumococcal vaccine Prevnar. The report predicts the global market for children's vaccines will exceed $16 billion by 2016. In-PharmaTechnologist.com (11/20)
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)
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)
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)
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-PharmaTechnologist.com (11/26)
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)
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)
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)
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)
Genetic profile services launched
DeCODE Genetics has launched deCODEme, a $985 genetic-profiling mail-order service that can provide information on a person's ancestral origins, bodily traits and risk of developing diseases. A second company, called 23andMe, also announced the start of its genetic mapping service for the public. NYTimes.com (11/17) American City Business Journals/Silicon Valley/ San Jose (11/19)
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)
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)
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)
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)
Duke partners with FDA to improve clinical trial process
The FDA is joining forces with Duke University Medical Center to address problems in the regulation of clinical trials. The public-private collaboration is likely to consider streamlining the structure of institutional review boards, creating accreditation programs for clinical researchers and developing standardized electronic forms to gather health records. The Wall Street Journal (11/20)
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)
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.
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 Imagination will often carry us to worlds that never were. But without it, we go nowhere."
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