News
More Access-Free Access to Scientific Publications
Friday, 29 May 2009 23:00
CrownBio greatly supports the efforts of open access to scientific publications. As we move into the age of personalized medicine, it is even more critical that strong, peer reviewed data is available to the public to enable them to ask questions, thus become educated, and force their caregivers to also be up to speed in the newest thinking in cancer therapies.
The following link from Wired is a great place to start. From there one can find the most relevant methods for accessing these important science papers. All your thoughts and comments welcome.
ASCO : Cancer Stem Cell updates
Tuesday, 12 May 2009 05:38
This article will focus on cutting edge cancer stem cell news.Biomarkers- Critical Path Initiatives
Tuesday, 12 May 2009 04:52
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm
The biggest challenge for the implementation of biomarkers into clinical trials is the absence of clear regulatory guidance over the use of biomarkers as validated surrogate endpoints in the clinical phase. However, the FDA is beginning to make improvements in the regulatory process, as illustrated in the recently published a report entitled “Innovation or Stagnation? Challenge and Opportunity on the Critical Path to new Medicinal Products”. This outlines that the FDA currently accepts biomarker data on a voluntary basis only, but once enough scientific evidence has been gathered, steps will be taken to provide fixed legislation for the validation of biomarkers as surrogate endpoints.
Another major challenge is the preconception in industry that biomarker tests are unreliable when used with different patients, but it is hoped that this preconception can only be improved as scientific knowledge expands, and this is being backed by the FDA request for voluntary data submission.
Biomarker development will initially require significant investment into research and development and result in a more complex clinical trial phase, but it is hoped that these investments will pay off in the long term future as the regulatory climate improves.
The link provided will provide an up-to-date resource for keeping up with gains made both legislature and in various initiatives across the research community which has gained critical funding for these efforts.