XClinical of Germany, developer of the Marvin system for electronic data capture (EDC), is working on a 6-year colon cancer trial. The technology was chosen by Signature Diagnostics, which develops lab tests. Philippe Verplancke, XClinical’s CEO points out: “Two particular factors make Marvin ideal for this cancer trial: long term follow-ups can be easily managed without the risk of loss-to-follow-up, thanks to the central storage of the patient’s real identification data while strictly separating the identifying and the medical data according to the German Federal Data Protection Act. And the CDISC-based metadata version management makes mid-study protocol amendments an easy and auditable task.”
The Wall Street Journal is shedding light on “doctor-only” contact lenses that can only be obtained from an optometrist or physician. A 2003 federal law, cleverly named the Fairness to Contact Lens Consumers Act, was supposed to end the practice. But companies like CooperVision, Hydrogel Vision and Sauflon Pharmaceuticals sell lenses only to the trade or firms like Lens Crafters, which employ optometrists. Internet-only sellers of contact lenses have joined in the fray, lobbying for a revision to the law.
There is skepticism about a plan to fight counterfeit drugs. All of the bar codes that will be used under a new system can easily be faked, experts say. IBM says one solution is RFID, or radio frequency identification, chips. “Once it’s written, it can’t be rewritten,” said Paul Chang, an executive at IBM’s RFID pharmaceuticals unit. “If you can link that number with a unique electronic product code, you have a truly unique combination of data.” But those tags won’t help with drugs that come from overseas. And there are two competing radio frequencies that the RFID tags use, making one global standard impossible. The life science niche of RFID is expected to become a $14 billion industry, a new IDC report suggests.
Affymetrix and Boston University will genotype 9,000 samples collected in the Framingham Heart Study. On the federal level, the work will be coordinated by both the National Heart, Lung and Blood Institute (NHLBI) and the National Center for Biotechnology Information (NCBI). “The Framingham Heart Study is one of the most recognized clinical research projects in history and we are honored that the NHLBI has entrusted the genotyping of these valuable samples to Affymetrix,” said Giulia C. Kennedy, Ph.D., senior director of genomics collaborations at Affymetrix. “Researchers have been waiting for decades for the right technology to come along and extract the genetic information contained in these samples. When this project is complete, researchers around the globe will have access to one of the richest medical datasets in existence.”
Curis will stop work on a cancer project with Genentech after suspending enrollment in a Phase I trial. Curis also halted work on a spinal muscular atrophy discovery-stage project, but the company continues to work on a multiple sclerosis drug.


