In an industry first, doctors and nurses can record and view clinical trials using a cell phone. California’s Nextrials announced that Prism, its electronic data capture (EDC) system, will be fully functional on the Apple iPhone. (Here’s a link to the nuances of web design for Apple’s little-known Safari web browser, also used on the iPhone. “You’ll want to avoid using Flash and Java for iPhone content,” Apple notes.) Nextrials hopes the Apple handsets will be helpful in fostering clinical site loyalty and productivity. In a statement, Nextrials CEO and co-founder James Rogers said: “By adding support for the iPhone, Prism increases its usefulness to sites and sponsors, particularly those who need access to clinical data while on the move. Researchers can now view clinical data in real-time on an iPhone at any place supported by the device’s wireless carrier, and see that data within the same user-friendly reports and graphs they are utilizing in the office.”

Open Text and Jazz Pharmacueticals have tested a new submissions technology in advance of a key January 2008 deadline. To quote the news release: “Using [Open Text’s] Livelink ECM Collaborative Submissions, Jazz Pharmaceuticals prepared and sent to the FDA a very sophisticated pilot submission that was composed of more than 500 documents, including SAS-format statistical information, supplied in native form; the FDA’s required Study Tagging File (STF); and the FDA’s Structured Product Labeling (SPL). In addition, the company provided several hundred PDF links between the submitted documents. The pilot submission was thoroughly verified by the FDA and passed with no issues.”

Veracity Biotechnology, a startup contract research organization (CRO) in Frederick, Maryland, focused on the examination of drug resistance, has moved out of the business incubator created by Frederick Innovative Technology Center, Inc. (FITCI) at Hood College and into a new facility on South Wisner Street. The new location is nearly three times the size of Veracity’s previous, 375 square-foot location. Victor Buckwold, who owns Veracity and serves as its president and only full-time employee, said: “FITCI helped start the business. I didn’t have to worry about getting the certifications required to run a laboratory.”

DiaMedica, a drug discovery and development company focused on novel treatments for type 2 diabetes, has announced the formation of DiaMedica Europe in the UK. DiaMedica Europe was formed to facilitate the performance of clinical studies in the EU and is a wholly owned subsidiary of DiaMedica. Karl-Gunnar Hidinger, president of DiaMedica, said: “The European Union is recognized as an excellent environment for conducting clinical studies, and our European entity has been established as part of our strategy to move products into the clinic rapidly.”

Bennett, Coleman & Co (BCCL), the publisher of The Economic Times and The Times of India, has acquired a stake in the Clinical Research Institute (India), an Indian institute offering education in clinical research. Clinical Research Institute director Vijay Moza, said: “Over 50,000 job openings for doctors, pharmacy and science graduates are expected to be created over the next four years. The association with BCCL will help generate high awareness levels for this sunrise industry.” CRI will also be opening centers in Delhi, Hyderabad, Bangalore and Kolkata over the next five months.

Pharsight Corporation, specializing in clinical trial simulation, announced that its Strategic Consulting Services Group is using a quantitative disease model developed by the FDA for non-small cell lung cancer (NSCLC). The model will support an oncology drug development program sponsored by a Pharsight client. Its scientists expect to refine their simulations with emerging data in new clinical studies to assist with key program decisions, including optimized dose selection and improved design of survival trials. Shawn O’Connor, Pharsight’s president, chairman and chief executive officer, said: “As outlined in FDA’s Critical Path Initiative, model-based drug development offers an important approach to improving drug development knowledge management and decision making.”

After all the hype related to stem cells recently, it was a relief to read this AP story. Its view is that the latest stem cell research (which does not require embryos) will have no immediate therapeutic implications. Regulatory obstacles, in particular, have been overlooked by stem-cell scientists in academia.
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