Thursday, September 30, 2010
Expanding the outsourcing support of its clinical trials, Eli Lilly is transferring U.S. medical writing and biostatistical services to i3 Statprobe, a move that expands the business relationship formed between the two companies in 2008 when Lilly transferred the majority of its domestic data management activities to i3.
Yale Medical Group, affiliated with Yale University’s medical school, has adopted a new conflicts-of-interest policy to regulate relationships between its doctor-academics and industry, Pharmalot reported. The new policy comes on the heels of a similar move at Harvard Medical School, and after a handful of other academic medical centers have reviewed their own rules. Yale Medical’s new regulations attempt to tread a fine line, designed to fend off accusations that industry money and relationships unduly influence its doctors without cutting pharma out of the equation completely. It addresses financial ties to drug and device makers; gifts, meals and other goodies from industry; ghostwriting; samples; consulting and continuing medical education. According to Pharmalot, drug sales reps bear the brunt of the rules; they’ll be allowed to visit only by invitation and with an appointment. Companies can still sponsor CME programs and provide meals during CME events. “We wanted to upgrade the guidelines to a full-blown policy so that faculty and others understand that these are no longer electives, because the landscape has changed,” CEO David Leffell said. The Yale Medical Group is staffed by roughly 800 academic physicians from the Yale School of Medicine; it is not a separate practice or foundation. The move reflects ongoing debate over the interactions between academics and drug and device makers. The National Institutes of Health has proposed new conflict rules for researchers. “Our view is that we continue to respect the role the pharmaceutical industry plays in contributing to and investing in the health of people,” Leffell said.
Daniel Berger is a happy man. The FDA has ruled that the Chicago internist and thought leader in the area of HIV can continue conducting clinical trials without any restrictions, despite evidence that his clinic submitted bogus data along with failing to perform basic tests including physical exams and electrocardiograms during one particular trial. Additionally, 200 tablets of the investigational drug went missing at his clinic during that trial.
Four small and mid-sized clinical research service companies—Averion International, Trio Clinical Research, Fulcrum Pharma and Clin-Research/ADDPLAN—have merged into one global biopharmaceutical and medical device development services organization that will focus on niche areas, including adaptive trials and new technologies, which can help sponsors make decisions about their drug candidates faster.
Fortune’s recent release of its 2010 list of 100 fastest-growing companies illustrates how sectors that perform in cycles, such as CROs, can either benefit or lose out when measured by a snapshot in time.
CROs are hiring exponentially more people than pharmaceutical companies or medical device makers, according to the brand-new Global Life Science Hiring Index produced by boutique talent management firm ZRG Partners. For the second quarter of 2010, the index showed that the category of outsourcing and services (mostly CROs) did a whopping 500% more hiring than pharma companies and 250% more than medical device and supply firms.