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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More




ORBIT: Aurora’s Biorepository Could Become Nation’s Largest



By Deb Borfitz

May 26, 2009 | Aurora Health Care, a large not-for-profit system based in Milwaukee, WI, recently launched what is expected to become the nation’s largest and most comprehensive biorepository. In a few years, it could trump the size of Iceland’s bank of biological specimens providing genetic details on virtually its entire populace.

The Open-Source Robotic Repository & Informatics Technology (ORBIT) is not only a unique investment for a non-academic health system, says Randall Lambrecht, Aurora’s VP of research and academic relations. It is also an uncommonly diverse biospecimen library because of the medical conditions, races, and ethnicities represented. Unlike many other biorepositories, researchers worldwide will be able to access DNA from the donated blood samples.

Randall_Lambrecht
Randall Lambrecht
If patients (18 and up) agree to participate, blood left over from their medical tests is sent to the ORBIT lab. Here a robot extracts DNA from the blood, bar codes the sample, and stores it in a freezer that holds up to 76,800 vials. The bar code allows the informatics technology to link each sample with the donor’s privacy-protected electronic medical record (EMR), creating a “living health record” that could help researchers determine the best drug for an individual based on that person’s genetic makeup, says Lambrecht. The current one-drug-fits-all paradigm is a bit of a crap shoot. Between 30% and 70% of patients treated for a cardiovascular condition with statin drugs don’t respond and the reason can often be traced to a genetic variant.

Equally important, ORBIT will facilitate the development of gene-specific preventive and diagnostic tests that could prompt positive behavioral changes in at-risk populations, says Lambrecht.

The overriding intent of ORBIT is to further the developing field of personalized medicine, wherein drugs are prescribed to patients based on such factors as their age, gender, race, weight, medical history, and genetic markers, says Lambrecht. But more immediately, the databank should quicken the pace of clinical trials by helping researchers zero in on patients best able to meet a study’s inclusion and exclusion criteria.

ORBIT is likely to quicken the translation of science to patient care in ways unthinkable until quite recently, says Lambrecht. Over 100 genetic variants were identified last year, compared to one or two annually between 2000 and 2005.

Although ORBIT launched only three months ago, it has already processed more than 12,000 blood specimens representing more than 2,600 individuals, says Lambrecht. The goal is 75,000 blood specimens by the end of 2009 and 100,000 annually thereafter.

Aurora sees about 1.8 million patients annually. Patients of Aurora St. Luke’s Medical Center, where the robotic system is housed, are the first eligible to contribute blood, says Lambrecht. By early next year, patients across Aurora’s 13 hospitals and 120 clinics in eastern Wisconsin will also be able to participate. The EMR tied to each specimen is updated as participants return to Aurora for care, when they can also opt to re-donate blood. Each donation translates into about ten vials.

With the consent rate at nearly 75%, Lambrecht says, Aurora is already looking to hire a fourth biologist to man the robot and handle incoming specimens and data requests. The robotic system can manage up to three freezers. The databank may eventually include saliva and tissue samples.

Access to ORBIT is contingent on returning research results to the databank to minimize study repetition and allow other researchers to build on the findings. Aurora, which has invested more than $1 million dollars in the project, will also get a portion of research grants to help cover its costs. “We want to make this self-supporting,” says Lambrecht.

Aurora itself will be the first to tap ORBIT to assess the prevalence of a gene variant predictive of cardiovascular disease, helping to validate a newly developed genetic test, says Lambrecht. But moving forward, ORBIT will be used by researchers primarily for gene sequencing or genotyping.

The biorepository was the brainchild of Alfred Tector, director of Aurora’s clinical research and transplant program, and his son, Matthew Tector, a molecular and cellular biologist who serves as ORBIT’s director.

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