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
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By Kevin Davies
July 7, 2009 | Last April Infinity Pharmaceuticals hit a major bump in the road when a review of the first few dozen patients in its Phase III trial for its lead compound, IPI-504, seemingly on course for approval around 2011, prompted the company to instantly halt the trial. Just hours earlier, I was listening to Julian Adams, President of R&D and CSO, and John Keilty, VP IT and Informatics, discuss the technologies and strategies behind Infinity’s evolution from a discovery to a clinical company. Though the news was a setback, Infinity still seems to be on the right track.
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| Julian Adams |
Five years ago, before implementing electronic data capture, or EDC, Infinity began filing everything electronically to the FDA—before it was the law—beginning with the IND for IPI-504. “We were the first fully electronic regulatory submission to the oncology division of the FDA,” says Keilty proudly. “It was an unbelievable company-wide effort. Some folks didn’t sleep for a month as we ensured every PDF was perfect. We actually downloaded the software from the FDA…” His voice trails off for effect. After evaluating a lot of platforms, he settled on ISI [Image Solutions]. “Over time, we’ve built other tools to complement their system.”
Infinity is at 150 submissions and counting. Worldwide regulatory filing IT is handled by a younger Infinity employee. “[Our Hsp90 program is] unpartnered,” says Keilty. “We use CROs, particularly for Europe, and for external regulatory submissions. Basically, we pack our own parachute. We do everything from discovery phase to regulatory filings and the intended launch—upon approval.”
Infinity’s first trial was performed on paper. “Mercifully only 18 patients,” recalls Adams, but he quickly figured they needed EDC, which would let them interface with the web-based data collection systems at the clinical sites. “EDC is much simpler than so many of the tools used in discovery,” says Keilty. Medidata edged out offerings from Phase Forward, DataTrack, and others, and Keilty was able to get EDC up and running for a trial being conducted at the Dana-Farber Cancer Institute a month after signing the contract.
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| John Keilty |
One reason for choosing Medidata was that Keilty had moved from a Java-centric shop to a mostly .NET shop. “We were able to take their system and expand on it,” says Keilty. “Regardless if it comes off the shelf or not, there are a lot of steps to make sure it works exactly as it was set up to do.” Keilty’s team has become adept at knowing what to look for.
Adams and Keilty soon realized that some of their discovery tools, like Spotfire, could be applied to looking at clinical data as well. Each night, the EDC system exports SAS datasets over secure FTP to Infinity. “This is such a rich data source, both for prospective and retrospective analyses… [If] I see an abnormal lab value, it’s nice to look across studies to see if we’ve seen that lab value before.”
Today, Infinity collects hundreds of fields of data, from age and body weight to lab chemistries and imaging results, in a clinical data warehouse designed by Keilty’s Informatics team—the Clinical Data Integration Platform (CDIP). Scientists can query the data in any number of ways, looking for gender differences, lab values, CT scans, tumor shrinkage, EKG monitoring, and so on.
This could expand to genomic differences too. “We haven’t ruled that out,” says Adams. At ASCO, Infinity reported better Phase II results for IPI-504 in patients with non-small cell lung cancer with the wild-type epidermal growth factor receptor than mutated forms. Eventually, Adams anticipates sequencing patients’ entire genomes before validating a multiplexed set of say 5-50 genes that defines a more homogenous sub-population. “If you could correlate that with better responses, we would absolutely go in that direction,” says Adams.
But Keilty cautions that next-gen sequencing is just a commodity, preferring to focus on core competencies. “We really want to be biomarker agnostic. We need something that’s really usable in the clinic.” It may be genome sequencing, it may be circulating tumor cells, or something else. “All we care is that this is a way to separate the patient populations into those that will respond, and those that don’t.”
Due Process
Another homegrown application—a transactional database called iTRAC—tracks all the processes around a clinical trial. Keilty calls it a “clinical trial management system on steroids.” A big component of the IPI-504 Phase III trial was imaging. Although challenging, all the imaging is analyzed centrally as the data arrive at Perceptive Informatics in Waltham, Mass.
Perceptive turned around the results within five days after review by independent radiologists, which became the primary blinded input. Trial managers logged into iTRAC to see if an imaging read was missing and ensure the information was on schedule. Electronic queries were generated automatically, saving Infinity staff auditing hassles. Adams received an email every morning providing a snapshot of the number of patients in the study, the proportion in screening, randomization, and so on.
“The same person doing regulatory submissions is also using iTRAC,” says Keilty. He can call up the CRO and find a missing read if necessary. “We can control the study without really being the one doing a lot of the work.” But normalizing those eclectic sets of data across studies and sites poses a challenge. If certain lab values look strange, the team needs to be able to retrieve similar incidences and “pull those data together instantly. We’ve done a good job of that.”
Over time, Keilty says iTRAC will become an important data source. If Infinity wants to expand into a new disease area, then it can be used to formulate a feasibility survey to identify the right people to run the trial.
For all Infinity’s intellectual and informatics capabilities, Adams admits that not all hypotheses bear out. His preliminary conclusion from the IPI-504 setback is that patients were receiving too high a dose of the drug. Until then, Infinity was planning to expand headcount this year by one third to more than 200 staff. “We want to be very pragmatic about this,” says Keilty. “We’re not Novartis. How can you do the most with the people you have?”
The full version of this story will run in the July/August issue of Bio-IT World magazine.
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Evaluating a Risk-based Approach to Good Clinical Practice
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