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Predicting Patient Response


Vertex CEO champions modeling in drug development.

By Allison Proffitt

June 10, 2008 | BOSTON—Joshua Boger, founder, president and CEO of Vertex Pharmaceuticals, opened the first full day of talks at the 2008 Bio-IT World Conference and Expo with three fascinating vignettes showcasing the use of information technology across commercialization, research, and development. Boger believes that information is being underutilized in a variety of ways, and there is still much opportunity to use information to “be more efficient and more effective in what we do.” 

In research, Boger emphasized that the best metric of success is “un-coerced adoption.” As an example, he cited Vertex’ electronic lab notebook (ELN) implementation. The key to successful ELN adoption was bringing in users from the very beginning. “We brought the community together and created a project that was owned by all the users,” he said. After four months, across three sites and two continents, Boger said Vertex had 100% adoption.

Adoption is key for IT in commercialization as well—adoption of health informatics to increase the efficiency of the health care system. He envisioned an informatics-driven environment to help patients life healthier lives.

“You can be in the supermarket and use [a health informatics device] to scan a bar code, the bar code can look up the information on a Doritos package and tell you that, ‘No, you idiot, you can’t eat Doritos. They’re not in your diet plan,’” Boger joked. “Information technology can speak to the whole patient, not just one part of the patient.” 

The Most Fertile Field
But the real prize, Boger believes, is in development. “A lot of IT effort is spent and has been spent in research,” he said. “There’s still a lot to do in the analysis of information, the presenting of data, the mining of various experimental databases, human genome, etc. This is all important work. But I would argue that the most fertile field for information technology is actually in development… As Willie Sutton said when he was asked why he robs banks, ‘That’s where the money is.’”

Boger’s most exciting illustration was Vertex’ recent work on the Hepatitis C virus (HCV). Hepatitis C infections are often fatal, with current treatment regimens (which typically last a year) less than 50% effective in curing patients. “This is a virus that mutates extremely rapidly, much faster than HIV, which sounds kind of scary,” says Boger. Finding a therapy effective on the both the wild type and mutated species of HCV was crucial.

After designing a molecule called Telaprevir that disables one of the proteins essential for viral replication, Boger’s team built a systems biology model of hepatitis C dynamics in patients, modeling all of the different species of HCV and adding data from hundreds of patients in the process. That model “consists of something like 1,700 differential equations, runs on a desktop computer, and actually starts to model and predict every single patient response,” said Boger.

“The viral object modeling is driving development—continuously being confirmed by flooding more information into the virus model—and continues to drive our cellular design, even making some predictions that help in the regulatory pathway.”

The model revealed that the mutant species of the virus were constantly present, and provided an explanation for why the virus would return even when the viral load was undetectable. The model also predicted that if Telaprevir could knock out the wild type of the virus quickly, follow-up with the current drugs could remove the remaining mutant species, successfully curing the disease.

“The model predicted that,” said Boger. “The clinical data actually backs it up.” But the model predicted more than just a successful treatment. “After 12 weeks with Telaprefir, the direct antiviral, it knocks the wild type down. It’s done everything that it’s going to do and having it on board in the patient longer than that actually doesn’t lead to any advantage,” explained Boger. The model suggested that a shorter duration of treatment would suffice; that patients needed less of the drug.

“That’s a very controversial prediction... We confirmed it in the clinic to both our satisfaction and to the satisfaction of the FDA, who allowed us to configure out phase III trials with that presumption,” Boger said. “We actually saved ourselves the $30 or $40 million, because at that point we believed the model.”

“It’s very exciting for the patients,” said Boger. “This was a case where the virologic modeling started literally on the first day of clinical trials, and has driven and reinforced decision-making through the entire clinical trials process.” 

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This article appeared in Bio-IT World Magazine.

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