Pacific Biometrics: Rapid response for biomarker-heavy adaptive trials
Pacific Biometrics
Targeting the right drug to the right patient may still be some years away for the public, but the challenge is confronting laboratories developing assays for clinical trials right now.
“Adaptive trials pose a disconcerting challenge for others, but this trend only plays to our strengths as a responsive service provider for drug development,” said Mario Ehlers of Pacific Biometrics, Inc.(PBI).
“Where pharmaceutical companies once needed to wait for an extended period before receiving the results of even preliminary trials of their compounds, pressure to shorten time-to-market and the increasing expense of large scale trials have forced a change toward the so-called adaptive trial design, ” he explained.
The former Chief Medical Officer for PBI, and now a member of the Board of Directors, Ehlers told partneringNEWS. “The tendency today is for trial designs of shorter duration using novel biomarkers with a complex statistical approach to evaluate results in real time.”
Ron Helm, CEO and Chairman, Pacific Biometrics
“Looking at data in real time, a company sponsoring a clinical trial can make decisions to change doses, increase patient enrolment in one arm versus another, or stop a trial early. This approach can save time and money for the sponsor, but it also means that outsource vendors, like central labs, need to be able to change direction quickly. We feel that PBI has the flexibility to respond rapidly to these changes” he stated.
“Adaptive trials also make more extensive use of novel biomarkers. This requires vendors like PBI that have the scientific depth and expertise to perform custom development of assays robust enough for clinical drug developed,” he added.
Over the past year, PBI has seen a 32 percent increase in revenues, boosted in part by the shift to increased reliance on science-heavy biomarker assays by its customer base of large pharmaceutical companies.
In a recent report to the Board, the CEO of PBI, Ron Helm, reported a second trend driving growth is the fast turnaround work the company performs developing assays for a growing scope of biomarkers, which favors “smaller labs, like PBI, that are nimble and flexible, and plays into our biomarker development strength.”
Mario Ehlers
PBI began 20 years ago as a specialist in what was once called “efficacy testing” and has emerged more recently as the industry buzz word “biomarkers,” said Ehlers.
The term refers to any surrogate that proves useful for drug development, whether biochemical, genomic, or even an imaging diagnostic, which is increasingly being used in clinical trials, he explained.
“We began as a specialty provider of assays for drug and diagnostic development and we have invested a great deal into expanding this internal capability to keep pace with the scale and scope of the increasing emphasis on biomarkers,” he added.
“We have added technologies, expertise and the instruments required to respond to the demand, and the innovation, in this area,” he explained. “Pharma and biotechs today are asking for assays tailored to highly specific populations.”
“There are not many labs that have a handle on the ability to build from scratch an assay robust enough for the demands of clinical drug development. It is one thing to build an assay for a one-time test, but what happens if the adaptive trial is successful? Will the assay be reliable and robust enough to go the distance for testing over the long course of a trial?” he remarked.
CEO Helm is coming to BIO-Europe 2009 in Vienna seeking more growth for his company, hoping to meet with a potential partner who can help build a cross-Atlantic exchange.
“To support customers with an increasing need for conducting global trials, we are seeking a partner with a similar profile to our own, a smaller lab with a solid scientific strength but who is based in Europe,” explained Board member Ehlers.
“We have a preference for Europe in our growth plans,” he added, “and it is critical a potential partner understands what is needed to support clinical trials.”
The other side of the partnering exchange is helping Europe’s small pharma and large biotech companies conduct clinical trials in North America.
“When European companies developing drugs need to sponsor a clinical trial in America, they will want to know about us,” he pointed out. “European biotechs generally do not know about us, and we would like to get onto their radar screens.”
“Partnerships between labs are complicated,” said Ehlers, explaining that there needs to be a seamless transfer of equivalent science across multiple programs. “Results from tests must be combinable, meaning that there is consistency and quality across datasets.”
PBI is open to a range of possibilities for partnering with the right European company.
“The Board has discussed the possibility for an alliance or a merger with a European partner,” concluded Ehlers.
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