Absorption Systems offers custom ADME-tox screening on demand.
By Rebecca Palmer
September 15, 2009 | It is no secret that a perceivable shift has been seen in the pharmaceutical industry. “Big Pharma” is not so big anymore, shrinking due to smaller pipelines, strong political pressures against rising health care costs, and increasingly difficult economic times. Pharmaceutical companies around the world are decreasing their discovery efforts and outsourcing more of that work to contract research organizations (CROs). Key partners are now needed to help get their compounds to investigational new drug (IND) submission with the FDA in a manner that is cheaper and faster.
Enter Absorption Systems. The Exton, Penn.-based company was founded over 10 years ago with the goal to “de-risk” compounds going forward in the approval process, according to CEO Patrick Dentinger. The group’s approach eventually came to focus on ADME (absorption, distribution, metabolism, and excretion), pharmacokinetics, and toxicology.
The company now offers custom work for their clients with an emphasis on human-derived models, including Caco-2 cell line-based systems. Custom testing for absorption through skin, intestine, and nasal barriers with complementary pharmacokinetic studies in various animal models set this group apart in the industry. Although great strides have been made in these ADME and pharmacokinetics areas, toxicology still remains a “black box” for those in the biopharmaceutical market.
To expand the breadth of their offerings, particularly in the toxicology arena, Absorption Systems acquired Perry Scientific in July 2009. Perry Scientific, the oldest and largest CRO in southern California, was founded 10 years ago to carry out preclinical studies for the pharmaceutical industry.
The partnership with Absorption Systems was obvious, but the new team’s outlook is unique. “We are a biology company—it’s what we do,” says Dentinger, “but tox assays blend nicely with our current offerings and they enable us to keep an eye on that IND filing with the FDA. I think it is unrealistic to envision a ‘one-stop-shop’ for CROs, but this acquisition allows us to expand and emphasize our tox offerings and provides us with a strong presence on the west coast of the U.S.”
To head this emphasis on toxicology is newly hired director of toxicology and pharmacology, Sarath Kanekal. Kanekal, most recently of Supergen (Dublin, Calif.), has experience taking several drugs from discovery to new drug application (NDA) with the FDA. As a former consultant for Perry Scientific, Kanekal is quite familiar with Perry’s offerings and goals for the future.
“For our clients, we offer overall guidance on their IND programs and then recommend and carry out specific experiments on a wide range of experimental models. The end result is a recommended safe starting dose for the first human clinical trials. We see that the testing program moves forward efficiently, and we do it in a cost-effective manner. In the end, the client is ready to take the candidate directly into Phase I clinical trials.”
With a new west coast presence and expanded toxicology offerings, Absorption Systems expects to grow by 50% in employee head count at the San Diego site within the next six to nine months. The combined resources of the new team are well placed to now help “Big Pharma” focus on improving pipelines.
This article also appeared in the September-October 2009 issue of Bio-IT World Magazine.
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