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Will New ADME/Tox Tools from Thermo, Beckman Fulfill Pharma s Data Needs?

San Jose, Calif. — At the Lab Automation conference held here this week, Beckman Coulter and Thermo Electron each highlighted new products targeting the automation of in vitro absorption, distribution, metabolism, excretion, and toxicology testing.

The launch of the two product platforms highlights the increasing interest among tool vendors in this step of the drug-development process. Interest in these technologies is also growing as a result of the widely publicized withdrawal of Vioxx, and the increasing pressure on pharma companies to cut their financial losses by killing drug candidates earlier in the development process.

But will these new tools from Thermo and Beckman meet pharma’s demands and help them to fail early and often?

ADME/tox analysis has been a focus of researchers for a decade now, and some experts, like Tony Hopfinger of the University of Illinois, Chicago, say the tools currently available are inadequate to address the level of customization needed for specific investigational tasks. A such, Hopfinger, who was speaking about the state of the market, said he questions the quality of data produced by current investigational methods (see article, page 5).

Neither of the two products introduced at Lab Automation addresses the quality of data produced — only the rate at which it can be produced through the automation of workflows.

With their new products, Thermo and Beckman are addressing the in vitro segment of the ADME/tox market, which is estimated at $250 million a year. Coupled with the in vivo ADME/tox segment, the market is estimated at more than $1 billion a year.

Thermo Electron’s LeadStream

At the front of the Thermo Electron pavilion at Lab Automation, four lab benches occupied a corner of the company’s presentation area, highlighting the LeadStream product package, which rolled out Tuesday.

Targeting major pharma customers with a high-end product, the LeadStream package includes either a TSQ Quantum quadrupole or ion-trap LC/MS instrument, the LeadStream WorkCell automated platform for conducting assays; and the LeadStream Reformatter, an automated plate-preparation technology. All is integrated through new software, the LeadStream Orchestrator, which collects and stores data and controls the workflow processes of the system. Additionally, the product includes the QuicQan instrument to auto-tune samples for analysis.

The configuration of the system as displayed would sell for between $1.5 million and $2 million, company representatives said, noting that it is built to a buyer’s needs and can be expanded through the use of modules.

“It’s the first on the market, and it will change how in vitro ADME/tox is done,” said Hansjoerg Haas, director of ADME/tox for Thermo.

The product is expected to ship in the third quarter and has been developed in collaboration with two unspecified partners, he said.

The product is designed to consolidate workflows, said Robert DeWitt, ADME/tox business relationship manager for Thermo.

“For people conducting ADME/tox, the principal barrier to scaling is complexity in the lab — which samples to use, which assays, and what to do with the data,” he said. “The act of consolidating all of that takes a lot of time, and takes the scientists away from what they do best.”

He declined to provide a breakeven target date for the product line, or to provide any projection of sales-revenue expectations for the product.

“We did our homework and took a top-down strategy, talking to multiple customers about their unfilled needs,” he said. “If it provides higher throughput, and higher turnaround, it will be successful.”

The 2-year product-development process was carried out by a cross-functional, cross-divisional team, including representatives from the company’s mass spectrometry, automation and integration, readout technologies and detection, controlled environments, and software and bioinformatics units.

“This was a new method of producing a workflow system and solution,” Haas said, adding that the team will remain together for other products.

The system, however, does not totally automate ADME/tox processes. People are still needed to load hotels of microtiter plates, deliver reagents as needed, empty refuse bottles, and, of course, to initiate and manage the analytical processes.

Beckman’s BioMek FX
ADME/tox Workstation

While the Thermo system addresses the high end of the ADME/tox market, Beckman’s BioMek FX addresses the A in ADME — specifically, it automates PAMPA (parallel artificial membrane permeability analysis) to determinr passive absorption of a drug candidate through an artificial lipid membrane.

The product, Beckman representatives said, was developed in collaboration with Pion, a Woburn, Mass.-based company with whom Beckman signed a five-year distribution agreement in December.

The new platform, which Beckman launched at Lab Automation, combines Beckman’s automation and liquid handling with Pion’s technology for permeability measurement.

One unit will cost $250,000, but the price will vary depending on whether the unit comes with one or two robotic “bridges,” said David Daniels, applications marketing manager for Beckman Coulter.

The BioMek FX is modular and may be installed in multiple units. The unit is expected to produce an additional $50,000 a year in consumables revenues, and is not expected to require a large maintenance cost.

Beckman is targeting pharma, biotechs, and academia with the instrument, Daniels said. “There is a broad interest level in the life sciences.”

Daniels said the BioMek FX will break even in two years and expects to sell 50 units in its first year.

— Mo Krochmal ([email protected])

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