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Almac Diagnostics' New Biopharma Biomarker Program Will Include Arrays, qPCR


By Justin Petrone

Seeking to capitalize on its experience with biomarker research and genomic technologies, Almac Diagnostics this week launched Biomarkers for Biopharma, a menu of services specifically designed to appeal to drug developers working in the preclinical setting.

Almac Diagnostics, which is part of the Craigavon, Northern Ireland-based drug development services firm the Almac Group, has offered its experience, particularly with array technology, to pharmaceutical partners before.

But the new program enables it to present its services as a single, comprehensive package specifically designed for biopharmas whose drug-development processes are in the early stages.

"The main target of this program is the emerging biopharma industry," said Austin Tanney, scientific liaison manager for Almac Diagnostics. "We are focused on the sector of the industry that is in the early stage of their development pipeline, [and] our aim is to work with these companies to help them develop and implement a biomarker strategy right from their early preclinical work."

Almac's Biomarkers for Biopharma services include pharmacodynamic services, markers for selecting study populations, assay development, and a bioinformatics and biostatistics consultancy.

As part of the new program, Almac will offer its own tools, including its recently launched Xcel discovery array and its Cancer DSA disease-specific arrays, Tanney said.

Almac in June launched the Xcel, which contains 92,000 transcripts and is optimized for use with formalin-fixed, paraffin-embedded tissue (BAN 6/8/2010). The array is intended for use in studies where cross-disease compatibility is important.

Meantime, its DSAs are designed specifically for breast, ovarian, colorectal, lung, and prostate cancers.

In addition to those chips, which are manufactured by Affymetrix, Almac offers "generic arrays and SNP arrays for discovery as well as platforms more suited to assay delivery," such as quantitative PCR and immunohistochemistry, Tanney said.

The company also has the "expertise to transition markers discovered on array platforms to more clinically suitable platforms for delivery," he added.

According to Tanney, the firm's pharmacodynamic service comprises applications that are "focused on better understanding [a] drug's effect on the body."

These include mechanism-of-action studies, discovering markers to help select optimal dosing, on- and off-target effect studies, understanding response and resistance mechanisms, and designing optimal combination therapies, he said.

The new program will also use Almac's tools for pre-discovery patient selection, phase I and phase II clinical trial enrichment, and companion diagnostic development.

Almac already has some experience with the latter, having in the past year inked companion diagnostic-development pacts with Merck, Lilly, and Pfizer (BAN 4/13/2010).

Finally, it will use its bioinformatics and biostatistics consultancy to help clients design studies to perform quality control and exploratory analyses, identify drug mechanisms of action and functions, and integrate data, Tanney said.

The total package is "really focused more on the early development stage and [is] tailored to work with those companies that may not already have a clear biomarker strategy," he noted. All of the services are "ideally suited to early development."

Within the Almac Group

Almac Diagnostics was founded as ArraGen in 2003 and rechristened ArraDx two years later before subsequently being acquired by the Almac Group. In addition to Diagnostics, the Almac Group maintains Clinical Services, Clinical Technologies, Pharma Services, and Sciences divisions.

The company markets these services to pharmaceutical companies as an integrated resource that can work with them from biomarker discovery through compound synthesis and drug production.

Within Almac, Tanney said Biomarkers for Biopharma clients can draw upon the firm's Rapidd drug-development services, which is a menu of services designed to support early-stage development from preclinical candidate modelling to Phase I regulatory submission.

It also includes API manufacturing, formulation development, analytical studies, and toxicology and regulatory support.

"As we move beyond Phase I we offer solutions for drug development from clinical trial supply and technology to commercial-scale manufacture," Tanney said.

Almac is also moving forward with its plans to bring a GeneChip-based test to market, the first of which is an assay for colorectal cancer recurrence. Almac has been in discussions with the US Food and Drug Administration for years concerning the regulatory path for the assay, which relies on a prognostic gene signature to predict relapse in colorectal cancer. The firm had previously said the test could be available for clinical use in the US by as early as 2008. It is expected to launch next year.

In addition to the colorectal cancer test, Almac is developing an assay for lung cancer that provides an early-stage prognostic signature for patients with early non-small-cell lung cancer. It is in the early stages of development.

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