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Addressing Pharma Demand, Almac Dx Opens Doors of New UK Bioinformatics Facility

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By Vivien Marx

Almac Diagnostics, a Craigavon, UK-based developer of diagnostics for personalized medicine, has opened a new facility dedicated to bioinformatics in Manchester, UK.

The new facility adds to bioinformatics capabilities that the company already has in Craigavon and Durham, NC, Paul Harkin, Almac Diagnostics' president and managing director, told BioInform via e-mail.

The firm plans to grow the bioinformatics team beyond its current level of 20 staffers, but did not disclose further details on its hiring plans.

"Due to the continued demand from pharma and biotech, we will need to expand further in the next year," Harkin said. "This may further increase in the future," he said, but did not elaborate.

The company has announced several recent agreements with pharmaceutical firms. In September, it announced a collaboration with Eli Lilly to develop a companion diagnostic for the non-squamous non-small cell lung cancer combination therapy of Alimta (pemetrexed) and cisplatin.

In May, the company said that it was collaborating with Pfizer and the Pan-European Trials in Alimentary Tract, or PETACC3, consortium in a project using its colorectal cancer array to identify molecular subtypes, biomarkers, and drug targets.

The company markets four other arrays under its Disease-Specific Array product line: for prostate, lung, ovarian, and breast cancer. As a result, Harkin said that the company's "core specialty" is mainly in microarray analysis — with gene expression data, SNP data, and microRNA data being particular specialties — though it also has experience with other types of experimental data associated with clinical and biological characteristics of patient samples.

The extension of the bioinformatics group relates to the firm's "commitment to the delivery of personalized medicine" in order to increase its expertise in companion-diagnostic development, pharmacodynamic biomarkers, disease classification, and prognostic markers, he said.

Harkin said the company has "a number" of staff members who develop and improve data analysis algorithms and methods. There are also "a number of people with very strong data analysis skills — in particular within multi-dimensional data analysis and integration; not limited to microarray data."

In addition to these areas, the bioinformatics staff has expertise in the design and analysis of complex clinical studies for the development of biomarkers and companion diagnostics, Harin said.

Although the firm does not own a sequencer, Harkin said, "we have extensive experience in sequence analysis, which we developed and utilized in order to characterize [the] transcriptome of various cancers," while developing its line of Disease-Specific Arrays.

Growth Strides

Harkin explained that the bioinformatics tasks lying ahead are in the areas of gene selection and disease characterization, to identify and validate molecular subgroups in patient samples, and to develop prognostic and predictive classifiers.

Bioinformatics impacts "critically" on all stages of discovery and development of companion diagnostics, Harkin said. For example, it plays a role in study design, ensuring that high-quality data is generated; for test validation , both prospectively and retrospectively; and for regulatory submissions.

Almac utilizes a range of off-the-shelf and proprietary statistical and functional data analysis tools, he said.

In a statement, the firm noted that bioinformatics is "well recognized as a major bottleneck in genomics" and that it hopes to address this issue by adding to its bioinformatics group.

The Almac Group, Almac Diagnostics' parent firm, said in a statement that the new bioinformatics facility is in line with "significant growth" that it has seen over the last year, in which it increased its employee ranks by 15 percent in the UK and 10 percent in the US.

The Almac Group, which employs 2,500 people worldwide, is made up of five divisions that offer a range of drug development- related services such as contract research, translational genomic services, formulation and manufacturing, and clinical trial supply and technology.

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