June 15, 2008 (Vol. 28, No. 12)

Five Divisions Offer Customers Many Options for Their Outsourcing Requirements

When it comes to outsourcing drug discovery and development, one could make the case that there are advantages to buying in all the services you need from one contractor. Almac (www.almacgroup.com) offers a wide range of integrated development services that include translational genomics and diagnostic developments, GMP manufacture, and clinical trial services.

The company started out in 1968 as Galen, which was founded by Sir Allen McClay, currently chairman of Almac. It went public in 1997, and Sir McClay subsequently bought back its service divisions and established the Almac Group.

Almac, which currently has ongoing projects with more than 600 customers worldwide, is headquartered in Craigavon, Northern Ireland, with facilities in Scotland and the U.S. The company will open a 240,000 sq.ft. facility in Pennsylvania in late 2009. This facility will operate as Almac’s North American headquarters and will initially accommodate the clinical services and clinical technology divisions.

Diagnostic Division

Almac Group is composed of five divisions: diagnostics, sciences, clinical services, clinical technologies, and pharma services. Almac Diagnostics has developed a research tool called the Cancer DSA™ (disease-specific array). The company says that this is the first high-density microarray based upon the transcriptome of an individual disease. “This is a unique microarray that works with both frozen and paraffin-embedded tissue samples,” explains Michael Sloan, vp of sales and marketing of the diagnostics division, adding that this technology allows access to the vast amount of clinical information locked away in FFPE tumor samples.

Almac envisages Cancer DSA as a powerful tool to enhance the understanding of the biology of cancer, with applications in basic research, diagnostics, prognostics, biomarker development, patient stratification, drug targets, and drug rescue. It is currently using Cancer DSA to develop a prognostic test for patients at risk of recurrence following surgery for colorectal cancer.

While it is known that surgery will provide a cure for 80% of such patients, there is currently no way of identifying the 20% who will experience recurrence within five years and could, therefore, benefit from adjuvant chemotherapy. The Almac test is based upon a 91 transcript signature and has been granted the 510K route by the FDA. “This is important as it will shorten the scale to application time,” says Sloan. “We are now in validation studies with hundreds of samples to finalize the signature.”

The stage II colorectal test could be on the market by 2009; a similar test for colorectal polyps and breast cancer is in development. In addition, the firm just signed an extended agreement with Affymetrix (www.affymetrix.com) to develop and commercialize diagnostics for all cancers.

API Development

Almac Sciences supports the development and supply of APIs, particularly potents, peptides, cytotoxics, and chirals, from discovery to launch. “We enable our customers to make their own connections, so if you are on a journey with Almac, you can take the route of your choice. We meet the needs of our customers across many projects or across one project,” explains Rosaleen McGuckin, Ph.D., vp of business development, Almac Sciences.

The division works with big pharmas, biotechs, and virtual companies, with roughly equal numbers of customers across these sectors. Dr. McGuckin illustrates the Almac approach with reference to one project that had six connections: synthesis of a chiral epoxide starting material, six-step synthesis to cGMP API, analytical methods, synthesis of radio-labeled analogue, scaling up (with a manufacturing partner), and drug product manufacture.

Clinical Services and Technologies

Meanwhile, Almac Clinical Services, which was established 20 years ago, is focused exclusively on clinical trial supplies and has now completed over 6,000 clinical protocols. “Innovation is one of our key drivers,” says Robert Dunlop, Ph.D., president and managing director, Almac Clinical Services.

This division has averaged over 20% growth each year for the last 10 years, working with all organization types. Besides the Craigavon facility, Almac Clinical Services also has a presence in the U.S. Services offered include: blinding, packaging, labeling, label generation, QP release, global distribution, depot network, analytical services, and project management. The company has pioneered a number of systems to meet client demand, including a web-based randomization and patient-management system, an automated vision label-verification system and inhaler blinding processing technology, according to Dr. Dunlop.

A suite of web services was launched in April that allows clients to approve their clinical labels online with an electronic signature. Another project involves the implementation of a global IT system that will allow for global management of all clinical trial activity.

Almac Clinical Technologies offers a number of technology and service solutions to increase the quality and efficiency of the clinical trial process, says Joe Cunningham, business development director. The core products are: interactive voice response systems (IVRS), IXRS™ (web- and phone-enabled IVRS), iDiary (ePRO—electronic patient reported outcomes), and iTrial EDC™ (electronic data capture). For sponsors with challenging timelines, less complex studies, and tighter budgets, Almac Clinical Technologies offers its Express line of services that include IVRS/IXRS Express and EDC Express.

IXRS is a cost-efficient technology for managing complex, global clinical trials covering study, patient, and drug management, adds Cunningham. The iDiary/ePRO solution is a cost-effective way to collect critical study data that helps clients retain their patients by making it easier to report health outcomes during clinical trials. The product fits well with recent FDA guidelines on electronic patient diaries. “Our system eliminates so-called parking-lot syndrome, where patients are forced to catch up on their entries at the last minute,” says Cunningham.

iTrial EDC is an integrated web-based data-capture system that allows clients to improve data quality, study timelines, and speed to market, Cunningham notes. “It gives us an advantage when integrated with our other tools, he adds. “For instance, there is no need for dual data entry.” Express is a tool involving prebuilt and tested solutions, it is of use to companies wanting to carry out less complex clinical trials. On Almac Clinical Technologies’ horizon is an expansion of the Express Suite and its integration with IXR, EDC, and ePRO.

Pharma Services

Finally, Almac Pharma Services offers product development, commercial manufacturing and packing, and commercial support for solid oral-dose drugs. Product development involves formulation, manufacture from Phase I to Phase III, and analytical support. Commercial manufacture and packing covers tablets, capsules, and powders packed into blisters, bottles, wallets, and sachets. “There is a very broad range of technologies in this facility,” explains Jim McGibbon, director of business development, Almac Pharma Services.

Commercial support covers EU import testing and QP release, storage services, secondary labeling and packing, distribution, and product launch support.

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