Genetic Engineering & Biotechnology News

AUG 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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8 | AUGUST 2018 | Genetic Engineering & Biotechnology News | Gail Dutton "Experience through zealous research" is part of the DNA of the 50-year-old Almac Group. That philosophy spurs the Almac Group to continuously build out its capabil- ities, including acquiring, in 2004, a young spinout that has become a global provider of diagnostics expertise for clinical trials. That company is now known as Almac Di- agnostics. Outsourcing Drives Growth As part of the large, well-established Almac Group, Almac Diagnostics is able to leverage the international trend toward outsourcing. The market for contract manu- facturing is increasing in Japan and Singa- pore—two regions Almac has marked for growth—as well as in its primary markets in the EU and the U.S. To accommodate continued growth, the Almac Group recently opened a 95,000-square-foot cold chain facility in Northern Ireland, established a new Eu- ropean campus in Dundalk, Ireland, ex- p a n d e d i t s U . S . operations, and in- creased headcount globally; all to bet- ter serve a grow- ing, international, client base. "The driving force behind this growth is simple: increased demand from our custom- ers," says Paul Harkin, Ph.D., president and managing director, Almac Di- agnostics. That means growth for Almac Diagnos- tics, too. The company, which provides di- agnostics support services for biomarker-led clinical trials, opened an additional labora- tory testing facility in Durham, NC in 2016 for its U.S.-based pharma and biotech cli- ents. The company's capabilities include biomarker discovery, assay development and validation, companion diagnostics de- velopment and commercialization, and clin- ical trial set up and clinical testing. Genesis: Extracting RNA from FFPE Samples Dr. Harkin spun out Almac Diagnostics— originally named ArraDx—from Queen's University Belfast in 2002 and incorporated the startup into the Almac Group in 2004. "In the early days, we were best known for gene expression profiling using partially degraded RNA extracted from formalin- fixed paraffin-embedded [FFPE] tissue and other challenging samples, to help acceler- ate biomarker discovery and validation for existing well annotated clinical trial datas- ets," Dr. Harkin says. "I was a professor at Queen's Univer- sity Belfast, recently back from a research fellowship at Harvard University and the Massachusetts General Hospital Cancer Centers. I had worked with Affymetrix™ arrays and gene expression platforms when they were new, and realized the full poten- tial of arrays were limited by access to suit- able tissue," he continues. Like any startup diagnostics company, establishing credibility was a challenge. "We'd chosen a difficult problem to solve, but believed that if we could generate re- producible gene-expression data from de- graded FFPE samples, other companies would adopt our technology," Dr. Harkin adds. His company spent the first few years refining the process and publishing some of its own biomarkers to demonstrate proof of concept. When the company presented reliable, preliminary data at ASCO in 2014, accu- rately selecting the Stage 2 colon cancer patients who were at high risk of relapse, he knew the company was onto something. Publishing more complete data in the Jour- nal of Clinical Oncology confirmed it. Dr. Harkin knew that for his company to realize its full potential, it needed the long- term stability that integration into a larger company could provide. At the time, per- sonalized medicine was a hot topic in the research community, he recalls. "Our board realized companion diagnostics [CDx] would be a part of that discussion. We saw a synergy with Almac, which focused on pro- viding clinical trial solutions around a clini- cal development pipeline." Now Offering: NGS, CDx, and More Rather than developing a proprietary platform, Dr. Harkin designed the com- pany to be platform-agnostic and works closely with the major genomic technology providers like Illumina, Thermo Fisher Scientific, Qiagen, and Roche, as well as NGS panel providers like Archer. "Choos- ing not to manufacture or distribute assays at this stage in our development eliminates a potential revenue flow, but it also offers certain advantages for clients," he says. Namely, it increase agility and enables the company to recommend the best technol- ogy for the job. A l t h o u g h A l m a c D i a g n o s t i c s w a s formed specifically to extract RNA from challenging samples, the management team understood that such a narrow niche lim- ited its potential growth. Gradually, its NGS services expanded to include RNA and DNA services from fresh tissue, blood, and other common sample types. The com- pany also provides biomarker discovery, RUO and IUO assay validation, CDx de- velopment, clinical testing, bioinformatics and software development, and regulatory guidance and support. Almac Diagnostics is continuing to de- velop its CDx strategy. "When clients con- sider a CDx strategy, they want a partner that can provide continuity and that will be around in a few years," Dr. Harkin points out. The former is allayed by Almac Diag- nostics' own low staff turnover. "We've had the same senior management team for more than a decade, thus bringing vast experience and industry connections." The Almac Group's 50-year history is a predictor of continued stability. It is operated by the McClay Foundation, a charity created in 2009 by the group's founder, Sir Allen Mc- Clay, and bequeathed to the Foundation to support its goal of funding partnerships to diagnose, treat, and cure disease. A Changing Clinical Trial Market "The development landscape is becoming increasingly aggressive," Dr. Harkin says. "Short turnaround times for every aspect of development is a competitive advantage. If a lab can't turn around assays within a few Demand from Customers Feeds Need for Expanding Capabilities Outsourcing Drives Growth at Almac Diagnostics On Your Radar A scientist at Almac Diagnostics uses a microtome to cut sections from a formalin- fixed paraffin- embedded tissue specimen. At Almac Diagnostics, a scientist manually dissects a sectioned and stained tissue section. Paul Harkin, Ph.D., president and managing director, Almac Diagnostics

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