August 1, 2018 (Vol. 38, No. 14)
Demand from Customers Feeds Need for Expanding Capabilities
“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 capabilities, 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 Diagnostics.
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 manufacturing is increasing in Japan and Singapore—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 European campus in Dundalk, Ireland, expanded its U.S. operations, and increased headcount globally; all to better serve a growing, international, client base.
“The driving force behind this growth is simple: increased demand from our customers,” says Paul
Harkin, Ph.D., president and managing director, Almac Diagnostics.
That means growth for Almac Diagnostics, too. The company, which provides diagnostics support services for biomarker-led clinical trials, opened an additional laboratory testing facility in Durham, NC in 2016 for its U.S.-based pharma and biotech clients. The company’s capabilities include biomarker discovery, assay development and validation, companion diagnostics development and commercialization, and clinical 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 accelerate biomarker discovery and validation for existing well annotated clinical trial datasets,” Dr. Harkin says.
“I was a professor at Queen’s University 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 potential of arrays were limited by access to suitable 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 reproducible gene-expression data from degraded 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, accurately 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 Journal 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, personalized 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 providing clinical trial solutions around a clinical development pipeline.”
Now Offering: NGS, CDx, and More
Rather than developing a proprietary platform, Dr. Harkin designed the company 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. “Choosing 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 increases agility and enables the company to recommend the best technology for the job.
Although Almac Diagnostics was formed specifically to extract RNA from challenging samples, the management team understood that such a narrow niche limited its potential growth. Gradually, its NGS services expanded to include RNA and DNA services from fresh tissue, blood, and other common sample types. The company also provides biomarker discovery, RUO and IUO assay validation, CDx development, clinical testing, bioinformatics and software development, and regulatory guidance and support.
Almac Diagnostics is continuing to develop its CDx strategy. “When clients consider 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 Diagnostics’ 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 McClay, 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 days, physicians steer their patients to competing trials.” Almac’s labs run seven days a week, 365 days a year to provide fast turnaround times.
“There’s also a rapid move to liquid biopsies for more complex clinical trial designs,” says Dr. Harkin. “We’re seeing umbrella studies that incorporate multiple biomarkers and drugs in the same trial.” With small quantities of rare samples, researchers are pressed to use as little as possible; preserving as much as they can for future use.
Therefore, Almac Diagnostics recently launched novel DNA and RNA panel solutions for multi-arm clinical trials. Based on Illumina’s NGS technology, they let clients evaluate multiple biomarkers from one sample, thereby saving tissue, time, and costs.
Overall, Dr. Harkin says, “We’re seeing pharma clients adopt much more aggressive Phase IB to registrational Phase II or Phase III trials.” That poses a particular challenge for both pharmas and their CDx developers. It’s sometimes difficult for the diagnostics pipeline to mirror an aggressive drug development pipeline, especially when the drug developers come to a CDx developer just before entering Phase IB/II. Oftentimes, the biomarker has not even been locked into its final format.
To respond to this challenge, Almac Diagnostics developed a single site premarket approval (PMA) strategy. “We validate the PMA process based upon data from a single lab rather than from multiple sites,” says Dr. Harkin. That lets the product go into limited production faster than waiting for studies from multiple sites, but limits products to material from that one lab. Later, as more material is validated, production can be migrated from that single lab to a kitted format. This option is particularly useful when there is a risk the kitted version won’t be available on time.
Looking to the Future
“We want to continue to grow organically and to broaden our technology platforms and assay offerings. I’m not planning a divergence in our strategy,” Dr. Harkin says. Almac Diagnostics’ growth plan includes diversifying into Parkinson’s and Alzheimer’s diseases, and blood-based biomarkers. To that end, Almac Diagnostics recently partnered with Archer to identify recirculating DNA in the bloodstream.
In the coming years, the Almac Group plans to expand its presence in Japan and other Asian countries, bringing its philosophy, experience, and zealous research to those growing markets.