This month we are excited to be featuring one of Northern Irelands biggest indigenous life science companies. Almac Diagnostic Services is a precision medicine company specialising in biomarker driven clinical trials.
The company was as a spin out from Queen’s University Belfast in 2002 called ArraDx. At this time precision medicine was in its early stages of adoption but it was becoming clear that with innovations in science and technology that utilising a precision medicine approach to drug development would radically improve treatment of patients across all diseases.
Sir Allen McClay, late founder and chairman of Almac Group, saw the potential of precision medicine and the impact it would have for drug development & patients and in 2004 ArraDx was incorporated into the Almac Group and rebranded as Almac Diagnostic Services.
Almac Diagnostic Services, with the support of the already globally established Almac Group of businesses, has continued to grow and evolve as a precision medicine company and is now a global leader and preferred partner to many of the world’s largest pharma and biotech companies.
The leadership team has remained largely the same, which is reflected in the knowledge, experience & stability of the company.
The company offers a broad range of services to the global biopharma industry supporting the discovery of novel biomarkers, the development of biomarkers into clinical trial assays for use in novel drug clinical trials, and companion diagnostic (CDx) development where tests are commercialised alongside approved drugs to select patients for treatment.
Michael Sloan, Global VP of Commercial Operations, talks about his role at the company’s Craigavon headquarters:
“I Iead the commercial teams, including business development, marketing, product management, project management and commercial operations and am responsible for the commercial strategy for Almac Diagnostic services and ensuring our business continues to grow in line with market demands. I am also responsible for growing the customer base and ensuring our existing customers satisfaction.
“I have been at Almac for 20 years, in which time I have seen our business grow from start up into maturity, the transformation in the precision medicine market and most importantly the impact of the work we do has had on healthcare, which is extremely satisfying.”
Almac Diagnostics Services has laboratories in Craigavon, Northern Ireland, Durham NC, USA and have strategic partnerships with labs in China.
“The business was founded in Northern Ireland, where I and the most of our leadership team are based.
I believe Northern Ireland is an excellent place for our business to have its base and roots. This is very much down to the people and the culture,” said Michael.
“We have two great universities in Queens University and Ulster University, providing extremely talented science graduates. A growing life science sector, supported by Invest NI and organisations such as Catalyst, MATRIX and HIRANI.
“Importantly, our people and working culture are second to none. We compete with global companies and in terms of the work ethic, responsiveness, transparency, expertise and determination to succeed, no global business competes with our teams. This culture is the reason most of our customers stay with us and is achieved whilst staying grounded and down to earth and still being able to have a laugh along the way.”
Almac Diagnostic Services offer a full range of services to support the end-to-end process from biomarker discovery, through to development of investigational assays for use in clinical trials to companion diagnostic development and commercialisation.
They fall broadly into three service lines:
Biomarker Discovery
“Almac has a range of genomic and proteomic technologies that we use to test large sample cohorts that generates data for research purposes to support biomarker discovery.
“Alongside this, we have an experienced bioinformatics team that can mine the data to support the discovery efforts.”
Technologies include hi-throughput DNA and RNA Next Generation Sequencing, Nanostring, qPCR and ddPCR, IHC, single cell sequencing and other proteomic solutions across multiple platform providers
Clinical Biomarker & CDx Development
Almac support the development of discovered biomarkers into clinical assays.
Almac has extensive biomarker product development expertise supporting the development of both molecular and proteomic assays for patient selection within clinical trials.
“We categorise our assay development service into three general areas:
- Research use only (RUO) assays for retrospective analysis
- Investigational use only (IUO) assays for prospective patient selection within clinical trials
- Companion diagnostics (CDx) for commercialisation with the approved drug
Almac has an experienced regulatory team with expertise to support regulatory filings across all global jurisdictions.”
Clinical Testing
Following the development of the clinical trial assay, Almac will then run the assay to support patient recruitment on to pharma partners global clinical trials.
Almac has CLIA/CAP accredited laboratories in both Northern Ireland and the US and CLIA/CAP accredited partner labs for patient testing within China.
“We have extensive experience in setting up global clinical trials and offer a range of integrated services that can reduce risk and costs and improve efficiency, by utilising our Specimen Collection Kit Design, Manufacturing & Logistics services.
We offer clinical testing across all our technology platforms on multiple sample types.”
Originally founded at Queen’s University Belfast and initially called ArraDx, founders Professor Patrick Johnson and Professor Paul Harkin were both leading research scientists in biomarker discovery in oncology. Professor Harkin continues to lead the organisation, now named Almac Diagnostic Services.
The company has always had a strong innovative culture. In its early years, Almac Diagnostic Services developed a number of oncology-based biomarker assays, which were licenced to global partners.
“Today we have optimised all our lab processes to enable us to work with even the most challenging sample types.
“We ensure we always have the most recent technology adopted and optimised to stay in line with markets changes.
“We have developed our own proprietary software for oncology biomarker discovery, called claraT.
“Innovation is at the heart of our business and is another reason our customers come to us. Nearly every assay we develop requires the Almac team to develop a bespoke solution to identify the required biomarker. We are innovating on every project, and we promote that culture both internally and externally.”
Almac Diagnostics Services continues to expand.
“We recently opened an additional 40,000 sq. ft laboratory and manufacturing facility in Craigavon and have plans to expand our Durham facility in the next year.
“We continue to invest in our IHC, pathology and digital pathology services, to support pharma clients with their antibody drug conjugate (ADC) clinical development programs.
“We have several ongoing companion diagnostic (CDx) programs with Pharma Partners.
“We continue to bring on new technologies, most recently becoming an Olink certified service provider (CSP) for proteomic services. We continually horizon scan and review future technology developments with a view to adoption if there is a strategic fit for the business,” said Michael.
You read more at:
PNPLA3 Genotyping Kit For Liver Disease Research – Launch
Almac Future Medicines Institute Partnership Announcement
https://www.almacgroup.com/news/almac-announces-key-partnership-with-future-medicines-institute/
Almac Diagnostic Services Lab and Manufacturing Capabilities Expansion
Almac Diagnostic Services NGS Capabilities Expansion
https://www.almacgroup.com/news/almac-expands-next-generation-sequencing-capabilities/
Almac claraT Report enhanced with new content for Cancer Researchers
To find out more about Almac Diagnostic Services visit: www.almacgroup.com/diagnostics
