Northern Ireland’s Almac Diagnostic Services, a member of the Almac Group, has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products.
Craigavon-based Almac, the global contract pharmaceutical development and manufacturing organisation, will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.
Under the terms of the new agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis and respiratory disease.
Almac will also seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics.
To date, a number of programmes have already been initiated under this unique model.
Hoping to further ‘develop and commercialise these companion diagnostic tests’, Professor Paul Harkin, president and managing director, Almac Diagnostic Services, explained: “We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship.
“We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies.”
Looking to the future and ‘dramatically improve patients’ lives globally’, Maria Orr, head of precision medicine, BioPharmaceuticals R&D, AstraZeneca, continued: “Precision medicine is at the heart of AstraZeneca’s ambition to dramatically improve patients’ lives globally.
“It is an interconnected cycle from early research, innovative pharmacology and drug modalities, to clinical trial design and diagnostic development.
“Through collaborating with our partners we can lead the way in a new era of precision medicines for complex chronic diseases.
“We are committed to matching life-changing medicines to patients most likely to benefit and we believe our collaboration with Almac will help us achieve this.”
Almac has grown organically over the past five decades now employing over 6,500 highly skilled personnel across 18 facilities including Europe, the US and Asia.
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