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laboratory informatics Te industry needs to implement more

predictive informatics capabilities that can marry the wealth of knowledge emerging from patient and genomic studies with in- house intellectual property on disease targets, compound families or biological molecules. ‘It needs to be a seamless process. Not so much looking at and evaluating the research data and then moving on to look at your compound data, but using that pre-discovery information as part of your discovery workflow, to improve your predictive power.’

Understand your disease Te approach works: understanding the genomic drivers of many cancers has enabled the development of targeted therapies, biomarkers and companion diagnostics that today translate to patients receiving the optimum drug, or combination of drugs, for their tumour type, Laoui points out. Understand your disease at its most basic level, and the prospect of personalised medicine for additional disease types can become a reality. It’s actually a very tall order, because most diseases are underpinned by multiple genes and biological pathways. For many complicated diseases the goal of personalised medicine has

still to be realised, at least in part because we don’t yet have the informatics capabilities that can really unpick the multifactorial basis of these diseases to identify the critical drivers, and their targets.’ Tis is where modelling and simulation tools

will be essential, he says. ‘Pathway analytics, sequencing analytics – and, for some diseases, digital tissue visualisation – will be key. FDA


already recognises that digital biomarkers, rather than molecular ones, can serve as an endpoint for clinical studies, and this is just another tier of data that can be added into the collection of information from disparate sources that all needs to be integrated, mined and turned into decision-relevant data to help pharma prioritise its development pipelines, and minimise risk of failure.’

Cheek by jowl with doctors and patients Te drive towards personalised medicine has inevitably led to the requirement for data management, analysis and transfer capabilities. Pharmaceutical companies delivering companion diagnostics and clinical diagnostics laboratories are directly servicing doctors and their patients, says Trish Meek, director of product strategy at Termo Fisher Scientific. ‘Pharma is leveraging biomarkers that

provided evidence of drug safety and efficacy through the clinical development and approval process, as clinical diagnostic tools for diagnosis, patient stratification and for therapeutic monitoring. Tat brings up a whole different challenge in terms of data and information flow, because the pharma company now needs an interface with the doctors who are administering the drug, and the clinical diagnostic laboratories that will be carrying out the tests.’ Many of Termo Fisher’s molecular

diagnostic customers perform omics testing for cancer therapy. ‘Te typical scenario is one in which a doctor will send a patient sample off for testing to the diagnostic lab,

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