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European Biopharmaceutical Review

Dynamising Biomarker R&D with Smarter Biospecimens

The emergence of the SARS-CoV-2 virus placed pharmacology firmly in the public gaze around the world. Coined the “biggest global crisis since WWII”, the 2020 pandemic threatened both physical and economic wellbeing internationally. While news outlets focused on the race for an effective vaccine, drug therapies would also be required to reduce COVID-19-associated morbidity and mortality. However, in early 2020 almost nothing was known about the disease. Then in 2021, Lui et al. published one of the first studies on SARS-CoV-2, revealing which organs could be infected by the virus (1). Making extensive use of human biospecimens, Lui et al. added vital insights into the disease biology of COVID-19 and potential treatments.

Recent advancements in ‘omics’, bioinformatics, and systems biology have highlighted that an early and detailed understanding of disease biology is essential to the discovery of new biomarkers and therapeutics. Akin to the COVID-19 example, fully understanding the molecular target of a drug molecule in situ is key. What tissues is it expressed in? How does the linked biology drive disease? And in what percentage of patients is that drive a significant disease modulating factor? Having a high level of confidence in the answers to these questions helps lay the foundations upon which a successful drug programme can be built (2).

The same level of understanding is also needed when evaluating diagnostic biomarkers or translational biomarkers of drug efficacy. It has long been known that individuals can metabolise drugs differently, but the extent of inter-individual variation in drug efficacy has become a key focus for precision medicine. Due to the stubbornly high number of drug candidates still failing during clinical trials, the demand for translational data has never been greater (see Figure 1 and Figure 2). Researchers want to study biospecimens and model systems that are more representative of human anatomy, genetics, and physiology in both healthy and diseased tissues – and there is no model more translational than human biospecimens.

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Zara Puckrin is Marketing Manager and resident writer for REPROCELL. After joining the contract research organisation in 2017, she has been helping scientists understand the benefits of human data. A molecular biologist by training, Zara’s mission is to make the world a better place through translational science and pharmacology.

David Bunton founded the human tissue assay service company (Biopta Ltd.) in 2002 and is now CEO of REPROCELL Europe. The company remains focused on the use of human fresh tissues, 3D models and the use of iPSCs to better characterise drug efficacy and inter-patient variability in drug responses.

Graeme Macluskie is Director of Precision Medicine at REPROCELL, with more than 15 years’ research experience in the pharma and biotech industry. Since 2011, he has been designing and delivering preclinical projects globally, and developing tissue-based assays for inflammatory diseases such as psoriasis, COPD and IBD.

Rachna Goyal manages the preclinical genomics services offered at REPROCELL. She is passionate about developing groundbreaking diagnostic technologies for earlier screening of diseases. With over 10 years’ experience in industry, Rachna enjoys helping scientists power their translational research and precision medicine.
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Zara Puckrin
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David Bunton
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Graeme Macluskie
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Rachna Goyal
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