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European Biopharmaceutical Review

Editors Letter

Since our last edition of EBR went to print, there have been significant innovations in new medicines, including those for heart disease, with the anti-inflammatory canakinumab (anti-interleukin-1 beta/ ACZ885) described in the media as the ‘biggest breakthrough in cardiovascular medicine since statins...’ (1). Additionally, the milestone approval of Kymrhia (tisagenlecleucel) in the US, the first chimerical antigen receptor (CAR) T-cell therapy for blood cancers, heralds “a new frontier” of medicine, according to Scott Gottlieb at the FDA (2). These are exciting new next-generation biopharmaceuticals, biological and advanced therapy medicinal products (ATMPs), the latter being the ultimate in personalised medicine, generated from the patient’s own lymphocytes.

A key component of the successful and, arguably, much more established drug development pathways for small molecules that require first pass liver metabolism is an understanding of their metabolism and kinetic properties, from both a safety and efficacy perspective. Dr Richard Weaver FRSC of XenoGesis Ltd highlights the importance of early expertise in drug metabolism and pharmacokinetics and absorption distribution metabolism elimination properties for development pathways. Meanwhile, Optibrium Ltd’s Matthew Segall looks at the role of mathematical and computational modelling of cytochrome P450 interactions.

For any therapy employing human tissue systems at the preclinical phase of development – such as the 3D organoid introduced by QGel’s Dr Colin Sanctuary or the tailored, precision medicine tissue systems the Glasgow-based Aridhia, ReproCELL Europe and Stratified Medicine Scotland team are continuing to pioneer – can better predict drug response outcomes in terms of safety and efficacy.

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Dr Deborah O’Neil, Chief Executive and Scientific Officer, NovaBiotics Ltd
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Dr Deborah O’Neil
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