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European Biopharmaceutical Review

Editors Letter

Fewer than 10 advanced therapy medicinal products (ATMPs) are currently licensed for use in Europe. The R&D pipeline of early stage ATMP candidates is strong at present, but the manifold challenges (including chemistry, manufacturing and controls, clinical trials, and complex regulatory pathways) to bringing these potentially transformational therapies to market are such that it will take considerable time before their full potential in healthcare is realised. In this autumn 2018 edition of EBR, The Christie Hospital’s Dr Fiona Thistlethwaite and Aptus Clinical’s Dr Ian Thomas introduce the Innovate UK-funded iMatch consortium of clinical and commercial researchers, who will aim to overcome some of the key barriers to successful progression of ATMPs and their scale-up for a range of chronic debilitating conditions (page 14). A major therapeutic focus of ATMP development is oncology, spearheaded by the recently approved Kymriah, for acute B-cell lymphoblastic lymphoma, and Yescarta, for non-Hodgkin lymphoma, from Novartis and Kite/ Gilead respectively. These classes of drug are one of the precision therapies included in N-of-One’s Dr Kathryn D Bungartz’s comprehensive summary of the current cancer therapy innovation landscape (page 56). So too are antibody-drug conjugates, the challenges in production of which and the potential means to circumvent are discussed by the Sanofi and Merck Group teams (page 80).

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