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European Biopharmaceutical Review

Editor’s Letter

This time last year, very few of us could have predicted that 2016 would unfold the way it did. The repercussions of Brexit and the US election result will have, as yet unknown, implications for the biopharmaceutical sector. In our first EBR of 2017, Kelly Waters at InstantGMP Inc. flags the likely challenges and potential opportunities that Brexit poses for British R&D (see full pdf). Despite the uncertainty, our sector will continue to prosper across Europe, according to Merck Life Sciences’ Daniel Stamm (see full pdf). One particular aspect of this growth with consequent shifts to capacity increases is bioprocessing writes Thermo Fisher Scientific’s Ileana Place (see full pdf). Companies will utilise a range of different internal build and partnering strategies to manage and mitigate risks during their growth. The role that collaborations will play during expansion is echoed by Alwyn Jones at Siemens, who points out that cooperation is required for automation and digitalisation when faced with a limited supply of appropriately skilled personnel – if the pharma sector is to retain its positioning at the forefront of British manufacturing (see full pdf).

One size rarely fits all and, in some cases, EU-wide legislation and regulation may not work for biotherapeutics developed across all member states, argue Dr Christian van den Bos and Somaiah MN at Mares Ltd with Dr Beate Walter at CONVIDIA clinical research GmbH (see full pdf). In the eight years since advanced therapy medicinal products (ATMPs) have been regulated in Europe though the centralised EU route, only a handful have been approved, despite the massive unmet need in the complex and often rare, ultra-rare and genetic diseases that they are developed for. Certain ATMPs can be exempted from the centralised pathway and, as a means to market, regulatory traffic may shift more significantly in this direction and to country-specific legislation.

It is a given that genomics will play an increasingly central role in stratification for clinical trials and eventual prescribing of ATMPs and other personalised medicines, say Medidata’s Jason Mezey and Geoff Low in one of this quarter’s Q&As (see full pdf). Patient registries are also becoming more of an essential tool and data source for the development of advanced and other therapies for rare diseases. Dr Paola Antonini, Lorna Graham and Dr Michael Murphy at Worldwide Clinical Trials illustrate how registries may in fact transform the clinical study landscape as a means to mitigate study failure (see full pdf).


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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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