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European Biopharmaceutical Review

Editors Letter

As 2013 closes and we ring in a new year, it is important to look back at some of the ‘best and worst’ news from our sector over the past twelve months. Controversy for pharma in China, the biotech initial public offering market ‘re-opening for business’, the 30th anniversary of the introduction of orphan drugs, more logistical reorganisation, and restructuring of some of our biggest pharma players in Europe have all taken place.

Another topic raised was the first approval under the Food and Drug Administration’s breakthrough programme, for an antibody therapy for acute lymphoblastic leukaemia. Pauline Carnell and Sarah Newell at NanoSight discuss a drug product concern that is highly relevant to this antibody and other biologicals: protein aggregation and how vital it is to be able to monitor and characterise it in formulated biological therapeutics (page 68).

Biologicals also comprise other drug classes beyond antibodies, and Vanessa Duncan, Douglas Fraser-Pitt and Derry Mercer from NovaBiotics provide an update on peptide therapeutics (page 56). Specifically, they look at their potential as nextgeneration anti-infective therapies for a broad range of bacterial, fungal, viral and other infectious diseases and conditions.

In 2013, EBR has featured a number of articles on biopharmaceutical therapeutics development for rare and orphan diseases, as well as the trend towards more R&D and commercialisation efforts Editor’s letter for these niche markets and indications. In this issue, regular contributor Emile Bellott challenges this viewpoint and, interestingly, argues that the nemesis of the orphan drug – the blockbuster – is still very much valid in an industry leaning more toward niche products and indications (page 82).

Monitoring the spectrum of variables to which cell-derived biopharmaceutical products are subject during bioprocessing is a key component of the more onerous control systems and regulations now demanded from this sector. Markus Luchner, Timo Schmidberger and Gerald Striedner from ACIB describe how facilitating real-time monitoring of bioprocessing may provide solutions to meeting these more stringent requirements (page 52).

Our industry is, and will always be, driven by the need to deliver new, safer and more efficacious drugs. The first step to doing so is target selection, and the means to accelerate and/or streamline hit rates on novel targets are discussed by Jim Freeth from Retrogenix (page 72) and Pooja Jain at PharmaPendium (page 76).

Freeth focuses on phenotypic screening as a ‘hypothesis-free’ toolset to increase target selection. Phenotypic screening, as the name suggests, is a cell-based, top-down efficacy/disease activity first, mode of action/safety/toxicology second approach to mining for new compounds with biological activity. It remains a component of the screening systems for many biotechnology and pharma companies.

Conversely, Jain discusses a ‘dry’ approach to increasing hit rates for novel therapeutic compounds through data-mining, and highlights the necessity of better and more flexible informatics solutions that encompass preclinical, clinical, post-marketing, safety and other data for the continued success of this tool in early-stage drug discovery.

After another eventful and, on balance, positive year for the biopharmaceutical industry, here’s to the next one, and to the health and success of all our readers in the year ahead. We look forward to tracking the key developments and sector trends with you in 2014.

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