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European Biopharmaceutical Review

Editor’s Letter

In the wake of allergy peptide company Circassia recently pulling off the most successful UK life sciences initial public offering (IPO) in two decades – and with 2013 being a ‘bonanza’ year for IPOs in our sector – this edition of EBR sees Sophie C McGrath of Brown Rudnick sharing her thoughts on the current fl oat boom. She discusses why, rather than being another ‘bubble’, this appears to be a continuing trend, and takes us through the pros and cons of a float for life sciences firms.

Biologics are also a key topic in this edition, with the clinical potential of cell therapies slowly maturing, as highlighted by R Lee Buckler at Cell Therapy Group, and Rolf Ehrhardt and Maria Thompson at BioCision. This article examines how improvements in process standardisation and reproducibility should be a focus for refinements in cell therapy across the industry.

Elsewhere, Regina Au from BioMarketing Insight looks at the combination of stem cell technologies and 3D printing as a means to regenerate entire tissues and organ structures. “The sky is the limit”, she says, suggesting that fully formed limb organ regeneration from combinations of stem cells, other matric components, inorganic materials and 3D printing might one day be possible.

Combined with advances in cell culture, protein production via bioprocessing can be a more efficient and flexible means to generate protein therapeutics. A great example of the application of these improved systems is broached by K John Morrow, Jr, at Newport Biotech and Ma Sha at Eppendorf, Inc, who highlight the displacement of older vaccine production techniques for viral diseases by improved mammalian cell culture systems.

Early-access programmes, such as the one just announced by the UK government, are highly significant for our industry – and a major step forward for patients who may not otherwise benefit from therapeutic candidates currently in development, should they have to wait until these medicines are approved. The issue of who pays for drugs provided to patients under these schemes needs to be re-examined before we see it truly ‘deliver’, but these are positive developments. Eyal Talor from CEL-SCI Corporation focuses on a patient group and an area of clinical investigation that would undoubtedly benefit from these programmes – current immunotherapeutic strategies being trialled to combat HPV infections and associated malignant disease, to which HIV patients remain increasingly at risk.

Perhaps some of the first candidates for adaptive licensing that the EMA recently announced it is ‘seeking’, post-introduction of this programme, will include antibody drug conjugates (ADCs). A new generation of safer and more potent tumour-targeting ADCs is emerging from improved preclinical drug profiling and efficacy/safety assessment, according to Neil Butt at PolyTherics.

Also relevant to this chemotherapeutic class of compound and enhanced preclinical assessment in drug development is the article by Dick Leopold and Patrick McConville of Molecular Imaging, Inc, which covers tumour modelling and how failure rates of oncology therapies in the clinic – due to non-predicted efficacy and toxicity – could be lowered with the application of a combination of more clinically predictive and relevant tumour models and enhanced imaging techniques. Another exciting development in imaging – neutron crystallography as a means to better visualise drug-target binding – is highlighted by Matthew Blakeley at the Institut Laue-Langevin.

Completing this edition is an overview of plans in Russia to develop more innovative drugs domestically, create more biotech start-ups and attract more inward investment. Maria Bomer at Bomer Pharma Consultancy warns that genuine commitment at the highest level within government is required for success here, and will help avoid potential roadblocks.

Let us hope for news of positive developments on this in time, as part of a stable and outward-looking future – both for the biopharmaceutical community in that part of the world, and that entire region generally.

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