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European Biopharmaceutical Review

Editor’s Letter

The reported impact from the delay of the meningitis B vaccine into clinical practice – post the Novartis-GlaxoSmithKline (GSK) asset swap earlier this year – was a stark reminder of the need for strategies to combat infectious diseases, regardless of whether the affected area is deemed to be ‘developed’ or ‘developing’. Even in 2015, challenges to public health from life-threatening, preventable infections are not limited to niche regions – like West Africa – and less common pathogens – such as Ebola.

Vaccination programmes do, and will continue to, play a vital role in combating infectious diseases, for which there are unlikely to be wholly efficacious therapeutics. Against the almost impossible task of winning the war against malaria through treatment-based approaches – and partly thanks to Plasmodium’s ability to develop resistance – John Haselden of GSK discusses progress in vaccine development and the obstacles associated with drug discovery programmes specific to diseases in the developing world – including those within Africa. The flip side is that this space – both in terms of geographical area and therapeutic scope – is very much empty, providing numerous opportunities for the industry in terms of the manufacture and introduction of new medicines that address local health issues. This timely topic is covered by EBR’s own Emma Naks.

Our industry’s aim is – and always has been – to produce more targeted therapies: drugs that will deliver better efficacy where needed within the body, and with fewer negative, off-target effects. Recent advances in precision medicine will be essential to achieve this, and a collection of articles in our current edition highlight very clearly the move away from more ‘shotgun therapy’ tactics towards personalised medicine. It is a complex area, and PPD’s Kenneth Butz and Holly Hilton provide an overview of the required co-development and application of a therapeutic, biomarker and companion in vitro diagnostic.

In two separate articles, Regina Au at BioMarketing Insight and Jenny Worthington of Axis BioServices look at stem cells in oncology in very different contexts: as a novel, targeted cancer treatment approach, and in instances where the stem cell is the cancer cell. The latter describes these cells as crucial targets often missed by conventional oncology approaches, but which new classes of therapy must address for improved clinical outcomes.

A wealth of undiscovered medicinal treasures, ripe for repurposing for new indications, remains untapped. This route to new drugs is becoming evermore important for both mainstream and orphan diseases – the proof being that in 2012, repurposed medicines generated over $20 billion in global drug sales. Two articles in this issue consider more informed, targeted methods for drug repositioning, as a means to identify potential new therapeutic indications of previously licensed medicines.

Adding the finishing touches to this letter while at an industry event where repurposed orphan therapies have topped the billing, I can only concur that any means to better identify much-needed new treatments for a range of unmet conditions – and fast-track their development – has to be positive.

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