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European Biopharmaceutical Review

Editor’s Letter

Welcome to our October edition of EBR. Our previous issue covered the topic of vaccines for medically unmet infectious diseases and, specifically, vaccination strategies against malaria. In a very positive development since then, the vaccine from the malaria programme discussed by GlaxoSmithKline’s John Haselden – developed by GSK and backed by the Gates Foundation (see EBR July 2015, page 40) – has now been approved for use by the EMA.

Nevertheless, there are still numerous infectious diseases against which truly effective vaccines are yet to be implemented or even developed. CureVac’s Ingmar Hoerr highlights how nucleic RNA approaches may offer a way forward to address gaps in both the West and emerging countries, and potentially form the next wave of therapeutic innovation for diseases, including flu, rotavirus and respiratory syncytial virus for which pilot work has already commenced. More rapid production and supply, as well as reduced manufacturing costs, are among the key advantages of RNA vaccines over conventional immunisation agents (page 54).

A major theme of this issue is biosimilars – particularly the need for appropriate analytical or analytic-functional techniques, and the commercial and regulatory challenges for their developers. These are covered by BioOutsource’s Andy Upsall (page 10); Andrew Reason and Howard Morris at BioPharmaSpec (page 18); Nick Beckett and Jane Lin of CMS (page 26); and Molekule Consulting's David Alderman (page 30).

While it is important to offer fair market protection for the originators of highly innovative and complex novel therapies – and to continue to incentivise the development of new biologicals – a balance has to be struck against allowing the introduction of safe and bioequivalent products to clinical practice and a wider patient base.

Remaining on topic with biologics, Feng Tian from Ambrx discusses genetically engineered antibody drug conjugates (ADCs) as a way of utilising antibodies as vehicles with a warhead effector of drug and a drug complex carrying non-natural amino acids (page 42). In addition, MicroScale Thermophoresis as a novel means of assessing both antibody and ADC – among other drug classes – drug-target and drug-drug binding characteristics is introduced by Thomas Schubert at 2bind (page 70).

Alzheimer’s disease remains the most common form of dementia and an unmet medical hurdle. Hamish McDougall and Peter Murphy from BioPharm Insight take us through the recent resurgence in therapeutic activity and progress (page 60), while Eric Karran from Alzheimer’s Research UK provides more insight into the current disease landscape in our industry interview. In particular, he reflects on the creation of the Dementia Consortium, which was established to accelerate the development of much needed breakthrough therapies (page 64).

A recent policy report published in Lancet Neurology suggests that dementia prevalence across Europe is levelling off – rather than increasing – as the overall health status of our ageing population improves. This is very positive news, but does not alter the fact that tens of millions of individuals are – and will continue to be – affected by dementia around the world. That the Dementia Consortium and others are pushing harder than ever for progress in combatting this disease is equally good news.

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