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European Biopharmaceutical Review

Invaluable Influences

The global prescription drug sales are forecast to grow robustly at 6.5% for the next five years, thus reaching $1.06 trillion in 2022 (1). However, it remains an increasing challenge to achieve FDA approval for a new drug application in an industry that runs high on failure rates. Figure 1 illustrates the number of FDA drug approvals from 1995 to 2016. After a high in the mid-to-late 90s, the number of drug approvals somewhat stagnated at around 23 per annum for a decade, before recovering more latterly.

Attrition in the pharmaceutical industry remains high at approximately 90% from Phase 1 through to launch of a novel drug (2). This is on the back of significantly higher attrition in the research phase. Typically 200-500 compounds are made during drug discovery, yet only one of these, synthesised in an iterative manner, will be nominated as the drug candidate. R&D spending has spiralled in recent years and has not resulted in more success.

In 2000, it typically cost approximately $1 billion to develop a new drug, versus $2.6 billion in 2015 (3). This misbalance of the books led to the dramatic change in the way that drugs are discovered and developed from traditionally pharma-in-house to often fully outsourced models, the consequence of which is the global shrinking of pharma sites and staff. Additionally, large pharma are increasingly active in acquisitions of biotechnology organisations and smaller firms to bolster their pipelines. Therefore, for the biotechs, reliance on capabilities, expertise and advice from the CRO sector is growing significantly.

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Dr Richard Weaver FRSC is the Managing Director of XenoGesis Ltd, a rapidly growing CRO based in BioCity Nottingham, UK. Having joined Astra Charnwood in 1997 within Discovery DMPK, he progressed to Group and Project Leader at AstraZeneca. Richard gained a first class honours degree in chemistry, with awards for the best performance in every year, followed by a medicinal chemistry PhD with a Wellcome Trust scholarship at the University of Leicester, UK, and two subsequent postdoctoral positions at the Welsh School of Pharmacy, Wales.
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