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Yearly Archives: 2012

June 27, 2012 no comments

Safety First: An open letter to biomedical inventors

DrugBaron is fortunate enough to review hundreds of exciting early-stage drug development projects every year, for organizations as diverse as the British Heart Foundation, Wellcome Trust and US National Institutes of Health as well as Index Ventures and Total Medical Ventures.

Such is the competition for resources, that only a small minority win support.  Thus will it ever be.  But observing so many candidate projects, a pattern has begun to emerge – a pattern that distinguishes the winners from the losers.

The winners have realistically assessed the safety of their approach – and backed up that assessment with data.  The majority that miss the cut, by contrast, gloss over the safety issues and rely on theoretical arguments rather than practical demonstration to support the contention they will achieve a viable therapeutic index.

A subtle tweak in the mindset of early stage biomedical researchers aiming to identify new therapeutic candidates would, therefore, deliver enormous benefits.  The projects that fail to win support for further development represent a waste of the talent of their inventors, a waste of bandwidth for the industry and a poor return for the money (whether from a charity, government or business) spent in their creation.

Here, then, is DrugBaron’s open letter to those inventors, imploring them to provide a better of assessment of safety for early stage therapeutic candidates:

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June 19, 2012 no comments

The mirage of “big data” in clinical trials

It is inevitable that clinical trials will fail.  …

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June 11, 2012 no comments

Constructing better multivariate biomarker composites

The earliest biomarkers, such a body temperature or …

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