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A year in pharma and biotech R&D: No meltdown fears for pharma's R&D productivity

This article was originally published in Scrip

The pharmaceutical research enterprise shows an encouraging bias towards progress rather than failure. Even discontinued projects provide a window on the value opportunities of the future, writes Christopher Bowe.

Behold a view into the reactor core of global pharma. Each company can be seen trying to power its R&D pipeline with varying degrees of resource allocation, momentum, strategy and attempted shots on goal. Company-by-company data provide a simple snapshot of relative generative capacity in leading global pharma industry R&D.

Overall, it's a positive, forward-motion story. Despite the negative headlines that tend to leave a lasting impression in people's minds (both inside and out of industry), most company summaries for 2010 show a bias toward progress, not failure. Introgen Therapeutics' bankruptcy, with discontinued projects across the board, is the exception here, not the rule. Even discontinuations due to Avandia (rosiglitazone) regulatory decisions do not overwhelm GlaxoSmithKline's continued progress forward. Each company can look at this picture and quickly gauge for itself whose pipeline movements subtly confer more progress than others.

But what is arguably most instructive for industry strategists is the set of Scrip Pipeline Watch data collated and grouped by status change of projects. There is a clear view of the opportunities that exist in old versus new strategies and disease treatment needs, as well as the uncomfortably graphic representation of R&D productivity questions.

The industry's increasing interest in orphan drugs, and treatments for rare diseases, is on display. In these data, there were 84 instances of orphan drug status notifications around the world. The target diseases ranged widely, from rare genetic diseases, historically thought of as orphan diseases, to other chronic conditions and cancers. The evolution of this category will be a priority comparison when the 2011 data arrive.

The data also suggest that the old standby strategy of developing fixed-combination products remains alive and well. One of the most interesting calculations derived from these data is that 12 of the 52 (23%) first launches of a product were for combination products. The hunt for hidden value in combinations and the timely delivery of this new value to the market is a crucial lifecycle management skill. The diversification of risk this brings is needed more than ever. A significant proportion of combination products are the result of these efforts, but they must deliver value in medical practice, lest the market becomes cynical of them.

There is a global snapshot of the challenges of managing R&D pipelines and improving productivity. This dataset shows 83 Phase III programmes initiated in various parts of compounds' lifecycles, compared with 276 Phase II studies initiated.

secrets of the dead

And finally, discontinued projects in this dataset speak volumes about the diseases and pharmacoeconomic challenges of our era. Somewhat counter-intuitively, discontinuations give a window on the value opportunities of the future. They frequently include the most difficult health problems to solve. The hardest questions produce the most dead-ends. In this context, it is valuable to see that projects are most commonly discontinued in cancer, diabetes/metabolism and CNS. Within CNS alone, there are 11 projects were dropped in Alzheimer's disease and cognition.

Taking a broader view, the discontinued projects/trials accounted for 13% of the total pipeline developments in this entire dataset. As R&D budgets and ROI come under increasing scrutiny, it is worth watching whether this kind of figure goes up, or goes down.

This article is part of Scrip's A Year in Pharma and Biotech R&D analysis. For the full analysis, including data and commentaries, visit scripintelligence.com/rd2010index.

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