The Industrialization of Pharma R&D 
Posted by Carlos on May 21, 2014

 

Chaplin Modern Times

What goes on behind the walls of Big Pharma?

An excellent analysis of the AstraZeneca pipeline performance was recently published in Nature Review. The objective of this study was to identify and assess key factors which drive R&D performance:

Maintaining research and development (R&D) productivity at a sustainable level is one of the main challenges currently facing the pharmaceutical industry. In this article, we discuss the results of a comprehensive longitudinal review of AstraZeneca’s small-molecule drug projects from 2005 to 2010. The analysis allowed us to establish a framework based on the five most important technical determinants of project success and pipeline quality, which we describe as the five ‘R’s: the right target, the right patient, the right tissue, the right safety and the right commercial potential. A sixth factor — the right culture — is also crucial in encouraging effective decision-making based on these technical determinants.

It’s a comprehensive analysis, and we urge anyone who is interested in understanding why drug candidates fail during development to read this article a few times. For an excellent overview of the article, check our Derek Lowe’s post and corresponding comments.

What Caught Our Attention

 Several times throughout the article, the authors note that the company used to use quantitative metrics to judge R&D productivity:

…part of this productivity issue can also be attributed to a shift of R&D organizations towards the ‘industrialization’ of R&D. The aim was to drive efficiency while retaining quality, but in some organizations this led to the use of quantity-based metrics to drive productivity. The hypothesis was simple: if one drug was launched for every ten candidates entering clinical development, then doubling or tripling the number of candidates entering development should double or triple the number of drugs approved. However, this did not happen; consequently, R&D costs increased while output — as measured by launched drugs — remained static

And…

This is because the focus of scientists and clinicians moved away from the more demanding goal of thoroughly understanding disease pathophysiology and the therapeutic opportunities, and instead moved towards meeting volume-based goals and identifying an unprecedented level of back-up and ‘me too’ drug candidates. In such an environment, ‘truth-seeking’ behaviours to understand disease biology may have been over-ridden by ‘progression-driven’ behaviours that rewarded scientists for meeting numerical volume-based goals 

Anyone who has been in the industry knows this has been the case for decades. But to have a large, multinational company come right out and say it is indeed refreshing. 

Fortunately for AstraZeneca, they have taken steps away from industrialization and towards what science should be:

The analysis we describe here was performed 3 years ago, and since then AstraZeneca has undergone considerable changes to implement the lessons learned…This has meant a conscious shift away from the high-volume-based strategy previously used in R&D to one where we focus on project quality and depth of understanding as a key driver of success.

Pharma scientists hard at work…

The Future of R&D

As the authors correctly note, it’s too early to decide if their shift towards a purer form of research will pay dividends in the form of greater efficiency. 

Maybe. Maybe not. 

But what is clear is that drug discovery research and development is damned hard. Biology does not easily divulge its secrets. And, even when it does, the secrets may not lend themselves to therapeutic approaches that are effective, safe, or convenient.

Coincidentally, VC and blogger Bruce Booth made an excellent point recently on the need for pharma researchers to learn their craft via a 5-10 year apprenticeship:

Without training in bigger pharma, there’s less talent for biotech; without that talent, biotech won’t make good drugs; without good biotech drugs, there’s no innovation for pharma, and then the end is nigh….in this brave new world, who is going to train the drug hunters of the future?  

Are we in a situation where “industrial” scientists are diluting the talent pool available for biotechs to hire? It’s certainly possible that this is happening now, and will continue to do so for the foreseeable future, worsening the problem Bruce Booth discussed in his post.

Update

The otherwise annoying Forbes website has a good article by Matthew Herper on R&D productivity. The article is a summary of a report which analysis and ranks 22 companies based on various measures of R&D productivity.

The winner? Bristol-Myers Squibb.

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