So the global pharma and biotech industry still has a pipeline problem: cost per new drug is sky rocketing, volume of new approvals continues to decline, and the influx of likely looking discovery assets is but a trickle. Meanwhile the industry continues to do what it has always done (i.e. implement new team re-structuring or budget allocation ideas), and get what it has always got.
Ready, Fire, Aim?
We still seem to know remarkably little about the drivers governing this pattern. The problem with this for me is that the nature of the appropriate solution differs markedly depending on your assessment of the cause. So for example:
- if your diagnosis indicates that economic efficiency is the problem – that we are just not efficient enough at drug discovery now that the easy coal has been mined by open cast methods – then we should focus all our resources on refining the technologies we are now using
- or if you think that specificity is the issue – that we should be looking for drugs specific to different patient groups rather than one-size-fits-all blockbusters – then Personalised Medicine is where we should focus our resources. Perhaps investment in more subtle biology is what is required?
or perhaps you blame the regulatory regime? Regulation very seldome loosens, as opposed to tightens, its grip. We need to focus on appropriate regulation perhaps. Afterall I am always being told that we couldn’t get aspirin through the system in today’s climate
- or is the problem an issue of addiction – by which I don’t mean that narcotics are the problem, but that we are addicted to any drugs we can lay our hands on (in which case prevention and education is where we should be spending the big bucks)
- or perhaps we have research inefficiency through dis-economies of scale such that big pharma is simply less capable of successful R&D than smaller economic units, should shut down all attempts at R&D (or at least R) and buy in biotech products. This is hypothesis-of-the-month for many of the pharma companies – and investors in pharma who now value pharma drug pipelines at virtually zero.
The interesting reality from such a list is that there are not actually that many alternative ‘diseases’ that the industry could be suffering from. Diagnosis should not be too difficult. Sure one’s first reaction is probably that the drug pipeline problem is caused by ‘a mix of all of the above’.
But which one do you think is the main culprit?
And how are we going to test to find out?
At government or global corporate level one needs to make a choice of action depending on your analysis of the primary cause. At small company level one has comparatively few resources to play with so taking decisions that change the whole industry is more difficult. For my own money I am focussing on the Personalised Medicine story – I have personal belief in the idea that specificity is the limiting issue and have gone and found superior technology to deploy.
But do you agree? Diagnosis please. Take aim.
Footnote 1: SOMETIMES time spent tweeking with your aim is wasted, counter productive and used as a procrastination tactic. Ready, Fire, Aim could be a useful strategy for those times. Check out Michael Masterson’s book of the same name to see what I mean. But I don’t think that the pharma pipeline problem is one of them.
Footnote 2: Meanwhile here is an interview summarising my own thoughts at BioBusiness 2012 in London http://t.co/ZVghiz1e