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The Micro Pharma

Pre-clinical drug discovery has traditionally been the preserve of large fully integrated pharmaceutical companies (FIPCO’s) in established geographical centres in the UK, US and Europe. It relied on tight integration of laboratory facilities and drug design expertise within monolithic mega-research facilities. As laboratory science has become more industrialised and experimental data resources become more widely available through the internet, drug discovery is moving out from the mega-Pharma into thousands of small mid-size Biotech or Pharma research businesses. These new “mini-Pharma” entrants usually focus on developing some biological insight emerging from academic research into potential drug development candidates and then license those to the mega-Pharmas that have the financial muscle to carry the costs of clinical development.

Although the mini-Pharma companies are smaller and operate more cost-effectively, they often operate as smaller versions of their larger role models. Their productivity may sometimes be higher, but they are not radically different. They remain expensive to set up, fixed costs are high and the majority fail commercially. Nevertheless, driven by unmet medical needs, growing populations and increasing wealth, there is a very large market for new clinical development candidates to fill the empty pipelines of the large FIPCO’s.

The revolution in information technology and emerging developments such as the semantic web, cloud computing as well as community data and software resources is now creating the right circumstances for a second wave of change. This change will be driven by solutions for managing information, extracting knowledge and making decisions in virtual organisations which will create opportunities for new entrants to this very valuable market, especially those with strong IT expertise. The new entrants will be “micro-Pharmas” that minimise fixed costs through accessing on demand, pay-as-you-go laboratory and computing services and exploit Web 2.0 technologies to access globally available services and expertise “on demand”. Driven by their expertise in Information systems, they will deliver new medicines at low unit cost and lower risk. These new micro-drug discovery companies will stimulate local markets for services and grow expertise core in biotechnology activities that create wealth for their investors and communities.

In this emerging landscape for Pharmaceutical research, the mega-Pharmas will increasingly focus on clinical development and commercialisation, in-licensing their products from high productivity mini- and micro-Pharmas. Services will be acquired from the best providers that operate globally and offer services on demand.

This emerging landscape creates new businesses opportunities in the provision of on demand services and in the formation of micro-Pharmas which may operate as businesses, charitable foundations or potentially as participants in open source drug discovery.


Beyond the Pale

Enthusiasts for open science come from many backgrounds and see different advantages. For me, open science is what science is supposed to be. Open publishing of results and data in such a way that the “educated layman” can repeat the work, check its validity and potentially come to alternative conclusions. After all science is the process, the debate, not the corpus. The corpus changes with new data, new interpretations and new theories, it’s the continuity of debate which is constant. Not all scientific research should be open. It requires confidentiality to take research through to a commercial product, but if there is an expectation of gaining credit from the work, then it should be. The other argument is that open data and open publishing create radically new opportunities for mining information and realising the potential of the semantic web in building new kinds of scientific understanding.

All of these are noble goals and scientists that go open, publish their data, software methods and conclusions, especially if they do it “live” as in Open Notebook Science are pioneers in an exciting new world of collaborative, transparent scientific discovery. One such pioneer is Steve McIntyre, whose blog I link to here, who operates fully “live” in the open publishing and archiving of data, his software and interpretations as he does the work and leaving himself open to continuous peer review by all comers at his blog as well as elsewhere, If he makes a mistake (which is unusual) it is quickly challenged. There are many good examples of his work to see on his blog and a recent analysis of his is representative. As an experiment in the sociology of open science and a window into what open science might look like, I find it fascinating to observe.

However, despite his site winning the Science blog of the year in 2008, his pioneering of open notebook science and his blog’s very high traffic, I don’t see any recognition of what he does in open science “circles”or in the mainstream scientific debate about open publishing. I don’t know why that is, because I see the same comments on his site about the importance of open data, transparency and rigorous analysis as elsewhere. What’s more he doesn’t just talk about it, he does it for real and does it well. I can’t help wondering whether this is because he is a climate change denier, someone whose scientific analysis undermines the basis of claims for man-made global warming. As such it is possible he is largely ignored because he is seen as “Beyond the Pale” and excluded from the respect I think he (and others) are due for their courage in working openly and publishing live.
I agree he is “Beyond the Pale”, but not in the modern sense of being outside what should be regarded as acceptable to polite society. Rather, I think he is Beyond the Pale as in its original meaning and if interpreted in that way, what he does, how he works and the reaction he gets has very important lessons for any scientist, whether working in the open or not.


Open Source Drug Discovery

Could you invent a drug for free?

No. It costs on average almost $1 bn to get a new drug launched. Although much of that cost comes from counting all the failures along the way, since for every 150 drug discovery projects that get started only one, 12 years later, makes it to market.

But could you invent a drug without spending any money?


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