New approaches to stimulating the productivity of pharmaceutical R&D

I’m sure we all remember the excitement generated by the sequencing of the human genome in the late 1990’s culminating in publication of the essentially complete genome in April 2003. This was accompanied by a lot of hype about the impact on pharmaceutical R&D productivity and a concomitant surge in investment into the sector.

Looking back as the end of the decade draws near it is clear that the much anticipated impact on pharmaceutical R&D has not materialised. The rates of new product approvals has declined whilst investment in R&D has continued to climb; a recent analysis of the Pharmaprojects database revealed that between 2000 and 2008, 1,941 drugs in development were discontinued (Biancardi, A. & Green, S. Scrip 100, S33–S36, 2008).

One of the principal factors contributing to the problem is the complexity of the biology underlying specific diseases. This, coupled with the recent explosion in large-scale biological data, is leading to a realisation that no individual organization has the resources to maximize the potential of molecular data to inform drug development.

It is interesting to observe the emergence of novel models for pre-competitive collaboration to help tackle the challenges of innovative drug development (see Hughes, B. Nature Reviews Drug Discovery 8, 344-345, 2009). Some of these models seek to leverage information in an open-access way (freely available with no intellectual property (IP) restrictions). Examples include:
· Sage (http://sagebase.org): using data from Merck and seed funding from private sources
· Two initiatives created and spun out by Lilly: InnoCentive (http://www.innocentive.com) and Collaborative Drug Discovery (http://www.collaborativedrug.com), harnessing the collective talent accessible through the Internet
Several other drug development challenges, such as biomarker identification and validation, are increasingly being addressed at a pre-competitive level, often through public–private partnerships. Examples include:
· The Biomarkers Consortium (http://www.biomarkersconsortium.org)
· Critical Path Institute consortia (http://www.c-path.org/consortia.cfm)
· The Innovative Medicines Initiative (http://imi.europa.eu/index_en.html)

The issue of who owns the IP arising from these partnerships has provoked much debate. The research tools that emerge from the IMI will be made available to other companies and academic groups for research purposes at a reasonable cost or free of charge, although the IP rights will belong to members of each consortium.

I am Chairman of Psynova Neurotech (www.psynova.com), which is a participant in one of the first projects funded by the Innovative Medicines Initiative. The project is just getting off the ground but our experience to date suggests that public–private partnerships have much to offer the pharmaceutical industry. A more flexible attitude to the creation and exploitation of IP appears to be the order of the day.