POLICY & REGULATION
Chan
P
ete
The view from Canary Wharf
Low R&D productivity and safety issues are among the most pressing problems facing
those involved in developing new medicines, but what’s the regulator’s perspective on
the situation? Ian Schofi eld spoke to Thomas Lönngren, executive director of the
European Medicines Agency, to fi nd out
Critical Path Initiative, have been set up to we can do to help. We want to stimulate
THOMAS LÖNNGREN
develop biomarkers and other tools to ensure innovation, we have the legislative tools. For
new drugs are better targeted, make the drug example, we have increased our provision of
F
ew would dispute that the R&D development process more effi cient and scientifi c advice, and we fully support the IMI,
productivity of the pharmaceutical predictable, and minimise attrition. But is this of course.”
industry is at a low ebb, with new the answer, or does the problem run even With initiatives like the new EU legislation
molecules fi nding it ever more diffi cult to make deeper? on advanced therapies, he says, “we are
it through to Phase III clinical trials Surveying the scene from his Canary Wharf moving away from pharmacology-based drugs
and beyond. offi ce in London, Thomas Lönngren, executive and towards more personalised medicines
The consensus is that bottlenecks in the director of the European Medicines Agency, and biomarkers. And preventive medicine is
drug development process are the reason for says that many explanations have been offered becoming more important.”
the high attrition rate seen with new drugs. for the low productivity rate, and that the Biomarkers are one area where the EMEA
Two public-private consortia, the Innovative agency has a role to play in addressing the has been quite proactive. Mr Lönngren cites
Medicines Initiative in Europe and the US problem. “We as regulators have asked what the 2008 joint qualifi cation, with the US FDA,
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