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Commentary

Funding for accelerating drug development initiative critical
Joanna Owens, Nature Reviews Drug Development, 3-20-06

Last week, the FDA issued its Critical Path Opportunities Report, an agenda for medical research to develop new tools to improve the current drug development “toolkit”, which, the FDA and its stakeholders agree, currently relies on technological platforms that are outdated and inefficient.

To date, the President's budget contains only modest funding (about $6 million) for Critical Path activities, and Owens worries that the FDA's ambitious initiative will flounder without an additional financial investment on the part of industry.

Identifying the 76 opportunities for improving drug development required a great effort; but even more will be needed to successfully address them. This is something that the FDA cannot accomplish by itself, (I think this is supposed to be in quotes, but it's not in the article, should we put in a “[sic]”?) warns Janet Woodcock, Chief Operations Officer at the FDA, and one of the main driving forces behind the initiative.

Success will require unique collaborations between academic, government and industry researchers. "The Critical Path Initiative could be transformative, but it's also very fragile," says Woodcock. "It's going to need real commitment across a number of sectors to get going."

Funding is a big issue. For instance, the institute set up specifically to facilitate the FDA's Critical Path Initiative is concerned as to where funding will come from to carry out the necessary research.



Project FDA.
  
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