I want a new drug…

Go to the profile of Joshua Finkelstein
Mar 27, 2019
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Nature Review Drug Discovery recently posted a “News and Analysis” article by Joanna Owens called “”http://www.nature.com/nrd/journal/vaop/ncurrent/full/nrd2015.html">Funding for accelerating drug development initiative critical," which is about a new initiative launched by the United States Food and Drug Administration called “”http://www.fda.gov/oc/initiatives/criticalpath/“>The Critical Path Initiative.” According to the Critical Path website:

The Critical Path Initiative is FDA’s effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product.

To achieve this goal, Joanna says that

the FDA announced a list of 76 ‘opportunities’, or projects, for developing new tools that could significantly improve the way that experimental drugs are tested. The opportunities cover six broad topic areas: development of biomarkers; clinical trial designs; bioinformatics; manufacturing; public health needs; and paediatrics.

So it looks like this initiative will complement the NIH Roadmap, which was launched several years ago to “”http://nihroadmap.nih.gov/overview.asp">identify major opportunities and gaps in biomedical research that no single institute at NIH could tackle alone."

I’m not sure if any of our readers are in the pharmaceutical industry, but I would be curious to hear what you think of these initiatives. Do you think that they’ll have a positive impact on human health (i.e. will these initiatives actually accelerate drug discovery and development?) If you don’t think that these initiatives will actually impact the number of new drugs coming to market, what do you think can (or should) be done? And if you are an academic scientist, what do you think about (another) governmental initiative that is focused on drug discovery and development, rather than pure scientific research?

Joshua

Joshua Finkelstein (Associate Editor, Nature)


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