12:00 AM
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Oct 08, 2012
 |  BioCentury  |  Politics, Policy & Law

Footnote or forecast?

White House report calls for public-partnership to fix drug R&D

The President's Council on Advisors on Science and Technology (PCAST) spent a year working on a report titled Propelling Innovation in Drug Discovery, Development, and Evaluation, and now the authors are trying to ensure it doesn't become just a footnote in future blue ribbon reports.

According to the blue ribbon panel, the best way to fill the gaps identified by PCAST's report - the need for more and better translational research, improving clinical trial capabilities and clarifying regulatory pathways - is to create a high-level Partnership to Accelerate Therapeutics Innovation.

According to PCAST, the partnership should include leaders from the biopharma industry; the academic biomedical research and ethics community; physician societies and pharmacists; patient-focused research foundations and advocacy groups; healthcare providers and insurers; and government.

The report suggests the partnership should develop detailed plans for shared science and technology projects, and business and operational plans for clinical trials networks.

In particular, PCAST's recommendations for revamping the design and conduct of clinical trials reflect a widespread view among biopharma executives and senior officials at FDA and NIH that improving clinical research is important and that it could yield benefits quickly.

The report calls for public-private partnerships to create "enduring clinical trials networks able to perform studies suitable for registration of a new drug, with efficiency and high quality."

In addition, PCAST said the Partnership to Accelerate Therapeutics Innovation should work on developing FDA guidance...

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