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Effect of Collaboration And Risk-Sharing On Drug Development Times

May 28, 2014

The Tufts Center for the Study of Drug Development (CSDD) is an independent academic non-profit research group at Tufts University in Boston, Massachusetts.

One of Tufts CSDD products is the bi-monthly Impact Reports,that summarize current original research from the organization in an easy compact format. This series of reports analyzes data and provides information on current drug regulatory and development issues.

The latest Impact Issue is the May/June 2014 issue titled, “Collaboration & risk-sharing programs experience longer development times”. The Summary Report is available for FREE. The latest CSDD Impact Report concludes that drug development programs involving collaboration and risk-sharing, experience longer development times.

Here are a few key conclusions from the Summary Report:

1)  Approximately 50% of new therapeutic drug approvals in the US, between 2000 and 2011, are developed under a “collaborateive, risk-sharing arrangement with” :

a) 57% involving licensing deals

b) 29% involving co-development.

2) Mean clinical phase times are 8.9 months longer for new drugs in “multi-firm, risk-sharing clinical development relationships” than for new drugs not in these type of development relationships.

3)  The percentage of new drugs developed clinically under a single developer, decreases from 47% (2000-2003 of US approvals) to 41% (2008-2011 of US approvals)

4)  The percentage of co-developed drugs almost doubles from 12% (2000-2003) to 22% (2008-2011)

5)   Median clinical phase times for co-developed drugs are 13.6 months longer than drugs developed by a single developer.

These conclusions from Tufts CSDD’s May/June 2014 Impact Report, should be kept in mind as companies collaborate and partner with advocacy groups for the development of new drugs and treatments for rare diseases.

Please Note: “Spinning Device To Mix Tissue Culture Medium” by National Cancer Institute [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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