Why Do Promising Therapies Stall in Development and How Can We Move Them Forward?

There are many reasons that molecules fail to progress to market and various principles of risk–benefit decisions that can help drive the molecule through development. This symposium included discussions on global strategies involved in pushing promising molecules to market, what to do when a molecu...

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Bibliographic Details
Published in:International journal of toxicology 2017-07, Vol.36 (4), p.340-349
Main Authors: Wegner, Craig D., Goodwin, Andrew, Cook, Jon C., Allamneni, Krishna, Sohn, Jane, McVean, Maralee
Format: Article
Language:English
Subjects:
Animals
Drug Evaluation, Preclinical
Drug Industry - standards
Drug Repositioning
Humans
Therapeutics - standards
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Summary:There are many reasons that molecules fail to progress to market and various principles of risk–benefit decisions that can help drive the molecule through development. This symposium included discussions on global strategies involved in pushing promising molecules to market, what to do when a molecule stalls in its progress to market, and options for rescuing the molecule and pushing it forward again. Innovative partnerships that bring stalled drugs back into clinical development were also addressed. A regulatory perspective on common reasons for a molecule to fail in its forward progress was presented. In addition, situations arise when a third-party advisory committee can provide input to help overcome issues identified by a regulatory agency. Using examples from the private and public domain, presentations centered on how to repurpose a molecule and when more science is needed.
ISSN:1091-5818
1092-874X
DOI:10.1177/1091581817709773