Challenge:
Our client's lead drug candidate was threatened by evidence of cardio-tox issues.
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Solution:
The Pharmaceutical Advisors team provided a rapid review of the data, identified the risks and non-issues and recommended additional tests to enable getting into man. A parallel process chemistry review identified polymorph and scalability issues requiring more work on the final salt form BEFORE doing any more tox studies.
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Benefit:
The lead candidate continues in development and roughly $400,000 in expense and nine months of lost time-to-market were avoided.
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