Pharmaceutical Advisors 
PharmAdvisors.com
About UsOur FocusCase StudiesAdvisor TeamsDownloadsEventsContact Us

Case Studies

Interpret Complex Toxicology and CMC Risks in Order to Move Forward

Challenge:

Our client's lead drug candidate was threatened by evidence of cardio-tox issues.


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.

Benefit:

The lead candidate continues in development and roughly $400,000 in expense and nine months of lost time-to-market were avoided.


Click here to see information on the Advisors Team that helped this client.