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Case Studies

High Powered Expert Panel Preserved and Created Value on a Deal- Breaker Issue

Challenge:

Our client identified a degredant as a known mutagen. The client needed to understand the implications for development and the value of the compound for a partner meeting. They also needed the right regulatory strategy, as well as an understanding of the trade-offs between salt forms to pursue appropriate development programs.


Solution:

In less than 2 weeks assembled a team that addressed their issues including 2 Gentox experts that wrote the ICH guidelines, 1 Gentox expert that convinced the FDA to act favorably with a similar situation,CMC expertise with polymorph expertise, Pharmacology, Tox expertise in early and late development strategies .

Benefit:

Provided the client with answers to the right questions to show their partner that they had control and a plan, Awareness of questions they had not considered, Understanding of what was NOT an issue, Insight into the right development strategies to manage risk, Confidence that they had explored all the alternatives, One place to go for follow-up and coaching... No one got on a plane, stayed overnight, or was wined and dined, No one had to assemble and assimilate the input.


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