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Case Studies

Rapid CMC and Clinical Development Review to Support a Complex Go / No-Go Decision

Challenge:

Our client acquired a drug candidate with tremendous potential but with possible safety and bioavailability issues and with clinical indications outside their area of expertise.


Solution:

The Pharmaceutical Advisors team provided a CMC and clinical development strategy review combining expertise in the therapeutic area and technology with expertise in drug substance, drug product, formulation and delivery, toxicology, pharmacology and manufacturing.

Benefit:

Sufficient gaps in previous clinical work were identified, supporting further development of the compound. A CMC-focused risk-reduction strategy gave the framework to move forward prudently, maximizing potential value but minimizing cost.


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