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Case Studies

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


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.


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.


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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