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.
|
