Modeling and Simulation Supports Competitve Product Profile Assessment

Modeling strategy provided sponsor timely and compelling support for positive efficacy signal of in-licensing candidate, helping to secure $23 Million financing round and advance compound to Phase IIB.

A specialty pharmaceutical company was seeking to provide rapid, quantitative support to fund its in-licensing strategy for an oral Type 2 anti-diabetic agent. Limited data from a single Phase IIa study was available on the drug candidate.

As the sponsor worked to finalize its in-licensing strategy and secure deal terms, it became critical to provide investors with rapid yet rigorous early quantitative support for the potential of the compound’s efficacy and safety profile versus currently marketed oral diabetes treatments, notably Avandia® (rosiglitazone) and Actos® (pioglitazone). In the absence of randomized controlled trials that directly compared the drug candidate’s performance to that of established competitors, making an “apples to apples” assessment would be particularly challenging.

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