Case Examples of M&S to Support In-Licensing Decisions
Phase II In-Licensing Strategy for Specialty Pharmaceutical Company
A specialty pharmaceutical company was seeking to provide rapid, quantitative support to fund its in-licensing strategy for an oral anti-diabetic agent. Limited Phase II clinical trial data was available on the drug candidate.
In the absence of randomized controlled trials that directly compared the drug candidate’s performance to that of established competitors, Pharsight developed models of the diabetes treatment landscape for key clinical endpoints (e.g., FPG and HbA1c) using its in-house database of mean trial results from publicly available data sources. The models accounted for the differences in response due to factors such as disease baseline value, dose, patient characteristics, and run-in length of monotherapy trials.
The models were then simulated to generate predictions of competitor trial arms that matched the exact characteristics of the available trial data for the drug candidate. The modeling and simulation strategy provided rigorous and timely support of a positive efficacy and safety signal for the drug candidate versus competing treatments, helping Pharsight’s client to secure a $23 million round of financing to in-license the compound and proceed with its development program.