Client Challenge: A biotechnology company was considering developing an early-stage asset for hypercholesterolemia but was concerned that the existing drugs, primarily the statins, left little unmet medical need or market potential for their asset.

Our Approach: Working with our client, we developed a target product profile for the drug, which we then tested in a series of in-depth interviews with a broad range of physicians – academicians, specialists, and PCPs – treating hypercholesterolemia. The goal of these interviews was to both assess level of unmet medical need and the type of clinical evidence – clinical trial endpoints – required for acceptance.

Results: Our interviews disclosed a number of important findings. First, there was a divergence among types of physicians regarding unmet needs, with those most actively involved in treating patients perceiving significant unmet needs and academicians far less so. Second, the level of evidence required for physician use did not require large and lengthy outcomes trials. Based on our recommendations our client decided to continue pursuing development of the drug.