Considerations for Biomarker Development when Optimizing Pharmaceutical Portfolios

Music City Center 

Predictive biomarkers have the potential to increase the benefit to patients and sponsors. Patient benefit from predictive biomarker is that they can receive more optimal treatment. For sponsors successful biomarker development can improve probability of product success and better differentiate the product if it is approved. However, biomarker development can add cost, complexity, and time to drug development. Additionally, biomarkers will reduce the market size, because they are usually approved only in a subset of population.
In this presentation we will first evaluate financial value of developing a biomarker in the context of one individual program. In practice, investment to develop a biomarker will usually compete with investments in other programs within the portfolio, and decision should be made in the portfolio context. The second part of this presentation will evaluate biomarker development in the context of portfolio, taking into account all decision parameters.

biomarker development

optimal decision

probability of success

differentiation

cost and complexity

market size 

Biopharmaceutical Section