There is an increased interest in biomarker-enriched development in the pharmaceutical industry. The FDA Guidance on Enrichment Strategies was published in 2019. This presentation will focus on predictive enrichment as it relates to the regulatory guidance.

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 the probability of product success (POS) 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 the population.

The presentation will evaluate the financial value of biomarker enrichment. It will consider the impacts of previously identified pros and cons and provide an optimal solution. The value of biomarker development will first be evaluated in the context of a single program and then in the context of the whole portfolio.

The Webinar is a joint webinar brought to you by OccamPoint and the Society of Decision Professionals.