Listen to this article |
The article titled “Reviving an R&D Pipeline: A Step Change in the Phase II Success Rate” discusses Pfizer’s efforts to improve its research and development (R&D) productivity. The pharmaceutical industry has faced declining R&D productivity, and Pfizer aimed to address this challenge by focusing on three key areas: biology, modalities, and decision-making.
Table of Contents
Key Points
- Background: Pfizer faced declining R&D productivity during the early 2010s, leading to a steep patent cliff with a significant revenue impact. The Phase II success rate was particularly low, reaching 5% in 2016.
- Biology: To improve R&D productivity, Pfizer narrowed its therapeutic focus from ten therapeutic areas (TAs) to five. This strategic alignment allowed the company to deepen its knowledge of disease pathophysiology and make better target and disease selections based on robust biology and clinical translatability.
- Modalities: Pfizer diversified its drug development approaches by exploring new modalities, such as gene therapy and biologics. By expanding the repertoire of potential drug targets, Pfizer aimed to address previously inaccessible disease targets.
- Decision-making: Pfizer implemented enhanced objective metrics to guide its decision-making process. They used the ‘signs of clinical activity’ (SOCA) paradigm to capture early clinical signals and determine whether to progress a candidate molecule. This approach enabled early go/no-go decisions based on clinical data beyond pharmacokinetics and safety.
- Results: Pfizer’s efforts showed early signs of improvement, with Phase II success rates increasing from 19% to 53% over a decade.
Overall, Pfizer’s experiences and learnings in improving R&D productivity may have broader applicability to the biopharmaceutical industry as a whole.