These discoveries present hope for patients with rare or untreatable diseases and for larger patient populations confronting emerging infectious threats.

However, in order to impact public health, a discovered therapy must be developed into a reliable and cost-effective process and formulation with validated test methods to assure its safety and effectiveness. Product shelf life is essential for building a reliable supply chain.

Acceleration creates a fundamental conflict between the pace of commercialization and the timeline needed to demonstrate shelf life. Product developers must bridge science and statistics to use short-term data to predict long-term product stability. The strategic application of statistical modeling to stability data is on the critical path for commercialization of these urgently needed new therapies.

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Who Should Attend The Webinar?

This interactive webinar is for scientists, engineers, product development team leads and portfolio managers who are interested in how practical strategies for stability assessment can support accelerated commercialization timelines.

Key Learning Objectives:

• Describe how the essential components of stability study design and analysis for biopharmaceuticals can be adapted to support acceleration of commercial timelines.
• Learn best practices for developing predictive models for long-term stability.
• Compare innovative approaches to conventional practices for establishing shelf life.