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Embracing risk for competitive advantage
A comprehensive series on late-stage biologics development
About the webinar series
In this comprehensive series, we aim to help you in managing risks associated with late-stage biologic development to help you gain a competitive advantage. Each webinar will feature experts from across the Thermo Fisher Scientific global network, who will discuss the various risks and challenges faced by developers, while outlining strategies to effectively manage them.
Throughout the series, you'll gain a holistic understanding of late-stage development risks, from scale-up through PPQ (Process Performance Qualification). The webinars will focus on integrating risk management strategies and mitigating project-specific PPQ risks, as well as optimizing laboratory methods for a seamless product launch.
Join us to enhance your knowledge and confidently navigate late-stage biologic development.
Webinar 1:
Late-phase biologics development: Embracing risk for competitive advantage
September 5, 2023 | 10:00am ET | 3:00pm GMT | 7:00am PT
Risk is omnipresent in biologics development, particularly in late-phase manufacturing. Fears of a therapeutic candidate not meeting efficacy goals despite early positive results, alongside safety, quality, and scale-up concerns, loom large. However, risk isn't the enemy; it's the narrow focus on certain risks that poses a threat. Neglecting regulatory, capacity, cost, IP protection, and environmental risks can derail even promising development programs.
This webinar will explore technical, program, and business risks, provide a roadmap to manage all risks in strategy development, and highlight how embracing risk can lead to competitive advantages.
Webinar 2:
Pitfalls of PPQ: top risks and how to mitigate them to ensure successful commercialization
September 19, 2023 | 10:00am ET | 3:00pm GMT | 7:00am PT
You’re almost at the finish line and you need to prove your biologic therapy's production process is robust and consistently meets purity, quality, and potency standards. A concise Process Performance Qualification (PPQ) report is crucial for commercialization. However, challenges like process complexity, variability, regulatory compliance, and change management make PPQ preparation demanding.
This webinar will address these issues, sharing mitigation strategies, emphasizing data integrity, and optimizing CDMO/sponsor collaboration to streamline the PPQ process and reduce late-stage risks, facilitating a quicker time to market.
Webinar 3:
Mastering analytical methods for fail-safe PPQ
October 10, 2023 | 10:00am ET | 3:00pm GMT | 7:00am PT
After investing significant financial and temporal resources in the development of a new biologic molecule, companies cannot afford any setbacks in the final stages. This is where laboratory methods become crucial for PPQ. Our expert panel will discuss the importance of establishing a robust analytical methodology to ensure accurate, precise, and reliable test results. Being familiar with the need for phase-appropriate analytical methods, they will share industry best practices and insights to meet evolving requirements, while minimizing risks and maximizing efficiency.
This webinar will provide a comprehensive understanding of laboratory methods for PPQ and outline strategies for reliable analytical methodologies.