#None #biotherapeutics #Xtalks #Clinical Studies

Webinar Overview

In an era where biotherapeutics are increasingly integrated into clinical settings, understanding the complexities of clinical in-use studies becomes essential. This upcoming free webinar, hosted by Xtalks on January 22, 2026, delves into the critical aspects of these studies and their impact on ensuring the safety and efficacy of biologic products.

What Are Clinical In-Use Studies?

Clinical in-use studies are designed to evaluate how biotherapeutics perform under real-world conditions, allowing researchers to assess challenges that may affect the stability, functionality, and overall patient safety of these therapies. As biotherapeutics transition from manufacturing settings to clinical use, the likelihood of encountering issues such as compatibility, handling errors, and aggregation risks increases significantly. This webinar will cover essential topics, including the following:

Importance of Safety and Efficacy

Research highlighted that as biotherapeutics leave controlled environments, there's a potential failure rate of up to 50%, primarily due to insufficient efficacy. Understanding the clinical use environment and the various stressors that occur during drug administration is vital for mitigating these risks. The featured speakers—experts from FUJIFILM Biotechnologies, Daniel Pettit and Natalia Harasimiuk—will share insights on ways to enhance the robustness of these studies.

Agenda Highlights

1. Analytical Methods: Evaluating critical quality attributes through targeted analytical method selection.
2. Compatibility Considerations: Addressing factors such as diluents, IV lines, filters, syringes, and infusion bags.
3. Risk Analysis: Translating findings into practical frameworks, including labelling adaptations, pharmacy SOPs, and strategic risk-benefit assessments.
4. Real-World Examples: The session will feature case studies illustrating common challenges encountered during clinical applications of biotherapeutics, alongside recommended mitigation strategies to ensure safe and efficient use.

Learning Outcomes

Participants will be equipped to design fit-for-purpose clinical in-use protocols that align with evolving regulatory expectations, including those from WHO, FDA, EMA, and USP. The goal is to foster a deeper understanding of how to apply physicochemical and biophysical analytical results meaningfully to support informed decision-making in clinical settings.

Registration Information

Today's complex landscape necessitates that healthcare professionals stay informed and adept. Therefore, this webinar aims to empower attendees to contribute to clinical trial success by reinforcing the safety, efficacy, and reliability of biotherapeutic drug administration.

To join this informative session, register today and learn from industry-leading experts about the pivotal role of clinical in-use studies in biotherapeutic administration.

For more information or to register, visit our event page on the Xtalks website.

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., serves as a premier provider of educational webinars and digital resources for the global life sciences industry. Annually, Xtalks facilitates thousands of industry practitioners to help them stay updated with sector developments, regulations, and opportunities. The platform also offers an avenue for leading professionals to share crucial insights on key industry issues.

To discover more about Xtalks, explore their website, and learn how to engage with quality content that meets your professional needs.

Register soon to secure a spot and advance your understanding of clinical in-use studies as they relate to biotherapeutics!