Clinical Trial Success through Novel Clinical In-Use Strategies

As biotherapeutics leave the controlled environment of the manufacturing facility and enter real-world clinical trials, the risk of failure due to lack of efficacy could be as high as 50%. This can be de-risked by evaluating how stressors during preparation and administration may affect therapy, using clinical in-use studies during drug product process development.

This webinar explores how clinical mimic studies sit at the intersection of stability, compatibility, handling and patient safety. The featured speakers will focus on the risks of aggregation, adsorption, subvisible particles and functional loss and will introduce considerations that accompany reconstitution, dilution and storage. Real case examples will be presented to highlight common failure modes and mitigation strategies to enable safe and efficient clinical use.

Participants will learn approaches to design robust, fit-for-purpose clinical in-use protocols aligned with evolving regulatory expectations (WHO, FDA, EMA and USP), selection of appropriate physicochemical and biophysical analytical methods and interpretation of data to support decision making and risk management with respect to clinical administration of biotherapeutic drug products.

Register for this webinar to learn how clinical in-use studies contribute to clinical trial success by strengthening the safety, efficacy and reliability of biotherapeutic drug administration.

Speakers

Daniel Pettit, Head of Analytical Development, FUJIFILM Biotechnologies

Daniel is a Senior Director and Head of Analytical Development at FUJIFILM Biotechnologies, UK. During the 24 years that Daniel has been with the company, he has worked on over 150 customer programmes and has experience in the analysis of a diverse array of biological molecules. Daniel now leads a team of 50+ analytical scientists based in the UK that support early and late phase process development activities across the global FUJIFILM Biotechnologies network.

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Natalia Harasimiuk, Director of Analytical Services, FUJIFILM Biotechnologies

Natalia is the Director of Analytical Services at FUJIFILM Biotechnologies, UK. Natalia has been employed in the biopharmaceutical industry for over 15 years in multiple roles, including Quality Control and Analytical Development. Natalia specializes in providing supportive studies for regulatory submissions. She is a subject-matter expert in formulation development, drug-product process development, clinical in-use mimic studies and other supplementary analytical studies.

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