The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is not only dependent on the similarity of the products themselves but also to the quality of the bioanalytical assay methods and the design and conduct of early PK/PD studies. Based on experiences gained from support of the first wave of biosimilar products to gain approval in the US and EU, Celerion will share key learnings gained from engagement with several biosimilar programs. This includes the rationale for the one assay approach and how the two-step approach can help set up such an assay.
Establishing a robust validation of a single assay with both the innovator and biosimilar compound aims to show analytical similarity and confirmation of comparable reactivity. This includes challenges in pushing the limit of precision of ligand binding assays, which is essential when processing samples from biosimilar studies, and how adapted routine analysis best practices can overcome those challenges.
Dr. Petra Struwe, Executive Director of Bioanalytical Services, Celerion
Dr. Petra Struwe is the Executive Director of Bioanalytical Services at the Celerion facility in Switzerland, a contract research organization (CRO) supporting biopharmaceutical industry drug development. She holds a PhD in chemistry and is an experienced scientific leader with more than 20 years working in the Bioanalytical and Biomarker segment of the pharmaceutical industry. In her current role she is in charge of both small and large molecule method development/validation and sample processing in an extremely automated and compliant environment.Message Presenter
Who Should Attend?
This program is intended for senior level professionals from biopharmaceutical companies working on biosimilar development, including:
- Heads of Research and Development
- Clinical Pharmacologists
- Project Managers
- Medical Directors
- Clinical Operations Directors, Managers
- Clinical Planning Directors, Managers
- Bioanalytical Scientists
What You Will Learn
In this webinar, the speakers will:
- Discuss the direct impact of the bioanalytical assay set-up on the statistical endpoint and, therefore, on the success of early clinical studies comparing a biosimilar drug candidate with the innovator compound
- Share key learnings gained from engagement with several biosimilar programs
- Learn the rationale for the one assay approach and how the two-step approach can help set up such an assay
- Get insight into how reagents can impact the assay performance
Celerion, a global leader in early clinical research services offers a unique combination of medical expertise, clinical operations experience and scientific excellence that gives our clients the confidence to make fast, accurate decisions about their drug development path. For fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic and pharmacodynamics studies in highly controlled clinic environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. Celerion offers feasibility, data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.