概览
Short Courses are not included in the conference registration and require a separate registration fee.
Short Course Registration: 12:30-5:00PM
In the determination of biosimilarity, clinical data may play a role in assessing the clinical relevance of differences between critical quality attributes of the reference and comparator products. Once the biosimilar developer has answered key questions about why, whether, and how much clinical data should be collected, the work of trial design can begin.
Biosimilar clinical trials differ in significant ways from studies on new biological entities, giving rise to multiple challenges in trial conduct and data generation. Appropriate trial design and anticipation of operational difficulties can help to mitigate these challenges.
This short course will apply learnings from regulatory guidances and from the programs of recently approved biosimilar products to provide insights on optimizing biosimilar clinical trial development, conduct, and data generation. Rather than focusing on any single class of biosimilar, the content will be inclusive of many classes, e.g. growth factors, monoclonal antibodies, fusion proteins.
You will work through the sequential steps of developing a given biosimilar product starting with analytical assessments and proceeding into comparative efficacy trials. Through a broad case study, you will make key decisions as you proceed towards demonstrating a high degree of biosimilarity to the approved reference product.