Scientific Senior Director Bristol-Myers Squibb Princeton, New Jersey
This symposium will allow participants to understand why sponsors may allow sites to procure a biosimilar use as a co-med in a clinical study. It will discuss bioanalytical challenges associated with the use of multiple brands and batches of within a clinical study and provide clear information on requirements for the PK and immunogenicity assessments that align with trial objectives and health authority guidance.
Learning Objectives:
Understand why sponsors may allow sites to procure a biosimilar use as a co-med in a clinical study.
Understand the bioanalytical challenges associated with the use of multiple brands and batches of within a clinical study.
Develop a bioanalytical strategy based on robust scientific rationale that aligns with health authority recommendations
