Hi colleagues,
I am relatively new to supporting gene therapy and when reading about AAV shedding I pictured it as a biomarker for safety, even if it uses the same PCR method as for PK. Am I incorrect? Is it a PK assessment? Are you collecting PK data in other tissues? The reason I am asking is because I want to ensure clear roles and responsibilities between the bioanalytical (PK and immunogenicity) and the Translational Leads (biomarkers). How is your company doing it?
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Johanna Mora Ph.D.
Bristol-Myers Squibb
Princeton NJ
[email protected]------------------------------