Zack Zhang
Company: Beam Therapeutics Inc.
Job title: Director
Seminars:
Panel Discussion: Navigating the Phase Appropriate Regulatory Prospective & Expectations of Potency Assays to Meet CQAs & CPIs to De-Risk Regulatory Submissions 12:00 pm
What is the phase appropriate expectation for potency assays? Protein expression versus activity-based methods What is the feedback on potency assays when using cell lines that do not match the site of indication? Debating the need to measure the potency of each component or drug substance of an mRNA-LNP, compared to just formulated drug product…Read more
day: Conference Day One
Enhancing Analytical Methods & Quality Control Validation to Bolster the Discovery & Clinical Progression of Novel mRNA Gene Editing Therapies 2:35 pm
The advancement of mRNA gene editing technologies presents significant therapeutic potential for precision medicines. However, the development and clinical progression of these therapies is armed with increasingly rigorous validation, characterization and optimization constraints requiring both new and modified analytical tools. This workshop aims to address these challenges and explore cutting-edge solutions for analytical and quality…Read more
day: Pre-Conference Workshop Day