Areas of Expertise
My work in gene and cell therapy has focused on the intersection of virology, viral vector analytics, CMC development, and manufacturing. I have worked across AAV and lentiviral vector programs, from early development through late-stage regulatory submissions, with an emphasis on practical, scientifically grounded decision-making.
Development Strategy
Gene delivery is never one-size-fits-all. Choosing the right system and development path can make the difference between a smooth regulatory submission and costly delays.
My experience spans AAV and lentiviral vector development, including vector characterization, manufacturing scale-up, and cross-functional decision-making.
Viral Vector Analytics
Analytical strategies need to evolve with the program while continuing to generate meaningful, fit-for-purpose data. My experience includes analytical strategy, assay development and characterization, method troubleshooting, and analytical risk assessment across viral vector programs.
CMC & Manufacturing
My experience includes process development, technology transfer, CDMO interactions, and coordination of analytical and CMC activities across development programs.
I have also supported regulatory submissions and post-approval activities through CMC document review and revision, data assessment, and responses to regulatory questions for viral vector programs.
