Cell and Gene Therapy Insights
Oncology Spinouts
Academic Partnerships
Oncology Spinouts
Optimized an early-phase oncology spinout’s IND-enabling workflow, achieving a 40% reduction in time-to-submission and enhancing FDA alignment through a biomarker-driven study design.
Gene Therapy
Academic Partnerships
Oncology Spinouts
Developed a dual-AAV preclinical plan and biomarker roadmap that facilitated the smooth IND preparation for a gene therapy startup.
Academic Partnerships
Academic Partnerships
Academic Partnerships
Transformed exploratory mouse model data into a GLP-compliant regulatory study package that was adopted by a collaborating CRO.