Achieving IND & BLA Approvals with Advanced Analytics

Landmark approvals from Orca Bio, Rocket Pharmaceuticals, and Regeneron, growing momentum behind in vivo CAR-T and autoimmune cell therapies, and new FDA initiatives designed to accelerate individualized genetic medicines are opening exciting opportunities across the industry. Yet these advances are also raising the bar for how therapies are characterized, controlled, and approved.

As novel therapies become more complex and development timelines tighten, analytical development is moving to the center of decision-making. From establishing meaningful potency assays and demonstrating comparability to defining biomarkers and generating robust product characterization data, analytical strategies are increasingly shaping whether programs progress successfully.

The 8th Cell & Gene Therapy Analytical Development Summit is the industry's leading forum dedicated exclusively to analytical development across cell and gene therapy. Bringing together analytical development, QC, characterization, CMC, and regulatory leaders, this is where the community comes together to share practical solutions, benchmark approaches, and stay ahead of evolving scientific developments and regulatory expectations.

For organizations looking to accelerate development, validate their strategies, and uncover proven approaches they can apply immediately, this is the meeting to attend in 2026.