Events Seminar: Keeping pace with emerging FDA expectations

Seminar: Keeping pace with emerging FDA expectations

Genomic safety assessment for nucleases and base editors: Keeping pace with emerging FDA expectations

Thursday, October 20, 2026

12:00 – 1:00 p.m.

Location & Description

University of Pennsylvania
Smilow Center for Translational Research (SCTR)
3400 Civic Center Boulevard, Philadelphia, PA 19104
9th Floor, Room 146

Join us for an engaging lunch-hour workshop designed for gene editing researchers interested in the latest approaches to genomic safety assessment for base editing therapeutics.

This session will explore a comprehensive, regulatory-aligned framework for evaluating off-target activity and structural genomic alterations, supporting the development of safer gene editing therapies.

Led by our expert scientists, this session will:

Present a regulatory-aligned framework for genomic safety assessment of base editing therapeutics
Explore complementary approaches for genome-wide off-target site nomination using ONE-seq and CHANGE-seq
Explain how the SeQure™ Edits of Relative Concern (ERC) framework prioritizes candidate off-target sites based on genomic and functional annotations
Review highly sensitive targeted sequencing methods for confirming off-target editing in relevant cell types and tissues
Highlight approaches for detecting structural rearrangements, including translocations and deletions, using SAFER detection
Demonstrate how these complementary technologies work together to support comprehensive genomic safety assessment and IND-enabling therapeutic development.

Whether you're developing or evaluating base editing therapeutics, this workshop will provide practical insights into integrating complementary off-target nomination, confirmation, and structural rearrangement analyses into a comprehensive genomic safety assessment workflow.

Space is limited—Reserve your seat today using the form below!

Speakers

Bob Policastro

Bioinformatics Manager, MaxCyte, Inc.

Bob Policastro is the Bioinformatics Manager at MaxCyte, where he bolsters the company's computational offerings to support clients in off-target assessment for cell and gene therapy programs. Prior to MaxCyte, he served as Head of Computational Biology at Ensoma, a clinical-stage in vivo cell and gene therapy startup. He began his biotech career at eGenesis, a clinical-stage company developing gene-edited porcine organs for xenotransplantation into humans. Bob received his PhD from Indiana University Bloomington, where his research focused on next-generation sequencing method development and the genomics of transcriptional regulation.