Birgit Schultes
Chief Scientific Officer Intellia Therapeutics
Birgit Schultes is Chief Scientific Officer at Intellia Therapeutics, where she leads platform and pipeline research across in vivo and ex vivo gene editing and engineered cell therapy. With over 20 years in biotech and pharma, she brings deep expertise in immunology and cell therapy. Prior to Intellia, she led In Vivo and exploratory immunology at Unum Therapeutics. Her career includes translational research roles at Momenta Pharmaceuticals, United Therapeutics, and AltaRex. Birgit also co-founded Advanced Immune Therapeutics. She holds a Ph.D. in Immunology from the University of Bonn and completed executive training at Boston University.
Seminars
- Identifying immunogenic responses to CRISPR components and developing mitigation strategies to prevent immune rejection and enable sustained therapeutic efficacy
- Implementing safety monitoring frameworks to detect genotoxicity, off-target effects, and immune activation ensuring patient safety throughout clinical development
- Navigating regulatory expectations for immunogenicity assessment and long-term safety follow-up to accelerate approval pathways while maintaining durability standards
- Identifying strategic, regulatory, and technical barriers limiting gene editing therapeutics to rare, single-patient applications and exploring pathways to expand into larger patient populations
- Examining how industry leaders are navigating manufacturing challenges, clinical development efficiency, and regulatory alignment to make genome editing commercially viable across multiple indications
- Discussing the organizational capabilities, investment priorities, and platform design decisions required to transition from boutique therapies to scalable, multi-disease treatment models