Yi Yang
Director of Cell & Gene Therapy Novartis AG
Seminars
T-cell engager programs are advancing toward the clinic, but developers face an important challenge in demonstrating efficacy and safety in a therapeutic class where traditional preclinical models often fail to predict human responses. Unlike oncology, where tumor killing can be readily measured, autoimmune TCEs must balance selective immune-cell depletion, cytokine control, and long-term disease modification in heterogeneous patient populations. This workshop will explore innovative approaches to generating more predictive translational data and overcoming bottlenecks in both preclinical and clinical development by:
- Advancing ex vivo and human-derived testing platforms to improve clinical predictability, exploring the use of patient-derived samples, diseased tissue models, organoid systems, and immune-cell co-culture assays to evaluate pharmacodynamic activity in settings that better reflect autoimmune biology
- Establishing translational frameworks for assessing efficacy and safety before firstin-human studies, examining which biomarkers, functional assays, and immunemonitoring approaches are most predictive of clinical outcomes
- Innovating patient recruitment and trial design for emerging autoimmune TCE programs, exploring approaches to identify appropriate patient subsets, leverage biomarker-driven enrolment strategies, and recruit patients with specific immunecell signatures most likely to benefit from targeted depletion therapies
As the autoimmune T-cell engager field rapidly expands, developers face increasing pressure to demonstrate meaningful differentiation beyond simply being first to market. At the same time, regulators are grappling with how to evaluate therapies originally developed for oncology in patient populations with fundamentally different risk-benefit expectations. The challenge is no longer just proving activity, it is demonstrating why a therapy deserves adoption, investment, and regulatory approval in an increasingly competitive market.
Join biotech innovators, regulatory experts, clinical developers, and investors as they discuss how companies can successfully position their programs for both commercial and regulatory success by:
- Defining meaningful differentiation beyond target selection, exploring how developers can distinguish their therapies through safety profiles, depth and durability of response, patient convenience, biomarker strategies, co-stimulatory approaches, and disease-specific mechanisms rather than relying solely on novel targets
- Aligning development strategies with evolving regulatory expectations, discussing how regulators are approaching autoimmune T-cell engagers differently from oncology therapies, including considerations around toxicology requirements, cytokine release syndrome risk, chronic safety monitoring, and benefit-risk assessment
- Designing clinical programs that support both approval and competitive positioning, evaluating which endpoints, biomarkers, patient populations, and clinical datasets will be most important for demonstrating value to regulators, physicians, payers, and potential partners in an increasingly crowded field
