Early Phase Excellence: Navigating B Cell Therapies In Autoimmune Conditions

This webinar will take a deep dive into the rapidly advancing landscape of B cell–targeting therapies for autoimmune diseases — a therapeutic area marked by scientific momentum, increasing clinical innovation, and growing interest from biotech developers. Expert panelists will share insights into the most critical considerations for navigating early-phase clinical development and designing studies that reliably translate mechanisms into meaningful patient outcomes.

Discussion topics will include:

• Drug delivery strategies

How evolving delivery modalities—from monoclonal antibodies to next-generation biologics and engineered platforms—are shaping efficacy, durability, and patient experience.

• Cohort selection and study design

Best practices for identifying appropriate patient populations, leveraging biomarkers, and structuring early-phase trials to generate robust, decision-enabling data.

• Safety management in first-in-human studies

Approaches to risk assessment, monitoring, and dose-escalation strategies tailored to B cell–modulating therapies.

• Bioanalytical and translational considerations

The role of immunogenicity testing, PK/PD modeling, and exploratory endpoints in understanding mechanism and guiding development.

Designed specifically for biotech sponsors, this session integrates scientific, clinical, and operational perspectives to help teams navigate complex trial design decisions and accelerate the journey from discovery to early clinical validation.

Panelists:

Prof. Sepehr Shakib, Consulting Medical Director, CMAX

Dr. Carolyn Luscombe, Therapeutic Strategy Manager, Novotech

Moderator: Dr. Karen Scalzo-Inguanti, Director of Therapeutic Strategy, Novotech