Late-stage attrition is one of the costliest problems in biotherapeutic development and one of the most preventable. Too many antibody and bioconjugate programs reach late preclinical or clinical stages with liabilities that could have been identified and addressed much earlier. The tools to do this exist, but the challenge is knowing how to deploy them effectively.

Two gaps that drive the problem:

• First, standard preclinical models routinely fail to capture how complex biotherapeutics behave in human immune tissue, leaving off-target immune activation or cytokine dysregulation undetected until it becomes a clinical finding.
• Second, immunogenicity risk assessment is still too often treated as a late-stage obligation rather than an early selection criterion, despite being a leading driver of attrition and post-approval withdrawal.

However, both gaps are addressable earlier than most programs attempt.

Join experts, Dr Sanne Holt (Associate Director, Immuno-Oncology, Ncardia) and Dr Erika Kovacs (Sr. Director of Bioassay, Abzena) on May 21^st, as they present a practical, case-based integrated approach to early safety assessment. Drawing on human iPSC-derived functional immune models, alongside in vitro immunotoxicity and immunogenicity evaluations, they will share key insights into the mechanistic understanding needed to make informed candidate selection decisions.

Key learning objectives

• Why conventional early safety tools leave predictable blind spots in antibody and bioconjugate development
• How iPSC-derived immuno-oncology models surface functional liabilities that standard assays miss
• How immunotoxicity and immunogenicity risk — using both in silico and in vitro approaches using primary human cells — can be assessed before IND-enabling studies
• How to combine these approaches into an integrated early safety strategy that reduces downstream attrition

Register to learn how to implement an integrated early safety strategy and assess how this approach could increase your biotherapeutics’ chances of clinical success.

Who should attend

For discovery, translational, and preclinical scientists working on antibody and bioconjugate programs who want to improve early safety assessment and reduce downstream risk.

Our Speakers

Erika Kovacs, PhD, Sr. Director of Bioassay, Abzena

Erika Kovacs is the Senior Director of Bioassay at Abzena. With over 19 years of pharmaceutical industry experience, she leads the Bioassay team at Abzena, supporting drug discovery and development efforts with cell-based assays for lead selection, characterization, potency, and safety. With her expertise in functional characterization and complex modes of actions, she is passionate about finding new modalities to fight cancer. Erika has a strong academic background, earning a PhD in Biochemistry from Eötvös Loránd University, Hungary, and completing a postdoc at the University of California, Berkeley, prior to joining Abzena. 

Sanne Holt, PhD, Associate Director Immuno-Oncology, Ncardia Services 

With over 10 years of experience in immuno-oncology and translational research, Sanne specializes in advancing large molecules and cell therapies from early discovery to IND-enabling studies. At Ncardia, she manages a scientific team and drives innovation in efficacy and safety testing of novel drug therapies on human iPSC-derived cell models. 

Previously, she held leadership roles at Merus N.V. and Charles River Laboratories, where she managed cross-functional teams and delivered impactful research solutions. She holds a PhD from King’s College London and is passionate about supporting the translation of cutting-edge science into real-world therapies. 

 About Ncardia

Ncardia is a research and development human iPSC technology company with facilities and offices located throughout Europe and North America. Ncardia is built on the belief that stem cell technology will help bring better therapies to patients faster. The company’s goal is to enable biopharmaceutical companies to accelerate the discovery and development of new therapeutics in any drug modality, including drug, cell, and gene therapy, through the efficient integration of human iPSC technologies. For more information, visit www.ncardia.com.