Beyond binding – iPSC-based functional safety screening for oncology modalities
Thursday, January 22 at 15:00 GMT | 16:00 CET | 10:00 EST | 07:00 PST
Biologics and cell-based therapeutics are expanding rapidly across oncology, yet early detection of safety liabilities remains a critical challenge. Off-target interactions and low-level antigen expression in healthy tissues can lead to severe clinical setbacks.
Recent FDA guidance emphasizes the need for human-relevant in vitro systems to assess functional toxicities before entering clinical trials. Induced pluripotent stem cell (iPSC)-derived models provide a reproducible, scalable solution for multi-tissue safety evaluation, including cardiac risk assessment.
In this webinar, industry experts will explore current challenges in oncology safety testing and the evolving regulatory landscape. They will introduce a novel iPSC-derived multi-tissue functional safety screening platform and demonstrate how comprehensive kinetic cardiac profiling can mitigate risk prior to clinical development, supported by case studies on antibody-drug conjugates (ADCs) and kinase inhibitors.
Key learning objectives
- Understand the current challenges and regulatory expectations for in vitro safety testing in oncology drug development.
- Learn how iPSC-derived multi-tissue models overcome limitations of traditional systems and improve translational relevance.
- Gain insights into integrating multi-tissue safety screening into drug development workflows and support regulatory alignment.
- Discover how early cardiac safety profiling can guide program decision and inform risk mitigation.
Who should attend?
- Big pharma: in vitro translational, pharmacology, toxicology and safety teams
- Biotechnology companies: in vitro translational, pharmacology, toxicology and safety teams
- Regulatory agencies employees: EMA and FDA
- Non-profit research organizations/foundations in oncology
- Oncology advocatory groups
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Speakers
Dr. Annie Delaunois, DVM, Ph.D., DSP, currently serves as Head of Safety & Secondary Pharmacology within the Non-Clinical Safety Evaluation group at UCB where she has worked for over 18 years. She previously spent seven years at the Lilly Development Center in Belgium. Throughout her career, Dr. Delaunois has developed extensive expertise in in silico, in vitro, and in vivo models, with a particular focus on cardiovascular and CNS safety. In 2026 she will be the Vice-president of the Safety Pharmacology Society and she has (co-)authored approximately 80 publications and participated in over 100 international conferences in the fields of safety pharmacology and toxicology.
With over 10 years of experience in immuno-oncology and translational research, Dr. Sanne Holt 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.
Dr. Silke Schwengberg holds a PhD in cell biology and immunology from the University of Hannover, Germany, and has over 20 years of experience in stem cell-based models for drug discovery. She is passionate about developing and applying functional iPSC cardiomyocyte assays to assess the efficacy and safety of novel drug therapies. Before joining Ncardia, Dr. Schwengberg led cross-functional teams at stem-cell technology companies and worked as an independent scientific consultant for eight years, providing expertise in assay development for drug discovery and toxicology. At Ncardia, she applies her extensive experience to advance innovative toxicology solutions, supporting the development of safer and more effective therapeutics.
Moderator
