Natalie Ketter
Director & Head of Investigative Toxicology Boehringer Ingelheim
Natalie Ketter is the Global Head of Early Safety Sciences at Boehringer, leading a multidisciplinary team focused on anticipating and mitigating safety risks early in drug discovery. Her organization integrates in silico prediction, in vitro systems, omics, immune safety and investigative pathology to deliver mechanism-driven insights that inform target selection and candidate design. With extensive experience in Investigative Toxicology, she has advanced early safety strategies for emerging modalities including protein degraders, to reduce attrition and accelerate the development of safe, effective medicines. Natalie champions collaboration across organizations to translate early safety signals into decision-ready strategies spanning diverse modalities and therapeutic areas.
Seminars
- What does “validated enough” mean in your organisation?
- How do validation expectations differ between discovery screening, candidate selection, and IND-enabling decisions?
- How are you selecting positive and negative control compounds, and where do gaps remain?
- What trade-offs exist between scientific relevance, historical data availability, and program timelines?
- How do you demonstrate human relevance when clinical anchoring data are limited or absent?
- What surrogate endpoints (e.g. biomarkers, exposure-response, phenotypic signatures) are most persuasive internally and externally?
- How do regulatory expectations influence your internal validation bar?
- Are FDA/EMA interactions raising standards, or creating flexibility around context-of use?
- Where do cross-industry frameworks (e.g. HESI, IQ MPS, consortia efforts) genuinely help, and where do they fall short?
- Target safety and in silico alerts: leverage data and mechanistic insights to identify hazards linked to target biology or chemical structure before synthesis
- Tailored in vitro models: beyond standard screens to understand toxicity drivers and prioritize candidates with the lowest risk
- De-risk earlier with confidence: integrate early data into a decision strategy to reduce attrition and accelerate decision
