Sabine Pilari

BlueViolin addresses all questions around the analysis of PK and PK/PD data. The services cover all stages of drug research and development. 

Preclinical

• Review and guidance on interpretation of PK and TK data
• Review and guidance on interpretation of in vitro and in vivo pharmacological studies
• PK and PK/PD analysis incl. dose-response and mechanistic modeling
• PK/PD modeling-supported design of pharmacokinetic, pharmacological and toxicological studies in animals or in vitro

Translational

• Human PK prediction and prediction of human efficacious dose & starting dose
• Fit-for-purpose approach: allometric scaling, in vitro-in vivo extrapolation, empirical PK and PK/PD modeling, physiology-based PK (PBPK), mechanistic PK/PD modeling
• Reporting for submission to regulatory authorities

Clinical

• Pharmacometrics: population PK analysis, physiology-based PK (PBPK), PK/PD modeling
• Guidance on dose selection and selection of dosing regimens
• Clinical trial simulations
• Modeling analysis plan and modeling reports for submission to regulatory authorities

Education

• M.Sc. Bioinformatics
• Dr. rer. nat. (PhD) Graduate Research Training Program "Pharmacometrics and Computational Disease Modeling" (https://www.pharmetrx.de/)

Experience

• Extensive experience in pharmacometrics & PK/PD modeling with a track record of supporting drug development in biotech and pharma.
• Former modeling scientist at Bayer and Abbott/AbbVie, contributing to early and late-stage research and development projects across multiple therapeutic areas
• Hands-on expert in human PK prediction and first-in-human dose selection
• Hands-on population PK and PK/PD analyses to support dose optimization, regulatory submissions, and decision-making in clinical programs
• Experience in mechanistic and PBPK modeling
• Close collaboration with multidisciplinary teams, including pharmacologists, toxicologists, clinicians, regulatory experts, and bioanalytical scientists, to integrate modeling into drug development
• Proven track record in supporting biotech companies by providing tailored modeling strategies for efficient and data-driven development decisions