The core activity of LYO-X AG is modeling and simulation as well as systems pharmacology for the preclinical and clinical development of biotherapeutics.
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Strategic consulting and PK/PD modelling for the preclinical and clinical development of biotherapeutics, including systems pharmacology to support development decisions.
On Demand Phase I PK/PD Analysis
Pharmacokinetic, pharmacodynamic and biomarker analyses for Phase I studies to support dose escalation and interpretation of study results.
Target Assessment
Assessment of target structures as part of early biotherapeutic development, based on mechanistic PK/PD and systems pharmacology approaches.
Format Selection
Support with selecting the drug product format for biotherapeutics, e.g. for antibodies, bi-specifics, ADCs, nanobodies or Fab fragments.
Candidate Selection
Support in selecting candidates for preclinical and clinical development programmes based on PK/PD and systems pharmacology analyses.
Preclinical PK/PD and Toxicology Study Support
Planning and evaluation of preclinical PK/PD and GLP toxicology studies for the development and translation of biotherapeutics.
First Dose in Human / MABEL
Support in defining the first human dose via MABEL-based assessments for biotherapeutics.
Paediatric Dose Finding
Dose finding and dose derivation for paediatric studies based on PK/PD modelling.
Clinical Dose Finding Studies
Support for clinical dose-finding studies to select dose and regimen during the development process.
Due Diligence
Assessment of development projects and drug substance programmes within due-diligence analyses for biotherapeutics.
Biobetter Design and Benchmarking
Design and benchmarking of biobetter candidates for biotherapeutics based on mechanism of action, PK/PD and development goals.
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