The program

9:00 – 10:00

Introduction to clinical pharmacology of biologics

  • Clinical pharmacology of biologics: rationale of unique PKPD characteristics
  • General considerations and guidelines for safe FiH starting dose calculation

10:00 – 11:00

MABEL approach for FiH dose selection: to be or not to be

  • Establishing minimal anticipated biological effect level (MABEL) criteria for biologics: current perspectives and recommendations
  • Step-by-step calculation of FiH dose for bispecific mAb based on MABEL using R statistics and  “Simurg” infrastructure
  • Beyond “conservative” MABEL approach: is the selected dose optimal?

11:00 – 11:15

Break


11:15 – 13:00

Model-based analysis of in vitro cytotoxicity data

  • Obligatory properties of bispecific antibodies: affinity Vs avidity
  • Diverse conditions of in vitro data: how to account for incubation time, E:T ratio, various cell lines, etc.
  • Количественная оценка «иммунологического синапса»: модель Т-клеточно-зависимой клеточной цитотоксичности (TDCC)

13:00 – 14:00

Lunch Break


14:30 – 16:30

Translational QSP modeling – from in vitro to human

  • Translational QSP model development to predict exposure-efficacy and exposure-safety relationships in patients R statistics and  “Simurg” infrastructure – from exploratory data analysis to advanced diagnostics
  • Implementing local and global sensitivity analyses: step towards virtual populations generation
  • Model-based calculation of pharmacology active and safety doses for FiH trials via virtual patient populations
  • Quick look at MID3 approaches in support of bispecific Ab development: towards sequential preclinical/clinical data integration via QSP approach

16:30 – 17:00

Concluding remarks and Q&A