Track 02 of 9
Clinical Pharmacology
PK/PD, dose-finding, adaptive trials, special populations.
Clinical pharmacology is moving away from MTD-driven oncology dose selection toward the FDA Project Optimus paradigm of optimized, tolerable dosing in registrational trials. The track will cover model-informed drug development (MIDD), population PK/PD with non-linear mixed effects modeling, exposure-response analyses, and the increasing role of physiologically based PK (PBPK) for pediatric, pregnancy, hepatic, and renal impairment dosing. Sessions will also address adaptive and platform trial designs, decentralized clinical trials with wearables and home dosing, and dose-finding in cell therapies and bispecifics where traditional 3+3 designs are inadequate.
Focus areas
- Project Optimus: oncology dose optimization beyond MTD
- Model-informed drug development and PBPK in special populations
- Decentralized clinical trials, wearables, and remote dosing
- Adaptive, platform, and master protocol trial designs
- First-in-human dosing for bispecifics, CAR-T, and radioligands
- Pediatric, pregnancy, and lactation pharmacology (PREA, BPCA)
- Drug-drug interactions: transporter and CYP-mediated risk