Predicting Human Pharmacokinetics and Doses of Diverse Modalities: The Current State of the Art and Case Studies

This PBSS workshop will present cutting-edge tools, methods, and case studies for predicting human pharmacokinetics (PK) and dose selection across various modalities, including small molecules, oligonucleotides, and biologics. Topics include machine learning-based PK prediction, cross-industry efforts from the IQ Consortium, and applications to emerging modalities such as siRNAs and PROTACs. The workshop will also cover the role of pharmacokinetic/pharmacodynamic (PK/PD) relationships in guiding first-in-human dose selection, with case studies on monoclonal and bispecific antibodies, as well as immunomodulators informed by HESI’s work beyond the minimal anticipated biological effect level (MABEL). A final case study will demonstrate the integration of PK/PD modeling with nonclinical data to support therapeutic index estimation. Attendees will gain practical insights into advancing predictive strategies for drug development of diverse modalities.

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