The 2nd Annual ADC Pharmacokinetics & Clinical Pharmacology Summit
Bioconjugation Insights 2025; 1(5), 213–215
DOI: 10.18609/bci.2025.033
As part of our ongoing coverage of key gatherings in the bioconjugation and ADC development space, Bioconjugation Insights presents a preview of the 2nd Annual ADC Pharmacokinetics & Clinical Pharmacology Summit, taking place December 9–11, 2025, in Boston, MA. The meeting will convene leaders in drug metabolism and pharmacokinetics, pharmacokinetics/pharmacodynamics, bioanalysis, pharmacometrics, and clinical pharmacology to address some of the most pressing translational challenges in ADC development, from first-in-human dose prediction to the complexities introduced by novel conjugation formats and emerging payload classes.
Translating preclinical insights into clinical dose prediction
A major focus of this year’s summit is strengthening pharmacokintetics-pharmacodynamics (PKPD) translation to inform clinical projections and reduce uncertainty in early development. Christina Vasalou (AstraZeneca) will discuss ‘Defining the therapeutic index in early ADC development: considerations from design parameters to clinical translation,’ outlining how consistent translational strategies can support the integration of preclinical efficacy and safety data into early-stage decision-making.
This presentation is part of the ‘Bridging the translational gap for PKPD: preclinical approaches for improved translation of PK and reduced reliance on animal models’ section, which will examine approaches designed to strengthen PK translation and inform clinical studies while reducing dependence on animal model data.
Additional perspectives on translational prediction come from Zuzana Antošová (SOTIO Biotech), who will explore how species-specific differences in ADC stability and degradation influence human PK prediction, and Werner Rubas (Sutro Biopharma), who will outline AI-based methods to efficiently identify ADC candidates with unfavorable PK profiles.
Dose optimization & exposure–response analysis
Dose selection continues to be a central challenge for ADC developers. Salaheldin Hamed (Astellas Pharma) will open the main program with ‘Dose optimization of antibody-drug conjugates & exploring the relevance of exposure–response relationships,’ addressing the integration of PKPD and exposure–response data in refining dose-finding strategies, including a case example focused on enfortumab vedotin.
The agenda includes further discussions on dose optimization for emerging ADC modalities. Hongmei Xu (Bicycle Therapeutics) will describe considerations for dose evaluation in bispecifics, incorporating preclinical and clinical datasets alongside quantitative system pharmacology (QSP) modelling. Amit Khatri (Daiichi Sankyo) will present on applying cross-ADC exposure–response learnings to streamline development where candidates share common payloads.
Later in the program, Souvik Bhattacharya (Astellas) will examine enfortumab vedotin exposure in patients with urothelial carcinoma through population PK modelling, exposure–response analyses, and clinical evaluation of dose modification.
ADC stability, tumor disposition, & bioanalysis
The summit will also explore the analytical and mechanistic factors that influence ADC behavior in both preclinical and clinical settings, with Marcel Hop (Genentech) presenting on ‘Tumor disposition of ADCs & implications for efficacy’. He will focus on ADC design principles guided by understanding mechanisms of cellular uptake and payload release, along with key drivers influencing ADC efficacy.
Bioanalytical complexity is further addressed in several sessions. Christopher Beaver (Daiichi Sankyo) will highlight the impact of in vivo biotransformation on the suitability of bioanalytical assay formats and strategies for managing these effects, while Yuting Wang (AbbVie) will explore analytical approaches for novel ADC modalities, including techniques for assessing structural integrity, DAR, and conjugation site characterization.
These sessions collectively reflect increasing attention to stability, biotransformation, and characterization challenges as ADC formats diversify.
Modelling-enabled decision-making
Modelling and simulation will feature prominently across both mechanistic and clinical applications. Prabhas Jagdale (GSK) will present on using advanced modelling to understand how ADC format, target binding, and payload dynamics inform dose decisions. Eshita Khera (Novartis Biomedical Research) will describe QSP-guided design considerations for selectively targeted payloads, including degraders.
Roundtable discussions will address how clinical pharmacology assessments, including organ impairment studies and drug-drug interaction evaluations, can be used strategically to support clinical trial planning and regulatory alignment.
The 2nd Annual ADC Pharmacokinetics & Clinical Pharmacology Summit brings together a focused community of ADC developers committed to improving the predictability, efficiency, and safety of next-generation conjugates. With deep dives into PKPD translation, dose optimization, stability assessment, tumor disposition, and advanced modelling frameworks, the meeting offers a rich platform for data-driven discussion across early discovery and clinical development. Attendees can expect rigorous scientific exchange and practical insights that reflect the increasing complexity of ADC design and the growing need for integrated, mechanistically informed development strategies.
For more information, visit the conference webpage.