As the Antibody‐drug conjugates (ADCs) space continued to thrive in 2024, with 12 approvals and a growing number of diverse candidates being developed, getting the dosing spot on is pivotal for success in bringing safe and efficacious ADCs to patients, quicker.

In the face of evolving regulatory guidance and more complex ADCs entering development, the inaugural ADC Pharmacokinetics & Clinical Pharmacology Summit came to life in October 2024 to provide in-depth pharmacokinetic and clinical pharmacology insights to help ADC developers select a clinical dose that maximizes efficacy whilst limiting toxicities and drive more ADCs to BLA approval quicker.

As the next generation of ADCs becomes even more complex, this further emphasizes the need to integrate insights within PK/PD, bioanalysis, pharmacometrics and clinical pharmacology to support the tricky translation from non-clinical studies into clinical trials.

Attendees heard first-hand insights on establishing a clear mechanistic link between ADC design and PK profile, utilizing pharmacometrics and PK/PD data to inform dose optimization for FIH, later phase dosage and ADC combination therapies, taking practical insights back to your own department to curate a clear strategy for striking clinical success with your next ADC candidate.