Six Dosing And Safety Considerations In The Era Of Emerging Therapies

By Peter Larson, M.D., Senior Medical Director for Hematology-Oncology

Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies.

Following are key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies.