Consulting

Six Dosing and Safety Considerations in the Era of Emerging Therapies

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. Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include: Using dose-finding trial designs...