Tag: oncology drug development

Clinical Research: Phase 1 - Phase 4

Considerations for Operationalizing Pediatric Oncology Studies

Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By closing the orphan drug exemption loophole and enabling earlier discussions with the FDA, the Research...

Patient and Stakeholder Engagement

The Art and Science of Selecting Patients for Phase I Oncology Studies

The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies of...

Advancing Drug Development: Join Us at Clin Ops in Oncology West

DURHAM, N.C., APRIL 20, 2018 — A Premier Research oncology expert will discuss advances in the development of cancer drugs at Clinical Operations in Oncology Trials West Coast in Burlingame, California. Brian Huber, Executive Director for Oncology Strategic Development, will present Transforming the Oncology Drug Development Process on Tuesday, April 24, at 10 a.m. Mr....