Clinical Research: Phase 1 - Phase 4

LSX 2021: The Path From Preclinical to and Through Clinical

Presented by:

Peter Larson, Vice President, Medical Affairs for Hematology-Oncology

Angi Robinson, Vice President, Specialty Areas

April Marquick, Cell and Gene Therapy Expert

Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies, highlighting these products’ unique challenges as well as their powerful potential to address a broad array of unmet patient needs.

Both the European and U.S. perspective are addressed with a focus on these three key areas:

Trial Design Considerations

Regulatory Study Start-Up Considerations

Study Execution for Advanced Therapies

“To achieve operational excellence in cell and gene therapy trials, sponsors must understand — and overcome — obstacles ranging from evolving regulations and comprehensive site selection to patient recruitment and retention,” says Dr. Marquick. “Drawing on Premier’s experience supporting over 60 cell and gene therapy trials in the past five years spanning oncology, hematology, metabolic disorders, and more, this presentation will provide actionable insights for sponsors looking to realize the potential of these life-changing therapies.”