For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
The cell and gene therapy (CAGT) pipeline represents incredible promise for the patients who need these products, many of whom have rare conditions without approved treatments or others who have exhausted treatment options. In bringing these novel therapies to market, sponsors face new regulatory and manufacturing challenges, operational complexity, and obstacles to market access.
Parexel helps sponsors innovate in this growing but uncertain space, so our experienced colleagues have strategized approaches to the persistent and prevalent barriers that CAGT developers may encounter. In this guide, we share some of those strategies — actionable insights for protecting the potential of your product in every phase of development.
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Three ways to improve your chances that insurers will pay for a new CGT
Feb 18, 2021
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Expedited Pathways Comparisons - US EU CHN
Oct 19, 2021
Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions
May 16, 2022
New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle
May 10, 2022
Chris Learn joins Parexel as Head of the Cell and Gene Center of Excellence
Apr 4, 2022
On-demand webinar: An expert guide to EU-CTR
Mar 10, 2022
New endpoints for early-stage cancer are gaining regulatory traction
Jan 28, 2022
Creating EU-CTR compliant and patient-friendly lay language summaries (LLS)
Jan 26, 2022
Biosimilar Development: Are therapeutic clinical trials needed?
Nov 16, 2021