Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success

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.

Open PDF

Return to Insights Center

Related Insights


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