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.
Related Insights
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Article
Three ways to improve your chances that insurers will pay for a new CGT
Feb 18, 2021
Podcast
CAR-T boxed warnings: What comes next?
Mar 6, 2024
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Feb 27, 2024
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Blog
CAR-T boxed warnings: regulatory precedents and opportunities
Feb 9, 2024
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Podcast
Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
Sep 19, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022
Related Insights
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Article
Three ways to improve your chances that insurers will pay for a new CGT
Feb 18, 2021
Podcast
CAR-T boxed warnings: What comes next?
Mar 6, 2024
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Blog
CAR-T product development: an assessment of FDA’s final guidance for industry
Feb 27, 2024
Blog
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Blog
CAR-T boxed warnings: regulatory precedents and opportunities
Feb 9, 2024
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Podcast
Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
Sep 19, 2022
Blog
Preparing for the New Era of Hybrid Regulatory Inspections
Jul 11, 2022
Article
EU Orphan Drug Designation – overcoming regulatory challenges
Jul 20, 2022