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

Report

New Medicines, Novel Insights: Accelerating development of cell and gene therapies

May 22, 2023

Podcast

Rare endpoints: Delivering on unmet patient needs

May 7, 2024

Video

Cell & Gene Therapies: A Regulatory Update

Jul 22, 2022

Blog

CAR-T boxed warnings: regulatory precedents and opportunities

Feb 9, 2024

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

Podcast

CAR-T boxed warnings: What comes next?

Mar 6, 2024

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

Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit

Sep 19, 2022

Blog

Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

May 16, 2022

Podcast

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

Jun 16, 2022