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Cell and Gene Therapies

Transforming Lives

According to ClinicalTrials.gov, there are over 1,500 registered ongoing clinical trials for cell and gene therapies (C&GTs). C&GT is poised to deliver on its promise of transforming lives. C&GT promises to deliver life-changing remedies to rare and orphan disease populations by finding a cure, as opposed to management or treatment.

While the Food and Drug Administration (FDA) approved the first therapy as recently as 2017, through 2022, the FDA approved a total of 27 C&GTs. This represents an increasing proportion of total approvals and approximately eight percent of the 340 approved biologics. The research landscape has been energized by recent significant therapeutic successes.

Our Insights

While gaining traction, biotech companies recognize the future of this unique research ecosystem means facing those challenges head-on in manufacturing, regulatory requirements, staffing, and investment from research to commercialization.

Did you Know?


of the top 100 cell and gene companies have used Advarra Technology or Services


of the top 10 pharma companies have used Advarra Services


of the top 100 cell and gene companies have worked with Advarra Consulting


or less business days to receive your NIH registered site review

Read our Related Resources


FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

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Regulatory Trends in Cell and Gene Therapies

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

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A Guide for Successful Cell and Gene Therapy Research

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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