End-to-end Gene Therapy Development Solutions

Gene therapy development is a young field with a wide range of challenges that include a dynamic regulatory environment, pre-existing and treatment-induced immunity to the viral vectors, and even patient recruitment and adherence for gene therapies targeting rare diseases.

Precision’s integrated approach to clinical development ensures that the comprehensive expertise needed to create solutions for every gene therapy development challenge, from IND-enabling assays to commercialization, is ready to advance your development program.

End-to-end Gene Therapy Development Solutions

Gene therapy development is a young field with a wide range of challenges that include a dynamic regulatory environment, pre-existing and treatment-induced immunity to the viral vectors, and even patient recruitment and adherence for gene therapies targeting rare diseases.

Precision’s integrated approach to clinical development ensures that the comprehensive expertise needed to create solutions for every gene therapy development challenge, from IND-enabling assays to commercialization, is ready to advance your development program.

Optimizing successful development of viral vector gene therapies, gene therapy trials, and companion diagnostics

Delivering evidence at every critical inflection point

Precision delivers leadership in regulatory strategy, specialization in immunogenicity studies and rare disease trials, and the expertise to effectively coordinate both a therapeutic and companion diagnostic strategy in parallel.
Industry-leading expertise in biomarker and immunogenicity assays

Biomarker assays are critical for gene therapy development, especially for evaluating T and B cell immunogenicity.

Precision is at the forefront of immunogenicity testing for gene therapy trials, with thought leaders who are helping to shape the regulatory landscape and standardize methods for AAV-based assays.

Learn more about our specialty lab services>

Full support for rare disease trial execution

Gene therapies often target small patient populations, presenting unique challenges. We design trials with a patient-centric approach and utilize advanced statistical methods to reach small populations and meet complex endpoints. Our expertise is reflected in a 100% data submission acceptance rate.

Learn more about our rare and orphan disease expertise>

End-to-end companion diagnostics and regulatory process experience

We develop and execute strategies for assays, trials and CDx development in tandem, an approach necessary to ensure rapid time to market. In addition, we offer fully-compliant (CLIA) cell-based NAb assays for CDx and commercial use.

Learn more about our companion diagnostics capabilities>

Gene therapy solutions

Learn more about Precision’s capabilities for accelerating the development of gene therapies.

Discover how our gene therapy expertise can advance your clinical development program

Discover how our gene therapy expertise can advance your clinical development program

Services that support the development of cell & gene therapies

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Cytokine Analysis

Build a quantitative understanding of the cytokines present in your sample. We leverage a range of assay technologies to maximize data from even challenging samples.

Bioanalytical Testing

Bioanalytical analysis of biologics, cell therapies, gene therapies, and companion diagnostics development from the globally-recognized leaders in immunogenicity testing.

Explore Other Areas of Expertise