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Cell & Gene Therapies

Cell & Gene Therapies

Reduce the time and risk in all stages of developing your cell or gene therapy.

Deep expertise and experience in both cell and gene therapies, supported by expert teams

Full suite of coordinated and flexible solutions supporting rapid transitions within and between phases of development

Patient centric approaches for an enhanced patient experience and improved clinical trial outcomes

Cell & Gene Therapy Thought Leadership

Cell & Gene Therapy Answers: The Evolving Cell & Gene Therapy Landscape

Your source for answers to the complex challenges of cell and gene therapy development. We recently sat down with Maryland Franklin, Vice President and Enterprise Head of Cell & Gene Therapy at Labcorp Drug Development, to discuss key considerations for developing cell or gene therapies in today's quickly expanding pipeline.

Cell & Gene Therapy Answers: Addressing Complex Analytical Needs with ddPCR/qPCR

As the rate of cell and gene therapy development increases, Labcorp Drug Development has continued to invest in the technology, capacity and expertise globally to support the evolving and complex analytical needs of our clients. 

Seamless End-to-End Logistical Coordination in CAR T-Cell Therapies: On Time, Tracked and Secure

The chimeric antigen receptor (CAR) T-cell journey includes three distinct phases: collecting the patient's white blood cells through apheresis, modifying the patient's T-cells to manufacture the CAR T-cells, and, finally, infusing the new fighter T-cells into the patient. Connecting these three phases for a timely process that optimizes the patient experience requires a well-coordinated logistical system.

Cell and Gene Therapy - High Quality and Safety from Vein to Vein: CMC Testing for CAR T-Cell Therapies

Chemistry, Manufacturing and Control (CMC) testing is an integral part of the CAR T-cell clinical journey during vector production and T-cell modification. These tests, mandated by the FDA and other regulatory agencies, uphold the safety, purity and potency of the product before being administered to the patient.

Reuters Event - Cell & Gene Therapy USA - Taking the Long View: Addressing the Unique Challenge of Long-Term Follow Up for Cell & Gene Therapies

Listen to Maryland Franklin, PhD, Vice President and Enterprise Head of Cell & Gene Therapy, Labcorp Drug Development, focus on addressing the complexity of long-term follow up for cell and gene therapy with a patient-guided approach in her presentation, Taking the Long View: Addressing the Unique Challenge of Long-Term Follow Up for Cell & Gene Therapies.

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Access unparalleled solutions across the entire cell and gene therapy development continuum– right from the start

Let’s Get Started

Gene therapies continue to hold promise as treatments for many diseases but there are numerous and unique challenges to developing them for submission as an Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) application for use in clinical trials. These applications require an optimized scientific program designed to address the scientific, regulatory and practical challenges of gene therapy development.

Preclinical solutions:

  • Assess safety, establish proof of concept and feasibility rapidly

  • Successfully prepare for regulatory agency meetings and IND/IMPD/CTA submissions

  • Seamlessly transition to first-in-human trials 

Clinical trial solutions:

  • Identify, recruit and retain clinical trial participants using data-enabled solutions

  • Design and conduct patient-centric clinical trials 

  • Prepare and file for BLA/MAA and other submissions 

Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
The lasting image of the initial health exchange roll out is that of persistent technical problems that plagued the federal government’s insurance exchange website Healthcare.gov

Post-approval solutions:

  • Conduct long term follow up studies, Phase IV trials, and fulfill post-marketing commitments

  • Test for CMC lot release and stability of manufactured product

  • Support patient access to your new therapies

By the Numbers

Supported development of 5 most recent FDA approved cell & gene therapies
20+ years of delivering development solutions for advanced therapies
300+ preclinical studies conducted using cell and gene products in the last 4-years (mostly in vivo)
90+ clinical trials conducted for cell & gene products in the last 5 years

Cell & Gene Therapy Info Sheets

Cell & Gene Therapy Enterprise Solutions

Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Preclinical Development Solutions

Cell & Gene Therapy preclinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Clinical Development Solutions

Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

Cell & Gene Therapy Post-Approval Solutions

Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.

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