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 to optimize your registrational trials and long-term follow up
New cell and gene therapy suite
Cell and gene therapies are incredibly intricate, but they’re making a huge difference in the drug development market and in the lives of patients. Learn all about our $9.2 million investment in cell and gene therapy.
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.
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.
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.
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.
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.
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
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
Conduct long term follow up studies, Phase IV trials, and fulfill post-marketing commitments
Test for CMC lot release and stability of manufactured product
Optimize your product’s value and commercial success
FDA approved gene replacement therapies
preclinical studies conducted using cell and gene therapy products in the last 5 years (mostly in vivo)
clinical studies conducted for cell and gene therapy products in the last 5 years
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 to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
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 to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.
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