Cell therapy products have the potential to treat a variety of cancers and other diseases. Whether you’re developing an allogeneic or autologous product, an adoptive cell therapy (such as CAR T, NK or DC) or a stem cell-derived product, you’ll benefit from our expert teams’ deep knowledge and experience.
Assess safety, establish proof of concept and feasibility to support IND/IMPD/CTA submissions, and rapidly transition to first-in-human trials
Conduct Phase I, II, and III trials to support BLA/MAA submissions and prepare for post-marketing approval studies
Conduct real-world evidence studies, fulfill post-marketing commitments and optimize availability to your cell therapy
In vitro & in vivo pharmacology & toxicology
Bioanalysis/PK: infiltration/engraftment, persistence & shedding
Biomarkers: strategy, assay development & testing
Regulatory & strategic product development consulting
Clinical development preparation & planning
BioCMC testing & analytical control strategy– safety, identity, strength & purity
Commercialization strategy
Patient identification & recruitment
Protocol modeling & development
Project & logistics management
Medical monitoring and specialized training for AEs
First in human / dose range-finding & escalation studies
Proof of Mechanism/Proof of Concept (PoM/PoC) trials
Lab testing: PK, Biomarkers, Central Labs, Genomics, Specialty Testing and BioCMC
Regulatory & strategic product development consulting
Long-term follow-up preparation and testing strategies
Real-world evidence studies
PIV and pharmacovigilance
Long-term follow-up studies (up to 15 years)
Differentiation studies
Combination Studies
Lab testing
Disease and product registries
Health economics
Field reimbursement
Clinical education
Payer and customer relations
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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.
MAKING YOUR BREAKTHROUGHS POSSIBLE
Over the past five years, we’ve invested more than $700 million in nonclinical development to enhance our capabilities for your programs. From expanded lab space in our U.S., European and Asia Pacific sites to state-of-the-art instrumentation and digitized workflows, we’ve innovated where it matters most to empower your healthcare mission.
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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