Gene therapies offer a new method of potential treatment, particularly for patients with rare genetic diseases. Whether you’re developing a viral vector-based therapy, such as an adeno-associated virus (AAV) or lentivirus (lenti) product, or applying gene editing technologies such as CRISPR/cas9, 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 preparation for post-marketing studies
Conduct real-world evidence studies, fulfill post-marketing commitments and optimize availability to your gene therapy
In vitro & in vivo pharmacology & toxicology (acute & chronic)
Bioanalysis/PK: biodistribution, persistence & shedding
Biomarker strategy, assay development & testing
Regulatory & strategic product development consulting
Clinical development preparation & planning
BioCMC Testing– safety, identity, strength & purity
Commercialization Strategy Development
Patient identification & recruitment
Protocol modeling & development
Project & logistics management and oversight
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 strategy development
Long-term follow-up studies
Lab Testing
Disease and product registries
Health economics
Field reimbursement
Clinical education
Payer and customer relations
Differentiation studies
Connect With Us
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.
REDEFINING WHAT’S POSSIBLE FOR YOUR STUDIES
We’ve invested more than $700 million in scientific innovations to advance your nonclinical studies. With our expanded lab space, newest technologies and digitized back offices, the solutions we provide are more innovative than ever.
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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