We specialize in preclinical safety studies that help advance novel gene therapies to testing in human clinical trials. Our team consults on experimental design and content of pre-IND packages, determines the safety and efficacy of the gene therapy products and provides final reports for submission to US and EU regulatory agencies. Lovelace Biomedical has been conducting studies in gene therapy for more than a decade, making us one of the country’s longest-running gene therapy programs in the preclinical space.
Gene Therapy Toxicology: Download
Gene Therapy Toxicology
Lovelace Biomedical has one of the longest-running gene therapy toxicology programs of any contract research organization, with more than a decade of experience conducting preclinical studies to evaluate safety, efficacy and biodistribution of gene therapy products.
Lovelace gene therapy toxicology program consults on experimental design and content of pivotal, pre-IND packages and provides final reports for submission to U.S. and European regulatory agencies. Preclinical studies in gene therapy are run in compliance with GLP standards in species ranging from rodents to nonhuman primates.
