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.
Development of novel models to evaluate efficacy of gene therapy approach
Monitoring of of unwanted lymphocyte or antibody responses to vector or expressed protein
Measurement of distribution of the vector in the body and transgene expression in the target location
Evaluation of safety and efficacy of the gene therapy product