Lovelace Biomedical has one of the longest-running gene therapy 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 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.
Lovelace Biomedical Research Institute (Lovelace) has served as the Pharmacology/Toxicology Core Laboratory (PTCL) to the NHLBI Gene Therapy Resources Program since its inception in 2007. The function of the PTCL within the GTRP is to conduct toxicology/safety assessments and evaluate biodistribution of the therapies in appropriate animal models under Good Laboratory Practice Guidelines. The results of these studies support approval of IND applications to initiate Phase I/II clinical trials in humans.
There are two components to the PTCL services: 1) Consulting, and 2) Pre-clinical study conduct and reporting. Consulting includes working with investigators to develop their request for funding from the GTRP, including assistance with pre-clinical study design and with pre-IND package preparation if requested. Once the GTRP approves study funding, Lovelace performs the needed safety and biodistribution studies and provides a GLP audited final report to be included in the investigator’s IND submission.
Dr. Benson holds a BS degree in Chemistry from the University of California, Berkeley and a PhD in Comparative Pharmacology and Toxicology from UC, Davis. She was a Diplomate of the American Board of Toxicology from 1981 - 2017. She has over 100 publications in the scientific literature. She currently serves on the US Transuranium Uranium Registry Scientific Advisory Committee and has served on scientific advisory Committees (National Academy of Sciences, the EPA IRIS review Committee, and American Conference of Industrial Hygienists Threshold Limit Value Committee).
