ALBUQUERQUE, NM., Jan. 22, 2019 /PRNewswire/ -- Lovelace Biomedical has won a third consecutive 5-year support contract to provide pharmacology and toxicology drug development services to the Gene Therapy Resource Program (GTRP) at the National Heart, Lung, and Blood Institute (NHLBI). With the $13M support contract, Lovelace provided support for investigational new drug (IND) studies to advance gene therapy candidates from the preclinical stage. These studies are conducted with GLP and non-GLP compliance, which are held in-line with the Food and Drug Administration (FDA) requirements by which the GTRP standards adhere to.
Established in 2007, the GTRP program at Lovelace is the longest running gene therapy program given to any contract research organization. The 5-year extension award will complete 15 years of the contract, which is intended to advance promising therapeutics from early discovery to the clinic. The GTRP was established with the intent to support gene therapy focused primarily on heart, lung, and blood disorders by providing U.S.-based researchers with resources critical to advancing investigational gene transfer products into clinical testing. Lovelace provides one component of the GTRP program, and also offers these services to commercial collaborators.
About Lovelace Biomedical
Building on a history of pioneering science and technological innovation, Lovelace Biomedical is a contract research organization that helps pharmaceutical and biotechnology companies advance their discoveries—no matter how complex—into clinical testing and beyond. The organization leverages its multidisciplinary toolset to push the limits of preclinical research and fully understand the behavior of its clients' investigational products. Lovelace Biomedical provides a unique scientific and logistical capacity to solve specialized challenges that other CROs are not equipped to handle, featuring expansive bio-secure facilities and ongoing access to industry-leading research experts and study directors. The team thrives on developing programs for difficult areas of drug development while delivering the same level of rigor and attention to seemingly straightforward studies that are just as critical to regulatory success.