Lovelace Biomedical has one of the longest-running preclinical gene therapy toxicology programs of any contract research organization, with more than a decade of experience conducting preclinical studies to evaluate the 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.
What We Do
Develop novel study designs to concurrently measure safety and efficacy of gene therapies
Monitor immune responses to vector or expressed protein
Measure biodistribution of vector and transgene expression
Evaluate traditional and non-traditional dosing routes
Endpoints That Matter
Vector biodistribution (qPCR)
running complex IND-enabling programs to support gene therapy development
lovelace Biomedical scientific staff experienced with pre-IND gene therapy programs
square feet lab space, including GLP-compliant operations
estimated sales of gene therapy products in the U.S. by 2020
Lovelace Biomedical is the leading CRO for performing Gene Therapy nonclinical development. We have been working with the FDA and scientists with leading pioneers in the industry to advance gene therapy products to the clinic for over 12 years. In 2007 our Gene Therapy pharmacology/toxicology Center was established by the NIH along with pioneers at the University of Pennsylvania. We have maintained this core for over 12 years, and have built on its foundation a successful resource for biotechnology and pharmaceutical companies aiming to advance their candidates from discovery to clinical stage by GLP enabling studies as rapidly as possible.
Gene Therapy Toxicology Expertise
PCR Development & Validation
Biodistribution & Gene Expression
Pre IND Package Development
Specialized Dose Delivery
Animal Model Propagation
Animal Model Development
*Lovelace Biomedical, through relationships with the NIH, working directly with the Gene Therapy Resource Program (GTRP), and also working closely with the FDA, allows us to have direct insight to “pre IND enabling,” new gene therapy development. Although we are not responsible for directly setting forth regulatory guidelines, we can offer direction and design for your program with our vast experience in gene therapy, to get your product to the next stage of IND development.