PDG provides strategic toxicology consulting from development through NDA submission. In terms of strategy, one of our most critical functions is to attempt to reduce toxicology study requirements.
For example, in a recent meeting with FDA, we presented data in support of waiving the carcinogenicity requirements for a new drug product. Our presentation consisted of an integrated reanalysis of carcinogenicity data from the scientific literature, FDA FAERS database and the sponsor’s own internal safety data. As a result, the carcinogenicity requirement was waived.
The toxicology assessments required for IND/NDA submissions depend on the nature of the drug product and the investigation phase. These toxicology assessments may include studies to describe acute, subchronic, and chronic effects of the drug related to dose effects, carcinogenicity, genotoxicity, mutagenicity, reproduction toxicity, teratogenicity, immunotoxicity, and phototoxicity. During the IND phase of product development, discussions with FDA help guide the type and length of toxicology assessments required. Once performed, these studies are then integrated into a summary of toxicological effects from both the in vitro and animal studies. Along with this integrated summary, sponsors also develop detailed tabulations of data from each study. These data compilations and integrated analyses form the basis of whether the proposed drug product is safe to be tested in humans. After the IND submission and during clinical studies of the drug, animal studies may continue to be conducted in order to provide additional safety data.
Included in our toxicology consulting services are the selection, audit, qualification and oversight of laboratories and Contract Research Organizations (CROs). We compile, review and edit protocols and review study reports, travel to study sites and monitor the conduct of studies, as needed.