Research Fellow Pfizer Worldwide Research Groton, Connecticut, United States
Sexually mature NHPs on repeat dose toxicity studies and pregnant NHPs should not be the default approach to inform pharmaceutical risks of infertility and during pregnancy, respectively. We challenge sponsors and regulatory authorities to evaluate those risks using a detailed weight of evidence approach. This weight of evidence not only evaluates potential risk based on the target and modality but the context of use and whether or not a NHP study would alter that assessment. If additional data are needed, we would advocate exhausting all reasonable and feasible non-NHP options to supplement and fill information gaps in the weight of evidence. If there are still gaps and use of sexually mature NHP are the only way to complete the developmental and reproductive toxicity assessment, then specific considerations are provided to optimize future use of this limited resource to advance the human safety assessment.
