Frequently Asked Questions

Q: What is an NHP study?

A nonhuman primate (NHP) study uses a primate model to evaluate the safety, pharmacology, biodistribution, immunogenicity, or biological activity of a therapeutic before clinical development.

Q: Why are NHPs used in preclinical development?

NHPs can provide valuable translational information for therapies where species-specific biology, immune response, anatomy, or delivery considerations make them relevant to the development program.

Q: Which NHP species are used in preclinical studies?

Rhesus, cynomolgus macaques, marmosets, baboons, African green monkeys, and squirrel monkeys are commonly used in preclinical development. The appropriate species depends on the therapeutic, mechanism of action, intended clinical route, and study objectives.

Q: What therapeutic modalities can be evaluated in NHP studies?

NHP studies can support development of gene therapies, viral vectors, RNA therapeutics, cell therapies, biologics, vaccines, and other advanced therapeutic programs. Study design and endpoints are tailored to the specific modality.

Q: What is NHP biodistribution?

NHP biodistribution studies evaluate where a therapeutic or vector is distributed throughout the body following administration. Depending on the modality, this may include molecular and tissue-based analysis.

Q: What is NHP immunogenicity testing?

NHP immunogenicity testing evaluates immune responses to the therapeutic, vector, or transgene. Depending on the program, this may include anti-drug antibodies, neutralizing antibodies, and cellular immune responses.

Q: What is vector shedding?

Vector shedding refers to the release of vector material from an administered subject into biological matrices such as blood, urine, feces, saliva, or other relevant samples. Shedding assessments can be incorporated into gene therapy studies based on the program and study objectives.

Q: How does NHP toxicology support an IND?

NHP toxicology can provide important safety information for regulatory development packages. Study design, species selection, endpoints, and GLP requirements depend on the therapeutic and development program.

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