NHP PK/PD Studies With Fast Start-Ups and Seamless Transition

A growing number of gene therapy (GT) programs are moving from preclinical research into clinical development, bringing heightened attention to the strengths and limitations of both viral and nonviral delivery modalities. Each approach introduces distinct challenges—particularly when nonhuman primates (NHPs) serve as the translational model. This session will explore practical examples of these challenges and the innovative strategies used to address them, including how to model immunosuppressive regimens, key considerations for study design, methods for investigating germline integration using PCR, and the relevance of NHP age categories.

Complementing this, attendees will learn about Altasciences’ Sacramento Center of Excellence, a site dedicated to fast-start, Non-GLP NHP PK/PD and biodistribution studies that enable rapid early-stage decision-making. Designed to overcome industry-wide limitations in NHP availability and non-GLP capacity, the Sacramento site offers study initiation within 4–6 weeks, specialized endpoints, veterinary and pathology expertise, and access to PK colonies, with seamless progression into MTD, DRF, and GLP toxicology studies at Altasciences’ harmonized preclinical facilities in Seattle, Columbia, and Scranton.

This combined program is ideal for biotechnology and pharmaceutical companies, as well as academic researchers advancing GT and CNS-focused therapeutics.