Translational Studies
Prisys Biotech provides integrated NHP-based translational studies designed to bridge the critical gap between discovery research and first-in-human clinical trials. Through our advanced Translational Medicine Platform, we align disease biology, drug mechanism, and clinically relevant readouts within a single, coherent experimental framework.
By combining well-characterized nonhuman primate disease models, clinical-grade diagnostic methodologies, and multimodal efficacy and safety assessments, Prisys supports global pharmaceutical and biotechnology partners in making data-driven go/no-go decisions with higher confidence.
Our translational studies are particularly suited for programs where rodent models show limited predictive value, including complex immune-mediated diseases, CNS disorders, respiratory indications, and biologics-based therapies.
Why Nonhuman Primates for Translational Research?
Nonhuman primates (NHPs) offer unparalleled translational relevance due to their close similarity to humans across multiple biological dimensions:
1. Anatomical and Physiological Similarity
Gyrencephalic brain structure relevant to CNS pharmacology
Human-like tracheobronchial branching supporting respiratory disease modeling
Comparable cardiovascular, metabolic, and reproductive systems
2. Molecular and Pharmacological Concordance
High homology in drug transporters, metabolizing enzymes, and receptor targets
Improved predictability of PK, PD, and exposure–response relationships
3. Immune System Relevance
Similar immune cell subsets, signaling pathways, and cytokine networks
High translational value for immunology, inflammation, and biologics
4. Clinical Phenotype Alignment
Ability to model disease initiation, progression, staging, and therapeutic response using clinically interpretable endpoints
Addressing a Key Challenge in Drug Development
A major bottleneck in drug development is the disconnect between target validation and early clinical outcomes. Many candidates fail because preclinical models do not adequately reflect human disease biology or clinical assessment paradigms.
The Prisys NHP Translational Platform mitigates this risk by:
- Aligning preclinical endpoints with clinical diagnostics
- Integrating mechanism-of-action (MoA) evidence across molecular to systemic levels
- Generating clinically interpretable efficacy and safety signals before IND or early clinical entry
Core Translational Study Capabilities
1. Integrated Pharmacology and Toxicology
General and target-organ toxicology in disease-relevant contexts
Early identification of on-target vs. off-target effects
Safety signals assessed alongside efficacy, not in isolation
2. Biomarker-Driven Study Design
Longitudinal sampling across disease phases:
baseline → early → onset → active → progression
Molecular, cellular, and functional biomarkers aligned with clinical practice
3. Mechanism of Action (MoA) Elucidation
Multi-level evidence linking:
target engagement → molecular signaling → tissue response → functional outcome
Support for regulatory-facing mechanistic narratives
4. Therapeutic Profiling and Dose Translation
Integrated PK/PD/ADME–efficacy–safety data packages
Clinically relevant dosing strategies and exposure margins
Side-by-side comparison with approved or benchmark therapies
5. Advanced Interventional and Imaging Techniques
Minimally invasive and atraumatic surgical procedures
Device implantation and local delivery (including imaging-guided interventions)
Multimodal imaging support (e.g., DSA, MRI, CT)
Representative Translational Applications
Allergen-induced acute asthma attack in NHPs, evaluated using non-terminal pulmonary function tests (PFTs)
AI-based hierarchical 3D motion learning systems for spontaneous NHP behavior mapping and functional outcome quantification
These approaches enable objective, quantitative, and repeatable translational endpoints that closely mirror clinical assessments.
Why Prisys Biotech?
- AAALAC-accredited NHP research infrastructure
- Deep expertise in complex disease modeling and translational pharmacology
- Strong integration of advanced imaging, biomarker analytics, and AI-driven quantitative analysis
- Scientifically rigorous, decision-oriented study designs-not exploratory for its own sake
FAQ
Q1: When should NHP translational studies be considered in a drug development program?
A: NHP studies are particularly valuable when rodent models lack predictive power, such as for biologics, immune-mediated diseases, CNS indications, and respiratory disorders, or when clinical-relevant endpoints are required before IND submission.
Q2: Are Prisys translational studies limited to efficacy evaluation?
A: No. Our studies integrate efficacy, safety, PK/PD, biomarker dynamics, and MoA evidence into a single translational framework to support informed development decisions.
Q3: Can clinical diagnostic methods be directly applied in your NHP studies?
A: Yes. We intentionally align preclinical assessments with clinical diagnostics (e.g., imaging, functional tests, biomarker panels) to improve translatability.
Q4: Does Prisys support customized translational study designs?
A: Absolutely. Each translational program is tailored based on the therapeutic modality, target biology, disease indication, and development stage.
Q5: How does Prisys ensure animal welfare while maintaining scientific rigor?
A: All studies are conducted under strict ethical oversight, with refined, minimally invasive procedures and longitudinal non-terminal assessments wherever possible.
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