HKEY-AI-NAM-Bridge™ 1.0 connects AI predictions, new approach methodologies and in vivo evidence for more targeted preclinical study design
BOSTON and SUZHOU, China, July 13, 2026 /PRNewswire/ — HKeyBio has established HKEY-AI-NAM-Bridge™ 1.0, its AI and New Approach Methodologies (NAMs) In Vivo Evidence Bridging Package. The service helps autoimmune and allergy drug-development teams identify evidence gaps and design more targeted in vivo validation paths from AI predictions, in vitro assays, organ-on-chip, cell-based, omics and preliminary PK data.
HKEY-AI-NAM-Bridge™ 1.0 at a Glance
What it is: HKEY-AI-NAM-Bridge™ 1.0 is HKeyBio’s preclinical evidence-bridging service for AI, NAMs and in vivo validation.
Problem addressed: It helps identify evidence gaps between AI predictions, in vitro systems, omics or organ-on-chip data and disease-relevant in vivo evidence.
Use cases: The service is designed for programs with existing AI prediction, in vitro, cell model, organ-on-chip, omics or preliminary PK data.
HKeyBio capability link: The service draws on HKeyBio’s in vivo efficacy evaluation, NHP models, pathology, immune phenotyping, biomarkers and translational interpretation.
AI and NAMs help design smarter in vivo studies
HKEY-AI-NAM-Bridge™ 1.0 is based on a practical principle: AI and NAMs do not simply replace animal studies; they can help design more targeted and more interpretable in vivo studies.
The package focuses on evidence gaps, minimal study design and bridging endpoints
1. Evidence gap analysis
Identifies gaps such as in vitro activity without disease-model efficacy, binding without downstream function, AI prediction without target engagement, or mouse data without cross-species interpretation.
2. Minimal in vivo validation questions
Prioritizes the few critical questions that an in vivo study should answer first.
3. Bridging endpoint design
Connects pharmacodynamic endpoints, mechanism endpoints, translational biomarkers, PK exposure, PK/PD correlation and basic safety observations.
HKeyBio integrates disease models, NHP research and translational reporting
Deliverables may include existing evidence summary, evidence gap assessment, in vivo validation rationale, minimal animal study design, biomarker and PK/PD bridging plan, NHP necessity assessment, IND-enabling relevance, risk and limitation statement and next-step recommendation.
"A more responsible approach is to use AI, in vitro and NAM data to ask better questions, and then validate the critical evidence in disease-relevant in vivo models," said the Head of Translational Medicine at HKeyBio.
About HKeyBio
HKeyBio is a preclinical CRO specializing in autoimmune and allergic diseases, supported by animal models, NHP models, pathology, immunology assays, PK/PD, biomarkers and English-language translational reporting.
For more information, please contact:
Website: www.hkeybio.com
Email: tech@hkeybio.com
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