# HKEY-AI-NAM-Bridge™ 1.0: HKeyBio Connects AI, NAMs and In Vivo Evidence

- Link: https://www.thailand-business-news.com/pr-news/hkey-ai-nam-bridge-1-0-hkeybio-connects-ai-nams-and-in-vivo-evidence
- Published: 2026-07-13T20:16:00+07:00
- Author: PR Newswire

**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](https://www.hkeybio.com)

Email: [tech@hkeybio.com](https://www.thailand-business-news.com/pr-news/tech@hkeybio.com)

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