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SMC Laboratories, Inc.

Table of Contents
Table of Contents

SMC Laboratories is a provider of drug evaluation testing & consulting services.High level of patented technologyThis section details examples of pathological models and case studies held by SMC Laboratories, which has Please use this as a reference when choosing a contracting company.

Features of SMC’s Contract Non-Clinical Study Services

Support for Diseases Lacking Established Disease Models

In the process of new drug development, models that accurately recapitulate the pathology of the target disease are required. At SMC Laboratories (SMC), even for diseases for which no model currently exists that can represent human pathology, the company can undertake the development of proprietary disease models. As a result, new drug development for untreated diseases can be enabled.

STAM™ Mouse: A Proprietary Disease Model

The STAM™ mouse—developed by SMC—mimics the progression from non-alcoholic steatohepatitis (NASH) to hepatocellular carcinoma (HCC). The disease progresses rapidly and shows a 100% incidence of hepatocarcinoma, making the model suitable for evaluating immunotherapies and molecularly targeted drugs. The tumor microenvironment can also be analyzed, and the model plays an important role in new drug development.

Extensive Experience in Liver Disease and Fibrosis

Over the past 10 years, SMC has provided services to more than 1,000 research institutions across 30+ countries, and studies using the patented STAM™ mouse have been published in numerous papers and presented at international conferences.

Reference: SMC Laboratories official website
https://www.smccro-lab.com/jp/service/#ser01

Examples of Disease Models Developed by SMC Laboratories, Inc.

It is essential to go through the testing of candidate compounds in animal models that reproduce the target disease before advancing to clinical trials.

However, clinically relevant disease models may not always exist, thus there are demands for animal models with strong clinical correlation.

Below are some examples of disease models offered at Ina Research.

STAM™ Model

This model shows pathological progression similar to human MASH/NASH–liver cancer. Mimicking late-stage type 2 diabetes , the disease progresses from fatty liver to NASH, fibrosis, and liver cancer. The disease progresses over a short period, with 100% liver cancer at 20 weeks of age;, as a result of these characteristics, research using this model has been published in more than 70 papers to date.

Reference: Japan Science and Technology Agency – Life Science Database Cross Search
https://dbsearch.biosciencedbc.jp/Patent/page/ipdl2_JPP_an_2011524600.html

Unilateral Ureteral Obstruction (UUO) Model

UUO model is widely used as a renal fibrosis model. It exhibits interstitial fibrosis, tubular atrophy, and infiltration of inflammatory cells, which are characteristic pathological features of chronic kidney disease.

With a study duration of only two weeks, this model is well suited for in vivo screening studies of antifibrotic drug candidates for kidney fibrosis.

SMC Laboratories’ Nonclinical Case Studies

Phase 2 study in NASH-related liver cirrhosis

Galectin Therapeutics Inc. (NASDAQ: GALT) conducted a drug evaluation study targeting fibrosis in STAM™ mice, supporting a Phase 2 study in NASH-related liver cirrhosis.

*Reference: https://www.smccro-lab.com/jp/quality/

Ongoing Phase 2 study in NASH at the hepatic fibrosis stage

Can-Fite BioPharma Ltd. (NYSE American: CANF, TASE: CFBI) conducted a drug evaluation study targeting NASH using the STAM™ model. A Phase 2 study targeting NASH at the hepatic fibrosis stage is currently ongoing.

*Reference: https://www.smccro-lab.com/jp/quality/

SMC Laboratories, Inc. (SMC) Information

SMC supports more than 1,000 pharmaceutical companies and bio ventures in 30 countries around the world, including Japan and North America*.

Address Technoport Kamata Center Bldg., 2-16-1 Minami Kamata, Ota-ku, Tokyo
Tel 03-6715-9101
Website https://www.smccro-lab.com/jp/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Labcorp Holdings Inc.
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
  • Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

By region
list of animal models
Expertise & Track Record
3 Recommended Contract Non-Clinical Testing Services