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Disease & Study Strategy

Table of Contents

Nonclinical testing is an essential first step in new drug development. In this phase, the safety and efficacy of investigational compounds are assessed, establishing the foundation for subsequent clinical trials. The sections below outline drug discovery efforts and the role of nonclinical testing for each disease area.

New Anticancer Drugs

Oncology drug discovery is a critical effort to develop therapies for the intractable disease of cancer. Nonclinical studies use animal models to assess the efficacy and safety of investigational agents. These studies aim to address significant unmet needs for patients.

New Drugs for Immune Diseases

Immune diseases occur when the immune system mistakenly attacks the body’s own tissues. Through nonclinical studies, researchers evaluate the efficacy of new drug candidates and establish the basis for subsequent clinical trials. Advancing these programs may improve patient outcomes.

Drug Discovery for the Treatment of Organ Fibrosis

Organ fibrosis is a serious condition affecting major organs such as the liver, lungs, and kidneys. Data generated in nonclinical studies are critical to support advancement to clinical studies. Successful drug development could substantially improve patients’ quality of life.

Drug Discovery for Retinal Neurodegenerative Diseases

Retinal neurodegenerative diseases are serious conditions that can lead to visual impairment. Nonclinical studies evaluate the safety and efficacy of new agents and investigate potential effects on visual function. Ongoing research and innovation are expected to enable new therapeutic options.

R&D in Neurodegenerative Diseases

Neurodegenerative diseases are characterized by the gradual loss of function in brain and nerve cells. Nonclinical studies verify efficacy and safety to enable progression to clinical trials. These efforts aim to advance treatments for Alzheimer’s disease, Parkinson’s disease, and related conditions.

R&D in Metabolic Diseases

Nonclinical testing is essential to drug discovery for metabolic diseases. These studies help establish the efficacy and safety of investigational agents and support the development of better treatment options. The role of nonclinical studies continues to grow as research advances.

Drug Discovery for Atopic Dermatitis and Other Allergic Diseases

Atopic dermatitis is a skin disease characterized by chronic inflammation and intense itching. Through nonclinical studies, the efficacy and safety of new agents are evaluated to inform more effective treatments. Continued drug development may improve patients’ quality of life.

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.