Hesperos, Inc. is a contract research organization in Orlando, Florida that describes contract research services using human cells in interconnected microfluidic systems. It describes itself as "a global contract research organization (CRO) providing compound safety and efficacy testing services using its Human-on-a-Chip? platform,"[S1] and states that it was "founded in 2015 ... by Drs. Shuler and Hickman with the goal of accelerating drug discovery by leveraging their Human-on-a-Chip?."[S1] No animal study service was found on the pages reviewed; that is an absence in those pages, not a finding that none exists. Where a provider works with human cell systems, the questions a sponsor normally asks ? GLP status, AAALAC accreditation, species availability ? apply differently, and this profile sets out what was and was not found. This profile summarizes the platform, services, and company facts most relevant to US sponsors, and sets out where this kind of data currently fits in a regulatory program.
The platform
The company describes Human-on-a-Chip as an "interconnected, reconfigurable, multi-organ in vitro platform reproducing the functional aspects of human physiology."[S3] Systems are built from human cell modules, including induced pluripotent stem cell-derived neurons, motoneurons, myotubes and blood-brain barrier cells, primary renal proximal tubule cells[S2], intestinal epithelial cells and the THP-1 monocyte line. A serum-free recirculating medium links the modules, and the company states that this "allows for complex pharmacokinetic profiles of compounds and metabolic products through absorption, distribution, metabolism, and elimination (ADME) depending on the organ systems incorporated."[S2] Named configurations include a two-organ heart and liver system, a three-organ heart, liver and cancer system, a four-organ heart, liver, neuron and skeletal muscle system, a two-organ neuromuscular junction model, and a heart, liver and skin system.[S2]
Services relevant to US drug developers
Cardiotoxicity, hepatotoxicity, and cardiac electrophysiology
The base two-organ heart and liver system is used for acute and chronic cardiotoxicity and hepatotoxicity screening, with the company stating that systems are "routinely operated up to 28 days."[S2] Readouts include contractile force, beat frequency and field potential duration as a surrogate for the QT interval. The company states that "our cardiomyocyte models adhere to the Comprehensive in vitro Proarrhythmia Assay (CiPA) Initiative guidelines concerning torsadogenic potential (TdP) risk."[S2] The company also states that the model is intended to replace whole-heart perfusion animal models in some discovery and development uses.[S2] That is a company objective, not a statement of regulatory acceptance; neither FDA nor ICH approves animal models in the sense that phrasing suggests. Sponsors should establish what a stated alignment with that initiative means for their specific submission.
Barrier tissues, disease models, and other modules
Barrier tissue modules can be added to the standard housing. The blood-brain barrier module is described as composed of iPSC-derived cells and "extensively characterized for tight junction-mediated barrier formation and paracellular (passive) and transcellular (active) transport mechanisms."[S2] The gastrointestinal module uses iPSC-derived enterocytes or immortalized patient biopsy intestinal epithelial cells so that "the absorption and first-pass metabolism characteristics of a novel compound can be determined."[S2] A kidney renal proximal tubule module assesses tubular reabsorption and secretion, barrier integrity and release of the KIM-1 injury biomarker.[S2] A skin module built on a synthetic membrane supports topical work, and THP-1 monocytes can be added to the circulating medium for inflammation and immune endpoints.[S2] On the disease side, the neuromuscular junction model is applied to neurodegenerative disease including amyotrophic lateral sclerosis,[S2] and a malaria model has been published.[S5]
Where this data fits in a regulatory program
The company has stated that data from its systems has been included in a regulatory submission by a third party. This profile does not reproduce that claim, because the only source located for it is the company itself and it concerns a filing by another organization. An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed. Including data in an IND is therefore not the same as FDA endorsing the method. The FDA Modernization Act 2.0, enacted as section 3209 of the Consolidated Appropriations Act, 2023, changed the statutory definition so that a nonclinical test need not be an animal test,[S6] but it did not require FDA to accept any particular alternative method. Sponsors should treat microphysiological system data as evidence to be discussed with FDA for a specific program rather than as a drop-in replacement for a required animal study.
Quality and compliance (as stated by the company)
The pages reviewed for this profile (home, about, services, technology and news; accessed September 3, 2026) do not state that the company conducts studies under Good Laboratory Practice regulations, and they contain no ISO certification statement. No AAALAC, USDA, OLAW or Institutional Animal Care and Use Committee statement was found on those pages either; that is an absence in those pages, not a finding about the status of the company. GLP can apply to in vitro nonclinical laboratory studies as well as animal studies,[R2] so a sponsor who needs GLP documentation should ask the company directly whether a given study can be run that way. The company's stated vision includes a world where "animals are no longer used for chemical testing or drug discovery";[S1] that is a mission statement rather than a description of a validated replacement.
12501 Research Pkwy, Suite 100, Orlando, FL 32826, United States[S1]
Founded
2015, by Michael L. Shuler and James J. Hickman[S1]
Ownership
No stock listing or investor is named on the website[S1]
Leadership
Lawrence Florin (Chief Executive Officer); Michael L. Shuler, Ph.D. (Co-Founder and President); James J. Hickman, Ph.D. (Chief Scientist and Co-Founder)[S1]
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.
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 approach allows 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)
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.
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 a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering 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.
Japanese
