TD2, which stands for Translational Drug Development, is an oncology-focused organization in Scottsdale, Arizona.[S1] It is unusual in this list because it spans the whole path from preclinical tumor models through regulatory strategy to running clinical trials, rather than specializing in one stage.[S3][S5][S6] It is a privately held limited liability company; Research Corporation Technologies acquired and invested in it on June 4, 2020 and holds two board seats.[S2] This profile covers the nonclinical part of the offering and is explicit about which parts are not GLP.
Nonclinical services relevant to US drug developers
In vivo oncology models
The preclinical offering covers in vivo tumor models including syngeneic models, patient-derived xenografts, cell line-derived xenografts and humanized mouse models, run in a facility the company describes as AAALAC accredited.[S3] For an oncology program these are the studies that support candidate selection and dose rationale before an investigational new drug application.
DMPK and tolerability, stated as non-GLP
The company describes its DMPK and ADME work and its safety and tolerability studies as non-GLP.[S4] That is an explicit statement rather than an absence of information, and it defines the boundary of what this organization can contribute to a regulatory package. Exploratory tolerability and exposure data from here can inform dose selection; the pivotal GLP toxicology supporting an IND would need to be placed at a GLP facility. The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.[S4] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2]
Regulatory strategy and the transition to clinic
Alongside laboratory work the company offers regulatory strategy and support for investigational new drug applications,[S5] and runs clinical trials under Good Clinical Practice.[S6] 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. For a small oncology sponsor the appeal of this structure is continuity: the team that generated the nonclinical data also prepares the submission and runs the trial. The trade-off is that the nonclinical safety package still has to come from elsewhere, so the handoffs need planning even within a single vendor relationship. In 2024 the company added a site in Bothell, Washington through the acquisition of FCSL and established a United Kingdom subsidiary.[S7]
Quality, compliance, and animal welfare (as stated by the company)
The company states that its preclinical work runs in an AAALAC-accredited facility.[S3] No USDA registration, OLAW Animal Welfare Assurance, Institutional Animal Care and Use Committee statement, ISO certification or CLIA certification was found on the pages reviewed, and no GLP regulation is cited anywhere. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6] This profile does not evaluate the company's animal care program; the statement above is the company's own.
Privately held limited liability company. Research Corporation Technologies acquired and invested in the company on June 4, 2020 and holds two board seats[S2]
Employees and revenue
Not disclosed
Focus
Oncology, from preclinical models through regulatory strategy to clinical execution[S1][S5][S6]
Preclinical models
Syngeneic, patient-derived xenograft, cell line-derived xenograft and humanized mouse models[S3]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
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.
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