TD2 (Translational Drug Development)

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.

Company facts