Small Molecule Cancer Drug Development Services

Integrated preclinical, regulatory, and clinical trial expertise to accelerate oncology small molecule programs

TD2 Oncology offers comprehensive preclinical development services for small molecule cancer therapeutics, accelerating the path from discovery to clinic. Our integrated approach combines deep oncology expertise with cutting-edge technologies to support small molecule optimization, pharmacokinetics (PK), pharmacodynamics (PD), mechanism of action studies, and in vivo efficacy modeling. Leveraging robust tumor model platforms and translational biomarker strategies, TD2 enables high-confidence decision-making to de-risk and advance small molecule drug candidates. Whether evaluating targeted therapies, kinase inhibitors, epigenetic modulators, or immune-oncology agents, our tailored preclinical programs are designed to generate the data needed for successful IND submissions and clinical success.


Features and Benefits:

  • Comprehensive Preclinical Platforms
    Full suite of in vitro and in vivo models, including syngeneic, xenograft, and humanized systems to evaluate efficacy and mechanism of action.

  • PK/PD and ADME Expertise
    Advanced capabilities for pharmacokinetic and pharmacodynamic modeling, metabolic stability, and bioanalytical support to inform dosing strategies.

  • Biomarker-Driven Study Design
    Integration of translational biomarkers and flow cytometry to track tumor response, target engagement, and immune modulation.

  • Accelerated IND-Enabling Pathways
    Streamlined preclinical workflows with regulatory insight to shorten timelines and reduce risk during IND preparation.

  • Customized Study Designs
    Flexible programs tailored to the unique properties of each small molecule candidate and aligned with clinical development goals.

Request more information about our Small Molecule Cancer Drug Development Services

Contact our experts to help advance your drug development with TD2's Comprehensive Oncology Ecosystem.

Preclinical Services to Support Small Molecule Cancer Therapy Development

In Vitro Characterization

In Vitro
Characterization

In Vitro ADME Characterization

Phosphoprotein Analysis

Gene and protein expression via flow and qPCR

2D/3D In Vitro assays tumor cellline screening

Flow analysis of cytotoxicity, DNA damage, cell cycle and apoptosIs

Drug solution analysis

Chemical stability

In Vivo Pharmacology

In Vivo
Pharmacology

Over 300+ CDX models

Rare tumors

Gynecologic Malignancies

Glioblastoma

In vivo efficacy studies

Specialty surgical & orthotopic models

Clinically-relevant combinations

Immuno-oncology

Microbiome

DMPK analytical services

Comprehensive CBC analyzer

PK evaluation

Optical Imaging

Metabolomic and Proteomic analysis

Non-GLP Toxicity Studies

Regulatory Support:

TD2 offers comprehensive regulatory support to expedite the development of small molecule therapeutics for oncology indications. Our team brings deep expertise in oncology-focused medical writing, along with regulatory proficiency across Chemistry, Manufacturing, and Controls (CMC), pharmacology, and toxicology specific to small molecule compounds. We provide a tailored, science-driven approach to navigating the evolving regulatory landscape, ensuring alignment with FDA expectations. Our services include strategic regulatory consultation, program management, and direct FDA engagement, all designed to streamline the IND-enabling process and reduce time to clinical entry for small molecule cancer therapies.

Clinical Trial Services:

TD2’s clinical trial services are purpose-built to accelerate the development of small molecule cancer therapies through every stage of the clinical process. With over 20 years of oncology specialization and a proven track record across a broad range of indications and trial phases, TD2 offers full-service clinical program management—from protocol design and patient recruitment to site activation, data management, and regulatory compliance. Our team leverages deep therapeutic expertise, advanced digital tools, and customized operational strategies to drive efficiency and data integrity across all trial activities. Supported by a history of success in early-phase oncology trials, including a high concentration of solid tumor and basket studies, TD2 delivers the strategic insight and operational excellence needed to bring small molecule therapies to patients faster.

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Put your clinical trial in the hands of a team who believes in your research as much as you do.

Are you ready to start your preclinical trial? Partner with a collaborative oncology CRO that believes in your treatment as much as you do. Take the first step today and contact our experts.