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.
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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 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
Rare tumors
Gynecologic Malignancies
In vivo efficacy studies
Specialty surgical & orthotopic models
Clinically-relevant combinations
Immuno-oncology
Microbiome
Comprehensive CBC analyzer
PK evaluation
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.
Comprehensive
Clinical Trial Services Include:
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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.