Translational Drug Development
Translational Drug Development (TD2) is a privately held, oncology-focused CRO founded in 2003 that provides integrated preclinical, clinical trial, regulatory, and flow cytometry services to biotech, pharmaceutical, and academic sponsors developing cancer therapies.
- Company typePrivate
- Founded2003
- HeadquartersScottsdale, United States
- Headcount101–250
- GTM typeB2B
- OfferingServices
What Translational Drug Development does
Translational Drug Development (TD2) is a privately held oncology-focused Contract Research Organization (CRO) founded in 2003 and headquartered in Scottsdale, Arizona. The company provides integrated drug development services to biotech and pharmaceutical companies developing cancer therapies, spanning four core service pillars: Clinical Trial Services (Phase I-III design, execution, and site management), Preclinical Services (over 400 proprietary cancer models including PDX, syngeneic, orthotopic, humanized, and CDX systems), Regulatory Support (IND filings, specialty designations, and FDA interactions), and Flow Cytometry (high-throughput immunophenotyping and biomarker assays). TD2 also offers PK/ADME, pharmacovigilance, medical monitoring, data management, and the Peak Partners site network for accelerated patient enrollment.
The company's underlying technology platform combines extensive in vivo model systems with bioanalytical capabilities (flow cytometry, metabolomics, proteomics, DMPK/ADME) and adaptive clinical trial design methodologies (rule-based, model-based, and model-assisted dose-finding approaches). TD2 serves three primary customer segments: early to mid-stage biotech companies requiring translational and clinical development support, large pharmaceutical companies seeking specialized expertise in complex modalities (radiopharmaceuticals, ADCs, CAR-T), and academic/research institutions conducting oncology research programs.
TD2 operates a professional services, fee-for-service revenue model with custom project-based engagements and multi-year contracts, priced on a study-by-study basis. The go-to-market motion is relationship-driven enterprise field sales, supported by content marketing, webinars, podcasts, conference participation, and thought leadership publications. The company has expanded into adjacent areas including autoimmune cell therapy development (via December 2025 In Vivo CAR-T services launch) and multi-omics biomarker capabilities (via May 2026 Panome Bio partnership), while maintaining a US-centric operational footprint aligned with FDA regulatory expertise.
Translational Drug Development firmographics
Firmographics- Name
- Translational Drug Development
- Legal name
- Translational Drug Development, LLC
- Website
- https://td2inc.com
- Company type
- Private
- Founded year
- 2003
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Translational Drug Development (TD2) is a privately held, oncology-focused CRO founded in 2003 that provides integrated preclinical, clinical trial, regulatory, and flow cytometry services to biotech, pharmaceutical, and academic sponsors developing cancer therapies.
- Ownership category
- akta.pro rank
Translational Drug Development industry classification
Industry- Product category
- Oncology Contract Research Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Medical and Diagnostic Laboratories (62151)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
- akta.pro secondary industries
- Translational Medicine & Biomarkers (HLAIALAF), Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB)
Keywords
Where Translational Drug Development is headquartered
LocationHeadquarters
- HQ city
- Scottsdale
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Translational Drug Development business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure, Supply Chain
Revenue model
- Oncology CRO Services: TD2 generates revenue by providing fee-for-service oncology contract research organization services to biotech and pharma companies. Services span preclinical studies, regulatory consulting, flow cytometry, and clinical trial management, typically billed as project-based engagements or retainer arrangements for ongoing program support.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based engagements for oncology drug development services |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
Translational Drug Development product offering
Product offeringCore offering
Translational Drug Development (TD2) is an oncology-focused contract research organization that provides integrated preclinical, regulatory, flow cytometry, and clinical trial management services to biotech and pharmaceutical companies developing cancer therapies. The company leverages a proprietary library of over 400 preclinical cancer models, high-throughput flow cytometry, adaptive trial design, and FDA regulatory expertise to translate drug candidates from preclinical studies through Phase I–III clinical trials. Services are delivered as custom, project-based engagements directly to sponsor companies in the United States.
Product overview
TD2 Oncology (Translational Drug Development, LLC) is an oncology-focused Contract Research Organization (CRO) offering an integrated ecosystem of drug development services. The portfolio consists of four interconnected service pillars: (1) Clinical Trial Services for Phase I-III trial design, execution, and site management; (2) Preclinical Services encompassing over 400 cancer models and bioanalytical capabilities including flow cytometry, metabolomics, and DMPK/ADME; (3) Regulatory Support for IND filings, specialty submissions, and FDA interactions; and (4) Flow Cytometry as a standalone high-throughput platform. Key service sub-products include Protocol Design, Data Management, Model Systems (PDX, syngeneic, orthotopic, humanized), Radiopharmaceutical Services, Hematologic Malignancies Services, ADC Services, and the Peak Partners site network program. The integrated approach enables sponsors to translate scientific hypotheses from lab settings into patient responses in the clinic.
Differentiator
Problem solved
Functional benefit
Brands
- Peak Partners: An alliance of high-performing research sites committed to operational excellence and innovation in oncology clinical trials.
- Dynamic Trial
Products and services
- Clinical Trial Services Phase I, II and III oncology clinical trial design, planning, and execution using a data-driven, flexible approach with innovative methods for capturing and analyzing data to identify early signals of response. Includes study design, protocol development, site management, biostatistics, data management, pharmacovigilance, medical monitoring, eTMF, and quality assurance. Target customers: biotech and pharmaceutical companies developing oncology therapeutics.
- Preclinical Services Extensive preclinical suite including over 400 cancer models (syngeneic, orthotopic, PDX, humanized, CDX, diet-induced obesity, and adoptive cell therapy models) and bioanalytical services such as preclinical flow cytometry, metabolomics, proteomics, DMPK/ADME, in vivo and in vitro characterization, optical imaging, and ADC therapeutic evaluation. Target customers: oncology drug developers needing translational preclinical support.
- Regulatory Support Veteran regulatory team providing IND readiness assessment, program evaluation, IND development and filings, regulatory and medical writing, gap analysis and roadmap development, expert panel discussions, full program management and consulting, program budget and timeline executive planning, trial enablement, and FDA interactions for oncology programs. Target customers: biotech and pharmaceutical sponsors preparing regulatory submissions.
- Flow Cytometry Services Standalone high-throughput flow cytometry platform supporting diverse assays and cell types with advanced immunophenotyping capabilities to uncover drug mechanism of action and pharmacodynamics. Includes preclinical and clinical flow cytometry services. Target customers: oncology drug developers and cell therapy developers needing flow-based biomarker and release assays.
- PK/ADME Services Pharmacokinetics and absorption, distribution, metabolism, and excretion (PK/ADME) services for oncology drug development, supporting preclinical characterization and clinical pharmacology. Target customers: biotech and pharmaceutical sponsors developing oncology drug candidates.
- Patient Identification and Site Engagement Strategic patient recruitment and site activation services leveraging oncology specialization, real-world data, and the Peak Partners high-performing site network to reduce recruitment timelines and enhance site collaboration. Target customers: sponsors of oncology clinical trials seeking faster patient enrollment.
- Protocol Design Clinical trial protocol development by oncology specialists with expertise in clinical pharmacology, pharmacokinetics, and diverse cancer indications, covering dosage forms and study designs. Target customers: biotech and pharmaceutical sponsors planning oncology trials.
- Clinical Trial Data Management Comprehensive clinical trial data management including CRF design per CDASH standards, real-time clinical trial metrics, data quality assurance, CDISC compliance, and EDC platform flexibility. Target customers: sponsors of oncology clinical trials.
- Model Systems Preclinical tumor model portfolio including Syngeneic Tumor Models, Orthotopic Tumor Models, Patient Derived Xenograft (PDX) Models, Humanized Mouse Models, Diet-Induced Obesity Tumor Model, Adoptive Cell Therapy Models, and Cell Line Derived Xenografts Models (CDX). Target customers: oncology drug developers needing translational preclinical models.
- Bioanalytical Services Preclinical bioanalytical services including flow cytometry, metabolomics and proteomics analysis, DMPK/ADME services, in vivo and in vitro characterization including optical imaging, and therapeutic evaluation for antibody-drug conjugates. Target customers: oncology drug developers.
- IND Filing and Submission Services IND compilation, eCTD publication, validation, regulatory submission, annual reports, safety reporting, and FDA regulatory point of contact services for oncology drug developers. Target customers: sponsors preparing and submitting INDs.
- Specialty Filing Services Pre-IND and INTERACT submissions, Orphan Drug Designation, FDA Expedited Programs including Breakthrough Therapy and Fast Track designations, and Real Time Review program submissions. Target customers: sponsors pursuing expedited regulatory pathways for oncology therapies.
- Radiopharmaceutical Clinical Trial Services Specialized clinical trial services for radiolabeled pharmaceuticals and radiopharmaceuticals, including protocol design, regulatory navigation, and trial execution. Target customers: sponsors developing radiopharmaceutical oncology therapies.
- Hematologic Malignancies Clinical Trial Services Comprehensive clinical trial services for hematologic malignancies including leukemia, MDS, and multiple myeloma. Target customers: sponsors of hematologic oncology drug programs.
- Antibody-Drug Conjugate Clinical Trial Services Specialized services for antibody-drug conjugate (ADC) therapeutic development, including preclinical-to-clinical translation and clinical trial management. Target customers: sponsors developing ADC oncology therapies.
- Small Molecule Clinical Trial Services Clinical trial services for small molecule oncology therapeutics from early phase through approval. Target customers: sponsors of small molecule oncology drug programs.
- Cancer Vaccine Development Services Clinical development services specifically designed for cancer vaccine programs. Target customers: sponsors developing cancer vaccine immunotherapies.
- Peak Partners Site Network Program Alliance of high-performing research sites committed to operational excellence and innovation in oncology clinical trials, fostering collaboration and accelerating timelines, including global community sites, hospitals, academic centers, and site networks. Target customers: oncology trial sponsors seeking streamlined site onboarding and accelerated patient referrals.
- Pharmacovigilance Services Drug safety monitoring and pharmacovigilance services for oncology clinical trials. Target customers: sponsors of oncology trials requiring safety reporting and adverse event management.
- Medical Monitoring Services Medical oversight and monitoring services for clinical trial conduct. Target customers: sponsors of oncology clinical trials requiring dedicated medical monitoring.
- eTMF Management Services Electronic Trial Master File (eTMF) management services for regulatory compliance and document management. Target customers: sponsors of oncology trials requiring TMF maintenance.
- Quality Assurance Services Quality assurance services ensuring compliance with regulatory requirements and study protocols. Target customers: sponsors of oncology clinical trials needing QA oversight.
- Clinical Flow Cytometry Services Advanced clinical flow cytometry solutions including immunophenotyping, receptor occupancy assays, biomarker assay development, and GLP-compliant testing for cell therapies. Target customers: cell therapy developers requiring clinical flow cytometry support.
Quantifiable outcome
- Accelerated trial startup timelines to 6–8 weeks for site activation and first patient enrollment up to 4+ months sooner through proactive site selection and early vendor engagement.
- +2 more outcomes
Companies that use Translational Drug Development
Customer profileSegments3 records
Ideal customer profiles3 records
Translational Drug Development technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Translational Drug Development partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Panome BiocoreTD2 Oncology and Panome Bio announced a partnership to advance translational oncology through integrated multi-omics capabilities. The collaboration combines TD2's clinical trial management and oncology expertise with Panome Bio's multi-omics platform to provide sponsors with enhanced biomarker discovery, translational insights, and integrated analytical capabilities across clinical development programs. This partnership strengthens TD2's translational ecosystem by adding comprehensive multi-omics data integration to its existing preclinical and clinical service offerings.
- Peak Partners NetworkcorePeak Partners is TD2's elite network of high-performing oncology research sites, including global community sites, hospitals, academic centers, and site networks. The program fosters collaboration, accelerates timelines, and strengthens communication between TD2 and trial sites. Benefits include faster startup timelines, more effective protocol design, quicker resolution of trial obstacles, and better outcomes for patients. Sites demonstrate consistent performance in clinical research and participate through a structured partnership with TD2.
Scale indicators5 records
Recent moves5 records
Expansion highlights5 records
Translational Drug Development competitors and assessment
Company assessmentMarket position
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Translational Drug Development social profiles
Digital presenceTranslational Drug Development financial estimates
Financial estimateRevenue estimate
Valuation estimate
Translational Drug Development leadership team
Management profileNumber of profiles
Profiles4 records
Translational Drug Development funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Translational Drug Development M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Translational Drug Development
What does Translational Drug Development do?
Translational Drug Development (TD2) is an oncology-focused contract research organization that provides integrated preclinical, regulatory, flow cytometry, and clinical trial management services to biotech and pharmaceutical companies developing cancer therapies. The company leverages a proprietary library of over 400 preclinical cancer models, high-throughput flow cytometry, adaptive trial design, and FDA regulatory expertise to translate drug candidates from preclinical studies through Phase I–III clinical trials. Services are delivered as custom, project-based engagements directly to sponsor companies in the United States.
Is Translational Drug Development a public or private company?
Translational Drug Development is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Translational Drug Development founded?
Translational Drug Development was founded in 2003. It employs 101 to 250 people.
Where is Translational Drug Development based?
Translational Drug Development is headquartered in Scottsdale, United States, in the North America region.
How does Translational Drug Development make money?
One revenue line is on record: oncology CRO Services.
Does Translational Drug Development have an API?
No public API is recorded for Translational Drug Development.
What industry is Translational Drug Development in?
Translational Drug Development's product category is Oncology Contract Research Services. Its primary akta.pro industry code is HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution), with a secondary code of HLAIALAF, Translational Medicine & Biomarkers. Its NAICS code is 541714 and its SIC code is 8731.