TD2 provides strong support for the clinical development program by offering innovative preclinical services. TD2 designs and executes in vitro and in vivo studies to evaluate efficacy of novel therapeutic agents and drug metabolism and pharmacokinetics studies (DMPK) to support IND filings. In vivo efficacy studies are designed to identify optimal and streamlined development strategies for the experimental agent.

In Vivo

Toxicity and Efficacy evaluation
TD2's 10,000 square foot state-of-the-art vivarium supports studies that allow for rapid development of oncology therapeutics. Development programs included:

• Human Tumor Xenograft Models
• Human Primary Tumor Grafts
• Murine Syngeneic Models
• Rare tumor xenograft models
• Non-GLP toxicity
• Histopathology services
• Bioavailability and PK determination

TD2 utilized e-data capture for xenograft studies that enables quick and accurate reporting of data.

DMPK Services

• Metabolic stability using, mLM, DLM, RLM and HLM or cryopreserved hepatocytes
• Permeability assays (PAMPA, Caco-2 or MDCK)
• Physicochemical Properties - Solubility and stability, pKa, LogP and LogD
• Plasma stability
• Plasma protein binding (rapid equilibrium dialysis using RED device)
• Radioactive studies including in vitro metabolism and in vivo mass balance and tissue distribution studies in rats and mice
• Reactive metabolite testing
• Other DMPK assays available

In Vitro

Pharmacogenomics

• High throughput siRNA using validated methods and standards
• Cell lines – pre-optimized, new established cell lines, primaries from xenografts and biopsies
• siRNA library – WHG, DG, Cancer set, Kinase set, client custom set
• High Throughput Compound Screening
• High Throughput Peptide/Antibody Screening
• Drug Activity Profiling on cell line panels
• Drug Synergy testing on in vitro models
• High Content Assays and endpoints

Pharmacogenomics
Evaluation of anti-cancer drugs in vitro in various cell-based assays using a broad variety of human established cell lines. These cell-based assays are designed to:

   
• Quantify growth inhibitory effects of experimental drugs
   
• Evaluate interactions between conventional chemotherapy and experimental agents
   
• Drug sequencing studies