Expertise available at SENDO

In house

SENDO offers a wide range of facilities and skills in the following areas:

Efficacy and toxicity studies
Facilities are available for small-scale mechanism-based screening employing defined molecular targets and for confirmatory antitumor testing on experimental tumors and human tumor xenografts.
Specific expertise is also available to study selected molecules affecting metastasis and angiogenesis.

Mode of action of new drugs
We can investigate the mechanism of action of novel compounds through molecular biology and molecular pharmacology techniques. Selected in vitro and in vivo models are available to study drug sensitivity and resistance, cell cycle checkpoints activation, cellular damage repair and signal transduction pathways relevant to cell growth inhibition, differentiation and death.
In vitro and in vivo systems are available to investigate compounds acting on tumor and endothelial cell functions related to the angiogenesis and metastatic process.

Metabolism, pharmacokinetics & pharmacodynamics
Expertise is available to develop and validate new analytical methods for metabolic and pharmacokinetic studies of new drugs in animals, and to validate end-points in potential surrogate tissues.
We are able to conduct pharmacokinetic, pharmacodynamic and imaging studies in man to confirm that sufficient levels of the experimental drug are achieved in patients and that the drug is acting on its target or on surrogate tissues.

Pharmacogenomics
Gene expression profiling techniques are available to validate novel targets, to screen new anti-cancer agents and to investigate their mechanism of action both in normal and tumor cells and fresh tissues. Proteomics approaches are under development.

Early clinical trials and clinical development support
SENDO designs and conducts its own phaseI/II clinical trials.
SENDO is also a resource center providing all necessary activities for clinical development support, including strategy planning, biostatistics, patient recruitment strategy, customized clinical data management, clinical monitoring, quality assurance and regulatory affairs.
 

On demand

Although the following capabilities are not directly available at SENDO, formal arrangements under SENDO’s supervision can be made with other facilities as required.

Drug substance preparation
Scale-up and process development of the synthetic preparation methods for preclinical testing of new compounds and development of the analytical methods
to characterize the substance and assess its purity.
Technology transfer to cGMP facilities.

Pharmaceutical formulation and production of drug supplies for clinical trials
Formulations for injectables, oral and other preparations to be used in clinical trials can be supplied. Developing an iv formulation involves studying the physico-chemical properties of the substance, its stability and the adequate storage conditions (including shelf-life) according to NCI standards.

Animal toxicology
A limited rodent-based toxicology program can be conducted in specialized GLP-laboratories. Safety studies include acute, subchronic, and chronic toxicity.
Under the SENDO-NCI agreement, the NCI is responsible for arranging US INDA requested nonrodent species toxicology for NCI-SENDO co-sponsored compounds.