Translational Research

Identification and validation of pharmacodynamic biomarkers. PK/PD studies for identification of the driver of efficacy, supporting clinical dose prediction and proving relevant exposure levels in early clinical studies. Identification of predictive biomarkers for indication profiling and patient selection.

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PREDICTIVE BIOMARKERS

Use of predictive Biomarkers for indication profiling and patient selection: Classical Immunohistochemistry remains the gold standard to detect target expression in tumor samples. Besides assay development and validation we also offer a broad indication profiling based on comprehensive sample collections comprising the most relevant tumor indications.

If high quality antibodies are not available, RNA in situ hybridization is a well established alternative for characterization of clinical samples in our lab.

PHARMACODYNAMIC BIOMARKERS

Identification and validation of pharmacodynamic biomarkers and PK/PD studies, supporting clinical dose prediction and proving relevant exposure levels in clinical studies.

These goals are best achieved using blood-based biomarkers which can be repeatedly sampled without too much burden for the patient.

We routinely use Multicolor Flow Cytometry is used to characterize blood cell populations, phosphoproteins or protein expression in peripheral blood cells and RT-PCR to monitor transcriptional regulation of biomarkers in blood cells.

The classical ELISA or electrochemiluminescence based MSD assays are our methods of choice for the quantification of soluble biomarkers in plasma or serum samples. Additional gene expression profiling platforms including quantitative capillary electrophoresis (Peggy) are also established.

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NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management