Preclinical

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BEST-IN-CLASS LIFE SCIENCE CHEMISTRY CAPABILITIES
Efficient design and synthesis of high-quality test compounds and chemical probes.

Close interaction with lead discovery in screening hit-list evaluation and long-standing expertise in the Hit-2-Lead process (hit selection, assessment and modification).

Rapid development of different cluster into viable lead structures to fit your lead structure profile.

Strong drug-hunting attitude within the Lead-2-Candidate process, short cycle-times in multi-dimensional lead optimization programs.

OPTIMIZATION OF MOLECULAR PROPERTIES IS A TEAM EFFORT
Close collaboration with computational compound design, therapeutic research functions (in vitro-, ex-vivo, in vivo studies for your target/ indication of interest) and preclinical compound profiling (DMPK property optimization) to identify a preclinical candidate according to an agreed target product profile.

Application of state-of-the-art methodologies (photochemistry, electrochemistry, final stage diversification) to quickly synthesize the target compounds of interest.

First-rate expertise in new modalities (e.g. PROTACs, ADCs) and modalities beyond small molecules (e.g. peptides).

UPSCALING & ROUTE SCOUTING
We synthesize your API or intermediate on large scale (up to 500g).

Route scouting and synthesis route optimization for your API or intermediates.

Special technology capabilities include e.g. high-pressure reactions, photochemistry, hydrogenation, carbonylation, flow chemistry.

We will develop with you for your candidate compound a customized profiling cascade which spans a broad panel of in vitro, in vivo, and human samples, assays, and models, addressing all relevant aspects you need to know, to successfully promote your compound towards the clinic.

We systematically assess the MoA of your compound on its target. Using in silico tools, big data mining, database screening, extraction and assembly, we identify pathway-disease-relationships and entity recognitions; we scrutinize your target and its signaling pathways, and the Mode of Action of your compound. We help you to identify pathomechanisms which offer therapeutic rationales with optimum fit to your compound.

Demonstrating on-target activity of the candidate in additional pharmacologically relevant in vivo models contributes to the understanding of PK/PD relationships.
These studies provide further confidence around the Mode of Action and help identify the driver of efficacy.

Testing and demonstrating efficacy of your candidate molecule in additional pharmacologically relevant in vivo models, may give opportunities to develop your compound in another therapeutic area.

We can support your drug discovery programs through the identification and characterization of predictive biomarkers. We will use a combination of disease-relevant preclinical in vitro / in vivo models complemented by studies in human clinical samples to ensure translatability of our findings.

Predictive biomarkers support the selection of relevant indications and patient populations that will most likely benefit from treatment. We will help you to identify the most suitable indications based on target expression in clinical samples and provide assays for patient selection supporting truly personalized medicine. In addition, target engagement / pharmacodynamic biomarkers are further optimized and used to demonstrate the on-target activity of a novel clinical candidate in early clinical trials and characterize PK/PD relationships.
Established assay technologies include IHC, RNA-scope and Next Generation Sequencing.

PK/PD in vivo studies are used to identify the driver of efficacy for the molecule in this phase of development and will help to support the prediction of the human starting dose.
PD read-outs can be based on drug efficacy, target engagement, or pharmacodynamic biomarker modulation.

We will develop with you for your candidate compound a customized profiling cascade which spans a broad panel of in vitro, in vivo, and human samples, assays, and models, addressing all relevant aspects you need to know, to successfully promote your compound towards the clinic.

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Our Services & Solutions along
the Drug Development Value Chain

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Discovery

PRECLINICAL

Clinical Phase I

Clinical Phase II

Overall Services

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

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