Translational Sciences

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Drug Repurposing

WE EVALUATE NEW POTENTIAL TARGET INDICATIONS FOR YOUR ASSET
We map the specific indication space for your asset using big data analysis tools. We propose not only first positioning, but also support your repurposing efforts for an established drug.
We aim to identify the most suited proof-of-concept indication for your asset. We suggest feasible paths forward by identifying the most translational in vivo or ex vivo models. We have a track record of projects that found their home in often unexpected indications. We perform in silico-, in vivo-, ex vivo-, and in vitro-studies for you in our labs - or we orchestrate your studies with third partners. We assist you from conceptual drafting to clinical translation and regulatory documentation by de-risking every step.

Expanded in vivo mechanistic activity & disease models

How likely is it that your compound's potential is limited to what you have in mind from the start?
In order to increase the value of your asset, we can systematically address the MoA of your compound on its target and suggest potential project expansions to other fields of indications or therapeutic applications. Whatever avenue your project takes, translational aspects from preclinical testing to clinical development are key for your ultimate success. To increase your probability of success (PoS), use of challenging preclinical models with standard-of-care references, back-translation of clinical parameters into preclinical models and in-depth analysis of publicly available as well as ICB-internal data will complement your data package. We can help you in identification, application, and validation of biomarkers as one basis for a smart design of your asset’s clinical development.  

Expanded Mode of action understanding

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 and disease-hypotheses which offer therapeutic rationales with optimum fit to your compound.

Indication Expansion

WE IDENTIFY MORE POTENTIAL TARGET INDICATIONS FOR YOUR ASSET
We map the specific indication space for your asset using big data analysis tools. We propose not only first positioning, but also expand the indication space of your asset, reposition dead-locked assets, or support your repurposing efforts for an established drug.
We identify the most suited proof-of-concept indication for your asset and propose feasible paths forward by identifying the most translational in vivo or ex vivo models. We have a track record of projects that found their home in often unexpected indications. We perform in silico-, in vivo-, ex vivo-, and in vitro-studies for you in our labs - or we orchestrate your studies with third partners. We assist you from conceptual drafting to clinical translation and regulatory documentation by de-risking every step.

Pharmacodynamic Biomarkers

To support you with data for clinical dose prediction as well as estimation of relevant exposure levels for your clinical studies, we evaluate and pre-clinically validate pharmacodynamic biomarkers and perform multi-parameter PK/PD studies.
With different methods we can help you to monitor your asset´s pharmacodynamic activity ex vivo.

We have a strong focus on using blood-based biomarkers which can be repeatedly sampled without too much burden for the patient in your clinical trials.
We routinely use Multicolor Flow Cytometry 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, which allows to.
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.

Pharmacology for SMOL & BMOL

YOUR LEAD SERIES WILL BE FURTHER OPTIMIZED TO EXAMINE THE EFFICACY IN IN VIVO ANIMAL MODELS
Further refinement of each of your early lead series, with respect to potency, selectivity, and PK properties, enables investigation of their efficacy in disease-relevant in vivo animal models.
We have long-standing experience not only with small molecules but also biologics, such as antibodies, and antibody drug conjugates (ADCs)

Predictive Biomarkers / Indication Profiling

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.
We support your drug discovery programs through the identification and characterization of predictive as well as target engagement / pharmacodynamic biomarkers. We use a combination of disease-relevant non-clinical 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 with your asset. Target engagement / pharmacodynamic biomarkers are valuable read-outs to demonstrate the on-target activity of a novel clinical candidate in early clinical trials.

Biomarker Readouts & back-translation

In order to help you in generating or refining your biomarker hypothesis on both stratification and pharmacodynamic activity, potential early clinical responses in humans in early clinical trials will be monitored and reverse translated to the bench-side.

Depending on the disease area, we can help you by retrospective analysis of predictive biomarkers during dose escalation in order to clinically prove your biomarker hypothesis. These data can provide a basis for indication expansion and may be used for threshold setting in parallel clinical diagnostics (CDx) development, further improving the value of your development campaign.

We can measure for you the target engagement / pharmacodynamic biomarker candidates identified in preclinical studies in early clinical trials to demonstrate that your asset has reached its target and exerted its pharmacological activity. Correlation of this activity to the actual exposure levels could serve as guiding of your dose escalation.

Early pharmacodynamic activities in humans may also provide new insights regarding potential resistance mechanisms that can be addressed in preclinical models.

Biomarker Readouts & back-translation

The clinical responses from patients in early clinical trials will be monitored. Depending on your envisioned indication and clinical development design, these data can be used for refining or validating your biomarker hypothesis. We can help you here by reverse translating your clinical data to the bench-side.

Depending on the disease area, we can help you by retrospective analysis of predictive biomarkers during dose escalation to clinically prove your biomarker hypothesis. These data can provide a basis for indication expansion and may be used for threshold setting in parallel clinical diagnostics (CDx) development, further improving the value of your development campaign. We can help you analyzing human data and/or clinical samples to provide new insights regarding potential resistance mechanisms. We could help you proving these hypotheses on resistance mechanisms preclinically before they are potentially being manifested in patients.

As risk mitigation we can offer you an extended drug characterization at the corresponding recommended human phase II dose e.g. in relevant combinations with or compared to (future) standard of care preclinically.

A valuation/characterization of potential pharmacological relevance of human metabolites can be performed.

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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