Do you need a quick expert opinion on your latest PK/PD data or full modelling support for your first in human study? Contact us, we support projects at all stages.
The first decisions during the initial stages of drug development are the most critical ones; they determine the therapeutic potential, value and success of a compound.
We support you from the earliest stage starting with target feasibility assessment, compound format selection and design:
- Are you having a revolutionary idea for a compound, but need to assess how it translates into a human PK/PD scenario? First projections can often be done with published data. It will give you the confidence to invest into the right idea.
- Are you evaluating different targets in a pathway and need to select? We assess target selection based on kinetics.
- Do you need to select the right format, the right affinity, the right valency? Experimental testing will blow your capacity. Let Systems Pharmacology do the job and test a few selected variants.
- Do you need to select the best candidate that can also stand out against competitors? Today it is not enough to have a compound, it has to be best in class.
- Are you observing Target Mediated Drug Disposition? We can do a risk assessment and provide mitigation strategies.
- Are you consider moving into first in human studies? We develop strategies for safe and informative studies.
We provide support to the whole spectrum of questions related to PK/PD for biologics and cell based therapies in preclinical and clinical development. In addition we do provide:
- Are you planning to expand your department to offer Systems Pharmacology? We help to identify the best areas of activities, identify gaps in the talent pool and devise an implementation strategy to ensure best impact in the organisation.
- Are you assessing a new opportunity with a biotech company with a novel mode of action? We help to integrate the data and provide an interpretation within a PK/PD, competition and early translation to human framework.
- Do you have a health authority question or request on biologics PK/PD and modelling? With our partner network we can rapidly address and resolve the issue ensuring the right group of experts.
Contract research organisations
PK/PD and Systems Pharmacology for Biologics and cell based therapies require particular knowledge. We provide expertise where needed to help you to provide the best service for your customers.
We collaborate with Universities to stay at the forefront of innovation and to provide students with the opportunity to work on real world applications of Systems Pharmacology.
- Do you have a new methodology?
We provide support to transition and apply new computational methodologies to drug development.
- Are you interested in student projects?
We have many interesting problems to be solved with systems approaches.
- Do you have a new methodology?
We help hospitals to analyze the data collected from their patients to optimise therapies and to advance the understanding of biologics and the pathology they interact with.
- Have you collected patient pharmacokinetics data and need to link it to other readouts?
- Do you want to understand non-responders?
- Do you want to investigate alternative dose-regimens?
- Are you looking for a commercial partner in the area of Systems Medicine or Systems Pharmacology to complement a research consortia for grant applications?
We can offer you our in-depth expertise in biologics therapies, we can help to analysis your data, and we can help to design efficient studies. We can be your analytical partner to complement your clinical expertise.