Personalized Medicine is becoming an increasingly important part of drug development. To make sure that the right patients are given the right drug at the right time and at the right dose seems logical, and yet so little is often done to ensure that this actually happens. However, this is rapidly changing, and we would like to help you be part of the transformation. We believe that a well planned and executed biomarker plan together with a robust understanding of your patient population, will take you closer to the final goal of evaluating the clinical potential of your projects.
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What we offer
- Biomarker identification and validation – We have extensive experience biomarkers for many different purposes in drug development; target engagement, proof of mechanism (PoM), proof of principle (PoP), proof of concept (PoC) and personalized medicine/patient stratification.
- Biomarker plan – Make sure the biomarker and the biomarker methods are fit-for-purpose and validated for the context of use. A biomarker plan helps you address critical questions and deliver the answers at the right time. This also creates possibilities for valuable bridging between animal models and early clinical trials in man.
- Platform of Evidence (PoE) - A useful tool to obtain a clear overview of available data and identify where the gaps are. Clearly links to the Translational Medicine Plan and TPP to get everything aligned and make sure nothing gets lost or forgotten.
- Preclinical Safety Evaluation plans - A safety plan helps you to foresee and mitigate risks and markedly increase the value of your project. The need for specific Safety biomarkers within your project can also be highlighted.
- Translational Medicine Plan (biomarkers & personalized medicine) – Integrates all aspects of translational medicine for your project, and provides clarity and line-of-sight. A translational medicine plan will help you integrate biomarker and patient stratification needs into your experimental and clinical plans.
- Target Product Profile (TPP) - A powerful tool in project management. Ensures full focus on the goal over time. Necessary in interactions with regulatory authorities, investors and clinical collaborators.
- Patient stratification studies – Do you really know who will benefit from your drug? We help you identify the relevant patient populations linked to your project strategy.