Clinical Drug Development
Deep Insights to Guide Clinical Drug Development, Trial Design & Evaulation
Clinical failures continue to plague pharmaceutical and biotechnology companies. Drug development is a risky, complex process; just 12 percent of drugs entering clinical trials ever make it to patients. Thousands never make it past the early discovery and preclinical testing stages. Despite the inherent risks and challenges,
In the clinical stage of the process, having confidence in target engagement, dose and
Metabolism is a key component across nearly every indication
The comprehensive and meaningful assessment of the molecular phenotype supports informed decision-making across the pharmaceutical R&D continuum. Our powerful technology is increasingly used not only in the process of bringing a pharmaceutical successfully to market, but also in precision medicine.
An Asset for Answering Key Clinical Questions
- Early Clinical Development
- Assess of target engagement, dose effects & safety
- Develop more informative
biomarkersfor PK/PD modeling
- Later-Stage Clinical Development & Clinical Trials
- Assess efficacy — individual, subset & group
- Identify responders and non-responders
- Delineate baseline characteristics
- Assess dose, drug concentration, & relationships to response and disease interaction
- Assess safety
- Individual patient changes
- Individual clinically significant abnormalities
- Study quality
- Study site issues
- Individual compliance
- Metabolic outliers
- Post-Marketing Surveillance
- Develop clear differentation
Metabolomics, Lipidomics & Targeted assays
Metabolon offers a range of metabolomics solutions to accelerate clinical drug development:
- Precision Metabolomics offers a comprehensive, global coverage of metabolism, identifying on the order of 1,000 metabolites in a sample with exquisite precision.
- If analysis of complex lipids is indicated, we have the capability to quantitatively measure more than 1,100 complex lipids with our Complex Lipid Panel™ and offer related lipid analysis tools.
- We provide 150 off-the-shelf targeted assays involving over 250 metabolites and the capability to rapidly develop novel, customized, sensitive assays to verify and validate discovery and/or for use in clinical trials. We have particular expertise in the development of metabolite biomarker panels.
Prior to a drug candidate advancing into clinical development, metabolomics can help with preclinical development, too.