Pharmacodynamic (PD) Biomarker Assays
Drug development costs are reported as high as $12 billion. Despite this increase in investment, failure rate is still averaging 80%, with a recent study showing positive results in Phase 2 have not always translated into success in Phase 3. Biomarker efficacy data generated in early phase clinical trials, using only a small proportion of the clinical budget, may crucially contribute to the decision to progress, translating directly into cost savings for you.
Charles River’s expertise in immunology allows us to map immune function in the clinic. Through implementation of a validated set of analytical, cellular, and even functional assays, as part of the clinical team in Phase 0-2 studies, confirmation that the drug is engaging with the target and is having the effect predicted is key to a successful program. In addition, identification of early warning signs related to immune toxicology, if these are present, can assist with trouble shooting.
Dr. Robin Brown and Prof. Neil Williams, Consultant of Immunology for Charles River, discuss the advantages of using clinical biomarkers.
We support our clients in the preclinical phase of their projects to identify potential biomarkers, and can support projects already entering the clinic to implement appropriate assays.
Industry data clearly shows that the use of pharmacodynamic (PD) biomarkers significantly improves the probability of projects progressing from Phase 2 clinical trials.
How We Help
CONFIRMING MECHANISM OF ACTION (MOA)
We identify and monitor PD biomarkers that confirm the MOA. If your molecule affects the immune system, we can employ analytical, cellular, or even functional assays to confirm that your molecule interacts with its target modulating immunological function as anticipated.
By carefully analyzing drug effects in the patient, our platforms support your drug discovery and development programs, providing high-quality data early in the process that will underpin the critical decisions taken to progress a molecule.
The consequences of novel treatments on the ability of patient-derived cells to produce inflammatory and anti-inflammatory cytokines are assessed in validated assays.
Using our immunotoxicology assays and our immunology expertise, we can also use biomarkers to de-risk programmes before they reach the clinic, by looking at how your molecules are affecting the immune system and identifying any potentially undesirable drug effects.
The potential for compounds to drive unwanted cytokine production can be benchmarked against existing biologics such as Orthoclone OKT3 and Lemtrada.
Who We Help
Clinical biomarkers help you select which drugs and targets to progress. This will save you money by ensuring you back the drugs with highest potential and make the right choices from your portfolio.
Clinical biomarkers provide you with evidence that your molecule works before you commit to the expense of larger clinical trials. Early PD and immunotoxicology data allows you to be smarter in your choices and more cash efficient in your development program.
With our state-of-the-art facilities and world-leading expertise, we can help you expand your client offering.