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Real-Time Bioanalysis, Biomarker, and DMPK Data
Real-time data sets now available in Apollo™
Charles River’s Apollo™ now has real-time, preliminary bioanalysis and biomarker data sets available for in vivo General Toxicology and Drug Metabolism and Pharmacokinetics (DMPK) studies. This addition to the secure cloud-based platform offers chart and table visualization for easy data interpretation, detailed insights into individual studies, and customization with data export capabilities.
What does this mean for biotech and pharma companies looking to expedite their drug development? Iain Love, Director, Chromatographic Bioanalysis and Discovery Sciences, shared his thoughts in this recent Q & A.
Apollo is an innovative platform that provides real-time access to data visualization, milestones, documents, and program planning tools. With the latest addition of bioanalysis and biomarker data sets, what added benefits can biotechnology and pharmaceutical companies expect?
In terms of their time, funding, and commercial plans, pharma or biotech experts are heavily invested in getting their candidate compound through the clinic, so anything we can do to reassure them throughout the process is a benefit. With access to preliminary biomarker and bioanalysis data in real time, clients can validate the progress of their studies and analyses. They can perform initial assessments internally and formulate plans for their next steps sooner.
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For example, timely access to data may assist in making decisions regarding adjustments to dose levels or help identify the key biomarkers to pursue in a clinical setting. Access to real-time data through Apollo affords all members of the project team, whether based at Charles River or the client, the means to collaborate on the latest available information. This addition also enables us to offer clients greater transparency on study progress resulting in a closer, more productive, partnership between ourselves and our clients.
With this enhancement, Apollo users will have the ability to view in vivo general toxicology and DMPK study data in real-time. How and when can clients currently see the data for these studies?
Project stakeholders may not see data until the audited draft report is issued, however we would often work with clients to manage agreements or requests to view preliminary data sooner. Apollo eliminates the need to make these agreements and requests. If an expert wants to see the data, it will be automatically available in the platform.
Maintaining momentum and efficiency is key to study planning and execution. In what ways do these changes represent time savings for Apollo users?
Requests for data shares can be time consuming and fulfillment could be delayed due to differences in time zones or key contacts availability. Apollo allows the seamless flow of information, so our stakeholders and project teams have access to data exactly when they need it. Additional savings may be offered in data processing as the Apollo data could be used for a preliminary assessment of statistical analyses.
Collaboration and transparency are crucial for informed decision making. What is the data from these studies used for and what are the next steps in their drug development journey?
Data from these studies would be used in planning the next steps in the drug development pathway, which may include deciding on doses/assessments in the next IND-enabling studies or determining early plans for entering the clinic. Having access to the initial data would support project planning and keep programs on track.
How will Apollo evolve to generate more value for project teams?
Apollo currently provides a platform for timely sharing of in vivo and analytical data generated by our scientists. This will continue to expand with greater access to real-time immunology, immunogenicity, and molecular biology outputs. Furthermore, the expansion of the Apollo platform to enable sharing of clinical laboratory data will aid decision-making during clinical studies and ultimately support patient safety.
The addition of biomarker and bioanalysis data for general toxicology and DMPK studies extends the existing capabilities within Apollo which have been growing in the year since it launched. Find out more about how Apollo can help you to expedite your drug development programs.