Exemplar Biomarker Discovery
The Problem
Despite major advances in biological technology, the costs to develop a drug have increased over the last decade. Some estimates have the cost as high as a billion dollars per drug. A large part of the cost of developing successful drugs is the cost of failures. Many drugs go through the costly design stage and enter clinical trials only to be rejected. When a drug fails a clinical trial, the question becomes whether the drug is actually entirely ineffective, or is it that the drug works, but only on a small subset of the patient population.
Key Points
Discovering key biological markers to predict treatment responders is one of the critical keys to success. Often multi-hundred million or even billion dollar decisions can hinge on the success or failure of being able to properly profile patients to a particular treatment. The lab technology to facilitate such decisions has seen major advances in the last decade in DNA assessment, expression profiling, proteomics and metabolomics. A comprehensive view of this data can provide information on the Pharmacodynamic activity within the clinical Subject.
Unfortunately information technology has lagged in being able to provide a holistic view of all the data starting from the sample through assay. In reality, even the most successful pharmaceutical and biotech companies often have this data in many different data stores ranging from LIMS to custom databases to spreadsheets. This inhibits researchers from doing interrogations across the Study or Studies, Treatment Groups, Subjects, Samples and Assay data.
The Solution - Exemplar Biomarker Discovery
In order to realize the goal of personalized medicine researchers need to be empowered with a solution that stores and tracks data from samples through and including all the diverse assay data that may be run. Exemplar Biomarker Discovery aggregates this into a single data store for all Clinical Study, Treatment Group, Subject, Sample and Assay result data. For the assay data, Exemplar has pre-built data loaders for most common platforms being used in modern labs including PCR, mutation detection, IHC, Western Blot, Flow Cytometry, etc. Exemplar is built on a highly scalable framework for managing this high volume data while ensuring timely responses for all system functions.
Built-in tools are provided for researchers to easily query the entire Exemplar system, or any subset of it, for information spanning all Study elements from Study level information through the assay results. The researchers do not need to understand database concepts or data structures to be able to build queries. Exemplar also integrates data normalization and other key statistics as well as exploratory analysis to enable true Knowledge Discovery on the aggregated data.
Sapio Sciences - Your Partner in Discovery
Sapio has extensive experience in assisting some of the most successful and well known biotech and pharmaceutical companies in managing their clinical study data and making important discoveries. While we value all settings in which Exemplar is utilized, this area of usage of the Exemplar family of products is particularly inspiring to Sapio's management and employees as a clear and direct connection between the work that is done by Sapio and key discoveries at our customers leading to treatments for cancer and other serious diseases is evident. Sapio will continue to push the boundaries of technology to enable more rapid and informed decisions to be made in the area of biomarker discovery for personalized medicine.
To schedule a demonstration of Exemplar, please contact us at sales@sapiosciences.com.