how Jumper 2.0 saved a life sciences company from the FDA.
A large life sciences company had spent several years and a few billion dollars developing a new drug.
The future of this company depended on whether the new drug could get speedy approval from the Food and Drug Administration (FDA). The new
drug application that had to be sent to the FDA would consist of tens of thousands of documents, images, and transactional data collected
from research labs, clinics, commercial systems, and other sources.
In order to make the new drug development process more efficient, the life sciences company had deployed a leading integration solution
to combine information systems used by the various process participants. The company faced a critical problem, however. The bulk of information
produced in the new drug development process was unstructured. It included lab notes, molecular images, toxicology reports, patient records,
dosing procedures, and other documents. How can they effectively link all the structured and unstructured information together?
Mapping the images and documents to rows in a relational database is not easy. Unstructured information is usually managed in one or
more content management system such as Documentum or Interwoven. These systems, however, are not designed to integrate information from
different repositories. They are used as a single consolidated place to store documents. Using a centralized content management system in
a drug development process is not feasible since the process participants are often separated by administrative and company
boundaries.
Linking the knowledge across each of these disparate data resources, mapping the correlations, attaching annotations and notes about
the findings became increasingly challenging across multiple partners, vendors platforms, and storage solutions. Finding supporting
documentation when it was needed across this morass was a needle in haystack.
What this life sciences company found was Jumper 2.0. A content and knowledge management solution that allowed them to link
unstructured content to structured data. Jumper provided a universal search platform with knowledge capture features that provided the
context necessary to locate the right documents when they needed them most, and to know how that document related to other documents
or data stored in disparate repositories. This allowed adverse events and the cause of those events in sub-populations to be identified
faster, to compare those results early in a clinical trial, to meet rigorous FDA requirements more easily and efficiently, leading
ultimately to faster approval.