The Allotrope Foundation is a consortium of major pharmaceutical companies and a partner network whose goal is to address challenges in the pharmaceutical industry by providing a set of public, non-proprietary standards for using and integrating analytical laboratory data. Current challenges in data management within the pharmaceutical industry often center around inconsistent or incomplete data and metadata and proprietary data formats. Because of a lack of standardization, several operations (e.g. integration of instruments/applications, transfer of methods or results, archiving for regulatory purposes) require unnecessary efforts. Further, higher level aggregation of data, e.g. regulatory filings, that are derived from multiple sources of laboratory data are costly to create. These unnecessary costs impact operations within a company’s laboratories, between partnering companies, and between a company and contract research organizations (CROs). Finally, the accelerating transition of laboratories from hybrid (paper + electronic) to purely electronic data streams, coupled with an ever-increasing regulatory scrutiny of electronic data management practices, further require a comprehensive solution. This talk will discuss how The Allotrope Foundation is providing a new framework for data standards through collaboration between numerous stakeholders.

We will provide an update on the rapid progress this consortium has made in recent years (currently a 1.1. release is available). We will discuss the use of a new standardized file type .ADF, which helps to provide a common anchor for laboratory data. We will also demonstrate the use of standardized taxonomies which provide needed metadata for improved data integration and search across the laboratory community. Last, we will highlight some of the long term plans for further deployment and show people how they too can become involved with this effort.

• Attendees will learn about advances in semantic technologies that are realistically impacting the pharmaceutical industry.
• This talk will provide a means to apply this information to other regulated industries struggling with data management.