Merck & Co., Inc. devotes itself to delivering innovative health solutions for patients in over 140 countries. With world-class researchers, state-of-the-art technologies and an unrelenting focus on scientific excellence at its Merck Research Laboratories (MRL), this global healthcare leader is at the forefront of discovering and developing innovative ways to treat and prevent disease.
Thousands of Merck employees use the E-Notebook electronic laboratory notebook, a key component of the PerkinElmer Ensemble® informatics platform for data management and integrated workflows. The E-Notebook solution enables scientists to easily record, access, share and manage scientific data and information in a collaborative, integrated and knowledge-driven environment. Merck wanted to leverage its investment in the E-Notebook platform, particularly the BioAssay structured results management module, by promoting development of additional functionality that would support its growing research and development in biologics. Working with PerkinElmer, Merck identified and provided the requirements for expanded biologics workflow functionalities. Subsequently, PerkinElmer embarked on further developing the BioAssay module for structured data, results, and sample tracking and management to address Merck's needs.
"One of the key factors to the success of this process was PerkinElmer’s willingness to collaborate and respond to our needs to enhance a commercial, not custom, product."
Challenge: Support for Structured Data
In 2009 and 2010, Merck Research Laboratories (MRL) identified biologics as an area of increasing focus and strategic growth. The organization sought to equip its scientists, researchers and engineers with world-class technology to support biologics R&D. There was a gap, however, in the ability of existing enabling technologies and processes to support the structured data capture, analysis, and workflow management required for the various complex stages of biologics research and development. In keeping with its collaborative environment, Merck also desired an integrated platform from which users could search, access and share biologics data and manage tasks. After its 2009 merger with Schering-Plough, MRL biologics researchers used spreadsheets, paper lab notebooks and the E-Notebook, which was introduced for paper replacement. Merck's objective was to deploy a standard solution with integrated biologics-specific workflow capabilities such as attached data structure, taxonomy or data models. Providing a data structure around research and development candidates would enable results to be searched and shared.
After completing a survey of its options, Merck elected to enter into a collaborative agreement with PerkinElmer, which would build out the E-Notebook solution as an integrated platform to support Merck's biologics workflows. Starting in 2011, Merck and PerkinElmer worked jointly to identify requirements to further develop the E-Notebook BioAssay module with sample tracking and management capabilities for a collaborative biologics environment.
"One of the key factors to the success of this process was PerkinElmer's willingness to collaborate and respond to our needs to enhance a commercial, not custom, product," said Dermot Barry and Walsh Executive Director for Vaccines/Biologics R&D IT at MRL. "We did not want substantial custom code that we would need to feed and care for. We wanted a commercial product with support behind it".
First the Bioassay and RDLIMS modules were evaluated in a "sandbox" environment to access the new functionality and determine if the solutions were fit for purpose. Once the proof of concept was completed, the new functionality was built out and the enterprise solution was tested in a production pilot deployment that began in August 2012.
With the pilot now complete, the biologics functionality for the BioAssay and sample tracking and management solutions is being rolled out to select users within Merck's Vaccines Development, Biologics Discovery and Biologics Development areas. Additionally, researchers in In Vivo data management within Merck's Discovery and Preclinical R&D groups will also deploy the E-Notebook BioAssay module for data collection, analysis and reporting.
Because of the broad base of existing E-Notebook users throughout MRL, the enhanced biologics BioAssay module, with sample tracking and management functionality, will be accessible to various functional groups based on roles and responsibility via the security system within E-Notebook.
Barry Walsh said Merck anticipates two levels of benefit from the expanded capability of Ensemble's E-Notebook for Biology:
1. MRL scientists will be able to capture data with context, enabling them to perform sequential and comparative analysis throughout the life cycle of a product and,
2. MRL lab managers and others will be able to assess productivity, cycle time, capacity understanding and perform full product life cycle analysis.
"Because it's a structured database, we can more easily access and analyze the data than if it's just attached as an Excel spreadsheet," continued Barry/Walsh.
Mark Jankowski, Merck's Director for Application Services, said the company looks forward to performance enhancements from aggregating, analyzing, reviewing and reporting data and a reduction of low-value experiments due to better visibility of that data. Measuring these improvements first requires a substantial aggregation of data in the Ensemble platform. At this early stage, however, enhancements to workflow management are being realized. A process that would have been completely manual before is now being performed by the E-Notebook's sample tracking and management functionality, which tracks samples generated by one group and processed by another and automatically reports results.
Future plans involve additional, iterative development of the enhanced E-Notebook BioAssay module as new requirements emerge from the pilot and subsequent waves of deployment. PerkinElmer and Merck will continue to address the areas of prioritized needs. Particular emphasis will be on enhancing the usability and flexibility. Merck is further interested in deploying the BioAssay module for its external partners so that outsourced work can be performed within BioAssay and seamlessly rolled back into Merck's system.