Infotrieve/ELN Case Study – Merrimack Pharmaceuticals

Infotrieve/ELN Case Study:
Merrimack Pharmaceuticals
 

Overview
Merrimack Pharmaceuticals is a biotechnology company that develops drugs in the fields of autoimmune disease and cancer. Merrimack Pharmaceuticals is currently conducting a Phase II clinical trial in rheumatoid arthritis (RA) with its lead candidate MM-093. Merrimack develops novel therapeutics using the company’s proprietary Network Biology drug discovery platform, developed with the help of leading scientists from MIT and Harvard,

Merrimack believes that in order to understand a disease and improve drug discovery and development, scientists must move past studying a single gene or protein and focus on the network of proteins with which key targets interact. The Network Biology platform capitalizes both on computational biologists’ protein network modeling and the experiments conducted by bench scientists to validate those models.

Outgrowing Data Storage
In 2003, Merrimack was experiencing rapid growth as well as a significant increase in the volume of data it was generating from high throughput experiments. The company determined that in order to optimize the performance of its Network Biology Platform, it needed to increase its data storage capacity and migrate its data collection process from paper laboratory notebook entries into an electronic format. It also had to improve the uninterrupted flow of communications among its research teams; the company could no longer depend solely on direct contact between scientists or lengthy searches for information through paper lab notebooks.

Merrimack evaluated several options to expand its data storage capacity and improve interdepartmental communications, including traditional laboratory information management systems (LIMS). LIMS – non-standardized computer-based data management solutions – can be implemented alone or in conjunction with other electronic systems. However, because they are designed primarily as static tools used to track and manage complex data sets, Merrimack found that LIMS could not be easily customized to optimize interdepartmental information sharing.

Discovering an Integrated Solution
After evaluating the needs of its scientists, IT, regulatory and management teams, Merrimack elected to bypass a LIMS solution due to their inflexibility and expense. Instead the company turned to electronic laboratory notebooks, or ELNs, as a sustainable long-term solution for R&D challenges involving scientific content management and information sharing.

Based on the company’s exploration of several ELN options, including an open source ELN, originally developed at Pacific Northwest National Laboratory and several commercial alternatives, Merrimack determined that their ideal system had to meet several important requirements. It had to:

  • Offer robust data storage
  • Enable rapid and secure data searches
  • Meet stringent FDA regulations, and
  • Support biologists as well as chemists.

Merrimack selected the Infotrieve/ELN because it was the only system that was able to meet each of these electronic record-keeping requirements and because it could also:

  • Enhance FDA filing preparation by supporting electronic submissions
  • Store a wide variety of scientific content through entry attachments of any file type
  • Protect intellectual property through the use of digital signature and witnessing capabilities

Specifically, the Infotrieve/ELN is an FDA (21 CFR Part 11) compliant system with respect to its best-in-class electronic signature and witnessing feature and electronic records management. Notebook entry version control and detailed audit trails enable users to track all changes to data or protocols. Supported by an Oracle database, the Infotrieve/ELN also enables the storage of massive amounts of data generated in high throughput experiments that can easily and quickly be queried through customizable data fields. Furthermore, the system enables flexibility in supporting variable scientific workflows – complex protocols written to perform complicated, low throughput experiments as well as more structured high throughput experiments. The Infotrieve/ELN is designed for ease of use and to promote rapid training by embedding familiar software programs such as Microsoft Word®, Microsoft Excel®, and Adobe Acrobat®.

Success
Deploring the Infotrieve/ELN has streamlined collaboration within Merrimack’s multidisciplinary teams, and all research departments have now integrated the system into their daily R&D activities. With the Infotrieve/ELN, computational biologists are able to quickly search all data independently of the bench scientists who carried out the experiments, eliminating time-consuming manual searches and allowing computational biologists to spend more time modeling protein networks.

The Infotrieve/ELN greatly facilitates continuity of experiments and projects. “When new scientists join Merrimack, the ELN database jump-starts their orientation to our research and smoothes the hand-off of projects. The ELN assures that no information gets lost during the transition.” explained Birgit Schoeberl, Director of Network Biology at Merrimack. Before we deployed the ELN, transitioning projects between scientists involved the sharing of protocols and data storage in disparate places – from paper lab notebooks to individual hard drives.”

Conclusion
Deploring the Infotrieve/ELN at Merrimack has eliminated communication bottlenecks that previously hindered R&D efforts among interdisciplinary groups The system establishes strong data continuity, protects valuable R&D assets, and streamlines project transitions among different scientists. It has increased their management team’s visibility into research projects, supporting their ability to make informed decisions. As Merrimack advances its pipeline toward clinical trials and eventual commercialization, the company can feel confident about its FDA-compliant electronic signature function and electronic entry audit trails to help streamline the FDA submission process.

For More Information, Please Contact:
Holly Sawyer
Senior Product Manager
Infotrieve, Inc.
E-Mail: hsawyer(at)infotrieve.com
Phone: 310-445-3054