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Case Study

Transforming Non-clinical Drug Development with SEND Explorer

Since 1999, Genmab has been developing therapeutic antibodies and antibody-drug conjugates (ADCs) for treating cancer. Their non-clinical safety group analyzes complex toxicology data that they receive from the CROs that conduct their toxicological studies to characterize the safety profiles of investigational new drugs.

Solutions

Preclinical

Products

SEND Explorer®

Challenges

Developing innovative cancer treatments is complex, requiring meticulous analysis of non-clinical study data. Genmab’s non-clinical safety scientists shared that they had faced the following challenges:

Research agility: Genmab generally had limited access to data collected in their outsourced toxicology studies until after the studies were completed.

Inability to analyze specialized immunology data: Data from non-clinical studies submitted to the FDA must use the Standard for Exchange of Nonclinical Data (SEND) format. Certain types of immunology toxicology data aren’t routinely provided by CROs in CDISC SEND format as they are not modeled in the currently published/accepted versions of SEND (SEND 3.1/3.1.1). However, the Genmab team wanted to analyze immunophenotyping data and other immunologic biomarkers to characterize the toxicological profiles of their drug candidates.

Time-consuming data visualization: The process of visualizing data from ongoing or completed toxicology studies was labor-intensive. The team performed manual coding to create simple visualizations that diverted valuable resources from core research activities. Because this manual coding was laborious, the Genmab team would pick a subset of endpoints for visualization rather than reviewing all their data.

Cross-study data comparisons: Genmab leverages data across multiple non-clinical studies to evaluate the safety profile of drug candidates. Because their methods to combine data were largely manual, it was historically challenging to synthesize and analyze data across studies.

Challenges faced by Nonclinical Toxicologists

  • Volumes of data to review and understand!
  • Dozens of numeric and non-numeric endpoints are collected over the course of the study
  • Need to recognize meaningful patterns and identify signals to understand whether (or not!) a compound is safe for advancement
  • Want to make drug development no-go decisions as soon as possible with the pressure of more efficient data review
  • Desire to succinctly communicate the message with drug development team members and regulators
  • Focus on the science, not data manipulation!

Solution

Certara’s SEND Explorer software enables and simplifies data analysis and visualization for non-clinical scientists in the pharmaceutical industry. Genmab scientists discovered that using SEND Explorer’s intuitive and interactive interface reduced the time required to create visualizations for ongoing studies from hours to minutes and allowed them to produce cross-study meta-analyses in hours instead of days.

Certara scientists helped establish an automated data pipeline using SEND Explorer Warehouse to transfer data for studies in progress from toxicology CROs to Genmab. This allowed Genmab to perform interim analyses on ongoing studies using SEND Explorer.

SEND Explorer Warehouse can even support custom electronic data standards for some data types that CDISC SEND doesn’t yet support. Depending on the data type, SEND Explorer can load and display the data and generate basic visualizations.

Genmab’s toxicologists have embraced the availability of new technology and are pleased that SEND Explorer allows them to visualize interim and final data holistically so they can focus on the rigorous scientific characterization of investigational drug safety profiles.

Value of Real-Time Data Assessment

  • Monitor findings as study progresses
  • Access real-time insights by tracking key measures of interest
  • Make real-time adjustments to study designs
  • Include additional biomarkers as warranted
  • Apply learnings to ongoing and planned programs
  • Facilitate communications with CRO study director
  • Feedback to drug development team to inform sponsor decision-making

Benefits

Implementing SEND Explorer at Genmab saved substantial time and improved the efficiency of data access, analysis, and visualization. The tool’s ability to quickly generate comprehensive visualizations and compare data across studies helps Genmab to better characterize the toxicological profiles of their drugs.

Choosing SEND Explorer, which is also used by the U.S. Food & Drug Administration (FDA), streamlines Genmab’s communications with the regulatory agency and helps prepare SEND datasets for submission in the Electronic Common Technical Document (eCTD) format.

SEND Explorer’s out-of-the-box visualizations, such as the histopathology severity heatmap, exposure plot, and multi-endpoint line graph, enhance Genmab’s internal communication and decision-making processes, ultimately accelerating their non-clinical safety timelines for cancer therapies.

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