Contents: Background | Introduction | Challenges | Journey | Why LabKey | Results | Conclusion
Background:
Candel Therapeutics is a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies that have demonstrated individualized, systemic anti-tumor immune responses in patients with cancer. The company has established two clinical platforms based on novel, genetically modified adenovirus and HSV gene constructs, respectively. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing investigator-sponsored phase 1 clinical trial in recurrent HGG. In addition, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors. CAN-2409 is the lead product candidate from the adenovirus platform and is currently in ongoing clinical trials in NSCLC (phase 2), borderline resectable pancreatic cancer (phase 2), and localized, non-metastatic prostate cancer (phase 2 and phase 3). Within its clinical trials, patient samples are collected and assessed for exploratory biomarkers, including blood derivatives and tissue samples for research purposes.
Introduction:
Realizing the many challenges with using Excel for sample tracking, Candel started looking for software solutions to manage biomarker samples from the collection at clinical sites to their externally performed assays.
Challenges:
Candel faced several challenges tracking their samples with Excel spreadsheets:
Version Control: Lab members frequently had to verify they had the latest version of the tracking spreadsheets, as new instances were made for a variety of reasons.
Lack of Audit Trails: When issues and audits arose, the team found Excel spreadsheets did not have useful enough functionality for mirroring the sample journey and tracking who did what.
Inefficiencies with Contract Organizations: The process of sending samples to a contract research organization (CRO) for assays required separate spreadsheets, leading to inefficiencies and conversations over the data.
The Journey:
The adoption of Sample Manager took several stages:
Identifying the Problem: The team began looking for the cause of the inefficiencies they experienced. They discovered their growth had led to high volumes of samples, a situation spreadsheets could no longer effectively track.
Data Curation and Compilation: The lab manager began curating and improving the various spreadsheets to prepare for migration to new software, deciding what was vital to carry over and what wasn’t needed anymore. This also allowed them to focus on what features were required as they searched for a new system.
Evaluation: Sample Manager stood out during the evaluation process due to its ability to provide an audit trail, user-friendly interface, and suitability for Candel’s clinical trial needs. Additional features, such as tracking aliquots and managing relationships between samples, aligned well with Candel’s requirements. The ease of use, thorough documentation, and support from the LabKey team contributed to the decision to adopt Sample Manager.
Implementation: The implementation of Sample Manager was efficient, taking two weeks to set up the sample structure and import thousands of aliquots. The software identified errors in sample metadata from Excel spreadsheets, allowing for swift corrections during the upload process.
Why LabKey:
Three features of Sample Manager stood out to Candel:
Audit Trails: Sample Manager offered easily accessible and readable audit trails, allowing the team to quickly trace sample activity in multiple ways.
User-Friendly Interface: The intuitive interface of Sample Manager made it easy to view sample aliquots and relationships with other samples, as well as enable multiple stakeholders to navigate and access the data they need.
Clinical Trial Suitability: LabKey could provide a complete lifecycle for samples, capture clinical data and maintain a relationship with samples used, all while preserving the needed levels of compliance.
Results:
Candel has adopted Sample Manager and has had success in:
Sample-Centric Tracking: The sample tracking feature eliminated the need for manual data cross-referencing, resulting in improved data integrity and accuracy.
Quick Implementation: The quick and straightforward implementation allowed Candel to meet project milestones and move on to other tasks.
Simplified Workflows: The product integrates well with Candel’s existing sample lifecycle, from collection at clinical sites to sending out samples to CROs for testing.
Conclusion:
The adoption of Sample Manager at Candel has proven to be a successful solution to the challenges associated with sample management. The software’s swift implementation, user-friendly features, and capacity to address issues identified during the transition from Excel spreadsheets have contributed to more efficient and accurate tracking of biomarker samples. This underscores the platform’s seamless integration into Candel’s sample management workflow, positioning it as a valuable tool for ongoing clinical trials and future research endeavors.