Streamlining the Selection and Qualification of Biomarker Laboratories
Author: Julie Neild
Contributors: Jay Turpen, Ian Macholl
The Demands and Challenges of Biomarker Research
Over half of drug approvals at the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been supported by biomarker data during at least one stage of development (2015 to 2019). Drug development programs with trials employing patient preselection biomarkers have a 2-fold higher likelihood of approval (15.9%) than those that do not (7.6%).
Figure 1: Clinical Trials Involving Biomarkers 2011 through 2020
• New biomarkers are continually being discovered and need to be developed and validated before they can be used clinically
• Biomarker trial strategy has become more complex over time; biomarker trials using 2 or more biomarkers has risen consistently over time.[8,9]
• Biomarkers are often associated with additional testing requirements, while validation and qualification processes and regulations are continually evolving.
• Finally, a biomarker lab that focuses on novel assay development for a new biomarker may not meet all the GCLP requirements for the intended purpose of evaluating clinical trial samples for the biomarker (eg, GCP standards for a primary endpoint in a clinical trial) or may not wish to obtain appropriate certification. Sponsors need a “fit-for- purpose” approach to qualify each Biomarker Lab for their intended use in support of their drug development strategy
A Risk-Based Approach to Qualifying Biomarker Lab Providers
The Diligent® Qualification Platform service builds on the AQC standards using a risk- based assessment of development program requirements. This innovative approach helps companies to manage vendor risk effectively and to document their vendor qualifications as required by global health authority regulations. The opportunity for companies to outsource vendor qualification to Diligent reduces variability and improves compliance. Once assembled, request for information details (RFIs) and vendor qualification assessments (VQAs) can be used many times by multiple trial sponsors, thus reducing costs and cycle times. Diligent can also customize the approach to assess biomarker labs including labs who want to develop biomarkers but may not want to participate in a clinical trial.
Qualification of biomarker lab providers is a foundational first step to realizing the benefits of biomarkers in drug development programs. The Diligent Qualification Platform service offers an effective approach that the industry can utilize to reduce variability, costs, and cycle times and effectively manage risk in selecting and qualifying biomarker lab providers.
Some providers of biomarker laboratory services with RFI details accessible via the Diligent Qualification Platform
|Eurofins Central Laboratory||eurofins.com|
|Frontage Laboratories Inc||frontagelab.com|
|Huidu (Shanghai) Medical Sciences Ltd||huidumed.com|
|Navigate BioPharma Services Inc.||navigatebp.com|
|NeoGenomics Laboratories Inc.||neogenomics.com|
|Q2 Lab Solutions||q2labsolutions.com|
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