A Collaborative Workshop to Discuss Bioanalysis
The Workshop on Recent Issues in Bioanalysis (WRIB) gathers industry and regulatory leaders from around the world, to discuss challenges in the discovery and development of bioanalytical, biomarker, and immunogenicity assays. The FDA, Regeneron, Pfizer, MHRA, Sanofi, EMA, Bristol-Myers Squibb, and Biogen were just some of the presenters from this year’s meeting. The meeting has become a must attend event for bioanalysis industry leaders, bringing this year’s attendance to over 900 participants! A day was spent on each of the three assay types: LCMS, LBA and LCMS/LBA hybrid assays. The common theme discussed across all three days was the continued need to develop an assay that is of clinical relevance and significance.
One of the goals of the workshop is to provide potential solutions, in line with regulatory requirements, to recent industry challenges. Another goal is to have conversations around the most recent scientific discoveries in the field of bioanalysis. The workshop provides the unique opportunity for industry leaders to openly discuss and shape guidance documents with the regulators and to ensure that regulatory documents are developed in collaboration with the most recent industry findings. Each year, a new white paper is created, based upon the discussions at WRIB, to communicate the most up to date recommendations in bioanalysis.
Recent Findings from FDA Inspections and Surveillance
The mission of the FDA’s Office of Study Integrity and Surveillance is to ensure data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA. This year, Dr. Sean Y. Kassim, Director of the Office of Study Integrity and Surveillance presented on recent findings during BA/BE inspections and surveillance.
In 2017, record keeping was the most common BEQ related deficiency and the second biggest issue in BA/BE studies. Deficiencies seen in record keeping included inadequate documentation of sample receipt, storage handling, or correspondence, and sample processing events. The most common deficiency from BA/BE studies was method validation. These included matrix effect not evaluated or fully addressed, specificity not established, dilution integrity covering study conduct not established, method not fully validated, and not all precision and accuracy (P&A) runs included in the assessment of intra- and inter-run P&A.
Leveraging Software to Enable Audit-Readiness
Dr. Kassim reviewed the critical points of a bioanalytical inspection:
- Pre-study analytical method validation
- Run acceptance criteria during subject sample analysis
- Documentation of sample handling
- Repeat analysis of study samples
- Audit trail
- Verification of on-site data with study report
- Equipment logs, SOPs
Thermo Fisher™ Watson LIMS™ software enables laboratories to quickly provide regulators with many of the critical items listed by the FDA during an inspection. Watson LIMS software was specifically designed to support the bioanalytical workflow, tracking metadata from method development through study archival. By utilizing Watson LIMS software, study directors can quickly provide regulators with sample chain of custody records, system audit trails, method validation and non-clinical/clinical runs, assay repeat and incurred sample reanalysis reports, and study archival records.
Industry and Regulatory Guidance on Conducting Immunogenicity Studies
A popular topic during WRIB 2018 was best practices for conducting immunogenicity assays. The main goal when conducting immunogenicity studies is to determine if drugs will elicit immune responses which will impact the efficacy or safety of a therapeutic. Industry and regulatory leaders in attendance agreed that there does not appear to be a reason to continue to increase the requirements for sensitivity and drug tolerance for most molecules apart from high risk molecules. It is important for biopharmaceutical organizations to focus on what is clinically relevant, and participants agreed that by increasing assay sensitivity and/or drug tolerance it may actually lead to less data being reported.
Industry and regulatory leaders agreed that the most common and widely used approach to conducting immunogenicity assays is with the tiered approach performing screening, confirmatory, and NAb assays. Watson LIMS software guides users through each step of the tiered approach, and has the capability to calculate and determine assay cut-points. Watson LIMS software provides principal investigators the ability to review complete patient assay data in one system for PK/ADA.
If you are interested in learning more about how Watson LIMS software can support your bioanalytical laboratory, visit the Watson LIMS software page on thermofisher.com.