The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop.  The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from small molecules, biomarkers, immunogenicity, cell and gene therapy, and vaccines.

The presentations touched on a broad range of topics as is expected each year including:

  • Challenges and lessons learned in development and use of assays for immunogenicity, biomarker, PK, gene, cell, and vaccine therapies
  • Changes between the draft ICH M10 and now final guidance for Bioanalytical Method Validation
  • Recent regulatory observations

One of the presentations summarized the FDA’s “Remote Regulatory Assessments” (RRAs) during the pandemic and provided insight into the process followed, scope of the RRA’s, and challenges faced.  As travel restrictions have subsided and FDA returns to on-site inspections, although no details were provided, it appears FDA will continue to use RRA’s in certain situations.

The one presentation that caught my eye was provided by WHO and titled “Inspection & Review of CROs’ Computerized Systems Validation”.  You may ask, why this one caught my eye?  This workshop does a great job year in and year out describing the regulatory requirements and the science behind bioanalysis, but fundamentally if the computerized systems are not adequately validated and tested to ensure the integrity of the data generated throughout its life cycle, all the hard work in the bioanalytical lab goes to waste.  You may think everyone validates their systems in this day and age.  Well only a couple of presentations later, MHRA took a look in the rearview mirror over the last 5 years and commented in 2020 that equipment was often not validated, and here in 2022 they are again seeing equipment not being validated.

Bioanalysis is a challenge with the fast pace and new compounds, new techniques, and new equipment; ensure your systems are properly validated so the integrity of the data generated and reported is not compromised.

If you or your organization have any questions or are in need of support for any aspect of your bioanalytical studies, please contact David O’Connor at d.oconnor@lachmanconsultants.com. .