Experiences at the 11th Workshop on Recent Issues in Bioanalysis (WRIB)

Bruce Stouffer, executive director of PPD^® Laboratories bioanalytical lab, weighs in on his recent experiences at WRIB.

Workshop on Recent Issues in Bioanalysis (WRIB) is a large international conference attended by hundreds of people from pharmaceutical companies, biotechnology companies and contract research organizations (CRO) across the world. The event consists of three days of presentations and panel discussions bracketed by a variety of training courses. At the conference, regulators and industry professionals convene to work together in the bioanalysis, biomarkers and immunogenicity fields to improve global health. Bruce Stouffer, executive director of PPD^® Laboratories bioanalytical lab, weighs in on his recent experiences at WRIB:

Why is it important for PPD to attend WRIB?

WRIB is a uniquely focused meeting for bioanalysis, engaging pharma, CROs and regulators to come together in a workshop format to discuss the latest topics and produce industry-leading white papers that are used as supplemental guidance in the industry. The growing, but reasonable, size of the meeting also provides close interaction between clients and CROs.

What were your top two takeaways from the panel discussions?

Multiple panels highlighted evolving regulatory expectations around bioanalysis, particularly in emerging areas such as hybrid LBA-LC/MS analysis, immunogenicity and biomarkers. The accompanying CRO-only meeting, as well as the meeting’s results and surveys were also very informative. The survey results indicated similar trends between pharma and CROs on frequency of U.S. Food and Drug Administration (FDA) audits and approaches on evolving best practices for bioanalysis.

What do you think are the biggest challenges facing the bioanalysis, biomarkers and immunogenicity fields?

For immunogenicity, there seems to be a wide range of scientific and statistical approaches being used in the industry for details in method validations (cut-point determinations, quality control placement, etc.). Some activity with regulators is beginning to emerge that is resulting in closer scrutiny of these approaches, occasionally resulting in FDA483 citations that seemingly result from draft guidance that was issued in 2016.

How is PPD working to overcome these challenges?

PPD is continuing its dialogue with regulators and clients and has updated its SOPs to reflect the revised expectations.

Bruce Stouffer is an executive director in PPD^® Laboratories bioanalytical lab.