Anti-Drug Antibody Assay Validation, An Industry Perspective
Abstract: Biotherapeutic compounds have a potential to induce unwanted immune response resulting in variable clinical impact – from no effect to potentially life threatening events. Reporting of unwanted immunogenicity is one of the key elements in the regulatory submissions for product approvals. Immunogenicity is typically assessed by detecting anti-drug antibody (ADA) responses in drug specific ADA assays. In this presentation we will discuss relevant regulatory FDA guideline document and industry challenges.
About Our Speaker:
Boris Gorovits is a Senior Director of the Bioanalytical lab at Pfizer. Boris earned Ph.D. in Enzymology from the Moscow State University and later completed postdoctoral research studies in Protein biophysics at the Medical Center, U of Texas at San Antonio, TX. In 2000 Boris joined Wyeth Research (later Pfizer Inc) to work as a bioanalytical group lead with a growing scope of responsibilities. Currently he leads the Bioanalytical group within Biomedicine Design department which is responsible for many aspects of the Regulated and Non-Regulated Bioanalytical support for the pan-Pfizer Biotherapeutic portfolio. Boris co-chairs Pfizer internal Immunogenicity Expert Working Group which is responsible for review of the biotherapeutic immunogenicity risk assessment and mitigation strategies. Recently Boris has been actively involved in industry discussions focusing on PK and immunogenicity assessment bioanalytical support of various modalities, including mAbs, bi-specific antibodies, antibody drug conjugates, gene therapy and CAR-TExternally, Boris authored 50+ manuscripts and book chapters, is a frequent presenter at various conferences, is a past Chair for the AAPS BIOTEC section, the lead for the AAPS PS360 2018 Conference, Biotherapeutic Bioanalysis track.