Perspectives on the draft ICH-M10 guidance: an interview with Boris Gorovits.

Abstract

Biography Boris Gorovits is a Senior Director of the Bioanalytical lab at Pfizer. Boris earned his PhD in Enzymology from the Moscow State University and later completed postdoctoral research studies in protein biophysics at the Medical Center, University of Texas at San Antonio, TX, USA. 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 Nonregulated 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 biotherapeutic modalities, including mAbs, bi-specific antibodies, antibody-drug conjugates, ADCs and gene therapy. Boris is proud to be an active member of the American Association of Pharma Scientists. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop(Silver Spring, MD, USA), 11 June 2019.