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Perspectives on the draft ICH-M10 guidance: an interview with Boris Gorovits
1Pfizer Inc., 1 Burtt Rd., Andover MA 01810, USA.
Bioanalysis
|September 7, 2019
Summary
Dr. Boris Gorovits leads Pfizer's Bioanalytical lab, focusing on biotherapeutic development. His work involves pharmacokinetic and immunogenicity assessments for diverse modalities like antibody-drug conjugates.
Area of Science:
- Biopharmaceutical Development
- Bioanalytical Sciences
- Immunology
Background:
- Boris Gorovits holds a PhD in Enzymology and postdoctoral research in protein biophysics.
- He leads the Bioanalytical group at Pfizer, supporting a wide range of biotherapeutics.
- He co-chairs Pfizer's Immunogenicity Expert Working Group.
Discussion:
- Focus on regulated and non-regulated bioanalytical support for Pfizer's biotherapeutic portfolio.
- Involvement in industry discussions regarding pharmacokinetic (PK) and immunogenicity assessment.
- Expertise spans various biotherapeutic modalities, including monoclonal antibodies (mAbs), bi-specific antibodies, antibody-drug conjugates (ADCs), and gene therapy.
Key Insights:
- Bioanalytical support is crucial for the successful development of diverse biotherapeutics.
- Risk assessment and mitigation strategies for immunogenicity are key considerations.
- Industry collaboration and expert working groups drive advancements in bioanalytical methods.
Outlook:
- Continued focus on advancing bioanalytical strategies for novel therapeutic modalities.
- Addressing challenges in immunogenicity assessment for complex biologics.
- Contributing to industry standards and guidelines for biotherapeutic development.
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