Ghanshyam Upadhyay

Head of Assay Development & Innovation-vaccine, Global Clinical Immunology @Sanofi

MA, US

Leading a high performing 20+ member team to develop and qualify GxP-compliant ECL, PCR, and spectral flow cytometry assays for stratification and efficacy assessment of respiratory vaccine candidates, driving go/no-go decisions and regulatory success.• Led the conceptualization and delivery of clinical assay/biomarker strategies, integrating 20+ assays into late-stage trials, collaborating with translational, clinical operations, and regulatory teams to align with study goals.• Drove translational analysis plans for vaccine programs (e.g, chlamydia CMI/ICS via spectral flow), harmonizing assay platforms with early-stage immunology teams to support patient segmentation and portfolio prioritization.• Supervised global transfer of 10+ assays to CROs and sites, ensuring compliance with GCP principles and delivering high-quality biomarker data packages for regulatory submissions.• Reviewed and approved assay qualification/validation reports and assay packages, ensuring alignment with FDA and EMA guidelines for late-stage clinical trials.• Accelerated go/no-go decision timelines by 3 months through rapid development and qualification of ECL based LBA assays, enabling faster progression of RSV vaccine candidates to Phase 3 trials.• Authored critical sections of Investigational New Drug (IND) applications and Clinical Study Reports (CSRs), integrating assay packages to secure regulatory approval for respiratory vaccine programs.• Established Crytek Aurora Spectral Flow and NGS (NextSeq 550) capabilities, enhancing biomarker precision for RSV, hMPV, and chlamydia vaccine development.

Banaras Hindu University

Doctor of Philosophy (Ph.D.)