Over 15 years of industry experience in small molecules, biologics, and gene therapies drug development. Experience in neurological diseases, CVMET, hematology, rare diseases. Co-authored IND/CTA submissions and global regulatory interactions. Extensive experience in integrating preclinical and clinical biomarker strategy through working across Research and Development organizations. Scientific and technical expertise in implementing translational biomarker, PK and immunogenicity strategy in pre-clinical, Phase 1-3 studies. Key driver for Biomarker-based clinical endpoint design and execution. Organized and invited speakers for multiple national/international conferences on biomarkers and precision medicine Demonstrated track record in building high-performing teams from inception, and leading cross-functional teams. Led by example and by enabling and inspiring others. Recognized leadership roles in external professional organizations (AAPS and SAPA). 35+peer-reviewed publications and book chapters, 6 US patents.. Authors of industry white papers on large molecule and biomarker bioanalysis. Authors of industry white papers on large molecule and biomarker bioanalysis.
Listed skills include Drug Discovery, Biomarkers, Drug Development, Assay Development, and 8 others.