Zhonghua Zhu, PhD

Leadership & Organizational Development • Built and led a high-performing team of 5 reports, including Ph.D.-level scientists and functional managers. Provided mentorship and strategic career planning within and beyond direct team; contributed to broader talent development initiatives. Process Development – Autologous TCR-T Cell Therapy • Directed end-to-end process optimization for multiple TCR-T programs targeting hematologic and solid tumors. Designed and optimized core unit operations. Led DoE-based process characterization and comparability studies to support IND filings and clinical manufacturing readiness • Supported GMP manufacturing, supported MSAT for internal and external tech transfer, supported AD’s assay development Vector Development – Non-Viral Gene Delivery • Developed and optimized a non-viral transposon/transposase vector system for clinical-stage TCR-T cell therapy, including mRNA transposase and DNA payload constructs. Drove vector design decisions to balance expression, stability, manufacturability, and regulatory requirements. Led CDMO selection, technology transfer, and GMP manufacturing for both mRNA and plasmid vectors Regulatory & Compliance • Authored and reviewed CMC sections for multiple IND and IND amendments. Participated in FDA meetings as CMC representative, addressing regulatory questions and presenting development strategies Strategic Projects, Business Development & IP • Technical lead in cross-functional evaluation of next-generation therapy opportunities, including lentivirus based in vivo CAR-T, iPSC-derived and allogeneic T-cell platforms. Conducted competitive and scientific landscape assessments on gene delivery vectors (viral, non-viral, LNP, VLP), gene editing tools, in vivo/ex vivo T-cell engineering technologies, and CDMO manufacturability • Performed scientific diligence; authored scopes of work (SOWs), MTAs, and technical briefs to support strategic collaborations • Contributed to multiple IP filings

Team & Project Leadership • Built and managed 4 junior level scientists, supporting scientific development and project execution • Partnered with program leads to align genetic model strategies for CNS diseases with target validation, compound screening, MoA studies and patient qualification Genome Editing & Model Development • Established iPSC Genome Editing function at Biogen • Delivered > 80 genome-edited iPSC models using CRISPR: SNP knock-ins, large-fragment integrations, knockouts, etc. Generated 10 transgenic mouse models including BAC-based humanizations, conditional knockouts, and reporter lines. Designed and developed viral vectors (lentivirus & AAV) with different payloads to support preclinical programs iPSC Differentiation & Assay Development • Established differentiation & production protocols of iPSC-derived OPC and GABA neurons • Developed a high-content imaging based assay of oligodendrocytes differentiation, for MoA study of a Phase I trial. Built vSMC differentiation assay to enable compound screening. Evaluated 3D drug screening platforms including organoids, 3D co-culture functional assay • Established functional genomics platform for MoA studies Enterprise Impact & Business Development • SME for implementation of a centralized company-wide bio-registration platform • Contributed to technical diligence of a small molecule screening platform for potential partnership