Haihua Gu

Pre-clinical discovery and research on CAR T projects and platforms

Immunology therapy oncology

Immunology cell therapy R&D and PD

Research and Development • Independently designs and executes studies to facilitate development of CAR-T, CAR-NK processes and enabling clinical trials • Develop and perform CAR-T, CAR-NK function assays • 2 of them are preparing for the FDA Phase I clinical trial this year Process Development • Strong experience developing CAR-T production processes • Rich experience with CAR-T processes such as PBMC/T cell isolation, T cell activation, T cell expansion, T cell harvest and storage • Proficiency in the use of CAR-T related equipment includes, but is not limited such as Sepax II, LOVO, MACS, GE WAVE • Rich experience with analytical methods, such as proliferation assays, qPCR, multicolor flow cytometry, ELISA, cytotoxicity assays • Executing gene editing using Crispr-Cas9 • Outstanding written and oral communication skills; generate report, SOP, batch record, and instructions • Execute 15 Optimize cell therapy manufacture processes, saving 20% time • Develop new cell culture methods to save 15% costs Management • Work closely with all related functions (e.g., Quality Assurance/Control, Manufacturing, Facilities, Process Development, Project Management) to ensure that objectives are met on schedule • Strong supervisory skills and contributes to the achievement of company and departmental goals and objectives • Strong collaborative relationships with internal and external groups • Investigate and resolve problems, identifying root cause and proposing process improvements through clear communication to senior management • Mentors a group of diverse

• Designs/executes preclinical PK, PK/PD in vivo ADME, MTD and efficacy studies • Manage multiple research projects • Performs complex in vivo experiments utilizing tumor models (syngeneic, xenograft tumor models and humanized mouse models) in both immunocompetent and immunocompromised mice • Performs the formulation of small molecules and PK/PD assay technologies • Operates more than 50 types mammalian cell culture in sterile condition, develops and performs in vitro/ex vivo immune cell-based assays • Isolates and characterizes primary immune cells from murine tissues and human blood. Performs T cell, Dendritic cell, macrophage, MDSCs and NK cell-related assays, flow cytometry (including FACS staining, analysis and interpretation) • Performs immunophenotyping, cell proliferation and cytotoxicity, cytokine profiling, ELISA and/or western blot analysis of tissue lysates and other functional assays • Executes in vivo skills: IV, PO, IP, SC dosing, tumor implantation, blood/tissue collection, etc • Manages site inventory, orders laboratory supplies and equipment • Maintains the laboratories and performs other job related duties as assigned • Manages and summarizes data analysis • Writes study reports and research manuscripts • Trains new employees Project I: Emerging roles of T helper and regulatory T cells in cancer progression and metastasis Project II: Build up novel immunology and oncology animal models by tail vein injection of PBMC Project III: Myeloid-Derived Suppressor Cells function changing in cancers Project IV: Immune checkpoint inhibitors for the treatment of advanced cancer

PK, PK/PD, in vivo ADME, MTD and efficacy studies for anti-tumor and metabolism diseases (diabetes, obesity and chronic hepatic disease) in nonhuman primate and rodent models. • Designs/executes preclinical PK, PK/PD in vivo ADME, MTD and efficacy studies. • Develops and applies modeling strategies. • Supports multiple target discovery efforts in vitro/vivo physiology and pharmacology research. • Maintains the laboratories and performing other job related duties as assigned. • Manages and summarizes data analysis. • Writes study reports and research manuscripts. • Trains new employees. SKILLS • Mammalians cell culture, developing and performing in vitro cell-based signaling and functional assays. • Performs fluorescence microscopy and immunology fluorescence staining. • Animal handling skills and strong hands-on experience with dosing different techniques (oral, intravenous, subcutaneous, transdermal, intratumoral, intraperitoneal, continuous infusion, intrathecal and inhalation), tissue sample collection. • Nonhuman primate and rodent surgical procedures. • Sets up and operates various scientific apparatus such as qPCR machine, spectrophotometer, centrifuges, incubators, homogenizers, water bath, and microscopes, etc. • Conducts various research experiments and assays such as DNA and RNA isolation from various tissue, quantitative PCR, ELISA, Western Blotting and other colorimetric assays, tissue homogenization. • Expertise using in vivo assays for characterizing metabolic parameters such as glucose measurement, glucose clamp technique, graded glucose infusion (GGI), intravenous glucose tolerance test (ivGTT), oral glucose tolerance test (oGTT), food intake, body weight, energy expenditure. • Uses DXA calculate the body fat distribution. • Generation of formulation. • Statistical analysis of data. • Performs the ultrasound system (Echo) monitoring cardiac function, chronic hepatic disease developing and in vivo tumor growing.

Mitochondrial function in Food Induced Insulin Resistance and Diabetes • Manage multiple projects simultaneously, prepare complex data findings, and present data to teams from several areas, including cell culture, aniaml care and dosing, and immunology test. • Managed laboratory functions including organization, ordering and scheduling equipment use. • Trained new students and employees.

Effect of Narcotics on HIV-mediated Pulmonary Endothelial Dysfunction of nonhuman primate (NHP) • Built up research proposals. • Created and conducted experiments. • Analyzed results of the experiments • Worked with other researchers to use and develop end product • Applied for grants to continue research.

Outstanding student leaders of Beijing University of Technology June 2004 Outstanding Graduates Honorable of Beijing University of Technology June 2005