R D Clinical Research

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XIAOHUI YI, MD

Lexington, MA 832-***-**** *********@*****.***

BIOTECHNOLOGY PHARMACEUTICALS

A resourceful Scientific Researcher with a successful 10+ year career history of spearheading complex scientific research projects from early drug discovery to clinical research in biopharmaceutical companies and the healthcare leader Cancer Center. Known for assessing progressive bioanalytical technologies and generating key analytical data to inform decision-making. Out-of-the-box, creative thinker committed to developing and implementing innovative quantitative and qualitative methods to support biopharmaceuticals. SKILLS & EXPERTISE

• Research & Development

• Project Coordination

• Purposeful

• Strategic Planning

• Study Design & Execution

• Data Analysis

• CAR-T Therapy

• mRNA-LNP

• Cancer Immunotherapy

• Drug Discovery

• Molecular and Cell Biology

• Oncology

• TME

• Cell and Gene Therapy

• People Management Skills

EDUCATION Doctor of Medicine

Huazhong University of Science & Technology, Tongji Medical College, Hubei, China PROFESSIONAL EXPERIENCE Sanofi, Cambridge, MA

Scientist, R&D, Cell Therapy (05/2023 – 05/2025)

• Lead in situ aVEGF/aAREG project, focusing on normalizing tumor vasculature to enhance cell therapy efficacy in solid tumors.

• Played a key role in reprogramming tumor-tropic CCR2 and CX3CR1 monocytes and macrophages to an anti-tumor phenotype using IRF5/IKKβ-laden lipid nanoparticles. Senior Associate Scientist, R&D, Cell Therapy (11/2021 – 05/2023)

• Led Synthetic PM21 project, bridging therapeutic programs and technology development.

• Developed and optimized cell therapy applications for immuno-oncology. FUHONG Therapeutics, Lexington, MA

Senior Associate Scientist, R&D, Translational Research (07/2021 – 11/2021) • Investigated BAFF and CD20-targeted B cell depletion for lupus treatment.

• Analyzed gene expression of BAFF and BAFF receptors in human cell lines. BELLICUM Pharmaceuticals, Inc., Houston, TX

Research Associate, R&D, Translational Research (04/2017 – 11/2020)

• Provided clinical evidence supporting the GoCAR-T® technology in patients with advanced solid tumors.

• Conducted functional assays evaluating T cell expansion and persistence in the tumor microenvironment. Internal

MD Anderson Cancer Center, Houston, TX

Research Assistant, Dr. James Allison’s Immunotherapy Platform (10/2012 – 01/2017)

• Focused on enhancing the efficacy of cancer immunotherapy through mechanistic studies.

• Investigated tumor resistance mechanisms and potential vulnerabilities to immunotherapy treatments. TECHNICAL SKILLS

• Cell Culture & Immunoassays: Mammalian cell culture, PBMC isolation, immune cell selection, co-culture assays (tumor cell killing, immune cell migration).

• Molecular & Cellular Techniques: DNA/RNA preparation, PCR/real-time PCR, lentiviral reporter cell lines through transduction of mouse cell lines, HEK293T transfection for production of lentiviral vectors for CAR- T cell construction, monocyte mRNA- LNP transfection, multiplex cytokine assays (MSD, Luminex).

• Flow Cytometry & Data Analysis: FACS analysis (Canto II, LSR II, Fortessa), multicolor panel design, FlowJo, Prism, PowerPoint, Photoshop.

• HUVECs Proliferation Assay & Cell Trafficking Assay: Evaluating endothelial cell proliferation and migration in response to therapeutic interventions.

• Experimental Design & Reporting: Protocol development, data interpretation, and presentation.

• Additional Skills: Buffer preparation, lab equipment maintenance, cross-functional collaboration in R&D teams.

• Regulatory Environment: Experience in GMP-like settings, CRO coordination, SOP adherence LEADERSHIP & MENTORSHIP

• Sanofi, Cambridge, MA – Managed and mentored Northeastern University co-op students, providing hands-on training in cell therapy research, experimental design, and data analysis.

• Guided co-op students in flow cytometry, PBMC isolation, and immune cell assays, ensuring adherence to lab protocols and research goals.

• Fostered a collaborative learning environment, offering career development advice and scientific discussions to enhance their industry experience.

• Acted as a mentor for junior scientists and research associates, supporting their technical growth and project execution.

PUBLICATIONS & PRESENTATIONS

• Yi, X., Gonzalo, J., Mahendra, A., Fantin, V., Shaffer, D., Amoozgar, Z. Blockade of VEGF/AREG to normalize tumor vessels and matrix. Sanofi R&D Week, Cambridge, MA, 2024.

• Yi, X., Cole, K., Nguyen, C., Gungaveesoon, J., Quellier, D., Nowicka, A., Fantin, V., Shaffer, D., Amoozgar, Z. Understanding lymphocyte expansion to engineer synthetic cell expanders. Sanofi R&D Week, 2023.

• Mednikov, M., Yi, X., Shin, E., Griset, A., Lemgart, V., Kuhlman, W., Strauss, L., Sawyer, A., Drummond, D., Nielsen, U., Shaffer, D., Amoozgar, Z. In Situ Reprogramming of Tumor Tropic Monocytes & Macrophages. Sanofi R&D Week, 2022.

• Shaw, J., Ballard, B., Yi, X., Malankar, A., Collinson-Pautz, M.R., Okrah, K., Becerra, C.R., Woodard, P., Foster, A.E. Tumor infiltration and cytokine biomarkers of PSCA-directed GoCAR-T® cells in pancreatic tumors. ASCO GI Symposium, 2020.

• Becerra, C.R., Manji, G., Kim, D.W., Gardner, O., Malankar, A., Shaw, J., Blass, D., Yi, X., Foster, A., Woodard, P. Ligand-inducible, PSCA-directed GoCAR-T® cells in solid tumors. ASCO Annual Meeting, 2019.

• Chen, L., Diao, L., Yi, X., et al. Tackling the tumor microenvironment with CD38 blockade to enhance cancer immunotherapy. Cancer Immunol Res, 2019.

• Chen, L., Li, Y., Yi, X., Gibbons, D.L. Targeting CD38 to improve anti-PD-1/CTLA-4 combination therapy in lung cancer. J Clin Oncol, 2018.

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• Chen, L., Diao, L., Yang, Y., Yi, X. CD38-Mediated Immunosuppression as a Mechanism of Tumor Cell Escape from PD-1/PD-L1 Blockade. Cancer Discovery, 2018.

• Ritthipichai, K., Haymaker, C.L., Martinez, M., Aschenbrenner, A., Yi, X. Multifaceted Role of BTLA in the Control of CD8+ T-cell Fate after Antigen Encounter. Clin Cancer Res, 2017. LANGUAGES

• English

• Chinese

COMMUNITY ENGAGEMENT

• Odyssey of the Mind – Volunteer Mentor

• School Volunteering & AIM Pilot Program – STEM Outreach

• Animal Shelter Volunteering – Advocacy & Support INTERESTS

• Cooking

• Hiking

• Traveling

• Swimming

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