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Shirley Bartido PhD, MBA
Director, Global Regulatory Affairs Cell Therapy Oncology
Takeda Pharmaceutical Company Limited
USA
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Dr. Shirley Bartido is currently Takeda’s Director of Global Regulatory Affairs in Cell Therapy Oncology. Dr. Bartido holds a PhD in Immunology and an MBA in Pharmaceutical Management from Rutgers University. She completed her doctoral studies at New York University elucidating an alternative Class II processing and presentation pathway utilizing a viral antigen. Her postdoctoral work at Memorial Sloan Kettering Cancer Center involved the development of DNA vaccines for the treatment of melanoma using the melanosomal antigen tyrosinase. Following her postdoctoral work, she joined the Carl Icahn Institute of Gene Therapy and Molecular Medicine as an Assistant Professor to serve as the Assistant Director of the Gene Therapy Immunology Core Laboratory. In this role, she developed several immunomonitoring tools for assaying efficacy of adenoviral directed immunotherapies using AdV-IL-12 vectors targeting metastatic liver cancer. This was followed by an 11-year role as the Senior Quality Manager of the Cell Therapy and Cell Engineering Facility at Memorial Sloan Kettering Cancer Center. In this role, she developed the QA program for the development and GMP manufacturing of autologous CD19 Chimeric Antigen Receptor T-cell therapies for several clinical trials which targeted several indications in leukemia and prostate cancer as well as gene therapy for the treatment of B-Thalassemia using lentiviral transduced CD34+ HPSCs. She was an integral member in the design and construction of a state-of-the-art GMP facility at MSKCC. She then proceeded to become the Director of Regulatory Affairs at Cellectis Inc, a French based company. The company’s platform consists of incorporating gene editing TALEN based technology in the development of allogeneic CAR T-cells targeting hematological malignancies. Currently, at Takeda, she is the global regulatory lead in several cell therapy projects that seek to broaden the impact of immunotherapy in cancer treatment by focusing on mechanisms that leverage innate immunity. She has authored several peer-reviewed publications in several well cited scientific journals and has been invited as speaker in many well attended international and regional conferences. This included recent presentations on “Targeting Cancer: Hitting the Bullseye with Cell and Gene Therapies” and “Gene Editing in Cell Therapy and Its Regulation” and on “Viral vectors manufacturing: Chemistry, Manufacturing, Control and Regulatory Aspects”, at the APEC Pilot CoE in Advanced Therapies at Seoul, Korea. and at the 25th PIC/S Expert Circle Meeting on Human Blood, Tissues, Cells and ATMPs in Djakarta, Indonesia, respectively.