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Shirley Bartido
Director Global Regulatory Affairs, Cell Therapy Oncology at Takeda
Professional Background
Shirley Bartido is a highly experienced professional specializing in Regulatory Affairs within the dynamic fields of biotechnology and research. With a career spanning over several years, Shirley has established herself as a leader in regulatory practices, particularly concerning Advanced Therapeutic Medicinal Products and vaccines. Currently, she serves as the Director of Global Regulatory Affairs for Cell Therapy Oncology at Takeda, where she oversees critical regulatory strategies that support the development and commercialization of cell therapies in oncology. Her vast expertise is not only recognized within her organization but also extends to the broader biotechnology community through her work with several prestigious organizations.
Shirley has an extensive background that showcases her dedication and impact in the field. Before her tenure at Takeda, she held notable positions including Director of Regulatory Affairs at Cellectis, where she was instrumental in leading regulatory submissions and ensuring compliance with stringent regulatory requirements. Her role as the Head of Clinical Stem Cell and Immune Engineering Facility at Charité - University Medicine Berlin further enhances her professional profile, providing her with a unique vantage point on the integration of clinical practices with biotechnological advancements.
Education and Achievements
Shirley Bartido's educational background is robust and firmly rooted in the sciences and business management. She obtained a PhD in Immunology from New York University, a program renowned for its rigorous scientific training and emphasis on research. This solid foundation in immunology has equipped her with an in-depth understanding of the biological mechanisms underpinning therapeutic products. Additionally, Shirley earned her MBA in Pharmaceutical Management at Rutgers University - Newark. This combination of advanced science and business acumen has uniquely positioned her to navigate the regulatory landscape effectively while also addressing the commercialization aspects of pharmaceutical development.
Throughout her career, Shirley has actively contributed to the field's knowledge base by participating in various professional groups. She has been a member of the Legal and Regulatory Affairs & Commercialization Groups at the International Society for Cell Therapy, where she collaborated with industry peers to shape regulatory policies that impact the development of cell therapies worldwide.
Achievements
Shirley Bartido's commitment to excellence and professionalism is evident in her numerous roles across various leading institutions. Her experience as a Senior Manager of Quality Assurance and Regulatory Affairs at the Memorial Sloan-Kettering Cancer Center highlights her capability in ensuring that clinical treatments meet the highest standards of safety and efficacy.
Additionally, her work as a Consultant for Cell Therapy at Charité testifies to her versatile expertise and the trust placed in her by institutions specializing in pioneering therapeutic solutions. Moreover, her initial role as Assistant Director at Mount Sinai School of Medicine paved the way for her present accomplishments by providing her with a solid foundation in regulatory frameworks that govern clinical research.
In every position held, Shirley has demonstrated a strong skill set in Good Manufacturing Practice (GMP), biotechnology, cell culture, and software documentation, making her an invaluable asset in the biotechnology sector. Her proactive approach and unwavering commitment to regulatory excellence have not only advanced her career but have also significantly impacted the organizations she has been a part of. She is dedicated to ensuring that innovative therapies are brought to market effectively while complying with all necessary legislation and regulatory requirements.