Cell and Gene Therapy

August 2022

Mission Statement

The Cell and Gene Therapy Special Interest Group (CGT-SIG) serves as a collaborative community of ISPE members to ‎discuss, develop, and improve study design, analytical methods, data elements, and quality for ‎pharmacoepidemiologic studies focusing on the various aspects of CGT, including but not limited to safety and ‎effectiveness.‎

Objectives

• To share knowledge and experience among members in the field of CGT
• To increase awareness of and discuss issues/challenges in pharmacoepidemiologic research on CGT
• To foster collaboration among the SIG members using novel real-world data sources and pharmacoepidemiologic ‎methods to study CGT‎
• To develop and advance pharmacoepidemiologic methods (e.g., multi-database methods, data linkage (e.g., use of ‎tokenization) and design-based approach to address bias) in the field of CGT
• To educate the general ISPE membership and external stakeholders on the role of pharmacoepidemiology in CGT
• To serve as a resource to ISPE membership by providing pharmacoepidemiologic research and training in CGT
• To increase participation, communication, and cooperation between ISPE members and other groups in academia, ‎industry, and regulatory agencies that are focused on CGT

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SIG leader(s)