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.‎


  • 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

Please visit our ISPE Community for the latest SIG news, upcoming meetings, membership, documents library, connecting with SIG members and leaders, and more. An account is needed to access the community and join it.

SIG leader(s)

Chair Kui Huang  
Vice Chair Quazi Ataher