Charter
The Process Automation, Analytics and Development (PAAD) Working Group is a sub-committee of the ISCT Process Development & Manufacturing Committee. PAAD works to gather feedback and insights across two focus areas, Process Development and Analytics as well as Automation and Digitization, to ultimately drive consensus and provide guidance as these focus areas develop.
They work to develop externally- facing content related to PDA and A+D activities in the form of Whitepapers/ Reviews/ Opinion Pieces, Surveys, Guidance Documents, and Webinars.
Goal
To engage and communicate within the CGT community, general public, governmental and non governmental organizations to raise the profile of ISCT to the extremal cell and gene community as a leader and resource for CGT translational education.
Projects & Objectives 2026:
5 Part Webinar Series:
1) Introduction of AI/ML in the Cell and Gene Therapy space: Definitions and Data Standardization. [Click here to view recording]
2) Harnessing AI and Advanced Analytics for Donor Selection and Starting Material Characterization . [Click here to view recording]
3) From Data to Decisions: AI and ML in CGT Process Development and Manufacturing. Webinar planned for February 2026
4) Cost Reduction & Predictive Analytics * Title TBC. Webinar planned for Q1 2026
5) Regulatory Applications of AI/ML* Title TBC. Webinar planned for Q2 2026
Survey: Working group recently distributed a U&A survey on Process Analytical Technologies and In-line Automation. Responses to inform upcoming PAT whitepaper, due for publish Q1 2026.
Analysis: initiate project group to address unique technology challenges in in vivo CAR-T compared to autologous/allogeneic therapies.
White paper: Artificial intelligence, machine learning, and digitalization systems in the cell and gene therapy sector (2025) https://www.isct-cytotherapy.org/article/S1465-3249(25)00713-3/fulltext