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Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements
Session Chair(s)
Robert (Mac) Gordon, MS
Director, Biostatistics
Johnson & Johnosn Innovative Medicines, United States
Planning safety reviews for a compound developed for multiple diseases is complex, requiring consistency across studies and analyses. A compound-level Data Monitoring Committee ensures unblinded safety review consistency, while an Aggregate Safety Assessment Plan (ASAP) supports post-study assessments. This presentation explores how an ASAP was implemented across a program to enable ongoing safety profile development as studies complete. It also introduces an interactive R Markdown application for real-time aggregate reviews, aligning with new draft regulatory guidance. This approach provides reviewers with access to program-level and individual study data during development, improving safety oversight. Key topics include the importance of coordination, teamwork, and standards to maintain a reliable safety database. A "year in review" will highlight lessons learned and enhancements made, concluding with an example of the application’s interactive capabilities.
Learning Objective : Comprehend and apply the Aggregate Safety Assessment Planning (ASAP) concept to drug development and aggregate safety analysis; Implement the ASAP effectively within their organization; Identify and utilize the importance of an interactive application for performing ongoing aggregate safety reviews.
Speaker(s)
Overview of the ASAP Process
Greg Ball, PhD
ASAPprocess, United States
Safety Data Scientist
Industry Perspective on the ASAP Process
Walter Straus, DrMed, MD, MPH, FACP
Moderna, United States
Vice President, Safety and PV
Perspective on the ASAP Process
Representative Invited
FDA, United States
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