We are pleased to announce our Keynote Presentations.

FDA Study Data Technical Rejection Update by Heather Crandall, FDA Heather Crandall, FDA Study Data Standards listed in the FDA Data Standards Catalog are required for clinical and nonclinical studies that started after December 17, 2016 (for ANDA, NDA and BLA) or December 17, 2017 (for Commercial IND). Through the technical rejection process, FDA can reject an application because of its technical deficiencies, based on the severity of the eCTD validation criteria. FDA has been conducting an analysis on submissions that contain study data that were already received by the Agency to assess conformance rates to Technical Rejection Criteria for Study Data (TRC). This presentation will share the FDA analysis result as well as common errors being noticed as part of this analysis. FDA plans to implement the “Technical Rejection Criteria for Study Data” in 2021 and begin rejecting submissions that do not conform. Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

Moving at the Speed of Science: Lessons Learned in Response to the Covid-19 Pandemic by Patti Compton/Henry Shen, Pfizer Henry Shen, Pfizer, China In March 2020, the FDA declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic. This presentation will highlight key strategies to accelerate the analysis process to support a COVID-19 EUA as well as lessons learned that may be considered for future programs. Patti Compton is currently the Head of Statistical Programming and Analysis at Pfizer. With over 20 years pharmaceutical academic and industry experience, she has been responsible for leading efforts to build a sustainable framework to optimize statistical reporting including strengthening data reporting environments, quality indicators and data sharing capabilities. Currently she is leading an implementation of a digitized analysis platform with modernized search, integration, and automation/ML to enable simplified workflows and predict risk. Additionally, she is accountable for developing functional sourcing strategies and partnerships and has implemented many development operational expansion efforts within Asia including China, India and Japan. She holds BA and MS degrees from the University of Michigan and Eastern Michigan University. Henry Shen is currently the Head of China Statistical Programming and Analysis Group at Pfizer. The group under his leadership since its inception now has ~250 statistical programmers in both Shanghai and Wuhan, contributing to Pfizer’s global phase 1-4 studies, regulatory submissions / responses, and Scientific and Commercialization Support projects, including the most recent Pfizer’s successful lightspeed launch of mRNA COVID Vaccine. He has led to establish a culture of continuous improvement and innovation in Pfizer China R&D Center with a sharp focus on technical excellence, quality & compliance, talent development and project management. He holds a PhD degree in Statistics from the State University of New York at Buffalo and has over 25 years of pharmaceutical industry experience in both US and China.