Ana Szarfman, MD, PhD, FAMIA

Ana Szarfman loves to engage in studying problems that are computationally and intellectually stimulating, and where there is a real potential to transform current analytical processes into solid information resources for reviewers and senior management to use in decision‐making. Ana provided the Scientific Foundation and Subject Matter Expertise that enabled the Development of the Data Mining and Informatics Evaluation Team within the CDER/OTS Immediate Office. In 1998 Dr. Szarfman took the lead role in developing, implementing, and optimizing the use of modern and systematic safety data mining tools to speed the analysis of large safety databases. These tools, further developed under a Cooperative Research and Development Agreement (CRADA) agreement, are currently incorporated in the Empirica Signal software. They enhance the ability of FDA to conduct post‐market surveillance of drug and vaccine safety. Their use has expanded to over 500 regular users across FDA. These tools are widely used by other regulatory Agencies and by the Industry. She was supported in this work by grants from the Office of Women’s Health, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Defense. Since 1994 Ana has been working at enhancing several analytical visualization tools for Clinical Trial data that were later implemented in several software packages used by Academia, and by other regulatory Agencies and the Industry. The tools included the early implementation of an interactive Napoleon's March graph to assess raw, multi‐patient data using a common timeline. They also included the interactive Patient Profile Viewer to assess raw individual patient data using a common timeline. Between 2005 and 2018 Ana has been working at enhancing WebSDM/Empirica Study, a software package also developed under a CRADA agreement. Empirica Study enabled the rapid loading of large clinical trial datasets and within hours can support the assessment of more than 6,000 analyses outputs, including interactive graphics displays of complex temporal patterns that allow reviewers to explore issues they might otherwise be unaware of. The software also provided in an automated way comprehensive auditable results, drill down functionality to the data behind the results including to individual or multi‐patient displays, and to sophisticated tools that perform advanced statistical analyses. By reducing the need to reconfigure the clinical trial data and the analytical tools for each new analysis and automating so much of data assessment, Empirica Study freed reviewers to focus on critical high‐level questions related to safety. The organized information also improves communication across teams of reviewers. Previously at the FDA, Ana was the Primary Medical Reviewer of numerous anti‐infective NDAs and assisted in the development of new electronic data analysis tools to enhance the assessment of clinical trial data. The following are the 2 very recent paper that I want AMIA to be aware: https://www.nature.com/articles/s43856-022-00148-x https://link.springer.com/article/10.1007/s40264-022-01186-z