Better Data, Better Tools, Better Decisions – An Overview of the FDA's Office of Computational Science

FDA’s Office of Computational Science (OCS) provides FDA reviewers at the Center for Drug Evaluation and Research (CDER) with innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, computational tools, and training. OCS helps reviewers understand, analyze, and use their data so they spend more time thinking about the results of the data analyses rather than setting up those analyses, thereby improving and expediting the review process. Join us on July 31 to hear from OCS scientists and learn how the FDA is leveraging computational tools, services and training into the scientific review process.

Where and When

Room 160, Helen Diller Bldg., UCSF Mission Bay (1450 Third St., San Francisco)
3:00 to 4:00 PM, Tuesday, July 31, 2018

About the Speakers

Lililam Rosario.png

Lilliam Rosario, PhD is the Director of the Office of Computational Science (OCS) in the Office of Translational Sciences, Center for Drug Evaluation and Research. OCS leads and directly supports the modernization of CDER’s scientific review capabilities. OCS innovates tools, technologies, and services specifically for drug product review and then provides these to reviewers at the right time backed up with training and support. Acknowledging that successful review starts with good data, OCS continues to support efforts to regularly achieve high quality data. OCS received the Health and Human Services Secretary’s Award for its work in developing CDER’s JumpStart program, an innovative initiative dedicated to enhancing the efficiency of CDER’s new drug development and review process. OCS continues to innovate and service reviewers as Dr. Rosario has led to the OCS to make real it’s motto: Better data, better tools, better decisions.

Crystal Allard.png

Crystal Allard is the Data Quality Team Lead in the Office of Computational Science at the FDA/CDER where she leads work in study data standards, data management, and business process in support of regulatory review. Crystal also manages all collaborations with the OCS. Crystal has a bachelor’s degree in Biology from Binghamton University and is a current masters student in Information Quality at the University of Arkansas at Little Rock. She has worked at the FDA since 2008 and at the OCS since 2012.

Qais Hatim.png

Qais Hatim received a dual Ph.D. degree in operation research and industrial engineering and graduate minors in statistics and high performance computing from Pennsylvania State University/University Park in 2015. In 2015, he also joined FDA. Currently Qais’s main roles as computer scientist/statistician at FDA is conducting research in statistical/operational modeling and computer science as well as supporting other activities at CDER/ Office of Translational Science (OTS)/ Office of Computational Science (OCS) in FDA. In his work, he is utilizing machine learning and data mining algorithms, natural language processing (NLP) techniques, Neural Networks procedures, and Bayesian analytics to extract meaning, patterns and hidden structures in structured and unstructured data. He is active member in several organizations within and outside FDA.

Matt Steele.png

After 7 years as a PM/BA at a software development company, Matt Steele joined FDA in 2016 as a project lead in FDA’s Office of Computational Science (OCS) for the inspectional and risk based tools. He is currently managing the effort to modernize and improve this suite of tools and is a member of multiple working groups aimed at improving the business processes and technology used across various offices within CDER.

Kendra Worthy.png

Kendra Worthy PharmD, is Team Leader, Tools, Technology & Innovation at OCS. She oversees a team that manages the development and maintenance of analytical tools that empower clinical reviewers to conduct their regulatory reviews with greater efficiency.

She was commissioned as a Lieutenant (O-3) in the U.S. Navy and served as a pharmacy manager at National Naval Medical Center during the Global War on Terrorism.  In 2004, she transferred to the U.S. Public Health Service (USPHS) Commissioned Corps as a Drug Utilization Analyst with the Food and Drug Administration Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology.  She’s held several leadership positions working in Risk Evaluation and Mitigation Strategies (REMS) and Medication Errors. As an officer USPHS, Kendra has deployed on missions for Hurricanes Katrina and Ike (both in Baton, Rouge, LA) as well as for the H1N1 Swine Flu outbreak.  She has also assisted the Attending Physician staff at the United States Capitol for State of the Union Addresses for President George W. Bush.