2023 Scientific Computing Days
Sharing and Collaboration in the Data Multiverse:
Scientific Computing for Public Health Solutions

Event Dates
September 12, 2023 (9:00AM – 3:00PM ET)
September 13, 2023 (9:00AM – 4:30PM ET)

Event Location
* In Person & Virtual
10903 New Hampshire Ave
Silver Spring, MD 20903
Building 31, Great Room

Co-Hosts & Collaborators
FDA Scientific Computing Board (SCB)
Center for Tobacco Products (CTP)
National Center for Toxicological Research (NCTR)
National Cancer Institute (NCI)

Co-Chairs
Matt Hartog, PhD (FDA/CTP)
Denny Skiles (FDA/NCTR)

View Recording Day 1: 9/12

View Recording Day 2: 9/13

View Posters

11th Annual Scientific Computing Days book cover

Questions?
Email FDASCB@fda.hhs.gov

View Program

Day 1 Agenda
Day 2 Agenda

Day 1: September 12, 2023
Time (EDT)
9:00AM – 9:05AM		Denny Skiles SCD Co-chair FDA/NCTR Day 1 - Welcome Speaker Bio Denny Skiles is a Senior Executive with the National Center for Toxicological Research in Jefferson Arkansas. Denny joined FDA in 2022, coming from USDA as Director of the Geospatial Enterprise Operations (GEO) Center. While at GEO, Denny’s geospatial science team developed the Land Change Analysis Tool. This AI/ML technology assisted in spatial and temporal image analytics – highlighting land use changes from millions of land images in less than 1% of the normal time necessary for human review. This technology spread into a joint USDA/FAA project where it has been helpful in identifying potential bird strike-hazard areas, supporting safer commercial air travel. While not an “IT guy” by trade, Denny continues to be fascinated by the evolution of technology and the people that are not afraid to push the digital envelope.
9:05AM – 9:25AM		Ram Iyer Chief Data Officer FDA/ODT Putting Our Data to Work at FDA Speaker Bio As the Chief Data Officer of the FDA, Ram C Iyer has the accountability to develop and execute an agency wide data modernization strategy, building robust central functions that can be leveraged by the centers and the agency for high value decisions. The scope spans the entire stack from data identification to actionable decision, including data policies and governance. Ram is an industry and peer recognized data and technology professional with experience in the Pharma, Consulting, Telecom and International Government organizations. His expertise includes Data and Decision Sciences, Digital and Technology Architecture, and Talent Development with a focus on building collaborative partnerships and Ecosystems. Before joining the FDA, Ram was the Head of Enterprise Architecture and Executive Director of Analytics Center of Excellence at Bristol Myers Squibb (BMS). He helped jumpstart several Data and Analytic practices at BMS including enterprise class platforms for reproducible research, model management and visual analytics. He also built a thriving network of data scientists, data analysts, visual story tellers, and agile specialists to tackle urgent and complex problems in the organization.
9:25AM – 10:00AM		Greg Singleton Chief Artificial Intelligence Officer U.S. Department of Health and Human Services (HHS) Scientific Computing in Action During COVID Q&A Speaker Bio Greg Singleton is a mission driven leader and technology expert that serves as the Chief Artificial Intelligence Officer (CAIO) for the US Department of Health and Human Services (HHS). In this role Greg leads efforts to promote strategic applications of AI and coordinates implementation of the Departmental AI strategy. Prior to his current role as CAIO, Greg served as the Program Manager for many of the national COVID-19 data systems. Originally from Ohio, Mr. Singleton graduated from the University of Virginia with a Bachelor of Science in Systems Engineering, and received Master of Science degrees in Political Science and Technology and Policy from the Massachusetts Institute of Technology.
10:00AM – 10:15AM		Break
10:15AM – 12:00PM		Artificial Intelligence’s Impact on FDA Organizer: Donna Mendrick, PhD (FDA/NCTR) Breakout Description and Session Agenda This breakout session will deal with three different, exciting AI topics. The first will be a talk about generative AI and provide use cases on how government agencies are using this approach to improve on how internal work is done. The second presentation will discuss the concept of using sensor-less (i.e. publicly available location and meteorological data) to model the climate inside a container to identify food quality degradation during transport. The third seminar will show how advances in machine learning and AI will impact the 3Rs and toxicology. Impact of Generative AI in Government (Wole Moses, Microsoft AI) Sensor-less Climate Monitoring of Shipping Containers: A Technology to Identify Food Quality Degradation in Transport (Arnab Chakrabarti, PhD, Hitachi) Applying Advances in Machine Learning and AI to the 3Rs and Toxicology: The Virtual Dog Challenge (Catherine Vickers, PhD, NC3Rs) Q&A (All speakers)
12:00PM – 1:00PM		Lunch
1:00PM – 2:30PM		Large Language Models in Play Organizer: Liang Zhao, PhD (FDA/CDER) Breakout Description and Session Agenda Join us for an extraordinary session that delves into the transformative realm of Large Language Models (LLMs) and their involvement in critical clinical decision-makings, review processes, and relevant computational technologies. This session brings together three distinguished speakers to explore cutting-edge advancements and applications in the fields of healthcare, regulatory review, and beyond. It will offer expert insights, real-world success stories, and a glimpse into the latest technologies propelling LLMs to new heights. Accelerating Decision Making for Clinical Data with LLMs at HIVE (Luis V. Santana-Quintero, PhD, FDA/CBER) An Introduction to Large Language Models and Their Potential in FDA Review Process (Jae Hyun Kim, PhD, FDA/NCTR) Advances in Foundation Models (Percy Liang, PhD, Stanford University) Panel (All speakers)
2:30PM – 2:40PM		Denny Skiles SCD Co-chair FDA/NCTR Day 1 Closing

Day 2: September 13, 2023
Time (EDT)
9:00AM – 9:10AM		Matt Hartog, PhD SCD Co-chair FDA/CTP Day 2 Welcome & Day 1 Recap Speaker Bio Matt Hartog is a toxicologist within the Division of Nonclinical Science, Office of Science, at the Center for Tobacco Products. Matt joined CTP and the FDA in 2020 and is involved in the review of tobacco product applications and researching the toxicological properties of tobacco products. He has extensive experience in studying the toxicological mechanisms of inhaled chemicals and in using computational methods to identify susceptible populations/groups and evaluate the human health risks associated with chemical exposures. Prior to joining the FDA, he worked at the United States Army Medical Research Institute of Chemical Defense where he used omics-based technology and computational methods to characterize the toxicity of inhaled chemicals and identify potential medical countermeasures for exposure.
9:10AM – 9:30AM		Nelson A. Colón, PhD AI/ML Lead FDA/ODAR The FDA AI Landscape, Today and Into the Future Speaker Bio Nelson Abdiel Colón Vargas is a Mathematician and AI Leader with a passion for Education, Equity and Civic Tech, and more than ten years of experience ranging from Academia, Startups, Fortune 100 companies, and the Federal Government. Prior to joining FDA as the AI/ML Lead in June 2023, Nelson served for three years as an Entrepreneur In Residence with the White House Presidential Innovation Fellows driving AI Innovation at VA, NSF, DOT and OSTP, followed by two years as a Digital Service Expert in AI/ML with the United States Digital Service (OMB/EOP) at the White House and the Defense Digital Service (CDAO/DOD) building AI/ML driven products as well as internal technical teams and communities to support them. He received a Special Act Award for the development and deployment of the Claims Attributes API, the first AI driven API deployed internally at the Department of Veterans Affairs which reduced cost of processing claims to the agency by 10 million dollars a year and reduced the wait time for Veterans by 7 days. Outside of government, Nel is also an Adjunct Faculty at the School of International and Public Affairs at Columbia University where he teaches students how to leverage Data Science for policy making.
9:30AM – 10:00AM		Jaime M. Guidry Auvil, PhD Director of Office of Data Sharing National Institutes of Health (NIH), National Cancer Institute (NCI) Data Data Everywhere: How to Harness its Power to Drive Cancer Care? Q&A Speaker Bio Dr. Jaime M. Guidry Auvil currently serves as the Director of the Office of Data Sharing (ODS) within the National Cancer Institute (NCI). In her role, Dr. Guidry Auvil oversees the NCI strategy and approach to development, interpretation and implementation of data sharing and public access policies to enhance NCI mission in the wider cancer research and care community. Since joining NCI in 2010, Dr. Guidry Auvil has led critical, high profile data sharing initiatives for NCI and NIH, including large-scale pediatric cancer research through Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative, Gabriella Miller Kids First Pediatric Research Program, and current flagship program for NCI, the Childhood Cancer Data Initiative (CCDI). Dr. Guidry Auvil is well-published and serves on several advisory committees within and across United States federal agencies, and international organizations, to provide expertise in optimizing data for cancer research. Dr. Guidry Auvil received her doctorate in Tumor Biology from Georgetown University, where she further holds a patent for a small molecule inhibitor targeting adhesion proteins in bone malignancies and metastases.
10:00AM – 10:30AM		Break
10:30AM – 12:00PM		Open Ledger Technologies and Machine Readability in Regulatory Space Organizer: Tomas Drgon, PhD (FDA/ORA) Breakout Description and Session Agenda Open Ledger (also called “distributed ledger” or “shared ledger”) is a peer-to-peer digital information sharing framework that allows de-centralized sharing of synchronized digital data in geographically and/or otherwise distributed sites, countries, or institutions. In contrast to centralized databases, an open ledger does not require a central administrator, and consequently does not have a single point-of-failure. In this session we will discuss the potential, the advantages, and the disadvantages of the implementation of open ledger technologies in FDA regulated industries and at the FDA. We will discuss the role of open ledger technologies via information traceability, document sharing, machine readability, and information security. Introduction to Open Ledger Technologies and the Role of ISPE GAMP (James C. Canterbury, ISPE-GAMP, Ernst & Young LLP) Mainstreaming of Decentralized Technologies (Daniel Burnett, PhD, Enterprise Ethereum Alliance) Product Tokenization and the Benefits of Inventory Visibility Across an Ecosystem of Business Partners (Sujatha Guruswamy, MS, Merck) Panel Discussion Tomas Drgon, PhD (FDA/ORA) James C. Canterburyl (ISPE-GAMP, E&Y LLP) James Gannon (PharmaLedger) Daniel Burnett, PhD (Enterprise Ethereum Alliance) Sujatha Guruswamy, MS (Merck) Seneca Toms, MS (FDA/ORA) Mark Walderhaug, PhD (FDA/CBER)
12:00PM – 1:00PM		Lunch
1:00PM – 2:00PM		Poster Session featuring Top 5 Scientific Computing Posters View Posters Top 5 Posters Data Central: Accelerating CDER’s Regulatory Review Process by Providing Quality Study Data at the Right Time, in the Right Place, in the Right Format Authors: Slyvester Ezeani, Maren Savignano, James Wedge, Matthew Wiley, Ketan Deopujari, Omolola Ajala, Matthew Robinson, Austin Ford, Jack Slattery, Sofiya Bandura, Sabrina Baldassarre, Christine Cushwa Presented By: Sylvester Ezeani Point of Contact: James Wedge Governing the Multiverse: Implementing Data Governance to Enhance Data Sharing and Collaboration in the Evolving and Expanding Landscape of CTP’s Data Multiverse Authors: Chrissie Cai, Yuan Tian, Katherine Kellermeyer, Jack Slattery, Kaitlyn Fisher, Jimmy Castro, Tara Chavda Presented By: Jack Slattery Point of Contact: Jack Slattery Enhancing Biologics Adverse Event Surveillance via Scalable, FHIR-based Infrastructure: Pilot Authors: Hussein Ezzeldin, Matthew Deady, Steven Anderson, Lance Jones, Aaron Walerysiak, Sofia Aschettino Presented By: Hussein Ezzeldin, PhD Point of Contact: Hussein Ezzeldin Scientific Review Alignment and Knowledge Gap Analysis in Data Multiverse Authors: Kwan Yuet Stephen Ho, Vichetra Sam, Jigar Shah, Lauren Benson, Ning Yu, Sarangan Ravichandran, Chetan Paul Presented By: Kwan Yuet Stephen Ho, PhD Point of Contact: Chetan Paul OCS Analysis Studio Authors: Shraddha Thakkar, Joy Li, Derek Ahneman, Justin Elfritz, Justin Gaskins, Thomas O’Neal Presented By: Shraddha Thakkar, PhD Point of Contact: Shraddha Thakkar
2:00PM – 2:15PM		Break
2:15PM – 4:15PM		Understanding the Landscape of Data Management and Sharing at FDA and NCI Co-organizers: Alexis Norris, PhD (FDA/CVM) & Emily Boja, PhD (NIH/NCI) Breakout Description and Session Agenda This session, co-organized with the National Cancer Institute (NCI) Office of Data Sharing, will explore commonalities and unique differences of data management and sharing (DMS) along the scientific data life cycle at the FDA and NCI. With different missions of both agencies, FDA and NCI have distinct and overlapping priorities and considerations when it comes to the data sharing and public access; this session will help stakeholders better understand the landscape and terminologies from data generation, submission and sharing, to data access and factors to consider associated with these steps. The first two presentations will present an overview and introduce the OSTP Open Access Policy for all federal agencies. Then, there will be a more in-depth look at what the challenges and priorities for data submission and access are at NCI. Next, a series of presenters will highlight different aspects at the FDA – from receiving, to internal sharing, to external sharing of both regulatory and research data. Finally, we will share a success story of data access and sharing through precisionFDA challenges. Understanding the Policies and Processes for NCI’s Research Data (Emily Boja, PhD, NIH/NCI) Receiving and Sharing Data at the FDA (Alexis Norris, PhD, FDA/CVM) NCI's Cancer Research Data Commons to Facilitate Data Sharing (Tanja Davidsen, PhD, NIH/NCI) Receiving and Sharing Data with the World on precisionFDA (Tyler Peryea, FDA/ODT) Multi-Center Collaboration with Regulated Industry to Pilot Approaches to Receiving and Analyzing Large Datasets (Qian Cao, PhD, FDA/CDRH), Thibaud Coroller, PhD (Novartis) FDA's Intelligent Data Lifecycle Ecosystem (FiDLE) for Cross-Center Data Management, and Advancing Data Science (Swati Kulkarni, FDA/ODT) FDA Cybersecurity, Counterintelligence, and Insider Threat Program (Sean Hanlon, FDA/ODT) Open Science at the FDA (Ben Hope, MLIS, FDA/ODT) Publishing Your Research Data on openFDA (Lonnie Smith, FDA/ODT) Leveraging Partnerships to Solve Public Health Problems (Elaine Johanson, FDA/ODT)
4:15PM – 4:30PM		Award Ceremony & Closing Remarks Scientific Computing Innovator Award presented by FDA Chief Data Officer: Ram Iyer (FDA/ODT) SCD Poster Session Contest Winners presented by SCD Co-chairs: Matt Hartog, PhD (FDA/CTP) & Denny Skiles (FDA/NCTR) SCB Collaboration Awards presented by SCD Co-chairs: Matt Hartog, PhD (FDA/CTP) & Denny Skiles (FDA/NCTR) SCB Leadership Awards presented by SCB Co-chairs: Jamie Pettengill, PhD (FDA/CFSAN) & Raju Rayavarapu, PhD (FDA/ODT)

U.S. Food and Drug Administration

Event Title

2023 Scientific Computing Days

September 12 - 13, 2023

Event Materials