program
All times are in Central Standard Time （GMT-6）
All times are in Central Standard Time （GMT-6）
A dive into digital transformation: navigating the FAIR data frontier of regulatory science: An EBTC Workshop
Tuesday, September 17, 2024, 1:30-4:30 PM
Moderators:
Dr. Paul Whaley, Evidence-based Toxicology Collaboration (EBTC) (www.EBTox.org)
Overview:
This interactive workshop is designed to elevate participants' understanding of FAIR (Findable, Accessible, Interoperable, and Reusable) data principles, with a focus on practical application in regulatory science. Through moderated discussions, attendees will gain in-depth understanding of the complexities of FAIR data, exploring its crucial role in research, risk assessment, and regulatory decision-making. By engaging participants from diverse backgrounds to share experiences and insights, the workshop aims to foster a collaborative environment that enhances engagement, encourages meaningful contributions, and strengthens professional networks at the GSRS Conference.
Speakers:
1. Dr. Paul Whaley, Co-Chair Open Science Working Group, EBTC
2. Dr. Alexander Tropsha, K.H. Lee Distinguished Professor, University of North Carolina at Chapel Hill
3. Dr. Katya Tsaioun, Executive Director, EBTC
4. Dr. Thomas Hartung, Director of the Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University
All times are in Central Standard Time （GMT-6）
Day 1—Wednesday, September 18
08:30-09:00
WELCOME REMARKS
• Dr. Weida Tong, GCRSR Chair
• Dr. Tucker Patterson, U.S. FDA/NCTR Director
• Dr. Robert M. Califf, U.S. FDA Commissioner
9:00-12:00 PM SESSION 1 (PLENARY SESSION): GLOBAL LANDSCAPE OF DIGITAL TECHNOLOGY IN REGULATORY SCIENCE
Co-Chairs: Dr. David Strauss (U.S. FDA); Dr. Tucker Patterson (U.S. FDA)
9:00-9:30
Transforming the Future of Regulatory Science
Mr. Ram Iyer, Chief Data Officer, Office of Digital Transformation (ODT), U.S. Food and Drug Administration (FDA), United States
9:30-10:00
Advancing Risk Assessments through FAIR Knowledge Exchange: The RAKIP Initiative
Mr. Matthias Filter, Head of Study Centre for Food Chain Modelling and Artificial Intelligence, German Federal Institute for Risk Assessment (BfR), Germany
10:00-10:30
Break
10:30-11:00
Modernizing regulatory practices through digital tools and technologies: Saudi Food and Drug Authority Experience
Dr. Adel Alrwisan, Executive Director of Research and Studies Department, Saudi Food & Drug Authority (SFDA), Saudi Arabia
11:00-11:30
Digital Transformation and Use of AI Tools: ANVISA Experience
Mr. Anderson da Mota Ribeiro, Data Analysis Manager, Brazilian Health Regulatory Agency (ANVISA), Brazil
11:30-12:00
When Culture Devours Strategy: Navigating the Cultural Challenges of AI Implementation in the Public Sector
Mr. Michael Renaudin, Lead Swissmedic 4.0, Swissmedic, Switzerland
12:00-1:30
Lunch Break
1:30-3:10 PM SESSION 2: DIGITAL TECHNOLOGY FOR REGULATED PRODUCTS AND PUBLIC HEALTH
Co-Chairs: Dr. Bill Slikker (Former Director of U.S. FDA/NCTR) ; Dr. Yoko Hirabayashi (National Institute of Health Sciences, Japan)
1:30-1:50
Digital Transformation of FDA Drug Labeling in the Era of AI
Dr. Hong Fang, Health Information Scientist, Office of Scientific Coordination (OSC), National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
1:50-2:10
Leveraging Reader Studies for Digital Pathology
Dr. Kim Blenman, Assistant Professor, Department of Internal Medicine and Department of Computer Science, Yale University, United States
2:10-2:30
Harnessing the Value of Digital Health Technologies in Clinical Development
Dr. Jie Shen, Director of Digital Science, AbbVie, United States
2:30-2:50
AllerCatPro 3.0 - Protein Allergenicity Prediction with 3D Structure Features
Dr. Minh Nguyen, Principal Scientist I at Bioinformatics Institute, A*STAR - Agency for Science, Technology and Research, Singapore
2:50-3:10
Current Status and Challenges for the Use of AI in the Pharmacovigilance Field in Japan
Dr. Noriaki Arakawa, Section Chief of Division of Medicinal Safety Science, National Institute of Health Sciences (NIHS), Japan
3:10-3:30
Break
3:30-5:10 PM SESSION 3: CHALLENGES AND OPPORTUNITIES OF AI/ML IN REGULATORY SCIENCE
Co-Chairs: Dr. Maurice Whelan (European Commission-JRC); Dr. Suzanne Fitzpatrick (U.S. FDA)
3:30-3:50
The Race for Regulation: Overview of Regulatory Efforts to Guide AI/ML Application and Acceleration
Mr. Cesare Furlanello, Director of LIGHT Center, Italy
3:50-4:10
AI at the European Food Safety Authority: Our Journey from Innovation to Implementation
Dr. Didier Verloo, Head of Knowledge Innovation and Partnership Management Unit (KNOW), European Food Safety Authority (EFSA), Italy
4:10-4:30
Utilization of Machine Learning on the Classification of Silicone Oil Droplets and Protein Particles in Biopharmaceutical Products
Dr. Hiroko Shibata, Section Chief of Division of Biological Chemistry and Biologicals, National Institute of Health Sciences (NIHS), Japan
4:30-4:50
Top 10 AI/ML Mistakes and Villains
Dr. Russ Wolfinger, Director of Scientific Discovery and Genomics, JMP Statistical Discovery, SAS Institute Inc, United States
4:50-5:10
ARPA-H and High-Risk/High-Reward R&D: Sparking Digital Transformations in Regulatory Science
Dr. Andrew Kilianski, Program Manager of Health Science Futures, Advanced Research Projects Agency for Health (ARPA-H), Department of Health and Human Services, United States
5:10-5:30
GROUP PHOTO
5:30-7:30 PM Poster Presentations (Drinks and hors d'oeuvres)
All times are in Central Standard Time （GMT-6）
Day 2—Thursday, September 19
9:00-10:40 AM SESSION 4 | GENERATIVE AI FOR REGULATORY APPLICATIONS
Co-Chairs: Dr. Kern Rei Chng (Singapore Food Agency); Dr. Dongying Li (U.S. FDA)
9:00-9:20
LLM Task Force Review: Lessons Learned and Future Challenges
Mr. Alexander Horst, Data Scientist, Swissmedic 4.0, Swissmedic, Switzerland
Mr. Michael Renaudin, Lead Swissmedic 4.0, Swissmedic, Switzerland
9:20-9:40
Harnessing Generative AI for Sense-Making of Foodborne Outbreak Investigation Reports
Mr. Benjamin ER, Team Lead of Food Safety Analytics & Epidemiology, Singapore Food Agency (SFA), Singapore
9:40-10:00
Revolutionizing Pharmaceutical Regulatory Policy Reporting: A Case Study on Harnessing Digitalization and Regenerative AI for maximizing Efficiency
Dr. Anna Litsiou, Director of International Regulatory Policy & Intelligence, International Regulatory Affairs, AstraZeneca, United Kingdom
10:00-10:20
AskFDALabel: Enhancing Drug Reviewers’ Experience with Large Language Model in Daily Missions
Dr. Leihong Wu, Research Scientist, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
10:20-10:40
Collaborative Innovation: Unveiling a Use Case from Our Collabathon
Dr. Nicolas Perez, Data Scientist, Swissmedic, Switzerland
10:40-11:00
Break
11:00-12:00 PM SESSION 5| EXPERT OPINIONS - IS REGULATORY SCIENCE READY FOR AI?
Moderator:
Dr. Weida Tong, Director of Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
Panel:
Dr. Thomas Hartung, Director of the Center for Alternatives to Animal Testing (CAAT), Johns Hopkins University, United States
Dr. Maurice Whelan, Deputy Director for Health and Food, Head of the Systems Toxicology Unit, European Commission Joint Research Centre (EC-JRC), EU
12:00-1:30
Break
1:30-2:50 PM SESSION 6| USE CASES AND DEMONSTRATION
Co-Chairs: Ms. Laila Sofia Mouawad (Brazilian Health Regulatory Agency); Mr. Michael Renaudin (Swissmedic)
1:30-1:50
SafetAI Initiative: Harnessing AI for Enhanced Drug Safety Assessment for Liver Injury
Dr. Shraddha Thakkar, Senior Research Scientist, Project Manager, Principal Investigator, Office of Translational Sciences (OTS), Office of Computational Sciences (OCS), Division of Regulatory Review & Research (DRRR), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, United States
1:50-2:10
Introducing TKPlate - Food Safety Without Animal Testing?
Dr. Didier Verloo, Head of Knowledge Innovation and Partnership Management Unit (KNOW), European Food Safety Authority (EFSA), Italy
2:10-2:30
Automating the Surveillance of Products on the Internet: EPINET Tool
Mrs. Mariana Adelheit Von Collani, Enforcement Advisor, Brazilian Health Regulatory Agency (ANVISA), Brazil
2:30-2:50
Streamline Clinical Review of Drug Application with a Widely Used Tool by Global Regulatory Agencies
Dr. Wenjun Bao, Chief Scientist and Director of Advanced Analytics R&D, JMP Statistical Discovery, SAS Institute Inc, United States
2:50-3:10
Break
3:10-4:50 PM SESSION 7 | DIGITAL TECHNOLOGIES – NOVEL APPLICATION
Co-Chairs: Dr. Tammy Collins (Burroughs Wellcome Fund); Dr. Catherine Carrillo (Canadian Food Inspection Agency)
3:10-3:30
Digital Innovations for Drug Review at the U.S. Food and Drug Administration
Dr. Lilliam Rosario, Director of the Office of Computational Science (OCS), Office of Translational Science (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), United States
3:30-3:50
Data Science and Machine Learning in Microbial Omics: Standardization, Applications, and Challenges
Dr. Julie Chih-yu Chen, Head of Data Sciences, Bioinformatics Section, National Microbiology Laboratory Branch, Public Health Agency of Canada (PHAC), Canada
3:50-4:10
Working Better Together – From Data Harmonization to Data Integration
Dr. William Hsiao, Associate Professor, Simon Fraser University (SFU), Canada
4:10-4:30
ML/AL Based Allergenicity Prediction of Novel Food
Dr. Norimasa Tamehiro, Section Chief of Division of Biochemistry, National Institute of Health Sciences (NIHS), Japan
4:30-4:50
Application of Deep Learning Convolutional Neural Networks to Identify Gastric Squamous Cell Carcinoma in Mice
Dr. Zhi Lin, Deputy Director of Pathology Department of National Center for safety Evaluation of Drugs, National Institutes for Food and Drug Control (NIFDC), China
4:50-5:10
ANNOUNCEMENT OF GSRS25 AND CLOSING REMARKS
Dr. David Strauss, U.S. FDA Acting Chief Scientist
5:30-7:30 PM
Closing Reception (Drinks and hors d’oeuvres at Museum of Discovery)
15:15-15:25
Opening Remarks
Co-chairs
15:25-15:45
Innovation in Regulatory Science Awards at Burroughs Wellcome Fund —Preview of the Latest Technologies and Progress Towards Equitable Clinical Outcomes
Q&A
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