All times are in Central European SummerTime （GMT+2）
Practical understanding and application of FAIR data principles.
• In silico-driven drug discovery and repurposing
• De-risk of drug applications via computational methods
• Digital technology for improved diagnosis and therapeutic options for rare disease
• Digital regulatory science to address the opioid crisis, and other significantly regulatory concerns such as CBD, Nitrosamines and PFAS
Enhance participant engagement and contribution at GSRS Conference.
Understanding FAIR data's role in research, risk assessment, and regulatory decision-making.
1. Presentations to prime detailed breakout discussion.
• Open science and FAIR data basics.
• Importance of data standards to regulators at the NIH.
• Case study on FAIRness: Drug-induced liver injury.
2. Presentations to prime detailed breakout discussion.
All times are in Central European SummerTime （GMT+2）
Pre-conference workshop on NAMs for regulatory application
Monday, September 15, 2025 | Garden Level, Room 2ABC
11:00- 18:00 REGISTRSTION
Katya Tsaioun and Paul Whaley
Evidence-based Toxicology Collaboration at Johns Hopkins Bloomberg School of Public Health www.EBTox.org
13:00-16:30 PRE-CONFERENCE WORKSHOP:
INNOVATIONS IN RETROSPECTIVE VALIDATION OF NAM
EVIDENCE: LESSONS LEARNED FROM SYSTEMATIC REVIEW
INSTRUCTORS:
•Gro Haarklou Mathisen, PhD. Norwegian Scientific Committee for Food and Environment
•Paul Whaley, PhD. Evidence-Based Toxicology Collaboration
•Angela Bearth, PhD. HF Partners
LEARNING OBJECTIVES:
Through a series of lectures and practical exercises, participants will develop an understanding of the concept of “internal validity” (systematic error arising from how a study is conducted), how to assess the internal validity of NAM studies in the context of systematic review (“retrospective validation”), and second-order skills relating to how to develop and select appropriate tools for assessing the internal validity of scientific studies.
AGENDA:
13:00-13:10 | Introduction to the workshop and the instructors
13:10-13:25 | Refresher on systematic review and the need for assessing bias
13:25-13:45 | How to assess internal validity, using the new INVITES-IN tool (beta version)
13:45-13:55 | How INVITES-IN was developed, with lessons for tool development in general
14:00-14:15 | Break
14:15-14:45 | Breakout session #1, familiarisation with INVITES-IN
14:45-15:05 | Q&A session, group discussion of INVITES-IN approach
15:05:15:20 | Coffee Break
15:20-16:10 | Breakout session #2, applying INVITES-IN to selected NAM studies
16:10-16:25 | Group discussion of results of assessing the selected studies
16:25-16:30 | Close
Practical understanding and application of FAIR data principles.
• In silico-driven drug discovery and repurposing
• De-risk of drug applications via computational methods
• Digital technology for improved diagnosis and therapeutic options for rare disease
• Digital regulatory science to address the opioid crisis, and other significantly regulatory concerns such as CBD, Nitrosamines and PFAS
Enhance participant engagement and contribution at GSRS Conference.
Understanding FAIR data's role in research, risk assessment, and regulatory decision-making.
1. Presentations to prime detailed breakout discussion.
• Open science and FAIR data basics.
• Importance of data standards to regulators at the NIH.
• Case study on FAIRness: Drug-induced liver injury.
2. Presentations to prime detailed breakout discussion.
All times are in Central European SummerTime （GMT+2）
Day 1—Tuesday, September 16, 2025|Campus Level, Auditorium B
9:00- 9:10 WELCOME REMARKS
• Michael Renaudin, Swissmedic
• Dr. Weida Tong, U.S. Food and Drug Administration (FDA), GCRSR Chair
9:10- 10:50 KEYNOTE PRESENTATIONS
Co-Chairs:
Katherine Serrano, U.S. Food and Drug Administration (FDA), Belgium;
Dr. Tucker Patterson, U.S. Food and Drug Administration (FDA), USA
9:10-9:35
The Regulator as Strategic Asset: A Swiss Perspective
Dr. Philippe Girard, Deputy Executive Director, Swissmedic, Switzerland
9:35-10:00
FDA's AI Programs: Challenges and Opporutnities
Dr. Tucker Patterson, Director, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
10:00-10:25
Regulatory Science and Innovation: A Perspective from the European Medicines Agency
Dr. Emmanuel Cormier, Head of the Regulatory Science and Innovation Task Force, European Medicines Agency (EMA), Netherlands
10:25-10:50
Risk Assessment and Regulatory Sciences in Times of Accelerated Change – How Can We Keep Up the Pace?
Dr. Carlos das Neves, Chief Scientist, European Food Safety Authority (EFSA), Italy
11:10-12:30 SESSION 1: AI AS A NAM
Co-Chairs:
Didier Verloo, European Food Safety Authority (EFSA), Italy; Maurice
Whelan, European Commission, Joint Research Centre (JRC), Italy
11:10-11:30
Are We There Yet? AI as a NAM to Replace Conventional Toxicity Testing in Pharma
Dr. Elisabeth Klenke, Head of Nonclinical Assessment and GLP Inspectorate, , Swissmedic, Switzerland
11:30-11:50
From Animals to Algorithms: AI in DILI Risk Evaluation
Dr. Weida Tong, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
11:50-12:10
Recent, Current and Future Case Studies of AI in Safety Evaluation: Can AI Become "Regulatory-Grade"?
Dr. Billy Amzal, Head of Strategic Consulting, Phastar, France
12:10-12:30
In Silico NAMs for Systemic and Topical Toxicity (STopTox) Assessment
Dr. Alex Tropsha, K.H. Lee Distinguished Professor, Division of Chemical Biology and Medicinal Chemistry, University of North Carolina at Chapel Hill, United States
14:20-15:20
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 2: AI IN MEDICINE: FROM MOLECULES TO POPULATION
Co-Chairs:
Dr. Masahiro Tohkin, Food Safety Commission of Japan (FSCJ), Japan; Dr. Zhan Yuin Ong, Singapore Food Agency (SFA), Singapore
14:00–14:20
Virtual Cells and Digital Twins: AI in Personalized Oncology
Prof. Charlotte Bunne, Artificial Intelligence in Molecular Medicine Laboratory (AIMM), Swiss Federal Technology Institute of Lausanne (EPFL), Switzerland
14:20-14:40
Identification of Genomic Biomarkers of Liver Toxicity Risk Using Formal Concept Analysis of UK Biobank Data
Dr. Federico Goodsaid, SVP Regulatory, Ariana Pharma, France
14:40–15:00
Insight to Standard: ML Prediction Models and LLMs for Omics Data Reanalysis and Standardization
Dr. Wenjun Bao, Chief Scientist and Director of Advanced Analytics R&D, JMP Statistical Discovery, SAS Institute Inc, United States
15:00-15:20
Exploiting AI in the Development of Adverse Outcome Pathways and Their Use in New Approaches to Safety Assessment
Clemens Wittwehr, European Commission, Joint Research Centre (JRC), Italy
15:50-17:30 SESSION 3: INTERACTIVE DISCUSSION ON REGULATORY
TRANSFORMATION: CULTURAL AND ORGANIZATIONAL BARRIERS
Moderators: Michael Renaudin, Swissmedic, Switzerland; Dr. Lilliam Rosario, Formerly U.S. Food and Drug Administration (FDA), USA
• Drs. Lixian Schmid and Grzegorz (Greg) Podrygajlo, CSL Behring, Switzerland
• Didier Verloo, European Food Safety Authority (EFSA), Italy
• Henric Taavola Gustafsson, Uppsala Monitoring Centre (UMC), Sweden
17:30-19:30 POSTER PRESENTATIONS & WELCOME RECEPTION
(Campus Level, Entrance Hall)
Co-Chairs: Didier Verloo, EFSA; Maurice Whelan, EC-JRC
• Are We There Yet? AI as a NAM to Replace Conventional Toxicity Testing in Pharma
Dr. Elisabeth Klenke, Chief Toxicologist, Swissmedic
• From Animals to Algorithms: AI in DILI Risk Evaluation
Dr. Weida Tong, U.S. FDA/NCTR
• In Silico NAMs for Systemic and Topical Toxicity (STopTox) Assessment
Dr. Alex Tropsha, University of North Carolina
• Exploiting AI in the Development of Adverse Outcome Pathways and Their Use in New Approaches to Safety Assessment
Clemens Wittwehr, EC/JRC
Co-Chairs:TBD
• AI-Augmented Chemical Research using Language Models
Prof. Philippe Schwaller, Laboratory of Artificial Chemical Intelligence | LIAC, EPFL
• Current Status of Understanding and Application of AI for Handling Chemical Structures
Dr. Tadahaya Mizuno, University of Tokyo
• Knowledge-Guided Toxicity Prediction – Beyond QSARs
Dr. Dongying Li, U.S. FDA/NCTR
• Language-Driven Organ Lesion Prediction in Large-Scale Toxicology
Dr. Tommaso Furlanello, HK3 Lab
4:30-4:50
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
4:50-5:10
Top 10 AI/ML Mistakes and Villains
Dr. Russ Wolfinger, Director of Scientific Discovery and Genomics, JMP Statistical Discovery, SAS Institute Inc, USA
All times are in Central European SummerTime （GMT+2)
Day 2-Track A—Wednesday, September 17, 2025
Main Conference | Campus Level, Auditorium B
9:00-10:40 SESSION 4: AI IN CHEMICAL SCIENCE
Co-Chairs: Dr. Yoko Hirabayashi, National Institute of Health Sciences
(NIHS), Japan; Dr. Alex Tropsha, University of North Carolina, USA
9:00-9:20
AI-Augmented Chemical Research using Language Models
Prof. Philippe Schwaller, Laboratory of Artificial Chemical Intelligence (LIAC), Swiss Federal Technology Institute of Lausanne (EPFL), Switzerland
9:20-9:40
Beyond QSARs – Quantitative Knowledge-Activity Relationships (QKARs) for Toxicity Prediction
Dr. Dongying Li, Research Scientist, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
9:40-10:00
Language-Driven Organ Lesion Prediction in Large-Scale Toxicology
Dr. Tommaso Furlanello, HK3 Lab, Italy
10:00-10:20
Current Status of Understanding and Application of AI for Handling Chemical Structures
Dr. Tadahaya Mizuno, Assistant Professor, University of Tokyo and Institute of Statistical Mathematics, Japan
10:20-10:40
Artificial Intelligence in Chemical Safety Assessment: Current Status, Perspectives, and Challenges
Dr. Predrag Kukic, Computational Science Leader, Safety, Environmental and Regulatory Science (SERS), Unilever, United Kingdom
11:10-12:30
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 5: THE ROLE OF GENERATIVE AI IN REGULATORY SCIENCE
Co-Chairs: Dr. Philippe Girard, Swissmedic, Switzerland; Dr. Dongying Li, U.S. Food and Drug Administration (FDA), USA
11:10-11:30
Evaluating the Black Box: How to Think About Generative AI in Medicine
Dr. Henric Taavola Gustafsson, Senior Data Scientist, Uppsala Monitoring Centre (UMC), Sweden
11:30–11:50
In 5 years from ChatGPT to Super-Intelligence? Reflection on Our Current Moment in AI
Prof. Marcel Salathé, Co-Director of AI Center, Swiss Federal Technology Institute of Lausanne (EPFL), Switzerland
11:50-12:10
Adopting Large Language Models for Regulatory Review
Dr. Joshua Xu, R2R Branch Chief, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration (FDA), United States
12:10–12:30
LLMs Task Force: Past, Present, and Future
Michael Renaudin, Lead Swissmedic 4.0, Swissmedic, Switzerland
14:00-15:20
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 6: FROM DATA TO ACTION: ADVANCING REGULATORY SCIENCE WITH EMERGING APPROACHES
Co-Chairs: Dr. Weida Tong, U.S. Food and Drug Administration (FDA), USA; Dr. Tammy Collins, Burroughs Wellcome Fund (BWF), USA
14:00-14:20
Experiments with AI in the Regulatory Assessment of Marketing Authorisation Applications
Dr. Philipp Weyermann, Head of Unit, Regulatory Assessment 2, Swissmedic, Switzerland
14:20–14:40
Navigating the Future in the NAMs ecosystem: Scientific Advances Driving Non-Animal Approaches in Toxicology and Drug Development
Dr. Madhu Nag, Chief Scientific Officer, InSphero, United States
14:40–15:00
The Sample-to-Reference Ratio (SRR) Framework: Ensuring Reproducibility of Quantitative Multiomics Data for Standardization and Regulatory Decision-Making
Dr. Leming Shi, Professor, School of Life Sciences and Shanghai Cancer Center, Fudan University; Director, International Human Phenome Institutes (Shanghai), China
15:00–15:20
Persistent Agentic Tasks for Regulatory Toxicology: From Property Inference to Hazard Surveillance
Dr. Thomas Luechtefeld, CEO, Insilica, United States
15:50-17:10
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 7: INTERNATIONAL EFFORTS IN DIGITAL SCIENCE
Co-Chairs: Dr. Supriya Sharma, Health Canada (HC), Canada; Dr. Carlos Das Neves, European Food Safety Authority (EFSA), Italy
15:50–16:10
From Closed Source to Open Source – Why Transparency is the Future of Regulatory AI
Alexander Horst, Data Scientist, Veanu, Switzerland
16:10–16:30
Beyond Big Data Analysis: Learn from the 2nd AMES/QSAR International Challenge Project
Dr. Ayako Furuhama, National Institute of Health Sciences (NIHS), Japan
16:30–16:50
Cutting Edge Technology in Regulatory Science – Who is doing what? A Landscape View of New Technologies Worldwide
Dr. Nicolas Löffler-Pérez, Data Scientist, Swissmedic, Switzerland
16:50–17:10
NAMs Without Borders: The 3Rs Collaborative Drives Global Awareness & Harmonization in Translational Science
Dr. Megan R. LaFollette, Executive Director, The 3Rs Collaborative, USA
17:10-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS26
All times are in Central European SummerTime （GMT+2）
Day 2-Track B—Wednesday, September 17, 2025
Nanotechnology Sessions | Garden Level, Room 1BC
9:00-10:40 NANO-SESSION 1: ADVANCED MATERIALS, SSBD IN THE
CONTEXT OF NANOMATERIALS
Co-Chairs: Dr. Birgit Sokull Kluettgen, European Commission, Joint Research Centre (JRC), Italy; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
9:00–9:20
OECD Working Party on Manufactured Nanomaterials – Important Achievements and Future Directions
Mar Gonzalez, Organization for Economic Cooperation and Development (OECD)
9:20-9:40
Safe-and-Sustainable-by-Design Drives Innovation Towards Safer and More Sustainable Nanomaterials
Drs. Hubert Rauscher & Irantzu Garmendia Aguirre, European Commission, Joint Research Centre (JRC), Italy
9:40–10:00
EFSA’s Approach to Risk Assessment of Nanomaterials and Materials Containing Small/Nanoparticles in the Food and Feed Chain
Irene Cattaneo, European Food Safety Authority (EFSA), Italy
10:00-10:20
Standardisation Efforts and Upcoming Challenges for Nanomedicines
Dr. Caterina Minelli, National Physical Laboratory, United Kingdom
10:20–10:40
Panel Discussion
11:10–12:30 NANO-SESSION 2: MEASUREMENT METHODS FOR REAL WORLD
MICRO(NANO)PLASTICS
Co-Chairs: Dr. Birgit Sokull Kluettgen, European Commission, Joint Research Centre (JRC), Italy; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
11:10–11:30
Challenges in Developing Methodologies for Legislative Monitoring of Micro(Nano)Plastics
Dr. Douglas Gilliland, European Commission, Joint Research Centre (JRC), Italy
11:30-11:50
Quantification, Characterisation, and Toxicity Assessment of Micro/Nanoplastics in Food and Drinking Water
Dr. Zhan Yuin Ong, National Centre for Food Science, Singapore Food Agency (SFA), Singapore
11:50–12:10
The POLYRISK Risk Assessment Framework for Micro- and Nanoplastic Particles (MNPs) and Its Application in Selected Case Studies
Dr. Andrea Haase, German Federal Institute for Risk Assessment (BfR), Germany
12:10-12:30
Panel Discussion
14:00- 15:20 NANO-SESSION 3: NANOMEDICINES: PROGRESS IN REGULATORY
SCIENCE
Co-Chairs: Dr. Michael Johnston, Health Canada, Canada; Dr. Birgit Sokull-Kluettgen, European Commission, Joint Research Centre (JRC), Italy
14:00–14:20
Progress and Challenges with Nanotechnology/Nanomedicines
Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
14:20-14:40
Work of the European Pharmacopeia (EDQM) on mRNA Vaccines
Prof. Gerrit Borchard, University of Geneva & EDQM, Switzerland
14:40–15:00
Quality Attributes for LNP-RNA Therapeutics: A New Generation of Medicines
Dr. Luigi Calzolai, European Commission, Joint Research Centre (JRC), Italy
15:00-15:20
Development of Prototype LNP Lyme Disease Vaccine
Dr. Michael Johnston, Health Canada, Canada
15:50–17:10 NANO-SESSION 4: NANOMEDICINES: EMERGING APPLICATIONS
Co-Chairs: Dr. Michael Johnston, Health Canada, Canada; Dr. Anil K. Patri, U.S. Food and Drug Administration (FDA), USA
15:50–16:10
Advanced Continuous Manufacturing to Accelerate Production of LNPs
Prof. Diane J. Burgess, University of Connecticut, USA
16:10-16:30
Regulatory and Research Progress on Nanomedicines in China
Dr. Xingchao Geng, National Institute for Food and Drug Control (NIFDC), China
16:30–16:50
Innovating Quality Characterization of Lipid-Based Nanomedicines: Advancing AFM and Cryo-EM Applications in Regulatory Science
Dr. Yuki Haraya, National Institute of Health Sciences (NIHS), Japan
16:50-17:10
Panel Discussion
17:10-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS26
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
16:25-16:45
Closing remarks
