program
All times are in Central Standard Time （GMT-6）
Day 0: Monday, Sept 15, 2025
Morning
Registration starts
Afternoon
(13:00-16:30)
Pre-conference workshop on NAMs for regulatory application
The Evidence Based Toxicology Collaboration (EBTC) and the Norwegian Scientific Committee for Food and Environment (VKM) are collaborating to organize a workshop titled "Innovations in retrospective validation of NAM evidence: lessons learned from systematic review." This timely event aims to address the critical challenges and opportunities in validating New Approach Methodologies (NAMs) within the context of toxicology and with application to preclinical research. The workshop aims to explore the development and application of tools for assessing NAM evidence, with a particular focus on leveraging insights from systematic review methodologies. Participants will engage in discussions on assessment tool development challenges, learn about selecting and modifying fit-for-purpose tools using the FEAT framework, and gain hands-on experience with the INVITES-IN tool for assessing risk of bias of in vitro studies. This collaborative initiative promises to advance the field by fostering dialogue, sharing best practices, and promoting more robust and transparent approaches to NAM evidence appraisal and integration.
Day 1: Tuesday, Sept 16, 2025
Morning
Opening Remarks and Keynote (8:00-9:00)
Session 1: Global Landscape on Regulatory Science (9:00-12:00)
Afternoon
Session 2: AI for Regulatory Decision-making (13:30-15:10)
How can AI support regulatory assessments and decisions? This session presents concrete use cases and discusses benefits, risks, and implementation challenges in regulatory contexts.
Session 3: Discussion/Debate on Regulatory transformation: Cultural and Organizational Barriers (15:30-17:10)
What holds back innovation in regulatory agencies? This session explores how organisational culture, legacy systems, and internal resistance shape the pace of regulatory transformation.
Evening
Poster Session (17:30-19:30)
Day 2: Wednesday, Sept 17, 2025 (parallel sessions)
Morning (9:00-12:00)
Session 4A: AI as a NAM
New Approach Methodologies (NAMs) offer enhanced precision, relevance, and efficiency in safety assessments, while reducing reliance on animal testing. As computational methods play an increasingly vital role in NAMs, a critical question arises: can AI be considered a distinct NAM in its own right, and what implications might this have for the future of safety evaluation?
Session 4B: Nanomaterials in the context of advanced materials & Characterization of real-world micro(nano)plastics
Engineered nanomaterials offer unique properties with novel application, a common trait with advanced materials that have broader scope beyond the dimensional considerations. The study of micro and nanoplastics contaminants is quite challenging with many unknown mixtures in regulated products. Both these topics will be covered in the context of regulatory science in this session in continuation from previous global summits.
Afternoon (13:30-17:00)
Session 5A:
From Data to Action: Advancing Regulatory Science with Emerging Approaches
Ms. Elaine Johanson, Director, Health Informatics Staff, Office of Data, Analytics, & Research (ODAR), U.S. Food and Drug Administration (FDA), USA
Session 5B: Nanomedicines: Regulatory & Emerging application
With the continued demonstrable success of nanomedicines and nanotechnology it is expected the use of these technologies will continue to expand into the foreseeable future for food and drug industries. This will require the regulatory community to develop additional capacity for the effective regulation to ensure safe and effective products are available to the public in a timely fashion. This session will focus on updates from regulatory agencies and industry leaders.
Closing Remarks (16:30-17:00)
Day 3: Thursday, Sept 18, 2025
Morning (9:00-12:00)
Unconference
• Topic Marketplace: Participants suggest discussion topics.
• Voting: Attendees choose the most relevant topics.
• Sessions: Self-organized discussions moderated by volunteers.
• Outcomes: Collective documentation of key insights and solutions
All times are local
Day 0 — Wednesday, 2 September 2026
11:00–18:00
REGISTRATION
13:30-16:30
LLM Task Force Review: Lessons Learned and Future Challenges
PRE-CONFERENCE WORKSHOP:
ADVANCING HEALTH THROUGH INNOVATION AND EMERGING TECHNOLOGIES IN ASIA
Co-Chairs: Hairuo Wen, PhD, Deputy Chief, Division II of Toxicology, Institute of Safety Evaluation, National Institutes for Drug Control (NIDC), China; Yongbin Zhang, DVM, PhD, Vice President & Global Head of Toxicology, WuXi AppTec, China
13:30-14:00
Research to Ensure the Safety of Oligonucleotide Therapeutics
Tokuyuki Yoshida, PhD, Section Chief, Section II, Division of Molecular Target and Gene Therapy Products, National Institute of Health Sciences (NIHS), Japan
14:00-14:30
Preclinical Safety Evaluation and Key Concerns for Cell Therapy Products
Ying Huang, PhD, Deputy Chief, Division I of Toxicology, Safety Evaluation Institute, National Institutes for Drug Control (NIDC), China
14:30-15:00
Innovative Toxicology Applications: A CRDMO Perspective
Yongbin Zhang, DVM, PhD, Vice President & Global Head of Toxicology, WuXi AppTec, China
15:00-15:30
Break
15:30-16:00
Research on Regulatory Science of Traditional Chinese Medicine
Lixing Nie, PhD, Professor, Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes for Drug Control (NIDC), China
16:00-16:30
Nuclear Magnetic Resonance-Based Quantitative Technique for Reagents Used for Assays of Herbal Medicines
Michiho Ito, PhD, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences (NIHS), Japan
Focus:
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
Aim:
Enhance participant engagement and contribution at GSRS Conference.
Emphasis:
Understanding FAIR data's role in research, risk assessment, and regulatory decision-making.
Structure:
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 0 — Wednesday, 2 September 2026
11:00–18:00
REGISTRATION
13:30-16:30
LLM Task Force Review: Lessons Learned and Future Challenges
PRE-CONFERENCE WORKSHOP:
ADVANCING HEALTH THROUGH INNOVATION AND EMERGING TECHNOLOGIES IN ASIA
Co-chairs: Hairuo Wen, PhD, Deputy Chief, Division II of Toxicology, National Institutes for Drug Control (NIDC), China;
Regulatory Science Research on the Safety Assessment of Oligonucleotide Therapeutics
Tokuyuki Yoshida, PhD, National Institute of Health Sciences (NIHS), Japan
Preclinical Safety Evaluation and Key Concerns for Cell Therapy Products
Ying Huang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Break
Nuclear Magnetic Resonance-Based Quantitative Technique for Reagents Used for Assays of Herbal Medicines
Michiho Ito, PhD, Head, Division of Pharmacognosy, Phytochemistry and Narcotics, National Institute of Health Sciences (NIHS), Japan
Innovation and Application of Key Technologies for Traditional Chinese Medicine Quality Evaluation Based on Regulatory Science
Ying Wang, PhD, National Institutes for Food and Drug Control (NIFDC), China
Pre-conference workshop on NAMs for regulatory application
Monday, September 15, 2025 | Garden Level, Room 2ABC
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
Focus:
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 China Standard Time （GMT+8）
Day 1—Thursday, 3 September 2026
7:00–18:00
REGISTRATION
8:30–9:00 OPENING REMARKS
Chair: Qingli Wang, PhD, Deputy Director General, National Institutes for Drug Control (NIDC),China
• National Medical Products Administration (NMPA), China
• Global Coalition for Regulatory Science Research (GCRSR) Chair: Tucker Patterson, PhD, Director, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
9:00-12:00
LLM Task Force Review: Lessons Learned and Future Challenges
PLENARY SESSION: PREPARING REGULATORY SCIENCE FOR TOMORROW
Co-chairs: Tucker Patterson, PhD, Director, National Center for Toxicological Research, Food and Drug Administration (FDA), United States; Philippe Girard, PhD, Deputy Executive Director, Swissmedic, Switzerland (TBC)
9:00-9:30
China's Regulatory Strategy and Regulatory Science Practices
Fudong An, PhD, Director General, National Institutes for Drug Control (NIDC), China
9:30-10:00
Regulatory Innovation: AI Adoption and Applications in FDA's Human Foods Program
Steven Musser, PhD, Associate Commissioner for Human Foods Research, Huamn Foods Program, Food and Drug Administration (FDA), United States
10:00-10:30
Break
10:30-11:00
From AI Experimentation to Regulatory-Grade Adoption: EFSA’s Path to Trustworthy, Human-Led AI
Didier Verloo, DVM, Head of Knowledge, Innovation, and Partnership Management (KNOW) Unit, European Food Safety Authority (EFSA), Italy
11:00-11:30
Regulatory Science, How EMA Prepares for the Innovation of Tomorrow
Emmanuel Cormier, PhD, Head of the Regulatory Science and Innovation Task Force, European Medicines Agency (EMA), Netherlands
11:30-12:00
New Approach Methods at FDA and NCTR: Bridging Emerging Science and Regulatory Decision-Making
Tucker Patterson, PhD, Director, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
12:00-13:30
Break
13:30-15:40
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 1: AI FOR THE FUTURE OF REGULATORY SCIENCE AND TOXICOLOGY
Co-chairs: Weida Tong, PhD, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, Food and Drug Administration (FDA), United States; Zhan Yuin ONG, PhD, Branch Head, National Centre for Food Science, Singapore Food Agency, Singapore
13:30-14:00
Shaping the Future of Toxicology with AI
Thomas Hartung, PhD, Chair, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health, United States; Professor, University of Konstanz, Germany
14:00-14:20
From Regulator to Innovator: Lessons Learned Applying AI in Highly Regulated Environments
Michael Renaudin, Co-founder, Veanu, Switzerland
14:20-14:40
Expert-driven Workflows for LLM-assisted Toxicological Risk Assessment
Christian Novello, Associate Consultant, Innovatune, Italy
14:40-15:00
Virtual Clinical Trials: A Tissue-Scale Population Platform for Arrhythmia Risk and Drug Safety
Zhen Song, PhD, Director, Institute of Intelligent Systems and Application Innovation, Peng Cheng Laboratory, China
15:00-15:20
AI-Enabled Drug Safety: A Regulatory Science Perspective from FDA
Weida Tong, PhD, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
15:20-15:40
From V3 to In Silico: One Validation Architecture for Digital and Computational NAMs
Szczepan Baran, DVM, PhD, Chief Scientific Officer, Instem, United States
15:40-16:00
Break
16:00-17:30
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 2: PANEL DISCUSSION: ARE NAMS READY FOR REGULATORY SCIENCE?
Moderators:
• Supriya Sharma, MD, MPH, Chief Medical Advisor, Health Canada, Canada
• Weida Tong, PhD, Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, Food and Drug Administration (FDA), United States
Panel:
• Thomas Hartung, PhD, Chair, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins Bloomberg School of Public Health, United States; Professor, University of Konstanz, Germany
• Emmanuel Cormier, PhD, Head of the Regulatory Science and Innovation Task Force, European Medicines Agency (EMA), Netherlands
• Steven Musser, PhD, Associate Commissioner, Human Foods Program, Food and Drug Administration (FDA), United States
• Madhu Nag, PhD, Chief Scientific Officer, InSphero AG, United States
17:30-19:30 WELCOME RECEPTION & POSTER PRESENTATIONS
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 local
Day 2—Friday, 4 September 2026
7:00–17:00
REGISTRATION
8:30-12:00
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 3: MICROPHYSIOLOGICAL SYSTEMS AND NEW APPROACH METHODOLOGIES FOR NEXT-GENERATION REGULATORY SCIENCE
Co-Chairs:
Didier Verloo, DVM, Head of Knowledge, Innovation, and Partnership Management (KNOW) Unit, European Food Safety Authority (EFSA), Italy; Xiaobing Zhou, PhD, Deputy Director, Institute for Safety Evaluation, National Institutes for Drug Control (NIDC), China
8:30-8:50
Advancing Regulatory Science Practices for NAMs in China
Xiaobing Zhou, PhD, Deputy Director, Institute of Safety Evaluation, National Institutes for Drug Control (NIDC), China
8:50-9:10
Organ-on-Chip Approaches in Regulatory Science: Experience from BfR
Philip Marx-Stoelting, PhD, Scientific Director, Testing and Assessment Strategies Unit, German Federal Institute for Risk Assessment (BfR), Germany
9:10-9:30
Use of NAMs in Food Safety Risk Assessment in China
Hui Yang, PhD, Deputy Director, Toxicology Laboratory, China National Center for Food Safety Risk Assessment (CFSA), China
9:30-9:50
NAMs: A Two-Way Journey Between Regulators and Industry
Z. Alex Xu, PhD, Founder and CEO, Axter Therapeutics, China
9:50-10:10
Co-Creating Confidence Building the NAMs Evidence Base With Regulators, Not For Them.
Madhu Nag, PhD, Chief Scientific Officer, InSphero AG, United States
10:10-10:40
Break
10:40-11:00
Development of a First-Pass Effect Model Using the Gut-Liver-on-Chip and Japanese Efforts Toward Proposing an Organisation for Economic Co-operation and Development Guideline
Daiju Yamazaki, PhD, Section Chief, Division of Pharmacology, National Institute of Health Sciences (NIHS), Japan
11:00-11:20
Environmental Health Applications of NAMs: Organ-on-Chip Systems and Their Relevance in Regulatory Contexts
Tommaso Serchi, PhD, Head of Environmental Health Group - Environmental Sustainability Assessment and Circularity Research Unit, Luxembourg Institute of Science and Technology (LIST), Luxembourg
11:20-11:40
Targeting the Blood-Brain Barrier via New Approach Methodologies: A New Paradigm for Central Nervous System Safety and Efficacy
Kaoru Sato, PhD, Lab Head, Laboratory of Neuropharmaclogy, National Institute of Health Sciences (NIHS), Japan
11:40-12:00
NAMs-Related Technologies; Trends in Standardization of Microphysiological Systems
Hiroki Nakae, PhD, Director General, Japan Bio-Measurement and Analysis Consortium (JMAC), Japan
12:00-13:30
Break
13:30-17:00
LLM Task Force Review: Lessons Learned and Future Challenges
SESSION 4: NANOTECHNOLOGIES
Co-Chairs:
Anil Patri, PhD, National Center for Toxicological Research, Food and Drug Administration (FDA), United States; Xingchao Geng, PhD, Director, Institute for Biological Products Control, National Institutes for Drug Control (NIDC), China
Development of New Therapeutics via Nanotechnology-Enabled Delivery
Guangjun Nie, PhD, Principal Investigator and Deputy Director, National Center for Nanoscience and Technology (NCNST), China
Analytical Strategies for LNP-RNA Characterization
Luigi Calzolai, PhD, Project Leader, European Commission, Joint Research Centre (JRC), Italy
Nanomedicine Validated in Phase 1 Translating Quality by Design into Human Safety
Rana Sanyal, PhD, Professor, Bogazici University Center for Targeted Therapy Technologies, Istanbul, Türkiye; RS Research Inc., Teknopark Istanbul, Istanbul, Türkiye
Break
Title (TBD)
Jiancheng Wang, PhD, Professor, Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, China
Establishing Harmonised and Standardised Workflows for the Detection and Characterisation of Microplastics and Nanoplastics in Water and Food to Support Safety Assessment
Dingyi Yu, PhD, Specialist Team Lead, Singapore Food Agency (SFA), Singapore
Korea's Advances in Micro- and Nanoplastic Metrology, from Rapid Detection to Hazard Assessment
Ik Hwan Kwon, PhD, Senior Researcher, Nanobio Measurement Group, Division of Biomedical Metrology, Korea Research Institute of Standards and Science (KRISS), Daejeon, Republic of Korea
17:00-17:30 CLOSING REMARKS & ANNOUNCEMENT OF GSRS27
• Qingli Wang, PhD, Deputy Director General, National Institutes for Drug Control (NIDC), China
• A/Prof. Joanne Chan, Centre Director, National Centre for Food Science, Singapore Food Agency, Singapore
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
8:00
Registration Open
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
10:40–11:10
Break
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
12:30- 14:00
Break
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
15:20-15:50
Break
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
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