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Wednesday, November 19, 2025
7:00 AM - 8:00 AM
(MT)
Continental Breakfast
7:00 AM - 8:00 AM
(MT)
Continental Breakfast
Location: Grand Sonoran Foyer
7:30 AM - 2:00 PM
(MT)
Registration Open
7:30 AM - 2:00 PM
(MT)
Registration Open
Location: Grand Sonoran Foyer
8:00 AM - 8:55 AM
(MT)
Human Organ Chips for Toxicology, Disease Modeling, and Drug Development (P2)
8:00 AM - 8:55 AM
(MT)
Human Organ Chips for Toxicology, Disease Modeling, and Drug Development (Plenary 2)
Location: Grand Saguaro North/South
Plenary Speaker:
Donald E. Ingber, MD, PhD
– Wyss Institute for Biologically Inspired Engineering at Harvard University
8:00 AM - 1:00 PM
(MT)
Speaker Ready Room Open
8:00 AM - 1:00 PM
(MT)
Speaker Ready Room Open
Location: Pinnacle Peak 1
9:00 AM - 12:00 PM
(MT)
Balancing Innovation and Caution: Artificial Intelligence (AI) and Machine Learning (ML) in Toxicology (S13)
Symposium Chair:
Mamta Behl, PhD, DABT
– Neurocrine Biosciences Inc.
Symposium Chair:
Ruth A. Roberts, PhD, ERT, FBTS, ATS, FRCPath, FRCB
– ApconiX Ltd.
Symposium Speaker:
Scott S. Auerbach, PhD, DABT
– National Institutes of Health
Symposium Speaker:
Kenneth Schafer, DVM, PhD
– Greenfield Pathology Services, Inc.
Symposium Speaker:
Layla Hosseini-Gerami, PhD
– Ignota Labs
Symposium Speaker:
Thomas Hartung, MD PhD
– Johns Hopkins Bloomberg School of Public Health
Panelist:
Weida Tong, PhD
– US FDA, National Center for Toxicological Research
Advanced
Emerging
9:00 AM - 12:00 PM
(MT)
Balancing Innovation and Caution: Artificial Intelligence (AI) and Machine Learning (ML) in Toxicology (S13)
Location: Grand Sonoran E
Symposium Chair:
Mamta Behl, PhD, DABT
– Neurocrine Biosciences Inc.
Symposium Chair:
Ruth A. Roberts, PhD, ERT, FBTS, ATS, FRCPath, FRCB
– ApconiX Ltd.
Symposium Speaker:
Scott S. Auerbach, PhD, DABT
– National Institutes of Health
Symposium Speaker:
Kenneth Schafer, DVM, PhD
– Greenfield Pathology Services, Inc.
Symposium Speaker:
Layla Hosseini-Gerami, PhD
– Ignota Labs
Symposium Speaker:
Thomas Hartung, MD PhD
– Johns Hopkins Bloomberg School of Public Health
Panelist:
Weida Tong, PhD
– US FDA, National Center for Toxicological Research
Advanced
Emerging
9:00 AM - 9:05 AM
(MT)
Introduction (S13-1)
Symposium Chair:
Mamta Behl, PhD, DABT
– Neurocrine Biosciences Inc.
9:05 AM - 9:30 AM
(MT)
Artificial Intelligence and Machine Learning in Drug Discovery and Development (S13-2)
Symposium Speaker:
Ruth A. Roberts, PhD, ERT, FBTS, ATS, FRCPath, FRCB
– ApconiX
9:30 AM - 9:55 AM
(MT)
Navigating the Limitations of AI in Toxicity Assessment (S13-3)
Symposium Speaker:
Scott S. Auerbach, PhD, DABT
– National Institutes of Health
9:55 AM - 10:15 AM
(MT)
Is AI Going to Overtake Pathology? Pros and Cons (S13-4)
Symposium Speaker:
Kenneth Schafer, DVM, PhD
– Greenfield Pathology Services, Inc.
10:15 AM - 10:45 AM
(MT)
Break (S13-Break)
10:45 AM - 11:10 AM
(MT)
Reviving Potential: Leveraging AI to Rescue Failing Drugs and Enhance Drug Safety (S13-5)
Symposium Speaker:
Layla Hosseini-Gerami, PhD
– Ignota Labs
11:10 AM - 11:35 AM
(MT)
AI Snake Oil? A Risk/Benefit Analysis for Toxicology (S13-6)
Symposium Speaker:
Thomas Hartung, MD PhD
– Johns Hopkins Bloomberg School of Public Health
11:35 AM - 12:00 PM
(MT)
Panel Discussion (S13-Panel)
Panelist:
Weida Tong, PhD
– US FDA, National Center for Toxicological Research
9:00 AM - 12:00 PM
(MT)
Consulting Is a Viable Career Path: How to Start and Build a Career as a Toxicology Consultant (S14)
Symposium Chair:
William J. Brock, PhD, DABT, ATS
– Brock Scientific Consulting, LLC
Symposium Chair:
Peter J. Korytko, PhD, MBA
– Preclinical GPS LLC
Symposium Speaker:
Ric Stanulis, PhD, DABT
– Akkeri, Inc.
Symposium Speaker:
Lisa Beilke, MSPH, PhD, DABT, ATS
– Toxicology Solutions, Inc.
Basic
Practical
9:00 AM - 12:00 PM
(MT)
Consulting Is a Viable Career Path: How to Start and Build a Career as a Toxicology Consultant (S14)
Location: Grand Sonoran F
Symposium Chair:
William J. Brock, PhD, DABT, ATS
– Brock Scientific Consulting, LLC
Symposium Chair:
Peter J. Korytko, PhD, MBA
– Preclinical GPS LLC
Symposium Speaker:
Ric Stanulis, PhD, DABT
– Akkeri, Inc.
Symposium Speaker:
Lisa Beilke, MSPH, PhD, DABT, ATS
– Toxicology Solutions, Inc.
Basic
Practical
9:00 AM - 9:05 AM
(MT)
Introduction (S14-1)
Symposium Chair:
Peter J. Korytko, PhD, MBA
– Preclinical GPS LLC
9:05 AM - 9:30 AM
(MT)
How to Start an Independent Consulting Company (S14-2)
Symposium Speaker:
William J. Brock, PhD, DABT, ATS
– Brock Scientific Consulting, LLC
9:30 AM - 9:55 AM
(MT)
Consulting in a Group Practice as a Career Path (S14-3)
Symposium Speaker:
Ric Stanulis, PhD, DABT
– Akkeri, Inc.
9:55 AM - 10:15 AM
(MT)
Growing a Consulting Business with General and Niche Services (S14-4)
Symposium Speaker:
Lisa Beilke, MSPH, PhD, DABT, ATS
– Toxicology Solutions, Inc.
10:15 AM - 10:45 AM
(MT)
Break (S14-Break)
10:45 AM - 11:15 AM
(MT)
Myths and Misconceptions for Consulting Practice: Emphasis on Marketing (S14-5)
Symposium Speaker:
Peter J. Korytko, PhD, MBA
– Preclinical GPS LLC
11:15 AM - 12:00 PM
(MT)
Panel Discussion (S14-Panel)
9:00 AM - 12:00 PM
(MT)
Nonclinical Considerations for the Development of Radiopharmaceuticals (S15)
Symposium Chair:
Dhanraj Deshmukh, PhD, DABT
– Eli Lilly and Company
Symposium Chair:
Michael Sievert, PhD, DABT
– Labcorp Early Development Laboratories Ltd
Symposium Speaker:
Matthew Dieter, PhD, DABT
– Eli Lilly and Company
Symposium Speaker:
Michaela Colestock, MS
– Labcorp
Symposium Speaker:
Frederic Thalacker, PhD
– Labcorp Early Development Laboratories Ltd
Symposium Speaker:
Lukas Carter, PhD, DABSNM
– Memorial Sloan Kettering Cancer Center
Symposium Speaker:
Robert Coover, PhD
– US FDA
Basic
Emerging
9:00 AM - 12:00 PM
(MT)
Nonclinical Considerations for the Development of Radiopharmaceuticals (S15)
Location: Grand Sonoran G
Symposium Chair:
Dhanraj Deshmukh, PhD, DABT
– Eli Lilly and Company
Symposium Chair:
Michael Sievert, PhD, DABT
– Labcorp Early Development Laboratories Ltd
Symposium Speaker:
Matthew Dieter, PhD, DABT
– Eli Lilly and Company
Symposium Speaker:
Michaela Colestock, MS
– Labcorp
Symposium Speaker:
Frederic Thalacker, PhD
– Labcorp Early Development Laboratories Ltd
Symposium Speaker:
Lukas Carter, PhD, DABSNM
– Memorial Sloan Kettering Cancer Center
Symposium Speaker:
Robert Coover, PhD
– US FDA
Basic
Emerging
9:00 AM - 9:25 AM
(MT)
Introduction to Nonclinical Safety of Radioligand Therapies (S15-1)
Symposium Speaker:
Matthew Dieter, PhD, DABT
– Eli Lilly
9:25 AM - 9:50 AM
(MT)
Cool Studies in Radiopharmaceuticals: The Design and Conduct of Preclinical Studies for Radiopharmaceutical Development (S15-2)
Symposium Speaker:
Michaela Colestock, MS
– Labcorp
9:50 AM - 10:15 AM
(MT)
Radiopharmaceuticals Biodistribution Studies (S15-3)
Symposium Speaker:
Frederic Thalacker, PhD
– Labcorp Drug Development
10:15 AM - 10:45 AM
(MT)
Break (S15-Break)
10:45 AM - 11:15 AM
(MT)
Dosimetry Approaches for Clinical Translation of Radiopharmaceuticals (S15-4)
Symposium Speaker:
Lukas Carter, PhD, DABSNM
– Memorial Sloan Kettering Cancer Center
11:15 AM - 11:45 AM
(MT)
Regulatory Considerations for Radiopharmaceuticals (S15-5)
Symposium Speaker:
Robert Coover, PhD
– US FDA
11:45 AM - 12:00 PM
(MT)
Panel Discussion (S15-Panel)
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: ApconiX—Benefits of Early In Vitro Screening for Seizure Liability in Problem Solving and Decision-Making
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: ApconiX—Benefits of Early In Vitro Screening for Seizure Liability in Problem Solving and Decision-Making
Location: Grand Sonoran H
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Charles River—A Revolution Awaits with ASOs and siRNAs: Success Factors from Discovery to Regulatory Toxicology
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Charles River—A Revolution Awaits with ASOs and siRNAs: Success Factors from Discovery to Regulatory Toxicology
Location: Grand Sonoran K
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Cyprotex—Developing a NAMs Approach to Address the FDA Roadmap to Reduce Animal Testing
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Cyprotex—Developing a NAMs Approach to Address the FDA Roadmap to Reduce Animal Testing
Location: Grand Sonoran J
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Ellegaard Göttingen Minipigs A/S—Case Stories on Göttingen Minipigs by Hoffmann-La Roche
12:00 PM - 12:55 PM
(MT)
Exhibitor-Hosted Program: Ellegaard Göttingen Minipigs A/S—Case Stories on Göttingen Minipigs by Hoffmann-La Roche
Location: Grand Sonoran I
12:00 PM - 1:30 PM
(MT)
2026 Program Planning Meeting
12:00 PM - 1:30 PM
(MT)
2026 Program Planning Meeting
Location: Wildflower A
12:00 PM - 2:00 PM
(MT)
Lunch on Your Own
12:00 PM - 2:00 PM
(MT)
Lunch on Your Own
1:30 PM - 3:00 PM
(MT)
Member Portraits
1:30 PM - 3:00 PM
(MT)
Member Portraits
Location: Desert Suite 1
2:00 PM - 3:15 PM
(MT)
Antibody-Drug Conjugate (ADC) Nonclinical Safety: Background, Challenges, and Mitigation Strategies (S16)
Symposium Chair:
Chang-Ning Liu, PhD
– Pfizer, Inc.
Symposium Chair:
Sean (Xiaochun) Chen, PhD, RAC
– InnoStar Biotech
Symposium Speaker:
Melissa A. Pegues, PhD
– Salamandra
Symposium Speaker:
Craig A. Miller, DVM, PhD, DACVP
– Pfizer, Inc.
Advanced
Emerging
2:00 PM - 3:15 PM
(MT)
Antibody-Drug Conjugate (ADC) Nonclinical Safety: Background, Challenges, and Mitigation Strategies (S16)
Location: Grand Sonoran F
Symposium Chair:
Chang-Ning Liu, PhD
– Pfizer, Inc.
Symposium Chair:
Sean (Xiaochun) Chen, PhD, RAC
– InnoStar Biotech
Symposium Speaker:
Melissa A. Pegues, PhD
– Salamandra
Symposium Speaker:
Craig A. Miller, DVM, PhD, DACVP
– Pfizer, Inc.
Advanced
Emerging
2:00 PM - 2:05 PM
(MT)
Introduction (S16-1)
Symposium Speaker:
Chang-Ning Liu, PhD
– Pfizer Inc.
2:05 PM - 2:25 PM
(MT)
Nonclinical Toxicity of Antibody-Drug Conjugates and Challenges in Predicting Clinical Adverse Events (S16-2)
Symposium Speaker:
Sean (Xiaochun) Chen, PhD, RAC
– InnoStar Biotech
2:25 PM - 2:45 PM
(MT)
Regulatory Considerations for Optimizing the Nonclinical Assessment of Antibody-Drug Conjugates (S16-3)
Symposium Speaker:
Melissa A. Pegues, PhD
– Salamandra
2:45 PM - 3:05 PM
(MT)
Translational Approaches to ADC-Related Toxicities: Bridging the Gap from Bench to Bedside (S16-4)
Symposium Speaker:
Craig A. Miller, DVM, PhD, DACVP
– Pfizer, Inc.
3:05 PM - 3:15 PM
(MT)
Panel Discussion (S16-Panel)
2:00 PM - 3:15 PM
(MT)
Optimize Your FDA Interactions: An Industry and FDA Perspective (S17)
Symposium Chair:
Brian Mulhern, MS, DABT
– SciLucent, Inc.
Symposium Chair:
Nicole Lay, MS, DABT
– SciLucent, Inc.
Symposium Speaker:
Sang Ki Park, PhD
– US FDA
Basic
Practical
2:00 PM - 3:15 PM
(MT)
Optimize Your FDA Interactions: An Industry and FDA Perspective (S17)
Location: Grand Sonoran G
Symposium Chair:
Brian Mulhern, MS, DABT
– SciLucent, Inc.
Symposium Chair:
Nicole Lay, MS, DABT
– SciLucent, Inc.
Symposium Speaker:
Sang Ki Park, PhD
– US FDA
Basic
Practical
2:00 PM - 2:10 PM
(MT)
Introduction (S17-1)
Symposium Speaker:
Brian Mulhern, MS, DABT
– SciLucent, Inc.
2:10 PM - 2:35 PM
(MT)
Set Yourself Up for Success: Best Practices for Meeting Preparation (S17-2)
Symposium Speaker:
Nicole Lay, MS, DABT
– SciLucent, Inc.
2:35 PM - 3:00 PM
(MT)
Enhancing Your Regulatory Interactions: An FDA Perspective (S17-3)
Symposium Speaker:
Sang Ki Park, PhD
– US FDA
3:00 PM - 3:15 PM
(MT)
Panel Discussion (S17-Panel)
2:00 PM - 5:00 PM
(MT)
Hot Topics (S18)
Symposium Chair:
Armaghan Emami, PharmD, PhD
– US FDA
Symposium Chair:
Paramita Mookherjee, PhD, DABT
– Regeneron
Hot Topic Speaker:
Laura Boone, DVM, PhD, DACVP, DABT
– Labcorp
Hot Topic Speaker:
Alex Eapen, PhD, DABT
– Cargill
Hot Topic Speaker:
Nakissa Sadrieh, PhD
– US FDA
Hot Topic Speaker:
Juan Carlos López, PhD
– Haystack Science
Advanced
Emerging
2:00 PM - 5:00 PM
(MT)
Hot Topics (S18)
Location: Grand Sonoran E
Symposium Chair:
Armaghan Emami, PharmD, PhD
– US FDA
Symposium Chair:
Paramita Mookherjee, PhD, DABT
– Regeneron
Hot Topic Speaker:
Laura Boone, DVM, PhD, DACVP, DABT
– Labcorp
Hot Topic Speaker:
Alex Eapen, PhD, DABT
– Cargill
Hot Topic Speaker:
Nakissa Sadrieh, PhD
– US FDA
Hot Topic Speaker:
Juan Carlos López, PhD
– Haystack Science
Advanced
Emerging
2:00 PM - 2:05 PM
(MT)
Introduction (S18-1)
Symposium Chair:
Armaghan Emami, PharmD, PhD
– US FDA
Symposium Chair:
Paramita Mookherjee, PhD, DABT
– Regeneron
2:05 PM - 2:40 PM
(MT)
Virtual Control Groups in Repeat-Dose Toxicity Studies: Opportunities and Obstacles (S18-2)
Hot Topic Speaker:
Laura Boone, DVM, PhD, DACVP, DABT
– Labcorp
2:40 PM - 3:15 PM
(MT)
Exploring Regulatory Impacts of Shifts in US Food Policy (S18-3)
Hot Topic Speaker:
Alex Eapen, PhD, DABT
– Cargill
3:15 PM - 3:45 PM
(MT)
Break (S18-Break)
3:45 PM - 4:15 PM
(MT)
CDER Considerations on Phasing Out Animal Studies: An Overview of the FDA New Approach Methodologies Roadmap (S18-4)
Hot Topic Speaker:
Nakissa Sadrieh, PhD
– US FDA
4:15 PM - 4:45 PM
(MT)
Impact of Conditional Approval Pathway for Ultra-Rare Conditions Based on a “Plausible Mechanism” (S18-5)
Hot Topic Speaker:
Juan Carlos López, PhD
– Haystack Science
4:45 PM - 5:00 PM
(MT)
Panel Discussion (S18-Panel)
3:45 PM - 5:00 PM
(MT)
Impurity Limits and Approaches for Endogenous Substances Commonly Identified in Biologic Therapeutics (S19)
Symposium Chair:
Ernest Fung, PhD, DABT, ERT
– Integral Consulting
Symposium Speaker:
Robert A. Jolly, CPH, MPH
– Eli Lilly and Company
Symposium Speaker:
Satheesh Anand, PhD, DABT
– Boehringer Ingelheim
Basic
Practical
3:45 PM - 5:00 PM
(MT)
Impurity Limits and Approaches for Endogenous Substances Commonly Identified in Biologic Therapeutics (S19)
Location: Grand Sonoran F
Symposium Chair:
Ernest Fung, PhD, DABT, ERT
– Integral Consulting
Symposium Speaker:
Robert A. Jolly, CPH, MPH
– Eli Lilly and Company
Symposium Speaker:
Satheesh Anand, PhD, DABT
– Boehringer Ingelheim
Basic
Practical
3:45 PM - 4:05 PM
(MT)
Methodology and Special Considerations for Setting Exposure Thresholds for Endogenous Sugars and Enzymes (S19-1)
Symposium Speaker:
Ernest Fung, PhD, DABT, ERT
– Integral Consulting
4:05 PM - 4:25 PM
(MT)
Methodology and Special Considerations for Setting Exposure Thresholds for Fatty Acids and Amino Acids (S19-2)
Symposium Speaker:
Robert A. Jolly, CPH, MPH
– Eli Lilly & Company
4:25 PM - 4:45 PM
(MT)
Approaches and Considerations When Establishing Exposure Thresholds for Endogenous Compounds (S19-3)
Symposium Speaker:
Satheesh Anand, PhD, DABT
– Boehringer Ingelheim
4:45 PM - 5:00 PM
(MT)
Panel Discussion (S19-Panel)
3:45 PM - 5:00 PM
(MT)
Nose to the Grindstone: Intranasal Therapies (S20)
Symposium Chair:
Meghan E. Rebuli, PhD, ATSF
– University of North Carolina
Symposium Chair:
Emily Hackshaw, PhD
– Labcorp
Symposium Speaker:
Ryan Owens, MS
– University of Rochester School of Medicine and Dentistry
Symposium Speaker:
Belete Teferedegne, DVM, PhD, DABT
– AstraZeneca
Basic
Emerging
3:45 PM - 5:00 PM
(MT)
Nose to the Grindstone: Intranasal Therapies (S20)
Location: Grand Sonoran G
Symposium Chair:
Meghan E. Rebuli, PhD, ATSF
– University of North Carolina
Symposium Chair:
Emily Hackshaw, PhD
– Labcorp
Symposium Speaker:
Ryan Owens, MS
– University of Rochester School of Medicine and Dentistry
Symposium Speaker:
Belete Teferedegne, DVM, PhD, DABT
– AstraZeneca
Basic
Emerging
3:45 PM - 3:55 PM
(MT)
Introduction (S20-1)
Symposium Speaker:
Meghan E. Rebuli, PhD, ATSF
– University of North Carolina
3:55 PM - 4:20 PM
(MT)
Sniffing Out Chemosensory Neurons and Immune Cell Subsets in Nasal Epithelium (S20-2)
Symposium Speaker:
Ryan Owens, MS
– University of Rochester School of Medicine and Dentistry
4:20 PM - 4:50 PM
(MT)
Nonclinical Safety Assessment of FluMist and Advancements in Intranasal Vaccine Development (S20-3)
Symposium Speaker:
Belete Teferedegne, DVM, PhD, DABT
– AstraZeneca
4:50 PM - 5:00 PM
(MT)
Questions & Answers (S20-Q&A)
5:00 PM - 6:00 PM
(MT)
Closing Social
5:00 PM - 6:00 PM
(MT)
Closing Social
Location: Grand Sonoran H–K
