Full Schedule

7:00 AM - 7:55 AM (MT)

Exhibitor-Hosted Program: AxiomBio—Using AI to Combine Many NAMs with Drug Exposure and Metabolism to Model DILI for Modern Molecules

Location: Grand Sonoran J

7:00 AM - 7:55 AM (MT)

Exhibitor-Hosted Program: Cyprotex—From TSA to Clinic: Leveraging NAMs and Biomarkers across the Safety Continuum

Location: Grand Sonoran H

7:00 AM - 7:55 AM (MT)

Exhibitor-Hosted Program: Envol Biomedical—2025 Changes at the FDA: Impact on Drug Development and Animal Use

Location: Grand Sonoran I

7:00 AM - 8:00 AM (MT)

Continental Breakfast

Location: Grand Sonoran Foyer

7:00 AM - 5:00 PM (MT)

Registration Open

Location: Grand Sonoran Foyer

8:00 AM - 8:55 AM (MT)

Infectious Disease Outbreaks and Disease Elimination in the 21st Century (Plenary 1)

Location: Grand Saguaro North/South

Plenary Speaker: – Stanford University School of Medicine

8:00 AM - 1:00 PM (MT)

Speaker Ready Room Open

Location: Pinnacle Peak 1

9:00 AM - 12:00 PM (MT)

Advancing Nitrosamine Risk Assessment for Human Health Risk Assessment (S01)

Location: Grand Sonoran E

Symposium Chair: – Eli Lilly and Company

Symposium Chair: – New York Medical College

Symposium Speaker: – White Oak Regulatory Tox, LLC

Symposium Speaker: – Eli Lilly and Company

Symposium Speaker: – Pfizer, Inc.

Symposium Speaker: – Instem

AdvancedEmerging

9:00 AM - 9:10 AM (MT)

Public-Private Partnerships Advancing the Science of Nitrosamine Testing (S01-1)

Symposium Speaker: – Eli Lilly and Company

9:10 AM - 9:35 AM (MT)

Current US Regulatory Expectations for the Safety Assessment of Nitrosamine Impurities in Drug Products (S01-2)

Symposium Speaker: – White Oak Regulatory Tox, LLC

9:35 AM - 9:55 AM (MT)

Optimizing the Ames Assay for Nitrosamine Testing: Results of a HESI Multi-Sector Ring Trial (S01-3)

Symposium Speaker: – New York Medical College

9:55 AM - 10:15 AM (MT)

Developing an In Vivo Strategy Supporting Nitrosamine Risk Assessment (S01-4)

Symposium Speaker: – Eli Lilly & Company

10:15 AM - 10:45 AM (MT)

Break (S01-Break)

10:45 AM - 11:10 AM (MT)

Building the Bridge: Exploring Alternative In Vitro Mammalian Cell Models to Support Nitrosamine Testing (S01-5)

Symposium Speaker: – Pfizer Inc.

11:10 AM - 11:35 AM (MT)

QSAR-QM Modeling of Nitrosamines Supporting Accurate Nitrosamine Potency Prediction (S01-6)

Symposium Speaker: – Instem

11:35 AM - 12:00 PM (MT)

Panel Discussion (S01-Panel)

9:00 AM - 12:00 PM (MT)

Oligonucleotide-Based Therapeutics, Hybridization-Dependent Off-Target Effects, and Impacts on Nonclinical Safety Packages (S02)

Location: Grand Sonoran F

Symposium Chair: – Eli Lilly and Company

Symposium Chair: – PepGen

Symposium Speaker: – Boehringer Ingelheim Pharmaceuticals

Symposium Speaker: – Eli Lilly and Company

Symposium Speaker: – Aclairo Pharmaceutical Development Group, Inc.

BasicEmerging

9:00 AM - 9:05 AM (MT)

Introduction (S02-1)

Symposium Chair: – Eli Lilly and Company

9:05 AM - 9:40 AM (MT)

Assessing Hybridization Dependent Off-Target Effects of Oligonucleotide Therapeutics (S02-2)

Symposium Speaker: – PepGen

9:40 AM - 10:15 AM (MT)

Hybridization-Dependent Off-Target Associated Toxicity and Derisking Strategies (S02-3)

Symposium Speaker: – Boehringer-Ingelheim Pharmaceuticals Inc.

10:15 AM - 10:45 AM (MT)

Break (S02-Break)

10:45 AM - 11:15 AM (MT)

Pathology Overview of Off-Target Associated Lesions (S02-4)

Symposium Speaker: – Eli Lilly and Company

11:15 AM - 11:45 AM (MT)

Evolving Regulatory Landscape for Oligonucleotide-Based Therapeutics (S02-5)

Symposium Speaker: – Aclairo Pharmaceutical Development Group

11:45 AM - 12:00 PM (MT)

Panel Discussion (S02-Panel)

9:00 AM - 12:00 PM (MT)

When to Waive: Balancing Risk and Flexibility in Nonclinical Safety Studies (S03)

Location: Grand Sonoran G

Symposium Chair: – Amgen

Symposium Chair: – Apellis

Symposium Speaker: – Takeda Pharmaceuticals

Symposium Speaker: – Genentech

Symposium Speaker: – Amgen

Symposium Speaker: – Merck

AdvancedEmerging

9:00 AM - 9:05 AM (MT)

Introduction (S03-1)

Symposium Chair: – Amgen, Inc.

9:05 AM - 9:40 AM (MT)

A Data Driven Approach to an Unconventional Nonclinical Safety Package (S03-2)

Symposium Speaker: – Takeda Pharmaceuticals

9:40 AM - 10:15 AM (MT)

Leveraging Platform Knowledge to Streamline Nonclinical Safety Assessment of T Cell Engaging Bispecifics (S03-3)

Symposium Speaker: – Genentech

10:15 AM - 10:45 AM (MT)

Break (S03-Break)

10:45 AM - 11:20 AM (MT)

Considerations for Requesting to Waive Developmental Toxicology Studies (S03-4)

Symposium Speaker: – Amgen, Inc.

11:20 AM - 11:55 AM (MT)

ICH S1B(R1) WOE Assessments: Industry Perspective 3 Years After Implementation (S03-5)

Symposium Speaker: – Merck

11:55 AM - 12:00 PM (MT)

Closing Remarks (S03-Closing)

9:30 AM - 6:30 PM (MT)

ACT Expo and Posters Open

Location: Exhibit Hall

11:15 AM - 12:15 PM (MT)

Member Portraits

Location: Desert Suite 1

11:30 AM - 1:00 PM (MT)

Student Poster Competition

Location: Wildflower A

12:00 PM - 12:55 PM (MT)

Exhibitor-Hosted Program: Charles River—Use of AI Technologies and Other Trends with Minipigs in Pharmaceutical Development

Location: Grand Sonoran J

12:00 PM - 12:55 PM (MT)

Exhibitor-Hosted Program: Harvard Bioscience—Alternative Approaches in Safety Pharmacology: Practical Applications in Toxicology Studies

Location: Grand Sonoran I

12:00 PM - 12:55 PM (MT)

Exhibitor-Hosted Program: Labcorp—Risks and Rewards of Virtual Control Groups in Repeat-Dose Toxicity Studies

Location: Grand Sonoran K

12:00 PM - 12:55 PM (MT)

Exhibitor-Hosted Program: Lhasa Limited—Extractables and Leachables: Managing Risk Using In Silico Solutions under ICH Q3E

Location: Grand Sonoran H

12:00 PM - 2:00 PM (MT)

Lunch on Your Own

12:15 PM - 1:30 PM (MT)

IJT Editorial Board Meeting

Location: Pinnacle Peak 2

2:00 PM - 5:00 PM (MT)

Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results (S04)

Location: Grand Sonoran E

Symposium Chair: – Certara

Symposium Chair: – Recursion Pharmaceuticals

Symposium Speaker: – Labcorp

Symposium Speaker: – Genentech

Symposium Speaker: – Merck

BasicEmerging

2:00 PM - 2:10 PM (MT)

Introduction (S04-1)

Symposium Speaker: – Certara

2:10 PM - 2:40 PM (MT)

The SEND Data Engineering Dilemma: Submission Ready or Analysis Worthy? (S04-2)

Symposium Speaker: – Labcorp

2:40 PM - 3:15 PM (MT)

Mining the Past, Shaping the Future: Integrating SEND Data and Study Report Conclusions for Predictive Toxicology (S04-3)

Symposium Speaker: – Genentech

3:15 PM - 3:45 PM (MT)

Break (S04-Break)

3:45 PM - 4:15 PM (MT)

Opportunities to Improve Toxicological Profile Characterization via New Predictive Modeling Approach Methodologies (S04-4)

Symposium Speaker: – Certara

4:15 PM - 4:45 PM (MT)

Leveraging SEND Harmonized Data for Multi-Modal Toxicology Relationships and Predictive Analytics (S04-5)

Symposium Speaker: – Merck

4:45 PM - 5:00 PM (MT)

Panel Discussion (S04-Panel)

2:00 PM - 5:00 PM (MT)

Predicting Adversities in New Modalities: Lessons Learned from Clinical and Preclinical in Cell and Gene Therapies (S05)

Location: Grand Sonoran F

Symposium Chair: – Genentech

Symposium Chair: – Sana Biotechnology

Symposium Speaker: – Altasciences

Symposium Speaker: – Biocytogen

Symposium Speaker: – Genentech

Symposium Speaker: – Dark Horse Consulting Group, Inc.

Symposium Speaker: – Sangamo Therapeutics, Inc.

AdvancedPractical

2:00 PM - 2:10 PM (MT)

Introduction (S05-1)

Symposium Speaker: – Genentech

2:10 PM - 2:35 PM (MT)

Gene Therapy Nonclinical Studies: What Has Been Learned (S05-2)

Symposium Speaker: – Altasciences

2:35 PM - 3:00 PM (MT)

Advanced Mouse Models for Novel Therapeutics: Enhancing Drug Evaluation and Toxicity Assessment (S05-3)

Symposium Speaker: – Biocytogen

3:00 PM - 3:15 PM (MT)

Applying New Modalities through Enhancing TCR Potency and Safety: In Vitro and In Silico Approaches (S05-4)

Symposium Speaker: – Genentech

3:15 PM - 3:45 PM (MT)

Break (S05-Break)

3:45 PM - 4:15 PM (MT)

Aligning Nonclinical Development Strategy with Regulatory Expectations for CGT Products (S05-5)

Symposium Speaker: – Dark Horse Consulting Group, Inc.

4:15 PM - 4:45 PM (MT)

A Case Study of Preclinical Development of ST-506: An AAV-Delivered Prion-Lowering Zinc Finger Repressor as a Potential Epigenetic Gene Therapy for Prion Disease (S05-6)

Symposium Speaker: – Sangamo Therapeutics, Inc.

4:45 PM - 5:00 PM (MT)

Panel Discussion (S05-Panel)

2:00 PM - 5:00 PM (MT)

Transitioning to the New ICH M12 Guideline on Drug-Drug Interactions: Concepts and Implications (S06)

Location: Grand Sonoran G

Symposium Chair: – BioIVT

Symposium Chair: – Zenas BioPharma

Symposium Speaker: – MSR Healthcare Consultants LLC

Symposium Speaker: – Novartis Institute of Biomedical Research

BasicPractical

2:00 PM - 2:35 PM (MT)

Evaluating Drug-Drug Interaction (DDI) Potential: A High-Level Overview (S06-1)

Symposium Speaker: – Zenas BioPharma

2:35 PM - 3:15 PM (MT)

In Vitro Tools and Methods to Assess Drug-Drug Interaction Potential Following the ICH M12 Guideline (S06-2)

Symposium Speaker: – BioIVT

3:15 PM - 3:45 PM (MT)

Break (S06-Break)

3:45 PM - 4:20 PM (MT)

ICH M12 Drug Interaction Studies: Global Harmonization Efforts towards Assessments and Interpretation (S06-3)

Symposium Speaker: – Novartis Institute of Biomedical Research

4:20 PM - 4:45 PM (MT)

Implications of DDI in Early Oncology Clinical Development (S06-4)

Symposium Speaker: – MSR Healthcare Consultants LLC

4:45 PM - 5:00 PM (MT)

Panel Discussion (S06-Panel)

3:00 PM - 4:30 PM (MT)

Member Portraits

Location: Desert Suite 1

5:00 PM - 6:30 PM (MT)

13-Week Topical Ocular Toxicity and Toxicokinetic Study of Ocular Surface Immunoglobulin in New Zealand White Rabbits with a 4-Week Recovery Period (P419)

Presenting Author: – Loyola University Chicago

Co-Author: – Brock Scientific Consulting, LLC

Co-Author: – Grifols Scientific Innovation Office

Co-Author: – Selagine, Inc.

Co-Author: – University of Illinois Chicago

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

A Comparison of Moxifloxacin-Induced QTcH Prolongation in the Telemetered Nanopig versus the Telemetered Beagle Dog via the Evaluation of Minimum Detectable Difference (P436)

Presenting Author: – CorDynamics, Inc.

Co-Author: – CorDynamics, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

A Machine Learning Model for Predicting Carcinogenic Potencies of Novel Nitrosamine Compounds: Comparisons to the Carcinogenic Potency Categorization Approach (CPCA) (P440)

Presenting Author: – Valeo Sciences

Co-Author: – Valeo Sciences

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

A New Approach Methodology (NAM) for Specificity Testing: ISTAND Qualification of the Membrane Proteome Array to Evaluate Off-Target Binding of MAb-Based Therapies (P203)

Presenting Author: – Integral Molecular

Co-Author: – Integral Molecular

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

A Pragmatic Approach for Deriving Provisional Points of Departure from Acute Toxicity Data: Validation of the LD₅₀/10 Method, A Novel and Important Tool, for Chemical Safety Assessment (P518)

Presenting Author: – Medline Industries LP

Co-Author: – Medline Industries LP

Toxicology Methods

5:00 PM - 6:30 PM (MT)

A Retrospective Analysis of the Good, the Bad, and the Ugly of Virtual Control Groups in Rat Studies (P126)

Presenting Author: – Labcorp

Co-Author: – Labcorp

General Toxicology

5:00 PM - 6:30 PM (MT)

A Risk-Based Material Characterization Framework for Shelf-Life and Change Management in Prefillable Syringes and Combination Devices (P302)

Presenting Author: – Gradient

Co-Author: – Gradient

Safety Evaluation Nonpharmaceuticals

5:00 PM - 6:30 PM (MT)

A Suite of Nonhuman Primate In Vitro Assays for Safety and Immunogenicity Screening of Drug Candidates (P442)

Presenting Author: – Iqvia Laboratories In Vitro Immunology

Co-Author: – Immunespec

Co-Author: – Iqvia Laboratories In Vitro Immunology

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

A Target-Centric Machine Learning Approach for Predicting Cardiotoxicity Using Multimodal Biomedical Data (P431)

Presenting Author: – SableBio Limited

Co-Author: – SableBio Limited

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

A Validation Study of the Effects of Milrinone and Clonidine on Left Ventricular Pressure in Conscious Telemetered Canines (P406)

Presenting Author: – Altasciences Preclinical Columbia

Co-Author: – Altasciences

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Activation of the Adenosine A2B Receptor Protects Against Acetaminophen Hepatotoxicity and Promotes Liver Recovery (P108)

Presenting Author: – University of Kansas Medical Center

Co-Author: – University of Kansas Medical Center

General Toxicology

5:00 PM - 6:30 PM (MT)

AI-Augmented Literature Mining for Developmental Toxicology: Identifying Prenatal Heavy Metal Exposure Risks through BioBERT-Based Toxicology Surveillance (P502)

Presenting Author: – The National University of Malaysia

Co-Author: – The National University of Malaysia

Toxicology Methods

5:00 PM - 6:30 PM (MT)

An Oral (Gavage) Two-Generation Reproductive Toxicity Study of Eugenol in Rats (P403)

Presenting Author: – Brock Scientific Consulting, LLC

Co-Author: – Charles River Laboratories

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Analysis of the Use of Two Species in Regulatory Toxicology Studies for Molecules Following ICHM3(R2) (P217)

Presenting Author: – NC3Rs

Co-Author: – NC3Rs

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Application of a High-Throughput Human Stem Cell Cardiomyocyte Assay for Predicting Drug-Induced Changes in ECG Parameters during Drug Discovery and Development (P404)

Presenting Author: – Jazz Pharmaceuticals

Co-Author: – Metrion BioSciences

Co-Author: – Jazz Pharmaceuticals

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Approaches to Assessing E&L: Optimizing Analog Identification for Read-Across and Defaulting to Threshold Levels When Appropriate (P206)

Presenting Author: – Instem

Co-Author: – Innovatune

Co-Author: – Instem

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Assessing Disparities in Environmental Toxin Exposure by Gender, Race/Ethnicity, and Family Income in the US Population: NHANES Insights on Perchlorate, Nitrate, and Thiocyanate (P220)

Presenting Author: – Zhengzhou University

Co-Author: – Zhengzhou University

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Assessing Inhalation Alternatives for Dogs and NHPs: Feasibility of 7-Day Inhalation Exposure Studies in Göttingen Minipigs and Sinclair Nanopigs (P510)

Presenting Author: – ITR Laboratories Canada Inc.

Co-Author: – ITR Laboratories Canada Inc.

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Assessing the Effects of Antibodies on Platelet Function—In Vitro Assays to Support Early De-Risking of Antibodies Discovery and Development (P447)

Presenting Author: – Platelet Services

Co-Author: – Platelet Services

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Assessment of the Potential Biological Effects of Tobacco-Free Nicotine Pouches Using New Approach Methodologies (P504)

Presenting Author: – Imperial Brands PLC

Co-Author: – Reemtsma Cigarettenfabriken GmbH, An Imperial Brands PLC Company

Co-Author: – ImmuOne Ltd

Co-Author: – Imperial Brands PLC

Co-Author: – Reemtsma Cigarettenfabriken GmbH, An Imperial Brands PLC Company

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Assessments for the In Vivo Tolerability and Efficacy of a JAK1-Silencing RNA Being Developed for the Highly Targeted, Infrequent, and Efficacious Treatment of Inflammatory Skin Diseases Using Various Application Techniques (P127)

Presenting Author: – Altasciences

Co-Author: – RNA Therapeutics Institute, University of Massachusetts

Co-Author: – Aldena Therapeutics

Co-Author: – Certara

Co-Author: – RNA Therapeutics Institute, University of Massachusetts

General Toxicology

5:00 PM - 6:30 PM (MT)

Bacterial IdeS Protease: Strategy for Tumor Regression (P453)

Presenting Author: – ANEWCRO, LLC.

Co-Author: – ImmunePropulsion

Co-Author: – Tavotek Biotherapeutics

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Bioinformatics-Driven Target Safety Assessment Accelerates Immunotherapy Development for Lung Cancer (P421)

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Heidelberg University

Presenting Author: – Metisox Ltd

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Bronchoalveolar Lavage Fluid Collection in African Green Monkeys (P409)

Presenting Author: – Virscio

Co-Author: – Virscio

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Cannabis Use Is Associated with Reduced Inflammasome Formation and Pro-Inflammatory Interleukin-1β (IL-1β) Secretion in Peripheral Monocytes Derived from HIV+ Individuals (P130)

Presenting Author: – Michigan State University

Co-Author: – Michigan State University

General Toxicology

5:00 PM - 6:30 PM (MT)

Challenges and Opportunities in Characterizing Nonhuman Primate Immune Checkpoint Receptor Expression to Boost Development of Immune Checkpoint Inhibitors (P520)

Presenting Author: – Labcorp

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Chemical Fingerprinting of Alternative Tobacco Products: Determining the Composition of Electronic Cigarette and Heated Tobacco Aerosols (P201)

Presenting Author: – University of Porto

Co-Author: – University of Porto

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Clustering-Based Analysis of Cellular Stress Responses to Elucidate Toxicological Modes of Action of Chemicals (P505)

Presenting Author: – Toxys

Co-Author: – Toxys B.V.

Co-Author: – Toxys

Co-Author: – Toxys B.V.

Co-Author: – Toxys

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Collection of Jacketed Electrocardiology Data in Nonhuman Primates: Can Animal Size Influence Data Quality? (P508)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Comparative Analysis of Background Gastrointestinal Characteristics in Cambodian, Vietnamese, and Mauritian Cynomolgus Monkeys: Optimizing Model Selection in Preclinical Safety Assessment of Antibody-Drug Conjugates (P407)

Presenting Author: – Altasciences

Co-Author: – Altasciences

Co-Author: – Certara

Co-Author: – Altasciences

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Comparative Assessment of Dose Sites after Exposure to Slow-Release Contraceptive Delivered via Microneedle Patches on Minipigs Using a Novel Applicator (P114)

Presenting Author: – Labcorp Early Development Laboratories Ltd

Co-Author: – Labcorp Early Development Laboratories Ltd.

Co-Author: – University of Bradford

Co-Author: – Cardiff University

Co-Author: – Labcorp Early Development Laboratories Ltd.

Co-Author: – Cardiff University

Co-Author: – Labcorp Early Development Laboratories Ltd.

General Toxicology

5:00 PM - 6:30 PM (MT)

Comparative Evaluation of Baseline Complement Activation Markers in Naïve Rhesus and Cynomolgus Macaques (P435)

Presenting Author: – Franklin Biolabs

Co-Author: – National Jewish Health

Co-Author: – Franklin Biolabs

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Comparison of Select Study Parameters in Göttingen™ Minipig Historical Control Data and the Sinclair Nanopig™ (P131)

Presenting Author: – Charles River Laboratories

Co-Author: – Sinclair BioResources

General Toxicology

5:00 PM - 6:30 PM (MT)

Comprehensive Screening of Adeno-Associated Virus Neutralizing Antibodies in Cynomolgus Monkeys: A Five-Year Survey of Serotype-Specific Prevalence (P122)

Presenting Author: – SNBL

Co-Author: – SNBL

General Toxicology

5:00 PM - 6:30 PM (MT)

Conducting Read-Across for Extractables and Leachables with Confidence (P416)

Presenting Author: – Lhasa Limited

Co-Author: – Lhasa Limited

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Considerations Regarding the Use of BMD Software Programs in Model-Averaged BMD Calculations for Continuous Data (P211)

Presenting Author: – Chemicals Evaluation and Research Institute, Japan

Co-Author: – Chemicals Evaluation and Research Institute, Japan

Co-Author: – National Institute of Health Sciences, Japan

Co-Author: – National Institute for Environmental Studies, Japan

Co-Author: – Chemicals Evaluation and Research Institute, Japan

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Correlation between Histopathological Findings and Respiratory Function Changes in Acute Lung Injury Induced Rats (P113)

Presenting Author: – ITR Laboratories Canada Inc.

Co-Author: – ITR Laboratories Canada Inc.

General Toxicology

5:00 PM - 6:30 PM (MT)

Cytotoxicity of Trastuzumab, Ado-Trastuzumab Emtansine, and Trastuzumab Deruxtecan on Human Corneal Epithelial Cells (P430)

Presenting Author: – Loyola University Chicago

Co-Author: – Loyola University Chicago

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Decoding Kidney Responses to Airborne Fine Particulate Matter: A Systems Bioinformatics Approach (P115)

Presenting Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Heidelberg University

General Toxicology

5:00 PM - 6:30 PM (MT)

Development of an Oral Mucosal Tissue Model for Toxicological Applications (P501)

Presenting Author: – Wake Forest School of Medicine

Co-Author: – Wake Forest Institute of Regenerative Medicine

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Developmental Changes in Blood Testing Parameters and Comparison with Adult Values in Juvenile Cynomolgus Monkeys (P120)

Presenting Author: – SNBL

Co-Author: – SNBL

General Toxicology

5:00 PM - 6:30 PM (MT)

Developmentally Informed Strategies for Impurity PDE Derivation in Pediatric Populations (P213)

Presenting Author: – Safe Bridge Consultants, Inc.

Co-Author: – Amgen

Co-Author: – Integral Consulting

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Dosing Regimen-, Gender- and Time-Dependent Genotoxic Effects of Cyclophosphamide in Rats Assessed by the Micronucleus Assay (P209)

Presenting Author: – Porsolt

Co-Author: – Porsolt

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Effects of Chronic Exposure to Di(2-ethylhexyl) Phthalate (DEHP) and Diisononyl Phthalate (DiNP) on the Colon of Female Mice (P101)

Presenting Author: – University of Illinois Urbana-Champaign

Co-Author: – University of Illinois Urbana-Champaign

General Toxicology

5:00 PM - 6:30 PM (MT)

Elucidating CYP2D6-Driven Metabolism and Novel Hepatotoxic Pathways of Metoprolol in Plateable Human and Animal Hepatocytes (P519)

Presenting Author: – Shanghai Bioduro Biologics Co., Ltd

Co-Author: – Shanghai Bioduro Biologics Co., Ltd

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Endothelin Receptor A Antagonist Attenuates Tegafur-Induced Hand-Foot Syndrome (P424)

Presenting Author: – Eisai Co., Ltd.

Co-Author: – Eisai Co., Ltd.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Epigallocatechin -3- Gallate Abrogates Diazinon-Induced Cardiorenal Toxicity via Suppression Oxidative Stress, Inflammation, and Upregulation of Antioxidant Pathways (P110)

Presenting Author: – University of Ibadan

Co-Author: – University of Ibadan

Co-Author: – Texas Southern University

Co-Author: – University of Ibadan

General Toxicology

5:00 PM - 6:30 PM (MT)

Epigenetic Response of Human Sperm to Environmental Exposures (P103)

Presenting Author: – University of Massachusetts

Co-Author: – University of Massachusetts

Co-Author: – Skolkovo Institute of Science and Technology

Co-Author: – University of Massachusetts

General Toxicology

5:00 PM - 6:30 PM (MT)

Establishing Reference Ranges for Lymphocyte Subsets in Healthy Bama Minipigs for Immunotoxicity Assessment (P425)

Presenting Author: – WuXi AppTec

Co-Author: – WuXi AppTec

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Establishing the Internal hERG Safety Margin Threshold Using a Series of Reference Drugs to Support the Integrated QTc Risk Assessment (P422)

Presenting Author: – WuXi AppTec

Co-Author: – WuXi AppTec

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Evaluating Per- and Polyfluoroalkyl Substances (PFAS) Definitions in the Context of Pharmaceuticals—Do Chemical Hazards Need to be Considered? (P412)

Presenting Author: – Stantec ChemRisk

Co-Author: – Stantec

Co-Author: – Stantec ChemRisk

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Evaluation of the Effects of 5 QT-Positive Drugs on J-Tpeak Interval of the ECG in Telemetered Dogs (P446)

Presenting Author: – UCB Biopharma SRL

Co-Author: – Biotrial Pharmacology

Co-Author: – UCB Biopharma

Co-Author: – Biotrial Pharmacology

Co-Author: – Boehringer Ingelheim Pharmaceuticals

Co-Author: – UCB Biopharma

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Evolving IVIVE: Analysis of Human and Animal Liver Microphysiological Systems for Improved Understanding of Species-Specific Drug-Induced Liver Injury (P125)

Presenting Author: – CN Bio Innovations

Co-Author: – CN Bio Innovations

Co-Author: – CN Bio innovations

General Toxicology

5:00 PM - 6:30 PM (MT)

Exosomal miRNA Profiles Distinguish Resolving vs. Persistent Pulmonary Inflammation Induced by Inhaled Nanoparticles (P102)

Presenting Author: – University of Iowa

Co-Author: – University of Iowa

Co-Author: – University of California

Co-Author: – University of Iowa

Co-Author: – University of California

Co-Author: – University of Iowa

General Toxicology

5:00 PM - 6:30 PM (MT)

Exosomal miRNA-Mediated Regulation of Pro-Apoptotic Pathways in Rotenone-Induced Parkinson’s Disease Model (P106)

Presenting Author: – Purdue University

Co-Author: – Purdue University

General Toxicology

5:00 PM - 6:30 PM (MT)

Exploration of Virtual Control Groups and Bayesian Approaches for Rat Fertility Studies (P515)

Presenting Author: – Pfizer, Inc.

Co-Author: – Pfizer, Inc.

Co-Author: – Pfizer Worldwide Research

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Exposure to Chromium (VI) during Pregnancy Increased Blood Pressure in Rats and Extracellular Matrix Dynamics of the Uterine Artery, Restricting the Blood Flow and Causing Fetal Growth Restriction (P216)

Presenting Author: – Texas A&M University

Co-Author: – Texas A&M University

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Higher Serum Globulins Are Not Always Indicative of Inflammation in NBE Toxicology Studies—A Retrospective and Prospective Evaluation (P112)

Presenting Author: – Boehringer Ingelheim

Co-Author: – Boehringer Ingelheim

General Toxicology

5:00 PM - 6:30 PM (MT)

High-Throughput Micronucleus Test Using Human TK6 Cells Detected by High-Content Analysis System CQ1 (P512)

Presenting Author: – Daiichisankyo

Co-Author: – Daiichisankyo

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Historical Data for Phototoxicity Safety Assessments—Correlations between In Vitro Photosafety Results and In Vivo Dermal and Ocular Phototoxic Responses (P414)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Co-Author: – Consultant

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Human Cardiac Transcriptomics Reveal Safety Signals for Kinase Inhibitors with Cardiotoxic Potential (P134)

Presenting Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Metisox Ltd

Co-Author: – Metisox-Cell Networks GmbH

Co-Author: – Heidelberg University

General Toxicology

5:00 PM - 6:30 PM (MT)

Δ9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) Attenuate Monocyte-Induced Inflammatory Factor Production by Astrocytes and Monocyte Chemotaxis in a Primary Human Co-Culture System (P128)

Presenting Author: – Michigan State University

Co-Author: – Michigan State University

General Toxicology

5:00 PM - 6:30 PM (MT)

Δ9-Tetrahydrocannabinol (THC) Impairs Both Interferon Gamma (IFNγ) Secretion by CD8+ T Cells from HIV+ Individuals and the Enhanced IFNγ Responses Associated with Primary Human Monocyte-CD8+ T Cell Co-Cultures (P132)

Presenting Author: – Michigan State University

Co-Author: – Michigan State University

General Toxicology

5:00 PM - 6:30 PM (MT)

Immunogenicity Concerns in Preclinical Safety Evaluation of Biologics in Nonhuman Primates (P451)

Presenting Author: – JOINN-Biomere

Co-Author: – JOINN-Biomere

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Immunological Assessment and Stability of Cell Surface Receptors Utilizing Flow Cytometry in Mauritian-Origin Cynomolgus Macaque Whole Blood Post-Collection (P443)

Presenting Author: – Meadhowhawk Biolabs

Co-Author: – ANEWCRO, LLC.

Co-Author: – Meadohawk Biolabs

Co-Author: – ANEWCRO, LLC.

Co-Author: – Meadohawk Biolabs

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Improved Method of Port Implantation for Intracerebroventricular Administration in Cynomolgus Monkeys (P514)

Presenting Author: – SNBL

Co-Author: – SNBL

Toxicology Methods

5:00 PM - 6:30 PM (MT)

In Vitro Developmental Toxicity Testing of PROteolysis-TArgeting Chimeras (PROTACs) (P506)

Presenting Author: – Toxys

Co-Author: – Toxys

Toxicology Methods

5:00 PM - 6:30 PM (MT)

In Vitro Irritation Assay Using Reconstructed Human Epidermis (RhE) Predicts Irritation Potential of Medical Device Extracts When Compared with In Vivo Skin Irritation and Intracutaneous Administration (P207)

Co-Author: – Becton Dickinson

Presenting Author: – Bard Access Systems

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

In Vitro Nonclinical Evaluation of Monoclonal Antibodies and Oligonucleotides Effects on Platelet Aggregation (P433)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

In Vivo Imaging and Quantification of Retinal and Choroidal Vasculature in Cynomolgus Monkeys Using Optical Coherence Tomography Angiography (P516)

Presenting Author: – JOINN-Biomere

Co-Author: – JOINN-Biomere

Toxicology Methods

5:00 PM - 6:30 PM (MT)

In Silico Design and ADMET Profiling of Novel 1,2,4-Triazolo-[1,5-a]pyridine Derivative as PHD Inhibitor (P410)

Presenting Author: – Master

Co-Author: – Maliba Pharmacy College

Co-Author: – Jai Research Foundation

Co-Author: – Master

Co-Author: – Jai Research Foundation

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Integrating the Use of Human Hepatoxicity Models for Prediction of Human Drug-Induced Liver Injury during Early Drug Discovery (P441)

Presenting Author: – Jazz Pharmaceuticals

Co-Author: – Jazz Pharmaceuticals

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Investigating Endocrine Disrupting Chemicals (EDCs): In Vitro Assays for Estrogen, Androgen, and Steroidogenesis Pathways (P214)

Presenting Author: – Adgyl Lifesciences Private Limited

Co-Author: – Adgyl Lifesciences Private Limited

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Investigating Limit Dose and Identifying Genotoxic Hazard of Common Pharmaceutical Solvents with ToxTracker (P420)

Co-Author: – Toxys, Inc.

Co-Author: – Eli Lilly and Company

Co-Author: – Toxys B.V.

Co-Author: – Toxys

Co-Author: – Eli Lilly and Company

Presenting Author: – Toxys Inc.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

In Vitro Complement Cascade Function Assessment during Drug Development (P413)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Is Genetic Difference a Factor for Response Variation in Laboratory Animals? (P202)

Presenting Author: – Indiana University

Co-Author: – Indiana University

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Leveraging Machine Learning for High-Throughput Systematic Review: Neurotoxicity of Polychlorinated Biphenyls in Rodent Models (P104)

Presenting Author: – University of Iowa

Co-Author: – University of Iowa

General Toxicology

5:00 PM - 6:30 PM (MT)

Leveraging Species-Specific Liver Microtissues and Low-Input RNA-Sequencing to Characterize Mechanisms of Drug-Induced Liver Injury (P411)

Presenting Author: – InSphero AG

Co-Author: – InSphero AG

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Lipid-Nanoparticle-Associated Pathology Findings in the Spleen of Rats and Cynomolgus Monkeys (P129)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

General Toxicology

5:00 PM - 6:30 PM (MT)

Liver Microtissues—A Highly Reproducible In Vitro Test System for Safety Assessment of Small Molecules (P432)

Presenting Author: – InSphero AG

Co-Author: – InSphero AG

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Longitudinal Evaluation of Cardiovascular Telemetry Data in Cynomolgus Monkeys with Implanted L11 Digital Devices (P426)

Presenting Author: – Labcorp

Co-Author: – Kymera Therapeutics Inc.

Co-Author: – Labcorp

Co-Author: – Kymera Therapeutics Inc.

Co-Author: – Labcorp

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Loss of MRP4 Exacerbates Hepatocyte Proliferation and Lipid Dysregulation in Mice Treated with Phenobarbital (P109)

Presenting Author: – University of Connecticut

Co-Author: – University of Connecticut

General Toxicology

5:00 PM - 6:30 PM (MT)

Magnetic Resonance Imaging: Repeated Intrathecal Administration of Gadolinium in Port Catheterized 3- and 12-Month Old African Green Monkeys (AGMs) to Support Antisense Oligonucleotide Administration for Pediatric Indication (P450)

Presenting Author: – Virscio

Co-Author: – Virscio

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Mechanistic Insights into Paris Saponin I-Induced Hepatic Oxidative Stress via Network Toxicology and Molecular Docking (P401)

Presenting Author: – University of Connecticut

Co-Author: – University of Connecticut

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Mechanistic Investigation of Antiviral-Induced Lung Toxicity in Dog: Evidence of Scaffold-Driven Pulmonary Phospholipidosis (P118)

Presenting Author: – Gilead Sciences, Inc.

Co-Author: – Gilead Sciences, Inc.

General Toxicology

5:00 PM - 6:30 PM (MT)

Mitochondria-Localized Photodynamic Therapy (PDT) Targets Chemoresistance Mechanisms Induced by Chronic, Human-Relevant Perfluoroalkyl Substances (PFAS) Exposure in Ovarian Cancer Cells (P107)

Presenting Author: – North Carolina State University

Co-Author: – North Carolina State University

Co-Author: – University of North Carolina

Co-Author: – North Carolina State University

General Toxicology

5:00 PM - 6:30 PM (MT)

MM120 (lysergide D-tartrate) Receptor Binding and Evaluation in the Rat Following 13 Weeks of Administration (P204)

Presenting Author: – Mind Medicine Inc

Co-Author: – Mind Medicine Inc

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Model-Informed Design of Preclinical Studies Using Quantitative Systems Pharmacology (QSP) to Improve Efficiency and Reduce Animal Use in Oncology Programs (P121)

Presenting Author: – Certara, Applied BioSimulations

Co-Author: – Certara

Co-Author: – GSK

General Toxicology

5:00 PM - 6:30 PM (MT)

Modulatory Effects of Berberine Chloride on Aluminum Chloride and D-Galactose Induced Cognitive Impairment in Rats (P105)

Presenting Author: – Baylor College of Medicine

Co-Author: – Dominion University Ibadan

Co-Author: – University of Ibadan

General Toxicology

5:00 PM - 6:30 PM (MT)

Monitoring Ototoxicity in Drug Development: Robust In Vitro, Ex Vivo, and In Vivo Models (P511)

Presenting Author: – CILcare

Co-Author: – Neuro-Zone S.r.l

Co-Author: – CILcare

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Multi-Target GLP-1RAs and ICH S1B(R1): Is the 2-Year Rat Study Still Necessary? (P452)

Presenting Author: – Gradient

Co-Author: – Gradient

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Neurovirulence Assessment of Vaccines in Suckling Mice via Intracranial Dose Administration (P445)

Presenting Author: – Southern Research

Co-Author: – Southern Research

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Nonclinical Development of OLN324, a Novel, Small-Format, Higher-Potency Bispecific Anti-VEGF/Anti-ANG2 Antibody for the Treatment of Age-Related Macular Degeneration and Diabetic Macular Edema (P119)

Presenting Author: – Ollin

Co-Author: – SNBL

Co-Author: – Innovent

Co-Author: – Ollin

General Toxicology

5:00 PM - 6:30 PM (MT)

Nonclinical Efficacy and Safety Evaluation of ALG-097558, A Novel Pan-Coronavirus Protease Inhibitor for the Treatment of SARS-CoV-2 (P405)

Presenting Author: – Aligos Therapeutics, Inc.

Co-Author: – Aligos Therapeutics, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Nonclinical Evaluation of Pharmacodynamic, Pharmacokinetic, and Toxicology Profile of ZB004, a CTLA-4-Ig Fusion Protein (P111)

Presenting Author: – Zenas BioPharma

Co-Author: – Zenas BioPharma

General Toxicology

5:00 PM - 6:30 PM (MT)

Nonclinical Safety Assessment of C-1101, an Allogeneic Platelet- and Plasma-Derived Therapeutic for Epidural Injection (P434)

Presenting Author: – Consano Bio

Co-Author: – Consano Bio

Co-Author: – BioAgilytix

Co-Author: – Consano Bio

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Nonclinical Safety Evaluation of MTA-Cooperative PRMT5 Inhibitors: Implications for Therapeutic Selectivity and Tolerability (P437)

Presenting Author: – Tango Therapeutics

Co-Author: – Tango Therapeutics

Co-Author: – Akkeri, Inc.

Co-Author: – Tango Therapeutics

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Nonclinical Safety of Fazirsiran, an N-Acetyl Galactosamine (GalNAc)-Conjugated Small Interfering (si)RNA for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (P417)

Presenting Author: – Takeda Development Center Americas, Inc.

Co-Author: – Arrowhead Pharmaceuticals, Inc.

Co-Author: – Takeda Development Center Americas, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Nonclinical Safety Strategies and Best Practices for mRNA-LNP Therapeutics (P215)

Presenting Author: – Novotech CRO

Co-Author: – Novotech CRO

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Pharmaceutical Safety Considerations for Cereblon-Recruiting Targeted Protein Degraders (P427)

Presenting Author: – ApconiX Ltd.

Co-Author: – ApconiX Ltd.

Co-Author: – Dana-Farber Cancer Institute

Co-Author: – Institute of Cancer Research

Co-Author: – University of Aberdeen

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Poster Session

Location: Exhibit Hall

5:00 PM - 6:30 PM (MT)

Predicting Secondary Pharmacology with In Silico Structure-Based Approaches Is Accurate and Actionable (P123)

Presenting Author: – Schrodinger

Co-Author: – Schrodinger

Co-Author: – Schrodinger Therapeutics Group

Co-Author: – Schrodinger

Co-Author: – Columbia University

Co-Author: – Schrodinger

General Toxicology

5:00 PM - 6:30 PM (MT)

Prediction of Heavy Metals Concentration in Surface Water from Selected Oil-Impacted Communities of Ogoniland, Nigeria—A Preliminary Machine Learning Approach (P503)

Presenting Author: – Centre for Marine Pollution Monitoring and Seafood Safety

Co-Author: – University of Port Harcourt

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Prolonged Exposure to Zero-Nicotine e-Cigarette Vapor Disrupts Neurovascular Integrity and Alters Neuronal Metabolism In Vitro (P303)

Presenting Author: – Texas Tech University Health Sciences Center

Co-Author: – Texas Tech University Health Sciences Center

Safety Evaluation Nonpharmaceuticals

5:00 PM - 6:30 PM (MT)

Read-Across Approach for Data Poor Medical Device Constituents According to ISO 10993-17:2023 (P219)

Presenting Author: – NAMSA

Co-Author: – NAMSA

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes for Medical Devices? (P117)

Presenting Author: – NAMSA

Co-Author: – NAMSA

General Toxicology

5:00 PM - 6:30 PM (MT)

Retrospective Evaluation of Preclinical Safety Data of Antibody Drug Conjugates (ADC) from One Charles River Laboratories Site (P205)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories Evreux

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Routine Urinalysis in Toxicology Studies: Are We Missing 3Rs Opportunities? (P218)

Presenting Author: – Fortrea

Co-Author: – NC3Rs

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Safety Assessment of Extractable Toxicophores Identified through In Silico Structural Analysis (P448)

Co-Author: – D&B ChemTox, LLC

Co-Author: – WM Bracken Consulting

Presenting Author: – ForthTox, Ltd

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Select P450 Enzymes in Uninduced and PB/BNF-Induced Hamster and Rat Liver S9: A Comparative Analysis (P116)

Presenting Author: – Molecular Toxicology, Inc

Co-Author: – Molecular Toxicology, Inc

Co-Author: – Errol Zeiger Consulting

Co-Author: – Pfizer Worldwide Research, Development, and Medical

Co-Author: – GSK Research & Development

General Toxicology

5:00 PM - 6:30 PM (MT)

SEND v4.0: Expanding Nonclinical Data Standards and Preparing for Change (P210)

Presenting Author: – Instem

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Study Design Considerations for Preclinical Safety Assessment of Targeted Protein Degraders (P444)

Presenting Author: – Novartis Institute of Biomedical Research

Co-Author: – Institute of Cancer Research

Co-Author: – Bristol Myers Squibb

Co-Author: – Novartis Institute of Biomedical Research

Co-Author: – Health & Environmental Sciences Institute (HESI)

Co-Author: – Novartis

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Study Design Considerations for Wound Healing Research in Göttingen Minipigs (P509)

Presenting Author: – Frontage Laboratory

Co-Author: – Frontage Laboratories

Co-Author: – Frontage Laboratory

Co-Author: – Preclinical Safety Associates, LLC

Co-Author: – Cassaderm RX

Co-Author: – Brock Scientific Consulting, LLC

Toxicology Methods

5:00 PM - 6:30 PM (MT)

T Cell Engager Toxicity Mediated by Off-Target Protein Binding (P415)

Presenting Author: – Boehringer Ingelheim Pharmaceuticals

Co-Author: – Boehringer Ingelheim Pharmaceuticals

Co-Author: – Boehringer Ingelheim

Co-Author: – Boehringer Ingelheim Pharmaceuticals

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Targeted AAV Vector Inactivation Following Intramuscular Administration (P438)

Presenting Author: – Kriya Therapeutics, Inc.

Co-Author: – Kriya Therapeutics, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

TBAJ-876, a Second-Generation Diarylquinoline for Tuberculosis (TB), Has a Safe Profile and Is Unlikely to Impact Male and Female Fertility Based on a Rat Fertility Study (P208)

Presenting Author: – RTI International

Co-Author: – RTI International

Co-Author: – Global Alliance for TB Drug Development

Co-Author: – RTI International

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

The Ameliorative Effects of Vitamin C and Curcuma Longa Extract on Monosodium Glutamate-Induced Reproductive Toxicity in Wistar Rats (P301)

Presenting Author: – Lagos State University

Co-Author: – Lagos State University

Safety Evaluation Nonpharmaceuticals

5:00 PM - 6:30 PM (MT)

The Utility of an In Vitro High Content Imaging Genotoxicity Assay in a Drug Discovery Case Example (P418)

Presenting Author: – Johnson & Johnson Innovative Medicine

Co-Author: – Johnson & Johnson Innovative Medicine

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

The Utility of Colony Formation (CFU) and Burst-Forming Unit (BFU) Assays in Assessing Synergism in Hematological Toxicity for Combination Drug Therapy of Oncology Drugs (P513)

Presenting Author: – Exelixis

Co-Author: – Exelixis

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Toxicological Evaluation and Hepatoprotective Potential of Polyherbal Unani Formulation Qurs-e-Sumbul in Paracetamol-Induced Liver Injury in Rats (P402)

Presenting Author: – National Research Institute of Unani Medicine for Skin Disorders

Co-Author: – National Research Institute of Unani Medicine for Skin Disorders

Co-Author: – National Institute of Pharmaceutical Education & Research

Co-Author: – National Research Institute of Unani Medicine for Skin Disorders

Co-Author: – National Institute of Pharmaceutical Education & Research

Co-Author: – Central Council for Research in Unani Medicine

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Toxicological Reference Data for 6- to 9-Month Male and Female Sinclair Nanopigs(TM) (P133)

Presenting Author: – Altasciences Preclinical Columbia, LLC

Co-Author:

Co-Author: – Altasciences

Co-Author: – Altasciences Preclinical Columbia, LLC

General Toxicology

5:00 PM - 6:30 PM (MT)

Toxicological Risk Assessment of Polyethyleneimine in Intravenous, Intracisternal, and Ocular Gene Therapy Products (P408)

Presenting Author: – Regenxbio

Co-Author: – RegenxBio

Co-Author: – GCS Global LLC

Co-Author: – RegenxBio

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Ultrasonic Vocalization in Drug-Induced Convulsion in Wistar Rats (P507)

Presenting Author: – Pfizer, Inc.

Co-Author: – AstraZeneca

Co-Author: – Moderna

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Umbrella Review of Systematic Reviews and Meta-analyses of GLP-1RA Treatment and Risk of Thyroid and Pancreatic Cancers (P449)

Presenting Author: – Gradient

Co-Author: – Gradient

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Use of Zebrafish for Investigative Toxicology in Early Drug Development (P428)

Presenting Author: – AbbVie

Co-Author: – AbbVie

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Validation of a Flow Cytometric Method for Immune Cell Populations Analysis in Miniature Swine Whole Blood with 71-Hour Pre-Stain Stability (P517)

Presenting Author: – Altasciences

Co-Author: – Altasciences

Toxicology Methods

5:00 PM - 6:30 PM (MT)

Weight-of-Evidence Analysis of the Carcinogenicity Potential of a Small Molecule Therapeutic—A Proposal for Waiving the 6-Month rasH2 Transgenic Bioassay (P212)

Presenting Author: – Jazz Pharmaceuticals

Co-Author: – Jazz Pharmaceuticals

Regulatory Toxicology

5:00 PM - 6:30 PM (MT)

Withdrawn (P124)

General Toxicology

5:00 PM - 6:30 PM (MT)

Withdrawn (P423)

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Withdrawn (P429)

Safety Evaluation Pharmaceuticals

5:00 PM - 6:30 PM (MT)

Withdrawn (P439)

Safety Evaluation Pharmaceuticals

6:30 PM - 9:30 PM (MT)

Early Career Professional Night

Location: Wildflower A