Full Schedule

3:00 PM – 5:00 PM CT

Registration Open

Location: Lone Star Ballroom Foyer

5:00 PM – 7:00 PM CT

ACT Council Meeting

Location: Room 401

7:00 AM – 8:00 AM CT

CE Continental Breakfast

Location: Lone Star Ballroom Foyer

7:00 AM – 8:00 AM CT

New Member Mingle and VIP Breakfast

Location: Room 303

7:00 AM – 6:00 PM CT

Registration Open

Location: Lone Star Ballroom Foyer

8:00 AM – 11:30 AM CT

Regulatory Toxicology Case Studies: An Interactive Session Involving Industry, CRO, Consultant and Regulatory Perspectives (CE1)

Location: Lone Star Ballroom F

CE Course Chair: – Charles River Laboratories

CE Course Chair: – Denali Therapeutics

CE Course Speaker: – SciLucent, Inc.

CE Course Speaker: – US FDA

CE Course Speaker: – Regeneron

CE Course Speaker: – PharmEng Technology

AdvancedPractical

8:00 AM – 8:10 AM CT

Introduction (CE1-1)

CE Course Speaker: – Denali Therapeutics

8:10 AM – 8:50 AM CT

Case Study Example #1: Advancing Gene Therapy: A Case Study on AAV Program Design for Central Nervous System Delivery in Orphan Indications (CE1-2)

CE Course Speaker: – Charles River Laboratories

8:50 AM – 9:30 AM CT

Case Study Example #2: Leveraging the 505(b)(2) Pathway for an Investigational New Drug Formulation Using New Administration Modalities (CE1-3)

CE Course Speaker: – SciLucent, Inc.

9:30 AM – 10:00 AM CT

Break (CE1-Break)

10:00 AM – 10:30 AM CT

Case Study Example #3: Local Safety Margins for Intra-articular Products (CE1-4)

CE Course Speaker: – US FDA

10:30 AM – 11:00 AM CT

Case Study Example #4: Residual Solvent Toxicity in Products (CE1-5)

CE Course Speaker: – PharmEng Technology

11:00 AM – 11:30 AM CT

Case Study Example #5: Applying Nonclinical Data in Requesting Study Waivers for NMEs (CE1-6)

CE Course Speaker: – Regeneron

8:00 AM – 11:30 AM CT

Fundamentals of Nonclinical Toxicology Study Pathology Reports, Peer Reviews, and Working Groups for Toxicologists and Regulators (CE2)

Location: Lone Star Ballroom C

CE Course Chair: – EPL, Inc.

CE Course Chair: – Eli Lilly and Company, Inc.

CE Course Speaker: – EPL, Inc.

CE Course Speaker: – US FDA

Foundational (Basic)Practical

8:00 AM – 8:05 AM CT

Introduction (CE2-1)

CE Course Chair: – EPL, Inc.

8:05 AM – 8:40 AM CT

The Pathology Report (CE2-2)

CE Course Speaker: – EPL, Inc.

8:40 AM – 9:15 AM CT

Pathology Peer Review (CE2-3)

CE Course Speaker: – Eli Lilly and Company, Inc.

9:15 AM – 9:30 AM CT

Case Study and Panel Discussion: Part 1 (CE2-Panel1)

CE Course Speaker: – EPL, Inc.

9:30 AM – 10:00 AM CT

Break (CE2-Break)

10:00 AM – 10:35 AM CT

Pathology Working Group (CE2-4)

CE Course Speaker: – EPL, Inc.

10:35 AM – 11:10 AM CT

Reading a Pathology Report, Peer Review, or PWG Report from a Regulator’s Perspective (CE2-5)

CE Course Speaker: – US FDA

11:10 AM – 11:30 AM CT

Case Study and Panel Discussion: Part 2 (CE2-Panel2)

8:00 AM – 11:30 AM CT

The Use of Novel Tools in Nonclinical Safety to Advance Drug Discovery and Early Development (CE3)

Location: Lone Star Ballroom D

CE Course Chair: – AstraZeneca

CE Course Speaker: – Genentech, Inc.

CE Course Speaker: – Pfizer

CE Course Speaker: – Merck

CE Course Speaker: – US FDA

AdvancedEmerging

8:00 AM – 8:30 AM CT

Overview Strategy of How Novel Tools Are Used at AZ to Advance Drug Discovery and Development (CE3-1)

CE Course Speaker: – AstraZeneca

8:30 AM – 9:00 AM CT

Human Blood-Brain-Barrier Spheroids as an In Vitro Model of Drug Delivery to the Brain (CE3-2)

CE Course Speaker: – Genentech, Inc.

9:00 AM – 9:30 AM CT

iScreen: The Next Frontier in Genotoxicity Testing (CE3-3)

CE Course Speaker: – Pfizer

9:30 AM – 10:00 AM CT

Break (CE3-Break)

10:00 AM – 10:30 AM CT

A Synergistic Approach with Combined In Silico, In Vitro, and In Vivo Models to Preclinically Derisk Peptide Mediated Pseudoanaphylaxis (CE3-4)

CE Course Speaker: – Merck

10:30 AM – 11:00 AM CT

Implementation of NAMs at FDA/CDER (CE3-5)

CE Course Speaker: – US FDA

11:00 AM – 11:30 AM CT

Panel Discussion (CE3-Panel)

8:00 AM – 11:30 AM CT

Safety Considerations for the Evaluation of Lipid-Based Nanoparticles (CE4)

Location: Lone Star Ballroom E

CE Course Chair: – US FDA

CE Course Chair: – Aclairo Pharmaceutical Development Group, Inc.

CE Course Speaker: – LoneStar PharmTox, LLC

CE Course Speaker: – Intellia Therapeutics

CE Course Speaker: – US FDA

CE Course Speaker: – Alnylam Pharmaceuticals

Foundational (Basic)Practical

8:00 AM – 8:10 AM CT

Introduction (CE4-1)

CE Course Chair: – US FDA

CE Course Chair: – Aclairo Pharmaceutical Development Group, Inc.

8:10 AM – 8:45 AM CT

Lipid-based Nanoparticles: What Have We Learned in the Past 60 Years? (CE4-2)

CE Course Speaker: – LoneStar PharmTox, LLC

8:45 AM – 9:30 AM CT

ADME Properties and Affects of Exposure to Lipid-Based Nanoparticles (CE4-3)

CE Course Speaker: – Intellia Therapeutics

9:30 AM – 10:00 AM CT

Break (CE4-Break)

10:00 AM – 10:45 AM CT

FDA Evaluation of Drug Products Containing Lipid Nanoparticles (CE4-4)

CE Course Speaker: – US FDA

10:45 AM – 11:30 AM CT

The Nonclinical Safety Profile of ONPATTRO® (patisiran), a Lipid Nanoparticle-RNAi Therapeutic for the Treatment of Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis) (CE4-5)

CE Course Speaker: – Alnylam Pharmaceuticals

11:00 AM – 4:00 PM CT

Speaker Ready Room Open

Location: Room 306

11:45 AM – 12:55 PM CT

IJT Editorial Board Meeting

Location: Room 301

12:00 PM – 12:55 PM CT

(EHP) Altasciences—Juvenile Nonhuman Primates for Gene Therapy Research: Use of Immunopathology Data to Adjust Testing Ages and the 3Rs

Location: Room 202

12:00 PM – 12:55 PM CT

(EHP) Certara—Real-Time Nonclinical Study Data: Benefits, Logistics, and Data Analysis and Visualization

Location: Room 201

12:00 PM – 12:55 PM CT

(EHP) Inotiv—Assessing the Genotoxic Potential of Lipid Nanoparticles (LNPs): Inotiv's In Vitro Study Experience

Location: Room 203

12:00 PM – 12:55 PM CT

(EHP) Lovelace Biomedical Research Institute—Challenges and Opportunities in Nonclinical Intranasal Drug Delivery

Location: Room 204

1:00 PM – 4:30 PM CT

Translational Challenges from Nonclinical to Clinical Program: Case Study Examples (CE5)

Location: Lone Star Ballroom F

CE Course Chair: – Eli Lilly and Company, Inc.

CE Course Speaker: – Greenfield Pathology Services, Inc.

CE Course Speaker: – Hawver Nonclinical Consulting, LLC

CE Course Speaker: – Gilead Sciences Inc.

Foundational (Basic)Practical

1:00 PM – 1:30 PM CT

Translating Monoclonal Antibody Nonclinical Findings Into Clinical Plans (CE5-1)

CE Course Speaker: – Eli Lilly and Company, Inc.

1:30 PM – 2:00 PM CT

Sensory Neurotoxicity: Getting Aligned to Translate Sensory Ganglion Findings from Nonclinical Studies to Clinical Trials (CE5-2)

CE Course Speaker: – Greenfield Pathology Services, Inc.

2:00 PM – 2:30 PM CT

Factors in Determining Safe Starting Doses and Safety Margins for First-in-Human Clinical Trials (CE5-3)

CE Course Speaker: – Hawver Nonclinical Consulting, LLC

2:30 PM – 3:00 PM CT

Break (CE5-Break)

3:00 PM – 3:30 PM CT

Translational Challenges from Nonclinical Hepatic Findings to Clinical Path: Case Study (CE5-4)

CE Course Speaker: – Eli Lilly and Company, Inc.

3:30 PM – 4:00 PM CT

Understanding the Impact of Local Tolerability of Long Acting Injectables in Nonclinical Species: Case Study (CE5-5)

CE Course Speaker: – Gilead Sciences Inc.

4:00 PM – 4:30 PM CT

Panel Discussion (CE5-Panel)

1:00 PM – 4:30 PM CT

Toxicologic Neuropathology of Novel Therapeutics (CE6)

Location: Lone Star Ballroom E

CE Course Chair: – Sanofi

CE Course Chair: – Charles River Laboratories

CE Course Speaker: – StageBio

CE Course Speaker: – Advanced Pathology Solutions

CE Course Speaker: – Ionis Pharmaceuticals

CE Course Speaker: – TCG Labs Soleil

CE Course Speaker: – Alnylam Pharmaceuticals

CE Course Speaker: – GEMpath, Inc.

AdvancedPractical

1:00 PM – 1:30 PM CT

Vector-Based and Cell-Based Therapies (CE6-1)

CE Course Speaker: – StageBio

1:30 PM – 2:00 PM CT

Case Presentation: Routed by ROA—Effect of Route of Administration on AAV Neuropathology (CE6-2)

CE Course Speaker: – Advanced Pathology Solutions

2:00 PM – 2:30 PM CT

Overview of Nucleic Acid-Based Therapies for Neurologic and Neuromuscular Diseases (CE6-3)

CE Course Speaker: – Ionis Pharmaceuticals

2:30 PM – 3:00 PM CT

Break (CE6-Break)

3:00 PM – 3:30 PM CT

Engineered Large Molecules for CNS Delivery (CE6-4)

CE Course Speaker: – TCG Labs Soleil

3:30 PM – 4:00 PM CT

RNAi Pharmacokinetics and Activity Assessment in CNS (CE6-5)

CE Course Speaker: – Alnylam Pharmaceuticals

4:00 PM – 4:30 PM CT

Concept Presentation: Grappling with Gliosis in Assessing Adversity (CE6-6)

CE Course Speaker: – GEMpath, Inc.

1:00 PM – 4:30 PM CT

Nonclinical Immunotoxicity Assessment: State of the Science and Future Directions (CE7)

Location: Lone Star Ballroom D

CE Course Chair: – US FDA

CE Course Chair: – Burleson Research Technologies, Inc.

CE Course Speaker: – Genentech, Inc.

CE Course Speaker: – US FDA

CE Course Speaker: – Oregon State University

Foundational (Basic)Emerging

1:00 PM – 1:30 PM CT

Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals: A Regulatory Perspective (CE7-1)

CE Course Speaker: – US FDA

1:30 PM – 2:00 PM CT

Strategies and Tools for Assessing Immunosuppression (CE7-2)

CE Course Speaker: – Genentech, Inc.

2:00 PM – 2:30 PM CT

Immunomodulation and Immunostimulation: Risk Identification and Assessment (CE7-3)

CE Course Speaker: – US FDA

2:30 PM – 3:00 PM CT

Break (CE7-Break)

3:00 PM – 3:30 PM CT

Assessing Dermal Sensitization in a Topical Pharmaceutical (CE7-4)

CE Course Speaker: – US FDA

3:30 PM – 4:00 PM CT

Tools for Assessing Developmental Immunotoxicological Impacts (CE7-5)

CE Course Speaker: – Oregon State University

4:00 PM – 4:30 PM CT

Panel Discussion (CE7-Panel)

1:00 PM – 4:30 PM CT

Toxicological Assessment of Pharmaceutical Impurities (CE8)

Location: Lone Star Ballroom C

CE Course Chair: – Genentech

CE Course Chair: – Roche Pharma Research & Early Development

CE Course Speaker: – Genentech Inc

CE Course Speaker: – Pfizer Research and Development

CE Course Speaker: – Gilead Sciences, Inc.

Foundational (Basic)Practical

1:00 PM – 1:20 PM CT

Introduction and Framework for Impurity Management (CE8-1)

CE Course Speaker: – Genentech

1:20 PM – 2:00 PM CT

Safety Assessment of Impurities in Biologic Therapeutics (CE8-2)

CE Course Speaker: – Genentech Inc

2:00 PM – 2:30 PM CT

Understanding Impurity Qualification (CE8-3)

CE Course Speaker: – Pfizer Research and Development

2:30 PM – 3:00 PM CT

Break (CE8-Break)

3:00 PM – 3:30 PM CT

ICH M7: Identification and Control of Mutagenic Impurities in Pharmaceuticals (CE8-4)

CE Course Speaker: – Gilead Sciences, Inc.

3:30 PM – 4:00 PM CT

Case Study: How to Assess and Control DNA Reactive (Mutagenic) Impurities in the Pharmaceutical Industry (CE8-5)

CE Course Speaker: – Roche Pharma Research & Early Development

4:00 PM – 4:30 PM CT

Leveraging Toxicology Data to Support Impurity Control Strategies in CMC Regulatory Submissions (CE8-6)

CE Course Speaker: – Gilead Sciences, Inc.

2:00 PM – 6:30 PM CT

Exhibition and Poster Setup

Location: JW Grand Ballroom

4:45 PM – 6:30 PM CT

Student Poster Competition

Location: Room 404

7:00 PM – 8:30 PM CT

Welcome Reception

Location: Griffin Hall

7:00 AM – 8:00 AM CT

Continental Breakfast

Location: Lone Star Ballroom Foyer

7:00 AM – 5:00 PM CT

Registration Open

Location: Lone Star Ballroom Foyer

8:00 AM – 8:55 AM CT

Generative AI for Toxicology and Drug Safety (Plenary 1)

Location: Lone Star Ballroom D/E

Plenary Speaker: – US Food and Drug Administration - National Center for Toxicological Research

8:00 AM – 1:00 PM CT

Speaker Ready Room Open

Location: Room 306

9:00 AM – 12:00 PM CT

Addressing the Challenge of Drug-Induced Kidney Injury (DIKI) within Preclinical Drug Development (S01)

Location: Lone Star Ballroom F

Symposium Chair: – Amgen Inc.

Symposium Chair: – Apellis Pharmaceuticals

Symposium Speaker: – AstraZeneca

Symposium Speaker: – Genentech, Inc.

Symposium Speaker: – Rutgers University

Symposium Speaker: – Crinetics Pharmaceuticals

AdvancedPractical

9:00 AM – 9:15 AM CT

Introduction (S01-1)

Symposium Speaker: – Amgen Inc.

9:15 AM – 9:45 AM CT

Utility of In Vitro Models for Predicting Drug-Induced Nephrotoxicity (S01-2)

Symposium Speaker: – AstraZeneca

9:45 AM – 10:15 AM CT

Utility of Kidney Biomarkers in Preclinical Toxicology Studies (S01-3)

Symposium Speaker: – Genentech, Inc.

10:15 AM – 10:45 AM CT

Break (S01-Break)

10:45 AM – 11:15 AM CT

Investigating Immune-Related Nephrotoxicity of Checkpoint Inhibitors in Humanized Mice (S01-4)

Symposium Speaker: – Rutgers University

11:15 AM – 11:45 AM CT

Discovery Toxicology Approaches to Assessment of Drug-Induced Kidney Injury (S01-5)

Symposium Speaker: – Crinetics Pharmaceuticals

11:45 AM – 12:00 PM CT

Panel Discussion (S01-Panel)

9:00 AM – 12:00 PM CT

Nonclinical Program Considerations for Peptide Safety Assessment (S02)

Location: Lone Star Ballroom C

Symposium Chair: – AstraZeneca

Symposium Chair: – Preclinical GPS

Symposium Speaker: – Genentech, Inc.

Symposium Speaker: – US FDA

Symposium Speaker: – Eli Lilly and Company, Inc.

Symposium Speaker: – Novo Nordisk

Symposium Speaker: – Genentech, Inc.

Foundational (Basic)Practical

9:00 AM – 9:25 AM CT

Peptide Safety Assessment: Current Regulatory Expectations (S02-1)

Symposium Speaker: – Genentech, Inc.

9:25 AM – 9:50 AM CT

Nonclinical Considerations for Development of Peptides: A CDER Perspective (S02-2)

Symposium Speaker: – US FDA

9:50 AM – 10:15 AM CT

EFPIA Peptide Safety Working Group Survey Results (S02-3)

Symposium Speaker: – Eli Lilly and Company, Inc.

10:15 AM – 10:45 AM CT

Break (S02-Break)

10:45 AM – 11:15 AM CT

Case Studies of Peptide Safety Assessment (S02-4)

Symposium Speaker: – Novo Nordisk

11:15 AM – 11:45 AM CT

Regulatory and Nonclinical Safety Considerations for Intravitreal Peptide Development (S02-5)

Symposium Speaker: – Genentech, Inc.

11:45 AM – 12:00 PM CT

Panel Discussion (S02-6)

9:00 AM – 12:00 PM CT

Immunogenicity Risk Assessment: Are Preclinical Methods Informative? (S03)

Location: Lone Star Ballroom A

Symposium Chair: – Eli Lilly and Company, Inc.

Symposium Chair: – US FDA

Symposium Speaker: – Pfizer

Symposium Speaker: – ImmunXperts, a Q2 Solutions Company

Symposium Speaker: – US FDA

AdvancedEmerging

9:00 AM – 9:20 AM CT

HESI/AAPS Reference Panel for Preclinical Immunogenicity Risk Assessment (S03-1)

Symposium Speaker: – Eli Lilly and Company, Inc.

9:20 AM – 9:50 AM CT

In Vitro Assay Methods for Pre-clinical Biosimilar and Generic Drug Product Evaluation (S03-2)

Symposium Speaker: – Pfizer

9:50 AM – 10:15 AM CT

In Vitro Immunogenicity Assessment: Perspective from a CRO (S03-3)

Symposium Speaker: – ImmunXperts, a Q2 Solutions Company

10:15 AM – 10:45 AM CT

Break (S03-Break)

10:45 AM – 11:15 AM CT

Can the Humanized Mouse Model Inform Immunogenicity Risk Assessment? (S03-4)

Symposium Speaker: – US FDA

11:15 AM – 11:45 AM CT

Testing Process and Product Related Impurities to Inform Immunogenicity Risk (S03-5)

Symposium Speaker: – US FDA

11:45 AM – 12:00 PM CT

Panel Discussion (S03-Panel)

9:30 AM – 6:30 PM CT

ACT Expo Live! and Posters Open

Location: JW Grand Ballroom

12:00 PM – 12:55 PM CT

(EHP) ATCC—High Throughput, Predictive, and Reproducible Models for Cardiovascular and Nephrotoxicity Studies

Location: Room 201

12:00 PM – 12:55 PM CT

(EHP) Labcorp—Radiopharmaceuticals Drug Development for Oncology: Is My Molecule a Potential Drug?

Location: Room 204

12:00 PM – 12:55 PM CT

(EHP) Marshall BioResources—Toxicology Biomarkers and AAV Seroprevalence in Göttingen Minipigs®

Location: Room 202

12:00 PM – 12:55 PM CT

(EHP) Simulations Plus, Inc—Machine Learning ADMET Predictor Workflow for DILIsym Use Enables Earlier, Higher Throughput Use

Location: Room 205

12:00 PM – 2:00 PM CT

Awards Ceremony

Location: Lone Star Ballroom D/E

2:00 PM – 5:00 PM CT

Seizure Liability: New Approaches to Detection (S04)

Location: Lone Star Ballroom F

Symposium Chair: – Charles River Laboratories

Symposium Chair: – ApconiX

Symposium Speaker: – Takeda Development Center Americas

Symposium Speaker: – HESI

Symposium Speaker: – US FDA

AdvancedEmerging

2:00 PM – 2:25 PM CT

Seizure Liability and Premonitory Sign Incidence: Opportunities and Pitfalls with Standalone EEG Studies or When EEG is Included in Repeat Dose Toxicology (S04-1)

Symposium Speaker: – Charles River Laboratories

2:25 PM – 2:50 PM CT

In Vitro Human Ion Channel Assays Predictive of Drug Induced Seizure (S04-2)

Symposium Speaker: – Takeda Development Center Americas

2:50 PM – 3:15 PM CT

Predicting Seizure Using Cell-Based Microelectrode Arrays: A HESI Consortium Study (S04-3)

Symposium Speaker: – HESI

3:15 PM – 3:45 PM CT

Break (S04-Break)

3:45 PM – 4:10 PM CT

Regulatory Challenges of Seizures in Toxicology Studies: Utility of Alternative Models in Regulatory Decision Making (S04-4)

Symposium Speaker: – US FDA

4:10 PM – 4:35 PM CT

An Integrated Approach for Early In Vitro Seizure Prediction Utilizing Human Derived Induced Pluripotent Stem Cells and Human Ion Channel Assays (S04-5)

Symposium Speaker: – ApconiX

4:35 PM – 5:00 PM CT

Panel Discussion (S04-Panel)

2:00 PM – 5:00 PM CT

Phage Therapy Development and Safety Evaluation: Opportunities and Challenges beyond Antibiotic Resistance (S05)

Location: Lone Star Ballroom A

Symposium Chair: – Biologics Consulting

Symposium Speaker: – Lawrence Berkeley National Laboratory

Symposium Speaker: – University of Pittsburgh

Symposium Speaker: – San Diego State University

Symposium Speaker: – US FDA

Foundational (Basic)Emerging

2:00 PM – 2:15 PM CT

Introduction: Challenges and Opportunities with Phage Therapy in the 21st Century (S05-1)

Symposium Speaker: – Biologics Consulting

2:15 PM – 2:45 PM CT

Pathogen Mitigation through a Target Specific Bacteriophage Characterization and Engineering Platform (S05-2)

Symposium Speaker: – Lawrence Berkeley National Laboratory

2:45 PM – 3:15 PM CT

Phage Therapy for Antibiotic-Resistant Bacterial Infections (S05-3)

Symposium Speaker: – University of Pittsburgh

3:15 PM – 3:45 PM CT

Break (S05-Break)

3:45 PM – 4:15 PM CT

Relevance of the Immune System in the New Era of Phage Therapy (S05-4)

Symposium Speaker: – San Diego State University

4:15 PM – 4:45 PM CT

Review of Phage Therapy Products for Safety (S05-5)

Symposium Speaker: – US FDA

4:45 PM – 5:00 PM CT

Panel Discussion (S05-Panel)

2:00 PM – 5:00 PM CT

Bench-to-Bedside: Preclinical and Translation Development of CAR T-Cell Therapies (S06)

Location: Lone Star Ballroom C

Symposium Chair: – Morphic Therapeutic

Symposium Chair: – RegenxBio

Symposium Speaker: – Merck

Symposium Speaker: – Sana Biotechnology

Symposium Speaker: – AstraZeneca

Symposium Speaker: – US FDA, OTP/CBER

AdvancedPractical

2:00 PM – 2:05 PM CT

Welcome (S06-1)

Symposium Chair: – Morphic Therapeutic

2:05 PM – 2:15 PM CT

CAR-T’s History and Setting Context on Auto and Allo (S06-2)

Symposium Speaker: – RegenxBio

2:15 PM – 2:45 PM CT

Considerations for Developing a Nonclinical Package for a Novel Ex-vivo CART: Case Example of a Package That Includes In Vitro and In Vivo Testing (S06-3)

Symposium Speaker: – Merck

2:45 PM – 3:15 PM CT

Preclinical Development of Off-the shelf CAR T cell Therapies for the Treatment of Cancer (S06-4)

Symposium Speaker: – Sana Biotechnology

3:15 PM – 3:45 PM CT

Break (S06-Break)

3:45 PM – 4:15 PM CT

Nonclinical to Clinical Translation of an Efficacious CAR T-Cell Dose (S06-5)

Symposium Speaker: – AstraZeneca

4:15 PM – 4:45 PM CT

Regulatory Considerations for Nonclinical Assessment of Chimeric Antigen Receptor (CAR) T Cell Products: A CBER/FDA Perspective (S06-6)

Symposium Speaker: – US FDA, OTP/CBER

4:45 PM – 5:00 PM CT

Panel Discussion (S06-Panel)

3:30 PM – 4:30 PM CT

Member Portraits

Location: 404

5:00 PM – 6:30 PM CT

-141C Insertion/Deletion Polymorphism of Dopamine Receptor D2 Is Associated with Acute Risperidone-Induced Changes in Body Metabolic Indices among Nigerians (P103)

Presenting Author: – University of Lagos

Co-Author: – Federal Neuropsychiatric Hospital

General Toxicology

5:00 PM – 6:30 PM CT

A 29 Day Two Dose and 3 Day One Dose Research and Development Study of Intrathecal Injection or Epidural Infusion in Rats (P522)

Presenting Author: – Labcorp Early Development Laboratories Inc.

Co-Author: – Labcorp Early Development Laboratories Inc.

Toxicology Methods

5:00 PM – 6:30 PM CT

A Balancing Act—Optimizing Efficacy vs. Safety with Better Tissue-Level PK/PD Data (P424)

Presenting Author: – Joanneum Research

Co-Author: – Joanneum Research

Co-Author: – Certara

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

A Comparison of Jacketed External Telemetry Procedures on NHP Pretreatment Heart Rate: Can Different Acclimation Procedures Provide Similar Results? (P129)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

General Toxicology

5:00 PM – 6:30 PM CT

A Data-Driven Approach to Determine Benchmark Response (BMR) for Continuous Endpoints (P203)

Presenting Author: – Indiana University

Co-Author: – DREAM Tech, LLC

Regulatory Toxicology

5:00 PM – 6:30 PM CT

A Novel Approach Method Combining GFP Reporter Cell Lines with Error Corrected Next Generation Sequencing (ecNGS) for In Vitro Genotoxicity Assessment of N-Nitrosamines (P439)

Presenting Author: – Toxys

Co-Author: – Toxys

Co-Author: – Toxys, BV

Co-Author: – Mutagentech

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

A Review of Exploratory Dose Range Finding Study Outcomes (P524)

Presenting Author: – Boehringer Ingelheim

Co-Author: – Boehringer Ingelheim

Toxicology Methods

5:00 PM – 6:30 PM CT

A Sensitive and Specific Human Primary Stem Cell-Based Assay for Predicting Diarrheagenic Potential of Therapeutic Agents (P512)

Presenting Author: – Altis Biosystems

Co-Author: – Altis Biosystems

Toxicology Methods

5:00 PM – 6:30 PM CT

A Systematic Evaluation of Off-Target Binding in Antibody-Based Molecules during Clinical and Preclinical Development (P209)

Presenting Author: – Integral Molecular

Co-Author: – Integral Molecular

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Adenopus Breviflorus Fruit Extract Exhibits Antioxidant and Cytotoxic Properties in a Cellular Model of Lung Cancer (P101)

Presenting Author: – University of Lagos

Co-Author: – University of Lagos

Co-Author: – Liverpool John Moore University

General Toxicology

5:00 PM – 6:30 PM CT

Administration of Sorafenib, an Anticancer Agent, Caused Oxidative Stress and Reproductive Dysfunction in Male Wistar Rats (P401)

Presenting Author: – University of Ibadan, Ibadan, Nigeria

Co-Author: – University of Ibadan, Nigeria

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Adrenal and Splenic Findings in a Toxicity Study of the Antibody GEN3009 May Be Related to ADA-Enhanced Hypotension (P202)

Presenting Author: – Genmab, Dept. of Nonclinical Safety and Toxicology

Co-Author: – Genmab

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Advancing Integrated Omics for Decision-Making and Prediction of Renal Toxicity, Hepatic Toxicity, and Carcinogenicity—An International, Cross-Industry, Academia, and Government Initiative (P414)

Presenting Author: – Independent (on behalf of the HESI eSTAR Committee)

Co-Author: – National Institute Environmental Health Sciences

Co-Author: – Health and Environmental Sciences Institute

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Advancing Noninvasive Electroencephalogram (EEG) Seizure Detection Methods Using Göttingen Minipigs (P504)

Presenting Author: – USAMRICD

Co-Author: – USAMRICD

Toxicology Methods

5:00 PM – 6:30 PM CT

African Green Monkeys (AGM) Quarantine Colony Census: Antiparasitic Treatment and Husbandry (P505)

Presenting Author: – Virscio

Co-Author: – Virscio

Toxicology Methods

5:00 PM – 6:30 PM CT

An 8-Week Repeat-Dose Intravenous Infusion Study in CD-1 Mice Using Peripherally Placed (Tail Vein) Pediatric Catheters (P502)

Presenting Author: – Charles River

Co-Author: – Charles River

Co-Author: – PepGen

Toxicology Methods

5:00 PM – 6:30 PM CT

An Examination of the Effects of Body Temperature on QT Interval in Non-Naïve Telemetered Göttingen Minipigs® (P120)

Presenting Author: – Altasciences Preclinical Columbia

Co-Author: – Altasciences

Co-Author: – Cardiovascular Analytics

General Toxicology

5:00 PM – 6:30 PM CT

Assessment of Genotoxicity Prediction Using New Approach Methodologies (NAMs): A Comparative Study with In Vitro Micronucleus Assays on Small Molecule Pharmaceuticals (P408)

Presenting Author: – Genentech

Co-Author: – Genentech

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Assessment of Leading Regulatory T Cell Immunophenotyping Methods using Flow Cytometry (P509)

Presenting Author: – Labcorp Early Development Laboratories Inc

Co-Author: – Labcorp

Co-Author: – Labcorp Early Development Laboratories Ltd

Toxicology Methods

5:00 PM – 6:30 PM CT

Assessment of Levels of Lead (pb) and Cadmium (cd) in Carrots (Daucus Carota) and Tigernut (Cyperus Esculentus) Sourced from Gwagwalada Market, FCT Nigeria (P303)

Presenting Author: – University of Abuja, FCT Abuja Nigeria

Co-Author: – University of Abuja

Safety Evaluation Nonpharmaceuticals

5:00 PM – 6:30 PM CT

Assessment of the Cardiovascular Impact of E-Vapour and Heated Tobacco Products Using New Approach Methodologies (P517)

Presenting Author: – Imperial Brands PLC

Co-Author: – Imperial Brands PLC

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

Co-Author: – Mimetas BV

Co-Author: – InnoVitro GmbH

Co-Author: – Imperial Brands PLC

Toxicology Methods

5:00 PM – 6:30 PM CT

Benefits of Early In Vitro Screening for Seizure Liability in Problem Solving and Decision Making (P407)

Presenting Author: – ApconiX

Co-Author: – ApconiX

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Blood Transfusions in Cynomolgus and Rhesus Monkeys: A Retrospective Analysis Over a 20-Year Period (P427)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Co-Author: – BioCryst Pharmaceuticals, Inc.

Co-Author: – Charles River Laboratories

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Cellular Characterization of the Comprehensive In Vitro Proarrhythmia Compound Library Using 2D vs. 3D Human iPSC Cardiomyocytes Models (P421)

Presenting Author: – Lumencor

Co-Author: – Lumencor

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Characterization and Toxicological Assessment of Heated Tobacco Product Aerosol through Nontargeted Analyses (P212)

Presenting Author: – RAI Services Company

Co-Author: – RAI Services Company

Co-Author: – BAT

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Characterization of a CNS Liability Observed in Dogs after Administration of a LPAR1 Antagonist (P440)

Presenting Author: – Gilead Sciences, Inc.

Co-Author: – Gilead Sciences, Inc.

Co-Author: – Preclinical Electrophysiology Consulting

Co-Author: – Gilead Sciences, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Chemoprotective Role of Gallic Acid on Steroidogenesis, Folliculogenesis, and Follicular Atresia in the Ovary of Rats Exposed to Cyclophosphamide (P102)

Presenting Author: – Lagos State University

Co-Author: – University of Ibadan

General Toxicology

5:00 PM – 6:30 PM CT

Comparison of Intratracheal and Inhaled AAV Pulmonary Deposition in Two Species (P506)

Presenting Author: – Labcorp

Co-Author: – Labcorp

Toxicology Methods

5:00 PM – 6:30 PM CT

Comparison of Mutagenic Potency of Three Positive Controls in the Enhanced Ames Test (P206)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Comparison of Time-Dependent Variation of Respiratory Function Parameters in Wistar Rats (P403)

Presenting Author: – Master

Co-Author: – Jai Research Foundation

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Comprehensive Evaluation of CAR T-Cell Efficacy and Safety in a Mouse Model of Acute Lymphoblastic Leukemia (ALL) Using Integrated Biodistribution and Kinetics Analysis (P301)

Presenting Author: – Noble Life Sciences Inc

Co-Author: – Noble Life Sciences Inc

Co-Author: – Stage Bio

Co-Author: – Noble Life Sciences Inc

Safety Evaluation Nonpharmaceuticals

5:00 PM – 6:30 PM CT

Considerations and Challenges for Acute Inhalation Toxicity Testing and Classification of Zinc Sulphide under REACH (P210)

Presenting Author: – Fraunhofer ITEM

Co-Author: – Fraunhofer ITEM

Co-Author: – International Zinc Association

Co-Author: – EBRC Consulting GmbH

Co-Author: – International Zinc Association

Co-Author: – Fraunhofer ITEM

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Considerations For Establishing Health-Based Exposure Limits (HBELs) For Small Molecule Protein Kinase Inhibitors (P211)

Presenting Author: – Genentech Inc

Co-Author: – Genentech Inc

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Could miR-133b and miR-208b-3p Become Translatable Biomarkers of Structural Cardiotoxicity in Human Stem Cell-Derived Cardiomyocytes? (P521)

Presenting Author: – UCB Biopharma

Co-Author: – Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital

Co-Author: – UCB Biopharma

Co-Author: – Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital

Co-Author: – Laboratory of Physiopharmacology, University of Antwerp

Toxicology Methods

5:00 PM – 6:30 PM CT

Determining a Class-Specific Parenteral Acceptable Daily Limit for Sugars (P437)

Presenting Author: – Integral Consulting

Co-Author: – Eli Lilly & Company

Co-Author: – Integral Consulting

Co-Author: – Stantec

Co-Author: – Integral Consulting

Co-Author: – Eli Lilly & Company

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Development of an Electrochemiluminescence-Based Immunoassay to Evaluate T Cell-Dependent IgG and IgM Responses to Keyhole Limpet Hemocyanin (KLH) Administration in the Juvenile New Zealand White Rabbit (P413)

Presenting Author: – Labcorp Drug Development

Co-Author: – Labcorp Drug Development

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Development of Fit-for-Purpose In Silico Models for the Assessment of Extractables and Leachables (P423)

Presenting Author: – Instem

Co-Author: – Innovatune

Co-Author: – Instem

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Developmental Neurotoxicity of Opioid Medication Assisted Treatments (MAT) in Long-Evans Rats (P204)

Presenting Author: – US FDA

Co-Author: – US FDA, NCTR

Regulatory Toxicology

5:00 PM – 6:30 PM CT

DICTrank: The Largest Reference Dataset for Drug-Induced Cardiotoxicity (DICT) Risk Annotation of 1318 Human Drugs Based on FDA Labeling (P124)

Presenting Author: – US Food and Drug Administration - National Center for Toxicological Research

Co-Author: – US Food and Drug Administration - National Center for Toxicological Research

Co-Author: – Boehringer Ingelheim Pharmaceuticals

Co-Author: – US Food and Drug Administration - National Center for Toxicological Research

General Toxicology

5:00 PM – 6:30 PM CT

Early Prediction of Drug-Induced Cardiotoxicity (DICT) Using Human Reporter Cell Lines (P515)

Presenting Author: – Toxys

Co-Author: – Toxys B.V.

Co-Author: – Toxys

Toxicology Methods

5:00 PM – 6:30 PM CT

Effects of BMS 204352, DEC and GoSlo-SR-5-69 on Ovo-SLO-1A’s Response to Emodepside (P402)

Presenting Author: – Iowa State University

Co-Author: – Iowa State University

Co-Author: – Creighton University

Co-Author: – Iowa State University

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Embryo-Fetal Development and Pre- and Postnatal Development Toxicity Study in Mice Following a Single Intravenous Administration of DTX301 (P419)

Presenting Author: – Ultragenyx Pharmaceutical Inc.

Co-Author: – Ultragenyx Pharmaceutical Inc.

Co-Author: – Charles River Laboratories

Co-Author: – Ultragenyx Pharmaceutical Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Enhancing Drug Safety with Organoids (P501)

Presenting Author: – HUB Organoids

Co-Author: – HUB Organoids

Toxicology Methods

5:00 PM – 6:30 PM CT

Environmental Risk Assessment Approaches of Human Pharmaceuticals in the US and EU: A Case Study with Neuroactive Steroid (P205)

Presenting Author: – SafeBridge

Co-Author: – SafeBridge

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Establishing a Decision Tree Model for Developmental and Reproductive Toxicology Strategy for Gene Therapies (P412)

Presenting Author: – Regenxbio

Co-Author: – RegenxBio

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Establishing In Vitro MultiFlow Assay for Identifying the Mode of Action of Potential Genotoxicants at ITR Laboratories Canada Inc. (P520)

Presenting Author: – ITR Laboratories Canada Inc.

Co-Author: – ITR Laboratories Canada Inc.

Co-Author: – Litron Laboratory

Co-Author: – ITR Laboratories Canada Inc.

Toxicology Methods

5:00 PM – 6:30 PM CT

Evaluation of (Q)SAR In Silico Mutagenicity Prediction Models Using a Proprietary Chemical Dataset (P428)

Presenting Author: – Amgen

Co-Author: – Amgen

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Evaluation of Endogenous and Ex Vivo Stimulated Matrices for Validation of Cytokine Expression Assessment (P525)

Presenting Author: – Labcorp

Co-Author: – Labcorp

Toxicology Methods

5:00 PM – 6:30 PM CT

Evaluation of NHP Exposure Systems—Pharmacokinetic, Respiratory, and Behavioral Quantification between Head Dome and Face Mask Exposures in NHPs (P511)

Presenting Author: – Lovelace Biomedical

Co-Author: – Lovelace Biomedical

Toxicology Methods

5:00 PM – 6:30 PM CT

FDA Montelukast Working Group Studies: Identification of Off-Target Neurological Receptors and Potential Molecular Mechanisms of Drug-Related Neuropsychiatric Adverse Effects (P208)

Presenting Author: – FDA, NCTR

Co-Author: – NCTR, FDA

Co-Author: – CDER, FDA

Co-Author: – NCTR, FDA

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Framework Approach for Priority Testing and Risk Assessment of N-Nitrosamine Degradants in Active Pharmaceutical Ingredients (P429)

Presenting Author: – Stantec ChemRisk

Co-Author: – Stantec ChemRisk

Co-Author: – NASA Johnson Space Center; University of Cincinnati

Co-Author: – Stantec ChemRisk

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Genotoxicity and Cardiotoxicity Studies of Novel Peroxy Acid-Based Alternative Sodium Hypochlorite Candidates (P302)

Presenting Author: – University of Science and Technology

Co-Author: – Korea Institute of Toxicology

Co-Author: – Daegu Catholic University

Co-Author: – University of Science and Technology

Safety Evaluation Nonpharmaceuticals

5:00 PM – 6:30 PM CT

Gnawing Device Enrichment Consumption in Rats: A Possible Indicator for Predicting Emetogenic Potential? (P518)

Presenting Author: – Japan Tobacco

Co-Author: – Japan Tobacco

Toxicology Methods

5:00 PM – 6:30 PM CT

High Content Assessment of GI Toxicity in a Self-Renewing Human Intestinal Epithelium Model (P513)

Presenting Author: – Altis Biosystems

Co-Author: – Altis Biosystems

Co-Author: – AstraZeneca

Co-Author: – Altis Biosystems

Toxicology Methods

5:00 PM – 6:30 PM CT

Historical Control Data for Phototoxicity Safety Assessments Performed in Compliance with ICH S10 (P422)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Co-Author: – Consultant

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Human and Preclinical Animal Microphysiological Systems for Assessing Drug-Induced Liver Injury during Drug Development (P516)

Presenting Author: – CN Bio Innovations

Co-Author: – Cn Bio innovations

Co-Author: – CN Bio innovations

Toxicology Methods

5:00 PM – 6:30 PM CT

Hyperglycemia-Induced Loss of Blood Brain Barrier Integrity: An In Vitro Model Representing Secondary Neuron Damage (P117)

Presenting Author: – Gazi University, Faculty of Pharmacy

Co-Author: – Gazi University, Faculty of Medicine

Co-Author: – Ankara University, Biotechnology Institute

General Toxicology

5:00 PM – 6:30 PM CT

ICH S1B Weight-of-Evidence Carcinogenicity Assessment for GLP-1RA Drugs (P417)

Presenting Author: – Gradient

Co-Author: – Gradient

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Immunomodulatory Approaches in Preclinical Gene Therapy Studies (P130)

Presenting Author: – Altasciences, Preclinical Seattle

Co-Author: – Altasciences Preclinical Seattle

General Toxicology

5:00 PM – 6:30 PM CT

In Vitro Platelet Function Assessment of Oligonucleotides and Antibodies by Flow Cytometry during Drug Development (P431)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Influence of Electrocardiogram and Hemodynamic Recording Methods in Nonrodent Toxicology Studies on Statistical and Pharmacological Sensitivity (P433)

Presenting Author: – UCB Biopharma

Co-Author: – UCB Biopharma

Co-Author: – Abbvie

Co-Author: – Amgen

Co-Author: – UCB Biopharma SRL

Co-Author: – Johnson & Johnson

Co-Author: – Merck

Co-Author: – Labcorp

Co-Author: – Charles River Laboratories

Co-Author: – Pfizer

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Influence of Vaccine-Induced Anti-PEG Antibodies on In Vitro Measurement of Pegylated Drug Concentrations (P207)

Presenting Author: – Food and Drug Administration

Co-Author: – Food and Drug Administration

Co-Author: – US FDA

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Inhaled Delivery of a Novel Broad Spectrum Immune Modulator to Minipigs Produces a Favorable Toxicity Profile (P438)

Presenting Author: – Labcorp Early Development Laboratories Ltd

Co-Author: – Labcorp

Co-Author: – OCI Biotech Limited

Co-Author: – Labcorp

Co-Author: – OCI Biotech Limited

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Integrative Analysis of Human and Cynomolgus Monkey Peripheral Blood Mononuclear Cells after T Cell Stimulation via scRNA-seq (P410)

Presenting Author: – Boehringer Ingelheim Pharmaceuticals, Inc.

Co-Author: – Boehringer-Ingelheim Pharmaceuticals Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Intracerebroventricular (ICV) Route in Mice for Administration of Gene Therapy Products (P435)

Presenting Author: – Altasciences Preclinical Seattle

Co-Author: – Altasciences Preclinical Seattle

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Intravenous Sampling and Administration Using Instech Vascular Access Buttons™ in Rodents: Pathology Findings Related to Indwelling Vascular Catheter (P122)

Presenting Author: – Altasciences Preclinical Seattle

Co-Author: – Altasciences Preclinical Seattle

General Toxicology

5:00 PM – 6:30 PM CT

Leveraging Nonclinical Safety Evaluation Findings to Expedite Next-Generation Glucagon-Like Peptide-1 Receptor Agonists Development for Metabolic Disorders and Beyond (P432)

Presenting Author: – Altasciences

Co-Author: – Altasciences

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Lipid Nanoparticles: A Comprehensive Assessment of Liver Enzymes, Clinical Presentation, and Immunopathology Markers in Nonhuman Primates (P123)

Presenting Author: – Altasciences

Co-Author: – Altasciences Preclinical Seattle

General Toxicology

5:00 PM – 6:30 PM CT

Liver-Specific Deletion of RNA-Binding Proteins, ZFP36L1 and ZFP36L2, Attenuates Acetaminophen-Induced Acute Liver Injury (P104)

Presenting Author: – North Carolina State University

Co-Author: – National Institute of Environmental Health Sciences

Co-Author: – North Carolina State University

General Toxicology

5:00 PM – 6:30 PM CT

Magnetic Resonance Imaging: Repeated Intrathecal Administration of Gadolinium in Adult and Juvenile African Green Monkeys (AGM) (P519)

Presenting Author: – Virscio

Co-Author: – Virscio

Toxicology Methods

5:00 PM – 6:30 PM CT

Mono-(2-ethylhexyl) Phthalate (MEHP) Exposure Suppresses Slit2 Expression in Peritubular Myoid Cells Primary Isolates from the Rat Testis (P127)

Presenting Author: – The University of Texas at Austin

Co-Author: – The University of Texas at Austin

General Toxicology

5:00 PM – 6:30 PM CT

Mouse versus Rabbit: Time Course of Corneal Ocular Toxicity of an Antibody Drug Conjugate (ADC) with a Maytansinoid Payload (P430)

Presenting Author: – Labcorp Early Development Laboratories Inc.

Co-Author: – Immunogen (now part of Abbvie)

Co-Author: – Ocular Services On Demand (OSOD, LLC)

Co-Author: – Labcorp Early Development Laboratories Inc.

Co-Author: – Immunogen (now part of Abbvie)

Co-Author: – Labcorp Early Development Laboratories Inc.

Co-Author: – Immunogen (now part of Abbvie)

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Nonclinical Assessment of KER-012, a Novel Modified ActRIIB Ligand Trap, for the Treatment of Pulmonary Arterial Hypertension (P416)

Presenting Author: – Keros Therapeutics

Co-Author: – Keros Therapeutics

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Nonclinical Determination of Pharmacodynamic, Pharmacokinetic, and Toxicology Characteristics of an Anti-TNFα Monoclonal Antibody ZB002 (P418)

Presenting Author: – Zenas BioPharma

Co-Author: – Zenas BioPharma

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Nonclinical Toxicology Profile of ALG-055009, a Novel and Potent Thyroid Hormone Receptor β Agonist, for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) (P436)

Presenting Author: – Aligos Therapeutics

Co-Author: – Aligos Therapeutics, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Nonclinical Vehicle Formulations: HP-β-CD (Hydroxypropyl-Beta-Cyclodextrin) and the Risk of Hemolysis (P131)

Presenting Author: – Frontage Laboratories

Co-Author: – Frontage Laboratories

Co-Author: – Atai Therapeutics Inc.

Co-Author: – Frontage Laboratories

Co-Author: – Atai Therapeutics Inc.

Co-Author: – Frontage Laboratories

General Toxicology

5:00 PM – 6:30 PM CT

Occupational Exposure Banding (OEB) for Mutagenic Compounds in Absence of Robust Dataset (P132)

Presenting Author: – SafeBridge Consultants, Inc.

Co-Author: – SafeBridge Consultants, Inc.

Co-Author: – SafeBridge

General Toxicology

5:00 PM – 6:30 PM CT

Osteogenic Differentiation of Human Pluripotent Stem Cells as a Model for Assessing Developmental Bone Toxicity (P514)

Presenting Author: – Toxys

Co-Author: – Toxys

Co-Author: – Unilever

Co-Author: – Toxys

Toxicology Methods

5:00 PM – 6:30 PM CT

Platelets Mediate Neutrophil Infiltration and Exacerbate Liver Injury and Endothelial Cell Damage after Severe Acetaminophen Overdose (P109)

Presenting Author: – University of Kansas Medical Center

Co-Author: – University of Kansas Medical Center

General Toxicology

5:00 PM – 6:30 PM CT

Poster Session

Location: JW Grand Ballroom

5:00 PM – 6:30 PM CT

Preclinical Development of LFA-9, a Dual Inhibitor of mPGES-1 and 5-LOX, for Prevention of Colorectal Cancer: GLP-Compliant, IND-Enabling 28-Day Toxicology and Pharmacokinetics Studies (with Recovery) in Rats and Dogs (P404)

Presenting Author: – IIT Research Institute

Co-Author: – IIT Research Institute

Co-Author: – Charles River - Pathology Associates

Co-Author: – National Cancer Institute

Co-Author: – University of Oklahoma Health Sciences Center

Co-Author: – IIT Research Institute

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Prevalence of Common Infectious Agents in Nonhuman Primates (P115)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Labs

General Toxicology

5:00 PM – 6:30 PM CT

Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations for Predicting Liver Safety of Acute Otenaproxesul Dosing (P411)

Presenting Author: – Simulations Plus Inc.

Co-Author: – Simulations Plus Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Repeated Intraperitoneal Injections of a Liposomal Suspension in Newborn Minipigs to Evaluate Its Safety Before Pediatric Use (P406)

Presenting Author: – Genfit SA

Co-Author: – Versantis AG

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Resolution Kinetics of Mixed Allergen-Induced Allergic Airway Inflammation in Mice (P105)

Presenting Author: – North Carolina State University

Co-Author: – North Carolina State University

General Toxicology

5:00 PM – 6:30 PM CT

Retrospective Analysis of Nonclinical Regulatory Strategy for Approved Oncology Antibody-Drug Conjugates (P213)

Presenting Author: – Labcorp

Co-Author: – Labcorp

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Retrospective Evaluation of the Use of Nonhuman Primates for Fertility Assessment of Marketed Medicinal Products (P201)

Presenting Author: – Utrecht University (NL), Medicines Evaluation Board (NL)

Co-Author: – Boehringer Ingelheim

Co-Author: – Medicines Evaluation Board

Co-Author: – Health and Environmental Sciences Institute

Co-Author: – Medicines Evaluation Board

Co-Author: – Johnson & Johnson Innovative Medicine

Co-Author: – US Food and Drug Administration, Center for Drug Evaluation and Research

Co-Author: – Pfizer Worldwide Research

Regulatory Toxicology

5:00 PM – 6:30 PM CT

Retrospective Immunophenotyping Analysis of Peripheral Blood Samples from Preclinical Species (P510)

Presenting Author: – Merck & Co.

Co-Author: – Merck & Co.

Toxicology Methods

5:00 PM – 6:30 PM CT

Retrospective Study of Survivability and Histopathology Findings in Cannulated Rodent (P119)

Presenting Author: – WuXi AppTec (Suzhou) Co., Ltd.,

Co-Author: – WuXi AppTec (Suzhou) Co., Ltd.,

General Toxicology

5:00 PM – 6:30 PM CT

Seasonal Comparison of Fine Particulate Matter (PM2.5) Concentration, Composition, and Oxidative Potential in Tennessee (P111)

Presenting Author: – University of Mississippi

Co-Author: – University of Mississippi

General Toxicology

5:00 PM – 6:30 PM CT

Sinclair Nanopigs as an Alternative Model for Implanted Cardiovascular Telemetry Data Assessment (P507)

Presenting Author: – ITR Laboratories Canada Inc.

Co-Author: – ITR Laboratories Canada Inc.

Toxicology Methods

5:00 PM – 6:30 PM CT

Species-Specific Liver Microtissues: A Set of Microphysiological Systems to Assess Translational Hepatotoxicity in Drug Development (P405)

Presenting Author: – InSphero AG, Schlieren, Switzerland

Co-Author: – InSphero AG

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Specificity Testing of Trispecific Antibodies for Treating Multiple Myeloma Using the Membrane Proteome Array (P425)

Presenting Author: – Integral Molecular

Co-Author: – Integral Molecular

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Spontaneous Convulsions and Tremors in Control Animals from Regulatory Toxicology Studies: A Multi-Site Retrospective Analysis Comparing Nonhuman Primates, Dogs, Minipigs, Rabbits, Rats, and Mice (P426)

Presenting Author: – Charles River Laboratories

Co-Author: – Charles River Laboratories

Co-Author: – Centre Veterinaire DMV

Co-Author: – Charles River Laboratories

Co-Author: – BioCryst Pharmaceuticals, Inc.

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

T2-MRI Mapping and Fluidic Neurofilament Light (NfL) as a Minimally Invasive Correlate of Central Nervous System (CNS) Toxicity in a Cuprizone Model: A Biomarker Study (P121)

Presenting Author: – US FDA/NCTR

Co-Author: – CDC/NIOSH

Co-Author: – US FDA/NCTR

Co-Author: – HESI

Co-Author: – ApconiX

Co-Author: – Albert Einstein College of Medicine

Co-Author: – Retired (US FDA/NCTR)

Co-Author: – US FDA/NCTR

General Toxicology

5:00 PM – 6:30 PM CT

The ABCs of Deriving Health-Based Exposure Limits for Antibody-Drug Conjugates: Adjustment Factors, Best Practices, and Challenges in Quantitative Hazard Assessment (P420)

Presenting Author: – SafeBridge Consultants, Inc.

Co-Author: – SafeBridge

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

The Biological Activities of Azadirachta Indica and Vernonia Amygdalina Plant Extract on Human Epithelial Colorectal Adenocarcinoma Cells (P110)

Presenting Author: – Texas Southern University

Co-Author: – Texas Southern University

Co-Author: – University of Ibadan

Co-Author: – Texas Southern University

General Toxicology

5:00 PM – 6:30 PM CT

The Effects of Carbon Nanodots on Ultrasonic Vocalizations and Other Behaviors of C57BL/6J and LDLr -/- Mice (P304)

Presenting Author: – University of North Carolina at Greensboro

Co-Author: – University of North Carolina at Greensboro

Safety Evaluation Nonpharmaceuticals

5:00 PM – 6:30 PM CT

The Impact of Diet-Induced Obesity on the Hepatic Transcriptomic Response to Dimethylbenz(a)anthracene Exposure in Female Mice (P107)

Presenting Author: – Iowa State University

Co-Author: – Iowa State University

General Toxicology

5:00 PM – 6:30 PM CT

To Seize or Not to Seize (P434)

Presenting Author: – Certara

Co-Author: – Certara

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Toxicity Beyond the Test Article—Database of Excipient Tolerability in Species Used for Nonclinical Studies (P118)

Presenting Author: – Charles River

Co-Author: – Charles River

General Toxicology

5:00 PM – 6:30 PM CT

Toxicology Assessment of High Concentration XeriJect® Trastuzumab Biosimilar Administered Subcutaneous in Cynomolgus Nonhuman Primates (P409)

Presenting Author: – Xeris Pharmaceuticals

Co-Author: – Xeris Pharmaceuticals

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Transcriptomic Profiling to Understand Retinal Function Deficits in Male vs. Female Wistar Rats (P116)

Presenting Author: – Pfizer

Co-Author: – Pfizer

General Toxicology

5:00 PM – 6:30 PM CT

Tristetraprolin (TTP) Protects Against the Ozone-Induced Acute Lung Injury and Inflammation in Mice (P108)

Presenting Author: – North Carolina State University

Co-Author: – North Carolina State University

Co-Author: – National Institute of Environmental Health Sciences

Co-Author: – North Carolina State University

General Toxicology

5:00 PM – 6:30 PM CT

Use of Buccal Swabs for Gene Expression Analysis as a Minimally Invasive Endpoint in Nonhuman Primate Toxicology Studies (P523)

Presenting Author: – Celldex Therapeutics, Inc.

Co-Author: – Celldex Therapeutics, Inc.

Toxicology Methods

5:00 PM – 6:30 PM CT

Utility of Immunodeficient SRG Rat in Identifying Immunogenicity-Related Hepatoxicity with a LNP-Encapsulated mRNA Encoding a Secreted Monovalent Antibody (P126)

Presenting Author: – Moderna

Co-Author: – Moderna

General Toxicology

5:00 PM – 6:30 PM CT

Validation of the Flow-Cytometric Peripheral Blood Micronucleus Assay in Mouse (P508)

Presenting Author: – WuXi AppTec

Co-Author: – WuXi AppTec

Toxicology Methods

5:00 PM – 6:30 PM CT

Variable DNA Methylation Regions Are Responsible for Conserved Patterns of Sperm Epigenome Response to Chemical Stressors (P106)

Presenting Author: – University of Massachusetts

Co-Author: – University of Massachusetts Amherst

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P112)

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P113)

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P114)

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P125)

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P128)

General Toxicology

5:00 PM – 6:30 PM CT

Withdrawn (P415)

Safety Evaluation Pharmaceuticals

5:00 PM – 6:30 PM CT

Withdrawn (P503)

Toxicology Methods

6:30 PM – 9:30 PM CT

Early Career Professional Night

Location: Room 301

7:00 AM – 8:00 AM CT

Chair Yoga

Location: Griffin Hall

7:30 AM – 5:00 PM CT

Registration Open

Location: Lone Star Ballroom Foyer

8:00 AM – 8:55 AM CT

(EHP) BioAgilytix—Strategies for Long-Term Success: Streamlining the Preclinical to Clinical Assay Transition

Location: Room 202

8:00 AM – 8:55 AM CT

(EHP) Scantox Group—How to Obtain Stress-Free Blood Samples in Minipigs

Location: Room 203

8:00 AM – 8:55 AM CT

(EHP) STEMCELL Technologies Inc.—Intestinal and Hepatic Organoid Systems: In Vitro Models of Drug Toxicity

Location: Room 205

8:00 AM – 8:55 AM CT

(EHP) Virscio—Strategies for Enabling Preclinical and Translational R&D Innovation in African Green Monkeys (AGM)

Location: Room 204

8:00 AM – 8:55 AM CT

(EHP) Xybion Digital—Application of AI and Machine Learning —Practical Use Cases in Pre-Clinical Research

Location: Room 201

8:00 AM – 9:00 AM CT

Breakfast Reception in Exhibit Hall

Location: JW Grand Ballroom

8:00 AM – 9:00 AM CT

Past Presidents’ Breakfast

Location: Room 303

8:00 AM – 1:00 PM CT

Speaker Ready Room Open

Location: Room 306

8:00 AM – 4:30 PM CT

ACT Expo Live! and Posters Open

Location: JW Grand Ballroom

9:00 AM – 12:00 PM CT

Biomarkers for CNS Toxicity—From Bench to Bedside (S07)

Location: Lone Star Ballroom F

Symposium Chair: – Eli Lilly and Company, Inc.

Symposium Chair: – QurAlis Corporation

Symposium Speaker: – Akkeri, Inc.

Symposium Speaker: – Biogen

Symposium Speaker: – US FDA/NCTR

Symposium Speaker: – US FDA

AdvancedEmerging

9:00 AM – 9:05 AM CT

Welcome (S07-1)

Symposium Chair: – Eli Lilly and Company, Inc.

Symposium Chair: – QurAlis Corporation

9:05 AM – 9:40 AM CT

Introduction to Neurotoxicity Biomarkers with Special Reference to AAV Gene Therapy (S07-2)

Symposium Speaker: – Akkeri, Inc.

9:40 AM – 10:15 AM CT

Fluid-Based Biomarkers of the Nervous System (S07-3)

Symposium Speaker: – Biogen

10:15 AM – 10:45 AM CT

Break (S07-Break)

10:45 AM – 11:15 AM CT

In Vivo Imaging Biomarkers of Neurotoxicity (S07-4)

Symposium Speaker: – US FDA/NCTR

11:15 AM – 11:45 AM CT

Biomarkers of Neurotoxicity: An FDA Perspective (S07-5)

Symposium Speaker: – US FDA

11:45 AM – 12:00 PM CT

Panel Discussion (S07-Panel)

9:00 AM – 12:00 PM CT

Hitching a Ride to Transduce Barriers: Nonclinical Safety Considerations for Developing Transcriptome Modulating Therapies (S08)

Location: Lone Star Ballroom C

Symposium Chair: – Eli Lilly and Company

Symposium Chair: – Avidity Biosciences

Symposium Speaker: – US FDA

Symposium Speaker: – Ionis Pharmaceuticals

Symposium Speaker: – Avidity Biosciences

Symposium Speaker: – TCG Labs Soleil

Symposium Speaker: – Denali Therapeutics

AdvancedEmerging

9:00 AM – 9:10 AM CT

Introduction (S08-1)

Symposium Speaker: – Eli Lilly and Company

9:10 AM – 9:40 AM CT

Targeted Delivery of Oligonucleotides with Antibody or Peptide Conjugates: An FDA Perspective (S08-2)

Symposium Speaker: – US FDA

9:40 AM – 10:15 AM CT

Adapting Nonclinical Strategies to Accommodate Evolution of Antisense Oligonucleotide Technologies (S08-3)

Symposium Speaker: – Ionis Pharmaceuticals

10:15 AM – 10:45 AM CT

Break (S08-Break)

10:45 AM – 11:15 AM CT

Nonclinical Safety Assessment of Antibody-Oligo Conjugates from IND-enabling through Late-Stage Clinical Trials (S08-4)

Symposium Speaker: – Avidity Biosciences

11:15 AM – 11:45 AM CT

Targeting Transferrin Receptor to Transport Antisense Oligonucleotides Across the Blood-Brain Barrier (S08-5)

Symposium Speaker: – TCG Labs Soleil

Symposium Speaker: – Denali Therapeutics

11:45 AM – 12:00 PM CT

Panel Discussion (S08-Panel)

9:00 AM – 12:00 PM CT

Tox Hack: Unleashing the Power of AI and Machine Learning (S09)

Location: Lone Star Ballroom D/E

Symposium Chair: – IDEAYA Biosciences

Symposium Chair: – US FDA

Symposium Speaker: – Genentech, Inc.

Symposium Speaker: – Cyprotex US, LLC

Symposium Speaker: – Genentech, Inc.

Symposium Speaker: – US FDA

Foundational (Basic)Emerging

9:00 AM – 9:05 AM CT

Introduction (S09-1)

Symposium Speaker: – IDEAYA Biosciences

9:05 AM – 9:40 AM CT

Opportunities for Harnessing the Power of AI in Toxicology (S09-2)

Symposium Speaker: – Genentech, Inc.

9:40 AM – 10:15 AM CT

An AI Approach to Drug-Induced Liver Injury Risk: Prediction of Safe Maximum Doses from Toxicogenomic Profiles (S09-3)

Symposium Speaker: – Cyprotex US, LLC

10:15 AM – 10:45 AM CT

Break (S09-Break)

10:45 AM – 11:15 AM CT

Detecting the Unseen: Histologic Anomaly Detection in Toxicologic Pathology (S09-4)

Symposium Speaker: – Genentech, Inc.

11:15 AM – 11:45 AM CT

Toxicological Profile Characterization via Application of Machine Learning to SEND-Formatted Toxicology Study Data (S09-5)

Symposium Speaker: – US FDA

11:45 AM – 12:00 PM CT

Panel Discussion (S09-Panel)

9:00 AM – 12:00 PM CT

Delivery of AAV Gene Therapies to Specialized Compartments (S10)

Location: Lone Star Ballroom A

Symposium Chair: – Akkeri, Inc.

Symposium Chair: – Regeneron

Symposium Speaker: – US FDA

Symposium Speaker: – Novartis

Symposium Speaker: – Atsena Therapeutics

Symposium Speaker: – Regeneron Pharmaceuticals

AdvancedPractical

9:00 AM – 9:05 AM CT

Welcome (S10-1)

Symposium Chair: – Akkeri, Inc.

9:05 AM – 9:40 AM CT

Regulatory Considerations for Delivery into Specialized Compartments (S10-2)

Symposium Speaker: – US FDA

9:40 AM – 10:15 AM CT

Preclinical Strategies for Development of rAAV Based Gene Therapies Targeting the Central Nervous System: Intrathecal Onasemnogene Abeparvovec as a Case Study (S10-3)

Symposium Speaker: – Novartis

10:15 AM – 10:45 AM CT

Break (S10-Break)

10:45 AM – 11:15 AM CT

Preclinical Development of Subretinally-Delivered Gene Therapy Products (S10-4)

Symposium Speaker: – Atsena Therapeutics

11:15 AM – 11:45 AM CT

Preclinical Considerations for Delivery of AAV Therapies to the Inner Ear (S10-5)

Symposium Speaker: – Regeneron Pharmaceuticals

11:45 AM – 12:00 PM CT

Panel Discussion (S10-Panel)

10:15 AM – 11:15 AM CT

Meet IJT Editor Mary Beth Genter

Location: ACT Booth (Exhibit Hall)

12:00 PM – 12:55 PM CT

(EHP) Charles River—Success Factors and Expectations for Gene Therapies: From AAV to Lentivectors and LNPs

Location: Room 202

12:00 PM – 12:55 PM CT

(EHP) Ellegaard Göttingen Minipigs A/S—IgG Humanized Göttingen Minipigs: Alternative to NHP in Safety Testing of Therapeutical Antibodies

Location: Room 205

12:00 PM – 12:55 PM CT

(EHP) InSphero Inc—In Vitro Hepatotoxicity Assessment with the 3D InSight™ Liver Microtissue Platform

Location: Room 204

12:00 PM – 12:55 PM CT

(EHP) Lhasa Limited—Setting Limits for Nitrosamines and Other Impurity Classes Using In Silico, Including Read-Across

Location: Room 201

12:00 PM – 12:55 PM CT

(EHP) WuXi AppTec—Maximizing Outcomes through Multi-Site Study Collaboration

Location: Room 203

12:00 PM – 1:30 PM CT

2025 Program Planning Meeting

Location: Room 301

12:00 PM – 2:00 PM CT

Lunch on Your Own

12:30 PM – 2:00 PM CT

Member Portraits

Location: 404

2:00 PM – 5:00 PM CT

Informing Risk of Infertility and Adverse Pregnancy Outcome: Are Nonhuman Primates Really Needed? (S11)

Location: Lone Star Ballroom F

Symposium Chair: – Pfizer Worldwide Research

Symposium Chair: – Medicines Evaluation Board

Symposium Speaker: – Apconix Ltd.

Symposium Speaker: – Merck

Symposium Speaker: – Utrecht University (NL), Medicines Evaluation Board (NL)

AdvancedEmerging

2:00 PM – 2:10 PM CT

Introduction (S11-1)

Symposium Speaker: – Medicines Evaluation Board

2:10 PM – 2:40 PM CT

Developmental Toxicity Risk Assessment of Pharmaceuticals: Current Use of NHP’s and Alternatives (S11-2)

Symposium Speaker: – Apconix Ltd.

2:40 PM – 3:15 PM CT

Current State of NHP Use Supporting Fertility Risk Assessment (S11-3)

Symposium Speaker: – Merck

3:15 PM – 3:45 PM CT

Break (S11-Break)

3:45 PM – 4:15 PM CT

Fertility Assessment in NHP: Evaluation of Marketed Products and Opportunities to Reduce Monkey Use (S11-4)

Symposium Speaker: – Utrecht University (NL), Medicines Evaluation Board (NL)

4:15 PM – 4:45 PM CT

Looking Forward: Are NHP Really Needed for DART Assessments? (S11-5)

Symposium Speaker: – Pfizer Worldwide Research

4:45 PM – 5:00 PM CT

Panel Discussion (S11-Panel)

2:00 PM – 5:00 PM CT

Advances and Challenges in Oligonucleotide and mRNA Therapeutics: New Strategies and Regulatory Perspectives (S12)

Location: Lone Star Ballroom C

Symposium Chair: – QurAlis Corporation

Symposium Chair: – Eli Lilly and Company, Inc.

Symposium Speaker: – AstraZeneca

Symposium Speaker: – Ionis Pharmaceuticals

Symposium Speaker: – US FDA

AdvancedEmerging

2:00 PM – 2:05 PM CT

Welcome (S12-1)

Symposium Chair: – QurAlis Corporation

2:05 PM – 2:40 PM CT

Strategies and Development of GalNAc siRNAs (S12-2)

Symposium Speaker: – Eli Lilly and Company, Inc.

2:40 PM – 3:15 PM CT

Nonclinical Safety Assessments of the Next Generation of mRNA Vaccines for SARS-CoV-2 and Other Respiratory Viruses (S12-3)

Symposium Speaker: – AstraZeneca

3:15 PM – 3:45 PM CT

Break (S12-Break)

3:45 PM – 4:15 PM CT

Expanding the Reach of Antisense Therapeutics: Facing Challenges Associated with Nonclinical Safety Assessment for Local IT Administration (S12-4)

Symposium Speaker: – Ionis Pharmaceuticals

4:15 PM – 4:45 PM CT

Safety Assessment of Oligonucleotides Administered via the Intrathecal Route (S12-5)

Symposium Speaker: – US FDA

4:45 PM – 5:00 PM CT

Panel Discussion (S12-Panel)

2:00 PM – 5:00 PM CT

Managing Nonmutagenic Impurities in Pharmaceuticals: Emerging Science (S13)

Location: Lone Star Ballroom D/E

Symposium Chair: – Genentech

Symposium Chair: – Pfizer Research and Development

Symposium Speaker: – Gilead Sciences, Inc.

Symposium Speaker: – Genentech, Inc.

Symposium Speaker: – US FDA

Symposium Speaker: – Innovatune

Symposium Speaker: – Eli Lilly and Co, Inc.

AdvancedEmerging

2:00 PM – 2:05 PM CT

Welcome (S13-1)

Symposium Chair: – Genentech

Symposium Chair: – Pfizer Research and Development

2:05 PM – 2:30 PM CT

Overview of Impurity Qualification and How is it Used by Chemistry? (S13-2)

Symposium Speaker: – Gilead Sciences, Inc.

2:30 PM – 2:55 PM CT

Best Practices in Impurity Qualification Study Design, 3R Considerations (S13-3)

Symposium Speaker: – Genentech, Inc.

2:55 PM – 3:15 PM CT

Durationally Adjusted Qualification Threshold (S13-4)

Symposium Speaker: – Pfizer Research and Development

3:15 PM – 3:45 PM CT

Break (S13-Break)

3:45 PM – 4:00 PM CT

US Regulatory Perspectives on the Safety Assessment of Non-mutagenic Impurities in Pharmaceuticals (S13-5)

Symposium Speaker: – US FDA

4:00 PM – 4:15 PM CT

Analysis of Non-Mutagenic Substances in the Context of Drug Impurity Assessment—Few are Potent Toxicants (S13-6)

Symposium Speaker: – Eli Lilly and Co, Inc.

Symposium Speaker: – Genentech

4:15 PM – 4:35 PM CT

In Silico Methods for the Derivation of Quantitative Safety Limits (S13-7)

Symposium Speaker: – Innovatune

4:35 PM – 5:00 PM CT

Panel Discussion (S13-Panel)

2:00 PM – 5:00 PM CT

That Which Does Not Kill You May Make You Stronger: Dietary Supplements and Nutraceuticals (S14)

Location: Lone Star Ballroom A

Symposium Chair: – US FDA

Symposium Chair: – Premier Research

Symposium Speaker: – US FDA

Symposium Speaker: – Washington State University

Symposium Speaker: – Einstein Healthcare Network, Jefferson Health

Foundational (Basic)Practical

2:00 PM – 2:15 PM CT

Introduction (S14-1)

Symposium Chair: – US FDA

2:15 PM – 2:45 PM CT

Dietary Supplements: Regulatory Overview and the Evaluation of Safety (S14-2)

Symposium Speaker: – US FDA

2:45 PM – 3:15 PM CT

Natural Product-Drug Interactions: Weeding the Challenges While Cultivating the Opportunities (S14-3)

Symposium Speaker: – Washington State University

3:15 PM – 3:45 PM CT

Break (S14-Break)

3:45 PM – 4:15 PM CT

Drug-induced Liver Injury Associated with Herbal and Dietary Supplements (S14-4)

Symposium Speaker: – Einstein Healthcare Network, Jefferson Health

4:15 PM – 4:45 PM CT

Differential Temporal Effects of Green Tea Extract on the Hepatotoxicity of Acetaminophen and its Clinical Relevance (S14-5)

Symposium Speaker: – Premier Research

4:45 PM – 5:00 PM CT

Panel Discussion (S14-Panel)

4:30 PM – 6:30 PM CT

Exhibition and Poster Dismantle

Location: JW Grand Ballroom

5:00 PM – 6:30 PM CT

ACT Members’ Meeting

Location: Room 301

6:30 PM – 7:30 PM CT

ACT Member Mixer

Location: Lone Star Ballroom Foyer

7:00 AM – 8:00 AM CT

Continental Breakfast

Location: Lone Star Ballroom Foyer

7:30 AM – 2:00 PM CT

Registration Open

Location: Lone Star Ballroom Foyer

8:00 AM – 8:55 AM CT

Medicinal Evolution of Natural Hormones to Transform the Drug Treatment of Obesity (Plenary 2)

Location: Lone Star Ballroom D/E

Plenary Speaker: – Gill Chair in Biomolecular Science at Indiana University

8:00 AM – 1:00 PM CT

Speaker Ready Room Open

Location: Room 306

9:00 AM – 12:00 PM CT

Basic Embryology to Predictive Toxicology: Investigating Human Neural Tube Defects Using New Approach Methodologies (NAMs) (S15)

Location: Lone Star Ballroom A

Symposium Chair: – Charles River Laboratories

Symposium Chair: – Indiana University

Symposium Speaker: – Baylor College of Medicine

Symposium Speaker: – University of Wisconsin-Madison

Symposium Speaker: – Dutch National Institute for Public Health and the Environment (RIVM)

Symposium Speaker: – Hurley Consulting

AdvancedEmerging

9:00 AM – 9:10 AM CT

Introduction (S15-1)

Symposium Speaker: – Indiana University

9:10 AM – 9:40 AM CT

NTDs: Physical Characteristics, Molecular Embryology, and Precision Toxicology (S15-2)

Symposium Speaker: – Baylor College of Medicine

9:40 AM – 10:15 AM CT

Bioengineering CNS Morphogenesis with Human Stem Cells for a Scalable HTS Risk Assay (S15-3)

Symposium Speaker: – University of Wisconsin-Madison

10:15 AM – 10:45 AM CT

Break (S15-Break)

10:45 AM – 11:15 AM CT

Computational Modelling of Neural Tube Closure Defects: Towards a Virtual Embryo (S15-4)

Symposium Speaker: – Dutch National Institute for Public Health and the Environment (RIVM)

11:15 AM – 11:45 AM CT

Integrating NAMs into Developmental Toxicity Testing: Case Study for Predicting NTDs (S15-5)

Symposium Speaker: – Hurley Consulting

11:45 AM – 12:00 PM CT

Panel Discussion (S15-Panel)

9:00 AM – 12:00 PM CT

Targeted Protein Degrader Therapeutics: Opportunities and Challenges (S16)

Location: Lone Star Ballroom C

Symposium Chair: – Novartis

Symposium Chair: – ApconiX

Symposium Speaker: – Dana-Farber Cancer Institute

Symposium Speaker: – Amgen Inc.

Symposium Speaker: – Crinetics Pharmaceuticals

Symposium Speaker: – Bristol Myers Squibb

Symposium Speaker: – US Food and Drug Administration, Center for Drug Evaluation and Research

AdvancedEmerging

9:00 AM – 9:05 AM CT

Introduction (S16-1)

Symposium Chair: – Novartis

9:05 AM – 9:25 AM CT

Understanding Safety Liabilities of Small Molecule Targeted Protein Degraders (S16-2)

Symposium Speaker: – Dana-Farber Cancer Institute

9:25 AM – 9:50 AM CT

Early De-risking: Human Cell-Based Proteomic Analysis to Identify Off-Target Proteins Associated with Targeted Protein Degradation (S16-3)

Symposium Speaker: – Amgen Inc.

9:50 AM – 10:15 AM CT

Strategies for Assessing Targeted Protein Degrader Modality Safety in Drug Discovery Programs (S16-4)

Symposium Speaker: – Crinetics Pharmaceuticals

10:15 AM – 10:45 AM CT

Break (S16-Break)

10:45 AM – 11:10 AM CT

Species Selection: How to Select a Pharmacologically Relevant Species for Cereblon Modulators (S16-5)

Symposium Speaker: – Bristol Myers Squibb

11:10 AM – 11:35 AM CT

Target Protein Degradation Therapies: A Regulatory Perspective (S16-6)

Symposium Speaker: – US Food and Drug Administration, Center for Drug Evaluation and Research

11:35 AM – 12:00 PM CT

Panel Discussion (S16-Panel)

9:00 AM – 12:00 PM CT

Revamping ICH S7A: Time for Change? (S17)

Location: Lone Star Ballroom F

Symposium Chair: – Eli Lilly and Company, Inc.

Symposium Speaker: – UCB Biopharma

Symposium Speaker: – Grunenthal

Symposium Speaker: – Federal Agency for Medicines and Health Products

Symposium Speaker: – Eli Lilly and Company, Inc.

Symposium Speaker: – Eisai Co., Ltd.

AdvancedEmerging

9:00 AM – 9:25 AM CT

Rationale to Evolve Safety and Secondary Pharmacology S7A Guidelines (S17-1)

Symposium Speaker: – UCB Biopharma

9:25 AM – 9:50 AM CT

Does ICH S7A Address the Future Needs for Secondary Pharmacology? (S17-2)

Symposium Speaker: – Grunenthal

9:50 AM – 10:15 AM CT

Regulatory Acceptance of 3Rs Testing Approaches in Support of Medicinal Product Development (S17-3)

Symposium Speaker: – Federal Agency for Medicines and Health Products

10:15 AM – 10:45 AM CT

Break (S17-Break)

10:45 AM – 11:10 AM CT

Clinical Arguments for Evolving Safety and Secondary Pharmacology S7A (S17-4)

Symposium Speaker: – Eli Lilly and Company, Inc.

11:10 AM – 11:35 AM CT

Revamping ICH S7A: A Non-Clinical Industry Perspective (S17-5)

Symposium Speaker: – Eisai Co., Ltd.

11:35 AM – 12:00 PM CT

Panel Discussion (S17-Panel)

10:15 AM – 10:45 AM CT

(Canceled) Meet & Greet with Dr. Richard DiMarchi

Location: Room 301

11:30 AM – 1:30 PM CT

Member Portraits

Location: 404

12:00 PM – 12:55 PM CT

(EHP) AmplifyBio—Advanced Strategies and Methods for Safety Testing Next-Generation Therapeutics

Location: Room 204

12:00 PM – 12:55 PM CT

(EHP) Instem—Information into Insights: How to reuse your SEND data within an S1B submission

Location: Room 203

12:00 PM – 12:55 PM CT

(EHP) MultiCASE, Inc.—Computational Approaches for N-Nitrosamine Assessments

Location: Room 205

12:00 PM – 12:55 PM CT

(EHP) Sinclair Bio Resources—Substituting the Sinclair Nanopig for Canine and NHP Models

Location: Room 202

12:00 PM – 12:55 PM CT

(EHP) Toxys—Applications of NAMs in Safety Assessment

Location: Room 201

12:00 PM – 1:45 PM CT

ACT Council Meeting

Location: Room 401

12:00 PM – 2:00 PM CT

Lunch on Your Own

2:00 PM – 3:15 PM CT

What Is the Safety Risk of Excipients to Humans? That Depends Who You Are Asking (S18)

Location: Lone Star Ballroom A

Symposium Chair: – Janssen Pharmaceuticals

Symposium Speaker: – D2team

Symposium Speaker: – Teva Pharmaceuticals

Foundational (Basic)Emerging

2:00 PM – 2:20 PM CT

Safety Assessment of Pharmaceutical Excipients in the EU and US (S18-1)

Symposium Speaker: – D2team

2:20 PM – 2:40 PM CT

Titanium Dioxide: Assessments of Its Safety across the Globe (S18-2)

Symposium Speaker: – Teva Pharmaceuticals

2:40 PM – 3:00 PM CT

Safety Assessment Using the One Substance One Assessment Approach: Every EU Regulatory Body on the Same Page? (S18-3)

Symposium Speaker: – Janssen Pharmaceuticals

3:00 PM – 3:15 PM CT

Panel Discussion (S18-Panel)

2:00 PM – 3:15 PM CT

Addressing the Presence of Mutagens and Carcinogens in Foods and Drugs (S19)

Location: Lone Star Ballroom C

Symposium Chair: – US FDA

Symposium Chair: – Allucent

AdvancedEmerging

2:00 PM – 2:30 PM CT

The Elephant in the Room: Addressing the Risk of Nitrosamines in Food (S19-1)

Symposium Speaker: – US FDA

2:30 PM – 3:00 PM CT

Addressing the Presence of Carcinogenic Compounds in Foods (S19-2)

Symposium Speaker: – Allucent

3:00 PM – 3:15 PM CT

Panel Discussion (S19-Panel)

2:00 PM – 5:00 PM CT

Hot Topics (S20)

Location: Lone Star Ballroom F

Symposium Chair: – US FDA

Symposium Chair: – Allucent

Hot Topic Speaker: – US FDA

Hot Topic Speaker: – EPL, Inc.

Hot Topic Speaker: – FDA, NCTR

Hot Topic Speaker: – Allucent

AdvancedEmerging

2:00 PM – 2:05 PM CT

Introduction (S20-1)

Symposium Chair: – US FDA

2:05 PM – 2:40 PM CT

New Draft Guidance on Platform Technology Designation: Key Highlights and a Mock Case Study (S20-2)

Hot Topic Speaker: – US FDA

2:40 PM – 3:15 PM CT

Digital Pathology and the Impact of Artificial Intelligence on Toxicologic Pathology Workflow and Reporting (S20-3)

Hot Topic Speaker: – EPL, Inc.

3:15 PM – 3:45 PM CT

Break (S20-Break)

3:45 PM – 4:15 PM CT

Neuropsychiatric Concerns and Potential Molecular Mechanisms Associated with Widely Used Medication Montelukast (Singulair®) (S20-4)

Hot Topic Speaker: – FDA, NCTR

4:15 PM – 4:45 PM CT

Safety Pharmacology Survey 2024: Insights on Investigations of the Nervous System (S20-5)

Hot Topic Speaker: – Allucent

4:45 PM – 5:00 PM CT

Panel Discussion (S20-Panel)

3:45 PM – 5:00 PM CT

Virtual Control Group: Using Advanced Analytics to Drive Animal Reduction in Nonclinical Safety Assessment Studies (S21)

Location: Lone Star Ballroom A

Symposium Chair: – Charles River Laboratories

Symposium Speaker: – Charles River Laboratories

Symposium Speaker: – Pfizer

Symposium Speaker: – Sanofi

AdvancedPractical

3:45 PM – 3:50 PM CT

Introduction, Database Development, and Implementation Plan (S21-1)

Symposium Speaker: – Charles River Laboratories

3:50 PM – 4:10 PM CT

Virtual Control Groups: Study Profiling, Endpoint Database, and Data Science Analysis (S21-2)

Symposium Speaker: – Charles River Laboratories

4:10 PM – 4:30 PM CT

Points to Consider Regarding the Use and Implementation of Virtual Controls in Nonclinical Toxicology Studies (S21-3)

Symposium Speaker: – Pfizer

4:30 PM – 4:50 PM CT

Path to VCG: Proof of Concept Studies and Validation of the Tools and Methods (S21-4)

Symposium Speaker: – Sanofi

4:50 PM – 5:00 PM CT

Panel Discussion (S21-Panel)

3:45 PM – 5:00 PM CT

Beyond the Conventional Paradigm: Rethinking the Necessity of Chronic Toxicity Studies for Biotherapeutics (S22)

Location: Lone Star Ballroom C

Symposium Chair: – Pfizer

Symposium Chair: – Trident Toxicology, Inc.

Symposium Speaker: – F. Hoffmann-La Roche Ltd.

Symposium Speaker: – Medicines Evaluation Board

AdvancedPractical

3:45 PM – 4:05 PM CT

Industry Perspective of Value of Chronic Toxicity in Identifying Adverse Safety Signal in Human (S22-1)

Symposium Speaker: – Pfizer

4:05 PM – 4:25 PM CT

Tick Box or Informing Patient Safety: Case Studies on the Value of Chronic Toxicity Studies for Biotherapeutics (S22-2)

Symposium Speaker: – F. Hoffmann-La Roche Ltd.

4:25 PM – 4:45 PM CT

European Perspective on the Need for Chronic Safety Studies for Monoclonal Antibodies (S22-3)

Symposium Speaker: – Medicines Evaluation Board

4:45 PM – 5:00 PM CT

Panel Discussion (S22-Panel)

5:00 PM – 6:00 PM CT

Closing Social

Location: Lone Star Ballroom Foyer