Full Schedule

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