Full Schedule

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

10th ToxTrot

Location: Sunset Lawn

7:30 AM - 5:00 PM (MT)

Registration Open

Location: Grand Sonoran Foyer

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

Exhibitor-Hosted Program: InSphero—The 3D InSight™ Liver Microtissues—A Comprehensive Tool For In Vitro Human and Animal Hepatotoxicity Studies

Location: Grand Sonoran H

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

Exhibitor-Hosted Program: Instem—Tomorrow’s Toxicology Tools: Multi-Endpoint Experiments, Virtual Control Groups, and New Approach Methodologies

Location: Grand Sonoran K

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

Exhibitor-Hosted Program: Scantox Group—Addressing Genetic Toxicology Assessments across Screening to Regulatory and Beyond

Location: Grand Sonoran I

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

Exhibitor-Hosted Program: Worldwide Primates—Evolution of Cynomolgus Monkey Usage in North American Research: Philippine and Indonesian Sources and Ensuring Supply Chain Integrity

Location: Grand Sonoran J

8:00 AM - 9:00 AM (MT)

Breakfast Reception in Exhibit Hall

Location: Exhibit Hall

8:00 AM - 9:00 AM (MT)

Past Presidents’ Breakfast

Location: Pinnacle Peak 2

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

Speaker Ready Room Open

Location: Pinnacle Peak 1

8:00 AM - 4:30 PM (MT)

ACT Expo and Posters Open

Location: Exhibit Hall

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

From Bench to Birth: Navigating DART Challenges in Next Generation Therapeutics (S07)

Location: Grand Sonoran E

Symposium Chair: – TOXPLUS

Symposium Chair: – Neuron23, Inc.

Symposium Speaker: – Aligos Therapeutics, Inc.

Symposium Speaker: – Regenxbio

Symposium Speaker: – Madrigal Pharmaceuticals

Symposium Speaker: – Schrodinger Therapeutics Group

Symposium Speaker: – Charles River Laboratories

AdvancedEmerging

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

Introduction (S07-1)

Symposium Speaker: – TOXPLUS

9:05 AM - 9:30 AM (MT)

Testing Oligonucleotides in DART Studies (S07-2)

Symposium Speaker: – Aligos Therapeutics

9:30 AM - 9:55 AM (MT)

Establishing a Decision Tree Model for Developmental and Reproductive Toxicology Strategy for Gene Therapies (S07-3)

Symposium Speaker: – Regenxbio

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

Germline Transmission Studies: Hitting a Safety Target without DART (S07-4)

Symposium Speaker: – Madrigal Pharmaceuticals

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

Break (S07-Break)

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

Early Teratogenicity Screening to De-risk Wee2 Kinase Inhibitors for Non-Hormonal Contraception (S07-5)

Symposium Speaker: – Schrodinger Therapeutics Group

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

Exploration of Novel Dose Routes in the Non-Human Primate (S07-6)

Symposium Speaker: – Charles River Laboratories

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

Panel Discussion (S07-Panel)

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

Harnessing Complex New Approach Methodologies (NAMs) to Tackle Discovery Toxicology Challenges (S08)

Location: Grand Sonoran F

Symposium Chair: – Johnson & Johnson Innovative Medicine

Symposium Chair: – Crinetics Pharmaceuticals

Symposium Speaker: – Merck KGaA, Darmstadt, Germany

Symposium Speaker: – Pfizer, Inc.

Symposium Speaker: – Johnson & Johnson Innovative Medicine

Symposium Speaker: – AstraZeneca

AdvancedEmerging

9:00 AM - 9:25 AM (MT)

Introduction: Harnessing Complex New Approach Methodologies (NAMs) to Tackle Discovery Toxicology Challenges: Are the Faster, Safer, and More Effective? (S08-1)

Symposium Speaker: – Johnson&Johnson Innovative Medicines

9:25 AM - 9:50 AM (MT)

HepSAFE: A Multi-Step AI-Powered Approach to Better Understand and Predict Drug-Induced Liver Injury (DILI) (S08-2)

Symposium Speaker: – Merck KGaA, Darmstadt, Germany

9:50 AM - 10:15 AM (MT)

Applications of Complex In Vitro Tools to Investigate Safety Concerns: Balancing Context of Use, Model Development, and Characterization (S08-3)

Symposium Speaker: – Pfizer Inc.

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

Break (S08-Break)

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

AI-Based Continuous Video Monitoring of Canines for Detection of Abnormal/Adverse Events in Nonclinical Safety Studies (S08-4)

Symposium Speaker: – Johnson&Johnson Innovative Medicines

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

Multimodal Omics Approaches for Resolution of In Vivo Toxicity Issues (S08-5)

Symposium Speaker: – AstraZeneca

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

Panel Discussion (S08-Panel)

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

Toxicologic Assessment of Psychoactive/Psychedelic Drugs: Disentangling CNS Pharmacology and Toxicity (S09)

Location: Grand Sonoran G

Symposium Chair: – atai Life Sciences

Symposium Chair: – Lightship Scientific Consulting, LLC

Symposium Speaker: – Mind Medicine Inc

Symposium Speaker: – Beckely Psytech

Symposium Speaker: – Lightship Consulting

Symposium Speaker: – Labcorp Early Development Laboratories Ltd

AdvancedEmerging

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

Introduction (S09-1)

Symposium Speaker: – atai Life Sciences

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

Challenges and Successes of a Toxicology Program for MM120 - a Tartrate Salt of LSD (S09-2)

Symposium Speaker: – Mind Medicine Inc

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

Toxicology Assessment of 5MeODMT and Psilocin (S09-3)

Symposium Speaker: – Beckely Psytech

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

Toxicity Assessments of EMP-01: A Single Enantiomer of MDMA with A Unique Pharmacologic, Dissociative and Toxicologic Profile (S09-4)

Symposium Speaker: – Lightship Consulting

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

Break (S09-Break)

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

Challenges to GLP Toxicology Study Execution with Psychoactive/Psychedelic Compounds: The SD and Animal Welfare (S09-5)

Symposium Speaker: – Labcorp Early Development Laboratories Ltd

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

Panel Discussion (S09-6)

Symposium Chair: – Lightship Scientific Consulting, LLC

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

Questions & Answers (S09-Q&A)

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

Meet IJT Editor Mary Beth Genter

Location: Exhibit Hall

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

Exhibitor-Hosted Program: Envol Biomedical—Drug Delivery and Nonterminal CNS Serial Sample Collections from NHP

Location: Grand Sonoran J

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

Exhibitor-Hosted Program: Marshall BioResources—Leveraging Minipigs as a Model to Assess Drug Safety of Immunotherapies

Location: Grand Sonoran K

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

Exhibitor-Hosted Program: Toxys—NAMs and Their (Regulatory) Applications in Safety Testing

Location: Grand Sonoran H

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

Exhibitor-Hosted Program: WuXi AppTec—The Strategic Role of DART in Drug Development: Enhancing Safety and Efficiency

Location: Grand Sonoran I

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

Awards Ceremony

Location: Grand Saguaro North/South

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

Lunch on Your Own

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

Navigating the Frontier of Science and Regulation: Exploring the Latest Breakthroughs in New Approach Methodologies (S10)

Location: Grand Sonoran E

Symposium Chair: – AbbVie

Symposium Speaker: – Sanofi

Symposium Speaker: – Amgen

Symposium Speaker: – NC3Rs

Symposium Speaker: – Pfizer, Inc.

AdvancedEmerging

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

Introduction (S10-1)

Symposium Speaker: – AbbVie Inc.

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

EFPIA: Use of New Approach Methodologies in Nonclinical Safety Strategies (S10-2)

Symposium Speaker: – Sanofi

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

NAMs-Based Global Regulatory Filings in Pharmaceutical Nonclinical Safety Assessments (S10-3)

Symposium Speaker: – Amgen

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

Break (S10-Break)

3:45 PM - 4:10 PM (MT)

Accelerating the Development and Impact of New Approach Methodologies (NAMs) in Pharmaceutical Development (S10-4)

Symposium Speaker: – UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)

4:10 PM - 4:35 PM (MT)

The IQ MPS Affiliate: Pharmaceutical Perspective and Overview of Activities Towards Implementation of Complex In Vitro Models and Microphysiological Systems in Drug Development (S10-5)

Symposium Speaker: – Pfizer

4:35 PM - 5:00 PM (MT)

Panel Discussion (S10-Panel)

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

Strategic Use of Transgenic Mice or Surrogate Molecules in DART Studies to Support Biologic Drug Development: Recent Success/Failure (S11)

Location: Grand Sonoran F

Symposium Chair: – Gilead Sciences, Inc.

Symposium Chair: – Argus International, Inc.

Symposium Speaker: – Labcorp

Symposium Speaker: – Akkeri, Inc.

Symposium Speaker: – Pharmaceuticals and Medical Devices Agency

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

Symposium Speaker: – Eli Lilly and Company

AdvancedPractical

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

Introduction (S11-1)

Symposium Speaker: – Labcorp

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

The US Regulatory Perspective on Using Transgenic Animal Models and Surrogate Molecules (S11-2)

Symposium Speaker: – Akkeri

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

DART Evaluation Using Transgenic Animal Models and Surrogate Molecules :A PMDA perspective (S11-3)

Symposium Speaker: – PMDA (Pharmaceuticals and Medical Devices Agency)

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

Break (S11-Break)

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

The Pharmaceutical Industry Perspective on Using Transgenic Animal Models and Surrogate Molecules (S11-4)

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

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

The Pharmaceutical Industry Perspective on Using Transgenic Animal Models and Surrogate Molecules for DART (S11-5)

Symposium Speaker: – Eli Lilly and Company

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

Panel Discussion (S11-Panel)

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

What to Do When Things Go Wrong: Perspectives from Early Career Experts on Navigating Unexpected Situations (S12)

Location: Grand Sonoran G

Symposium Chair: – Bristol-Myers Squibb

Symposium Chair: – Toxicology Solutions, Inc.

Symposium Chair: – Deerfield Discovery and Development (3DC)

Symposium Speaker: – Gad Consulting Services

Symposium Speaker: – Labcorp Biopharma Laboratory Services

Symposium Speaker: – Deerfield Discovery and Development (3DC)

Symposium Speaker: – BlueRock Therapeutics

AdvancedPractical

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

Introduction (S12-1)

Symposium Chair: – Bristol-Myers Squibb

2:10 PM - 2:30 PM (MT)

My Feminine Products Might Be Toxic with Metals: Should I Be Concerned? (S12-2)

Symposium Speaker: – Gad Consulting Services

2:30 PM - 2:50 PM (MT)

Under Control: Unexpected Lung Findings in a Juvenile New Zealand White Rabbit Synthetic Surfactant Inhalation Study (S12-3)

Symposium Speaker: – Labcorp Biopharma Laboratory Services

2:50 PM - 3:15 PM (MT)

Tremors v. Convulsions and Implications for When They Are Confused (S12-4)

Symposium Speaker: – Deerfield Discovery and Development (3DC)

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

Break (S12-Break)

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

Regulatory Challenges Faced During the Drug Review Process: Cell Therapy Edition (S12-5)

Symposium Speaker: – BlueRock Therapeutics

4:15 PM - 5:00 PM (MT)

Panel Discussion: Navigating as an Early Career Professional (S12-Panel)

4:30 PM - 5:30 PM (MT)

Poster Dismantle

Location: Exhibit Hall

4:30 PM - 6:30 PM (MT)

Exhibition Dismantle

Location: Exhibit Hall

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

ACT Members’ Meeting

Location: Wildflower A

6:30 PM - 7:30 PM (MT)

ACT Member Mixer

Location: Grand Saguaro East