Full Schedule

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