Full Schedule

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

CE Continental Breakfast

Location: Grand Saguaro East/West

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

New Member Mingle and VIP Breakfast

Location: Pinnacle Peak 2

7:00 AM - 6:00 PM (MT)

Registration Open

Location: Grand Sonoran Foyer

7:59 AM - 4:30 PM (MT)

Strategies for Successful Nonclinical Studies: Study Director and Study Monitor Workshop (CE1)

Location: Wildflower A

CE Course Chair: – Labcorp

CE Course Chair: – Altasciences

CE Course Speaker: – Inotiv

CE Course Speaker: – Labcorp Early Development Laboratories Ltd

CE Course Speaker: – Blueprint Medicines, a Sanofi Company

CE Course Speaker: – GSK

CE Course Speaker: – Hartsough Nonclinical Consulting, LLC

CE Course Speaker: – Preclinical Safety Associates, LLC

Panelist: – Labcorp

BasicPractical

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

Welcome and Introduction (CE1-1)

CE Course Speaker: – Labcorp

8:30 AM - 8:50 AM (MT)

You Were Awarded Some Studies Today (CE1-2)

CE Course Speaker: – Altasciences

8:50 AM - 9:30 AM (MT)

Mise en Place: Nuts and Bolts for a Study Protocol Development (CE1-3)

CE Course Speaker: – Inotiv

9:30 AM - 10:00 AM (MT)

Break (CE1-Break)

10:00 AM - 11:30 AM (MT)

Getting a Study off the Ground and Staying in the Air: Managing the Expected Unexpected (CE1-4)

CE Course Speaker: – Labcorp Early Development Laboratories

11:30 AM - 12:30 PM (MT)

Lunch On Your Own (CE1-Lunch)

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

Mitigation: Toxicity is Expected and Deviations Will Happen! (CE1-5)

CE Course Speaker: – Blueprint Medicines, a Sanofi Company

1:30 PM - 2:30 PM (MT)

Study Conduct and Study Monitoring: A Collaborative Dance (CE1-6)

CE Course Speaker: – GSK

2:30 PM - 3:00 PM (MT)

Break (CE1-Break)

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

FDA: Friend or Foe? (CE1-7)

CE Course Speaker: – Hartsough Nonclinical Consulting, LLC

3:15 PM - 4:20 PM (MT)

Data Interpretation and Study Results: Report Writing and Knowing Your Audience (CE1-8)

CE Course Speaker: – Preclinical Safety Associates, LLC

4:20 PM - 4:30 PM (MT)

Panel Discussion (CE1-Panel)

Panelist: – Labcorp

8:00 AM - 11:30 AM (MT)

Assessing Suitable Transgenic/Humanized Mouse (huMouse) Models and Their Utility for Nonclinical Safety Evaluation—Case Study Examples (CE2)

Location: Grand Sonoran F

CE Course Chair: – Lilly ExploR&D Development Sciences

CE Course Chair: – Regeneron Pharmaceuticals

CE Course Speaker: – US FDA

CE Course Speaker: – Roche Glycart AG

CE Course Speaker: – Experimental Pathology Laboratories, Inc.

Panelist: – Lilly ExploR&D Development Sciences

AdvancedPractical

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

An A-Z of Transgenic and Humanized Mouse Models (CE2-1)

CE Course Speaker: – US FDA

8:30 AM - 9:00 AM (MT)

Characterization of Genetically Engineered Mouse Models (GEMMs) for Nonclinical Safety Assessment, A Case Example (CE2-2)

CE Course Speaker: – Roche Glycart AG

9:00 AM - 9:30 AM (MT)

Diagnostic Challenges Encountered During Pathology Evaluation of Humanized Mouse Models (CE2-3)

CE Course Speaker: – Experimental Pathology Laboratories, Inc.

9:30 AM - 10:00 AM (MT)

Break (CE2-Break)

10:00 AM - 10:30 AM (MT)

Utilizing Velocigene® Humanized Transgenic Mice to Evaluate Efficacy and Safety of Immuno-Oncology Therapeutics: Case Study and Considerations (CE2-4)

CE Course Speaker: – Regeneron Pharmaceuticals

10:30 AM - 11:00 AM (MT)

Humanized Mouse Model for Safety Assessment of Immunotherapeutic Antibody: Case Study Example (CE2-5)

CE Course Speaker: – Lilly ExploR&D Development Sciences

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

Panel Discussion (CE2-Panel)

Panelist: – Lilly ExploR&D Development Sciences

8:00 AM - 11:30 AM (MT)

Fundamentals of Artificial Intelligence/Machine Learning in Toxicology and Regulatory Decision Making (CE3)

Location: Grand Saguaro North/South

CE Course Chair: – IDEAYA Biosciences, Inc.

CE Course Chair: – US FDA

CE Course Speaker: – Genentech

CE Course Speaker: – Charles River Laboratories

CE Course Speaker: – National Institutes of Health

CE Course Speaker: – Certara

BasicEmerging

8:00 AM - 8:10 AM (MT)

Introduction (CE3-1)

CE Course Speaker: – IDEAYA Biosciences, Inc.

8:10 AM - 8:50 AM (MT)

Introduction to Artificial Intelligence: Key Concepts and Definitions (CE3-2)

CE Course Speaker: – Genentech

8:50 AM - 9:30 AM (MT)

Methodologies and Applications in Toxicology (CE3-3)

CE Course Speaker: – Charles River Laboratories

9:30 AM - 10:00 AM (MT)

Break (CE3-Break)

10:00 AM - 10:35 AM (MT)

Real-World Applications of AI in Toxicology (CE3-4)

CE Course Speaker: – National Institutes of Health

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

Challenges and Future Directions for AI in Toxicology (CE3-5)

CE Course Speaker: – Certara

11:10 AM - 11:30 AM (MT)

Interactive Panel Discussion (CE3-Panel)

8:00 AM - 11:30 AM (MT)

Growing Up in the ICH S11 Era: Advanced Topics in Juvenile Animal Toxicology (CE4)

Location: Grand Sonoran G

CE Course Chair: – Johnson & Johnson

CE Course Chair: – SciLucent, Inc.

CE Course Speaker: – Amgen

CE Course Speaker: – Charles River Laboratories Montreal

CE Course Speaker: – GEMpath, Inc.

CE Course Speaker: – European Medicines Agency

CE Course Speaker: – US FDA

AdvancedEmerging

8:00 AM - 8:05 AM (MT)

Introduction (CE4-1)

CE Course Chair: – Johnson and Johnson

8:05 AM - 8:35 AM (MT)

Navigating Nonclinical Pediatric Development: An Industry Perspective (CE4-2)

CE Course Speaker: – Amgen

8:35 AM - 9:05 AM (MT)

Do I Need Specialized Bone Evaluations for My Juvenile Animal Toxicity Studies? (CE4-3)

CE Course Speaker: – Charles River Laboratories Montreal

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

Design of Neurotoxicity Evaluations for Juvenile Animal Toxicity Studies (JAS) (CE4-4)

CE Course Speaker: – GEMpath, Inc.

9:30 AM - 10:00 AM (MT)

Break (CE4-Break)

10:00 AM - 10:30 AM (MT)

Enhancing Regulatory Alignment: Insights and Recommendations from 3 Years of ICH S11 Experience in the EU (CE4-5)

CE Course Speaker: – European Medicines Agency (EMA)

10:30 AM - 11:00 AM (MT)

An FDA Perspective of Pediatric Submission Post-ICH S11 (CE4-6)

CE Course Speaker: – US FDA

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

Panel Discussion (CE4-Panel)

8:00 AM - 11:30 AM (MT)

Neurotoxicology Case Studies: An Interactive Session Involving Industry and Regulatory Perspectives on Pharmaceutical Development (CE5)

Location: Grand Sonoran E

CE Course Chair: – Charles River Laboratories

CE Course Speaker: – Greenfield Pathology Services, Inc.

CE Course Speaker: – Bedard ADME-Tox Solutions

CE Course Speaker: – Roche Innovation Center Basel, F. Hoffman-La Roche

AdvancedPractical

8:00 AM - 8:50 AM (MT)

Functional Neurotoxicology: Regulatory Case Studies Including Expected and Unexpected Effects (CE5-1)

CE Course Speaker: – Charles River Laboratories

8:50 AM - 9:30 AM (MT)

Scoping Neuropathology: Tales from the Bench (CE5-2)

CE Course Speaker: – Greenfield Pathology Services, Inc.

9:30 AM - 10:00 AM (MT)

Break (CE5-Break)

10:00 AM - 10:30 AM (MT)

Assessment of Brain Penetration in CNS Drug Discovery & Development: Addressing the Challenges to Improve Outcomes (CE5-3)

CE Course Speaker: – Bedard ADME-Tox Solutions

10:30 AM - 11:00 AM (MT)

An Interactive Session on Toxicological Considerations for an Antisense Oligonucleotide (ASO) Program Design for a Neurodegenerative Disease Indication (CE5-4)

CE Course Speaker: – Charles River Laboratories

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

Convulsions in Göttingen Minipigs: A Case Study (CE5-5)

CE Course Speaker: – Roche Innovation Center Basel, F. Hoffman-La Roche

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

Lunch on Your Own

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

Exhibitor-Hosted Program: Altasciences—Nonhuman Primate Juveniles for Preclinical Studies: Breeding Colony Challenges and Opportunities

Location: Grand Sonoran I

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

Exhibitor-Hosted Program: Certara—The Future Is Now: Integrating New Approach Methodologies (NAMs) Into Your Drug Safety Assessment Program

Location: Grand Sonoran J

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

Exhibitor-Hosted Program: HUB Organoids—Redefining Toxicity Prediction with Patient-Derived Organoids

Location: Grand Sonoran H

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

Exhibitor-Hosted Program: Smithers—Strategies for Developing High Quality Bioanalytical Methods with Speed and Accuracy to Support Nonclinical Program Timelines

Location: Grand Sonoran K

1:00 PM - 4:30 PM (MT)

Do It Right: How to Interact with Global Regulatory Affairs on the Way to the Clinic and Through Marketing Approval (CE6)

Location: Grand Sonoran G

CE Course Chair: – Virscio

CE Course Chair: – Scilucent, Inc.

CE Course Speaker: – Intrinsik Corp.

CE Course Speaker: – US FDA

CE Course Speaker: – Avalyn Pharma

BasicPractical

1:00 PM - 1:10 PM (MT)

Introduction (CE6-1)

CE Course Speaker: – Scilucent, Inc.

1:10 PM - 1:50 PM (MT)

Nonclinical Decisions That Have Impacted Development (CE6-2)

CE Course Speaker: – Intrinsik Corp.

1:50 PM - 2:30 PM (MT)

Navigating Pre-IND and IND Submission: A Regulatory Perspective (CE6-3)

CE Course Speaker: – US FDA

2:30 PM - 3:00 PM (MT)

Break (CE6-Break)

3:00 PM - 3:40 PM (MT)

From IND to NDA: Toxicology and Regulatory Insights for NDA Submission (CE6-4)

CE Course Speaker: – US FDA

3:40 PM - 4:20 PM (MT)

Presentation of the Nonclinical Package for Enabling Clinical Studies in the EU, UK, Australia, and Canada (CE6-5)

CE Course Speaker: – Avalyn Pharma

4:20 PM - 4:30 PM (MT)

Panel Discussion (CE6-Panel)

1:00 PM - 4:30 PM (MT)

Minipigs in Toxicology: Where Are We Now and What Does the Future Hold? (CE7)

Location: Grand Sonoran E

CE Course Chair: – Florian Consulting in Toxicology and Safety Assessment

CE Course Chair: – JRF Global

CE Course Speaker: – GCS Global LLC

CE Course Speaker: – Roche Innovation Center Basel, F. Hoffman-La Roche

CE Course Speaker: – Andrew Makin Preclinical Consulting ApS

CE Course Speaker: – Hastings Toxicology Consulting

BasicPractical

1:00 PM - 1:05 PM (MT)

Introduction (CE7-1)

CE Course Speaker: – Florian Consulting in Toxicology and Safety Assessment

1:05 PM - 1:50 PM (MT)

Points to Consider with Minipigs in Systemic Toxicology Studies (CE7-2)

CE Course Speaker: – GCS Global LLC

1:50 PM - 2:30 PM (MT)

Safety Pharmacology in the Minipig: A Valuable Non-rodent Species (CE7-3)

CE Course Speaker: – Roche Innovation Center Basel, F. Hoffman-La Roche

2:30 PM - 3:00 PM (MT)

Break (CE7-Break)

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

What Data Gaps Need to Be Filled to Support the Use of Minipigs in DART Studies? (CE7-4)

CE Course Speaker: – Andrew Makin Preclinical Consulting ApS

3:35 PM - 4:10 PM (MT)

Immunology Considerations and Future Possibilities with Humanized Minipigs (CE7-5)

CE Course Speaker: – Hastings Toxicology Consulting

4:10 PM - 4:30 PM (MT)

Panel Discussion (CE7-Panel)

1:00 PM - 4:30 PM (MT)

The Discovery of MicroRNAs and the Evolution of Small RNA-Based Therapeutics (CE8)

Location: Grand Sonoran F

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

CE Course Speaker: – Levin Biosciences

CE Course Speaker: – Atalanta Therapeutics

CE Course Speaker: – Ionis Pharmaceuticals

BasicEmerging

1:00 PM - 1:10 PM (MT)

Introduction to MicroRNAs (CE8-1)

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

1:10 PM - 1:50 PM (MT)

MicroRNAs: A Nobel Experiment of Nature (CE8-2)

CE Course Speaker: – Levin Biosciences

1:50 PM - 2:30 PM (MT)

Advances and Challenges in the Development of microRNA Therapeutics (CE8-3)

CE Course Speaker: – Atalanta Therapeutics

2:30 PM - 3:00 PM (MT)

Break (CE8-Break)

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

Evolving Regulatory Landscape for miRNAs and Other Oligonucleotide-Based Therapeutics (CE8-4)

CE Course Speaker: – Aclairo Pharmaceutical Development Group

3:35 PM - 4:10 PM (MT)

Investigation of miRNA Upregulation of Gene Expression in the Treatment of Diseases of Haploinsufficiency (CE8-5)

CE Course Speaker: – Ionis Pharmaceuticals

4:10 PM - 4:30 PM (MT)

Panel Discussion (CE8-Panel)

1:00 PM - 4:30 PM (MT)

When, What, and How Developmental and Reproductive Toxicity Data Impact Clinical Trials and Labeling (CE9)

Location: Grand Saguaro North/South

CE Course Chair: – Pfizer, Inc.

CE Course Chair: – Insmed Incorporated

CE Course Speaker: – PTC Therapeutics, Inc.

CE Course Speaker: – ApconiX Ltd.

CE Course Speaker: – EdGe Toxicology Consulting Limited

CE Course Speaker: – Johnson & Johnson

CE Course Speaker: – PTC Therapeutics, Inc.

CE Course Speaker: – US FDA

AdvancedPractical

1:00 PM - 1:20 PM (MT)

Introduction to DART and Challenges Navigating Impact on Trials and Labeling (CE9-1)

CE Course Speaker: – PTC Therapeutics, Inc

1:20 PM - 1:40 PM (MT)

Perspectives and Examples from a Nonclinical Project Team Representative (CE9-2)

CE Course Speaker: – ApconiX Ltd.

CE Course Speaker: – EdGe Toxicology Consulting Limited

1:40 PM - 2:05 PM (MT)

Details Matter: How DART and Genetic Tox Assessment Support Clinical Trials and Labeling in Female Subjects/Patients (CE9-3)

CE Course Speaker: – Pfizer, Inc.

2:05 PM - 2:30 PM (MT)

Details Matter: How DART and Genetic Tox Assessment Support Clinical Trials and Labeling in Male Subjects/Patients (CE9-4)

CE Course Speaker: – Johnson & Johnson

2:30 PM - 3:00 PM (MT)

Break (CE9-Break)

3:00 PM - 3:40 PM (MT)

Clinical Perspective of How Nonclinical DART and Genetic Tox Studies Impact Clinical Trials (CE9-5)

CE Course Speaker: – PTC Therapeutics, Inc.

3:40 PM - 4:20 PM (MT)

Regulatory Perspective of the Nonclinical DART Assessment and Its Role in Clinical Risk Management (CE9-6)

CE Course Speaker: – US FDA

4:20 PM - 4:30 PM (MT)

Panel Discussion (CE9-Panel)

2:00 PM - 6:00 PM (MT)

Exhibition and Poster Setup

Location: Exhibit Hall

4:30 PM - 6:00 PM (MT)

Sip and Schmooze Social

Location: Grand Saguaro East/West