APT 2025 AGENDA
| May 13, 2025 | Discovery Toxicology |
| May 14, 2025 morning | Discovery Toxicology |
| May 14, 2025 afternoon | Development Toxicology |
| May 15, 2025 | Development Toxicology |
Agenda Updated 05/02/2025
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DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 13, 2025 Times listed in the agenda are local (Pacific) time |
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| Session | Topic | Speaker | Company | Time |
| Registration and Lunch | 12:00-1:00 | |||
| Conference Opening and Plenary Speaker Introduction |
Jodi Goodwin |
Takeda | 1:00-1:10 | |
| Plenary Lecture: Integrating Generative AI with Active Learning to Power Next Generation Drug Discovery | Richard Bonneau | Genentech | 1:10-1:55 | |
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Session I: Digital Pathology & Spatial Transcriptomics (Applications) Moderators: Yoav Timsit, Novartis, Darcy Clark, Merck & Jodi Goodwin, Takeda |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 1:55-2:00 | |||
| Comparison of Supervised and Unsupervised Machine Learning Scoring of Histology Images | Tom Forest | Merck | 2:00-2:30 | |
| Model Detection of the Seen and Unseen: A Multi-paradigm Approach to Histologic Anomaly Detection | Fangyao Hu | Genentech | 2:30-3:00 | |
| Vendor Talk: h-VIOS: A Human-relevant Drug Discovery and Development Platform Using Bioprinted Tissues | Taci Pereira |  |
3:00-3:25 | |
| Break | 3:25-3:50 | |||
| Computational Pathology Applied to Toxicologic Pathology | Byunghak (BK) Kang | Novartis |
3:50-4:20 |
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| Context-specific Applications Across Spatial Transcriptomic Platform | David Gallegos | Takeda | 4:20-4:50 | |
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Rapid Fire Poster Presentations: 1. Logan Porter, Lena Biosciences, 2. Maria Walczak, Jagielllonian Univ. Medical College, Poland 3. Julia Co, Genentech |
4:50-5:10 | |||
| Day 1 Closing Remarks | 5:10-5:15 | |||
| DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 14, 2025 | ||||
| Registration and Breakfast | 7:00-8:00 | |||
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Session II: Traditional & New Modalities - Case Studies Moderators: Connie Wu, Genentech, Jonathan Heyen, Treeline Bio & Helen Yu, Vertex |
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| Session Introduction | 8:00 - 8:05 | |||
| Safety Considerations for Developing Molecular Glues and other Targeted Protein Degraders | Jessica Sims | Genentech | 8:05 - 8:35 | |
| Global Off-Target Profiling of Targeted Protein Degraders with a Cell-Based Proteomics Platform | Xiaoting Wang | Amgen | 8:35 - 9:05 | |
| Oligonucleotides in Discovery: A Case Study of an siRNA for the Treatment of Chronic Hepatitis B Virus Infection | Dinah Misner | Aligos Therapeutics | 9:05 - 9:35 | |
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Vendor Talk: Preclinical Neurotoxicity Prediction Using a High-Throughput Neural Spheroid Model
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David A. Gallegos | Takeda | 9:35-9:50 | |
| Break | 9:50 - 10:10 | |||
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Session III: 4th Generation of ADC's Moderators: Rama Pai, Merck & Prathap Kumar Mahalingaiah, AstraZeneca |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 10:10 - 10:15 | |||
| Nonclinical Safety Assessment of Antibody-Oligo Conjugates from IND-enabling through Late-Stage Clinical Trials | Laura Leung | Avidity Biosciences | 10:15 - 10:40 | |
| The Use of In Vitro Assays for Novel Payload Selection in New-Generation ADCs | Diana Lac | Genentech | 10:40 - 11:05 | |
| Opportunities and Challenges for Preclinical Assessment of Next Generation ADCs | Haley Neff-LaFord | Pfizer | 11:05 - 11:30 | |
| Integrating PKPD Modeling and Clinical Toxicity Meta-Analysis towards Therapeutic Index prediction for Antibody-Drug Conjugate | Mahua Roy | AstraZeneca | 11:30 - 11:55 | |
| Vendor Talk: An AI Approach to Drug-Induced Liver Injury Risk: Prediction of Safe Maximum Doses from Toxicogenomic Profile | Chris Strock |  |
11:55-12:20 | |
| Lunch | 12:20-1:40 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 14, 2025 | ||||
| Workshop Introduction and Speaker Introduction | 1:40 - 1:50 | |||
| Plenary Lecture: Harnessing Generative AI in Nonclinical Safety Evaluation | Zhichao Liu | Boehringer Ingelheim | 1:50 - 2:30 | |
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Session IV: Revolutionizing Toxicology & Reducing Animal Experimentation: New Approach Methodologies (NAM's) and Virtual Controls Moderators: Betty Pettersen, Alexion, Yuan Lu, CinRx Pharma & Surekha Akella, AbbVie |
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| Session Introduction | 2:30 - 2:35 | |||
| Opportunities and Insights From Pharma On the Use of NAMs to Replace Large Animal Studies in Nonclinical Safety Assessments for Biotherapeutics | Kim Homan | Genentech | 2:35 - 3:05 | |
| Advancing Pre-Clinical Safety Assessment with Advanced Cell Models | Natacha Bohin | AstraZeneca | 3:05 - 3:35 | |
| Break | 3:35 - 3:55 | |||
| Leveraging the Proteome: Harnessing in vitro NAMs to Understand Human and Non-Human Protein Binding Profiles for Therapeutics | Nick Brown | Charles River Laboratories | 3:55 - 4:25 | |
| Insights into Building a Robust Virtual Control Database and Selection Methods for Use on Retrospective Analysis of Nonclinical Safety Assessment Studies | Jillian Wendel | LabCorp | 4:25 - 4:55 | |
| Poster Session and Reception | 4:55 - 6:10 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 15, 2025 | ||||
| Breakfast | 7:00 - 8:00 | |||
| Workshop Introduction | 8:00 - 8:05 | |||
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Session V: New Generations ADC's ( Antibody-siRNA-Conjugates (ARC), Peptide-drug Conjugates (PDC) Moderators: Christine Mollica, Amgen, Ed Dere, Genentech, Daniella Pizarro, Merck & Pia Kasperkovitz, Bright Peak Therapeutics |
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| Session Introduction | 8:05 - 8:10 | |||
| Nonclinical Safety Strategies for ADC Development - Looking Back to Move Forward | Christina de Zafra | Pfizer | 8:10 - 8:35 | |
| Unique Platform Toxicities of ADCs - Learnings Over the Last Decade | Magali Guffroy | AbbVie | 8:35 - 9:00 | |
| Case Study: Regulatory Interactions and Path to IND for a Novel Antibody-Protein Conjugate | Pia Kasperkovitz | Bright Peak Therapeutics | 9:00 - 9:25 | |
| AM Break | 9:25 - 9:45 | |||
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Session VI: Pioneering Cell and Gene Therapies: Expanding Horizons Beyond CAR-T Moderators: Heather Kowalski, BlueRock Therapeutics, Joe Cichocki, Vertex & Michael Santostefano, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:45 - 9:50 | |||
| Protecting Allogeneic Transplants from Immune Rejection is the Key to Bringing Cell-Based Therapies to Patients | Sonja Schrepfer | Sana Biotechnology | 9:50 - 10:15 | |
| Supporting Clinical Trials for Non-Cancer Cell Therapies - From Patient and Treatment Plans, Backwards | Lauren Black | CRL | 10:15 - 10:40 | |
| Modeling Approaches to Support Dose Selection for Cell and Gene Therapies | Raibatak Das | Quantilogix, LLC | 10:40 - 11:05 | |
| Conference Closing | 11:05 - 11:10 | |||