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 03/11/2025
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DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 13, 2025 |
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| Session | Topic | Speaker | Company | Time |
| Registration and Lunch | 12:00-1:00 | |||
| Conference Opening and Plenary Speaker Introduction |
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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: TBA | TBA | TBA | 3:00-3:25 | |
| Break | 3:25-3:50 | |||
| Title TBA | Byunghak (BK) Kang | Novartis | 11:15-11:45 | |
| Vendor Talk: TBA |
TBA |
TBA | 4:20-4:30 | |
| Context-specific Applications Across Spatial Transcriptomic Platform | David Gallegos | Takeda | 4:30-5:00 | |
| Day 1 Closing Remarks | 5:00-5:10 | |||
| DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 14, 2025 | ||||
| Registration and Breakfast | 7:00-8:00 | |||
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Session II: New Modalities & Traditional Molecules - 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 | |
| Talk title TBA | TBA | TBA | 9:05 - 9:35 | |
| Break | 9:35 - 9:55 | |||
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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 | 9:55 - 10:00 | |||
| Integrating PKPD Modeling and Clinical Toxicity Meta-Analysis towards Therapeutic Index prediction for Antibody-Drug Conjugate | Mahua Roy | AstraZeneca | 10:00 - 10:25 | |
| Nonclinical Safety Assessment of Antibody-Oligo Conjugates from IND-enabling through Late-Stage Clinical Trials | Laura Leung | Avidity Biosciences | 10:25 - 10:50 | |
| The Use of In Vitro Assays for Novel Payload Selection in New-Generation ADCs | Diana Lac | Genentech | 10:50 - 11:15 | |
| Talk Title TBA | Haley Neff-LaFord | Pfizer | 11:15 - 11:40 | |
| Vendor Talk: TBA | TBA | TBA | 11:40-12:05 | |
| Lunch | 12:05-1:25 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 15, 2024 | ||||
| Workshop Introduction and Speaker Introduction | 1:25 - 1:35 | |||
| Plenary Lecture: Harnessing Generative AI in Nonclinical Safety Evaluation | Zhichao Liu | Boehringer Ingelheim | 1:35 - 2:15 | |
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Session IV: Revolutionizing Toxicology: Virtual Controls, Digital Pathology, NAMs, and Species Alternatives in Drug Development Moderators: Betty Pettersen, Alexion, Yuan Lu, CinRx Pharma & Surekha Akella, AbbVie |
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| Session Introduction | 2:15 - 2:20 | |||
| Opportunities and Insights From Pharma On the Use of NAMs to Replace Large Animal Studies in Nonclinical Safety Assessments for Biotherapeutics | Kim Homan | Genentech | 2:20 - 2:40 | |
| Break | 2:40 - 3:00 | |||
| Vendor Talk: TBA | TBA | TBA | 3:00 - 3:10 | |
| Insights into Building a Robust Virtual Control Database and Selection Methods for Use on Retrospective Analysis of Nonclinical Safety Assessment Studies | Jillian Wendel | LabCorp | 3:10 - 3:30 | |
| Title TBA | TBA | TBA | 3:30 - 3:50 | |
| Title TBA | TBA | TBA | 3:50 - 4:10 | |
| Panel Discussion - Session IV Speakers | 4:10 - 4:30 | |||
| Poster Session and Reception | 4:30 - 5:45 | |||
| 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 | Merck | 8:10 - 8:40 | |
| Unique Platform Toxicities of ADCs - Learnings Over the Last Decade | Magali Guffroy | AbbVie | 8:40 - 9:10 | |
| Case Study: Regulatory Interactions and Path to IND for a Novel Antibody-Protein Conjugate | Pia Kasperkovitz | Bright Peak Therapeutics | 9:10 - 9:40 | |
| AM Break | 9:40 - 10:00 | |||
| Vendor Talk: TBA | TBA | TBA | 10:00 - 10:25 | |
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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 | 10:25 - 10:30 | |||
| Protecting Allogeneic Transplants from Immune Rejection is the Key to Bringing Cell-Based Therapies to Patients | Sonja Schrepfer | Sana Biotechnology | 10:30 - 11:00 | |
| Supporting Clinical Trials for Non-Cancer Cell Therapies - From Patient and Treatment Plans, Backwards | Lauren Black | CRL | 11:00 - 11:30 | |
| Title TBA | TBA | TBA | 11:30 - 12:00 | |
| Conference Closing | 12:00 - 12:05 | |||