APT 2026 AGENDA
| May 5, 2026 | Discovery Toxicology |
| May 6, 2026 morning | Discovery Toxicology |
| May 6, 2026 afternoon | Development Toxicology |
| May 7, 2026 | Development Toxicology |
Agenda Updated 04/16/2026
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DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 5, 2026 |
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| Session | Topic | Speaker | Company | Time |
| Registration and Breakfast | 8:00-9:00 | |||
| Conference Opening and Plenary Speaker Introduction |
Kathryn Fraser |
Merck | 9:00-9:10 | |
| Plenary Lecture: DILI Risk Prediction: Focus on Mechanism | Jack Uetrecht | University of Toronto | 9:10-9:50 | |
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Session I: Obesity Drugs - Toxicology Insights for GLP-1 and Peptide Therapeutics Moderators: Michael Kerins, Eli Lilly and Rama Pai, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:50-9:55 | |||
| Body Weight Modulation: Contributors and Cardiometabolic Health Consequences | Qi Sun | Harvard | 9:55-10:20 | |
| Navigating the Nuances: Key Considerations in Peptide Toxicology Strategy | Wei Wang | Eli Lilly | 10:20-10:45 | |
| Break | 10:45-11:10 | |||
| Addressing Safety Concerns of GLP-1 Receptor Agonists - A Case Study | John Vahle |
Eli Lilly |
11:10:11:35 |
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| Vendor Talk: Intestinal and Hepatic Organoid Systems: In Vitro Models of Drug Toxicity | Riya Sharma | Stemcell Technologies | 11:35-12:00 | |
| Lunch | 12:00-1:15 | |||
| Vendor Talk: Southern Research Institute: The Oldest US CRO? | Bill Coode | Southern Research | 1:15-1:25 | |
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Session II: Incorporating the Immune System into Discovery Toxicology Moderators: Prathap Kumar Mahalingaiah, AstraZeneca, Kathryn Fraser, Merck and Jonathan Heyen, Treeline Bio |
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| Session Introduction | 1:25-1:30 | |||
| Immune System Evaluation and Immunopathology Considerations in Discovery Toxicology | Tracey Papenfuss | StageBio | 1:30-1:55 | |
| Integrating T‑Cell Engagers: Evolution, Preclinical safety packages in Oncology | Nirav Patel | AstraZeneca | 1:55-2:20 | |
| Exploring Hapten Formation in Anti-Drug Antibody Development | Sophie Tourdot | Pfizer | 2:20-2:45 | |
| Break | 2:45-3:10 | |||
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Session III: AI in Toxicology - From Prediction to Oversight/Decision-Making Moderators: Jodi Goodwin, Takeda and Yoav Timsit, Novartis |
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| Session Introduction | 3:10-3:15 | |||
| Redefining How We Discover Safer Medicines with AI and NAMs | Russ Naven | Novartis | 3:15-3:40 | |
| AI-enabled Prediction of DILI with Transcriptomics | Matt Wagoner | Takeda | 3:40-4:05 | |
| AI-powered Translational Safety Intelligence to Anticipate Drug Safety | Ramon Flores | Clarivate | 4:05-4:30 | |
| From Cell Morphology to Human Safety: Predictive Liver Toxicity Across Cell Types Using Cell Painting and Machine Learning | Runxi Shen | Broad Institute | 4:30-4:55 | |
| Day 1 Closing Remarks | 4:55-5:00 | |||
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DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 6, 2026
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| Registration and Breakfast | 8:00-9:00 | |||
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Session IV: NAM's - Case Studies & Practical Application Moderators: Gina Yanochko, Johnson & Johnson, Satoko Kiyota, Genentech and Helen Yu, Vertex |
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| Session Introduction | 9:00 - 9:05 | |||
| New Approach Methodologies (NAMs): Role of Nonclinical Scientists | Radha Sura | Gilead | 9:05 - 9:35 | |
| Use of NAMs to Support Early Safety Assessment in Drug Development | Rebecca Kohnken | AbbVie | 9:35 - 10:00 | |
| From Discovery to Safety: Human-relevant Complex In Vitro Models as Fit-For-Purpose Decision Tools | Xinming Tong | Genentech | 10:00 - 10:25 | |
| Break | 10:25 - 10:50 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 6, 2026 | ||||
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Session I: NAM'S and the FDA Roadmap: Regulatory Evolution & Industry Practice Moderators: Betty Pettersen, Alexion, Yuan Lu, CinRx Pharma, Birgit Fogal, Sanofi, and Radha Sura, Gilead |
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| Session Introduction | 10:50-10:55 | |||
| Plenary Lecture: Right-Sizing The Use of Animals In The Nonclinical Safety Assessment | Ron Wange | Alcario Pharmaceutical Development Group/former FDA | 10:55-11:35 | |
| Nonclinical Toxicology Package To Support The Clinical Development of a TcE | Zhechu Peng | AstraZeneca | 11:35-12:00 | |
| In vitro Developmental Toxicity Testing of PROteolysis-TArgeting Chimeras (PROTACs) | Giel Hendriks | Toxys Netherlands | 12:00-12:25 | |
| Lunch | 12:25-1:40 | |||
| Vendor Tak Intro | 1:40-1:45 | |||
| Vendor Talk: Benefits of Early In Vitro Screening for Seizure Liability in Problem Solving and Decision Making | Kim Rockley | AconiX | 1:45-2:10 | |
| Break | 2:10-2:25 | |||
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Session II: “Expect the Unexpected: Regulatory Curveballs in Today’s Nonclinical Development” Moderators: Satheesh Anand, Boehringer Ingelheim, Surekha Akella, AbbVie, Michael Santostefano, Merck, and Heather Kowalski, BlueRock Therapeutics |
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| Session Introduction | 2:25-2:30 | |||
| Alternative Approaches During T Cell Engager Development: Regulatory Interactions, Scientific Rigor and Reduced NHP Usage | Petra Lutterbuese | Amgen | 2:30-2:55 | |
| IQ Survey - Strategies to Reduce NHP Use in the Nonclinical Development of Oncology Therapeutics | Kaushik Datta | Merck | 2:55-3:20 | |
| Lost In Translation: From ePPND Study to Label | Marie Lemper | USB | 3:20-3:50 | |
| Round table discussion | 3:50-4:10 | |||
| Reception | 4:10-5:25 | |||
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DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 7, 2026
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| Breakfast | 8:00-9:00 | |||
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Session III: Next-Generation Biotherapeutics & Complex Modalities Moderators: Yu-Mee Kim, Genentech, Emma Karey, AstraZeneca, and Nardos Tassew, The Janssen Pharmaceutical Companies of Johnson & Johnson |
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| Session Introduction | 9:00 - 9:05 | |||
| Nonclinical Developmental Considerations of RNA-based Complex Biologics | Sheroy Minocherhomji | Eli Lilly | 9:05 - 9:30 | |
| Insights From Evaluations of Two Next-generation Trastuzumab Auristatin Conjugates - Trastuzumab-MMAU and Trastuzumab-AS269 | Onyi Irrechukwu | Johnson& Johnson | 9:30 - 9:55 | |
| T Cell engagers for no-Oncology indications: Bench to Bedside Considerations for Dose and Safety |
Kavita Raman Ryan Polli |
Amgen Novartis |
9:55 - 10:25 | |
| Vendor Talk: Title TBA | TBD | Evotec | 10:25-10:45 | |
| AM Break | 10:45-11:15 | |||
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Session VI: Breaking It Down: Preclinical Development Strategies for Targeted Protein Degraders Moderators: Jon Maher, Pliant, Christine Mollica, Amgen, and Daniella Pizzurro, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 11:15-11:20 | |||
| Evolving Discovery Toxicology Strategies for Targeted Protein Degraders | Rhiannon Harwick | BMS | 11:20-11:45 | |
| CRBN-Based Degrader Specificity Eliminates Potential Developmental Toxicity | Matthew Lalonde | Kymera Therapeutics | 11:45-12:10 | |
| A Novel Bile Duct Toxicity In Dogs Associated With a Heterobifunctional Protein Degrader | Lise Loberg | AbbVie | 12:10-12:35 | |
| Conference Closing | 12:35-12:40 | |||