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 03/04/2026
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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: Title TBA | 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 | |
| Title TBA | Wei Wang | Eli Lilly | 10:20-10:45 | |
| Break | 10:45-11:05 | |||
| Title TBA | John Vahle |
Eli Lilly |
11:05:11:30 |
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| Vendor Talk: Intestinal and Hepatic Organoid Systems: In Vitro Models of Drug Toxicity | Jenna Moccia | Stemcell Technologies | 11:30-11:55 | |
| Lunch | 11:55-1:10 | |||
| Vendor Talk: Title TBA | TBD | Southern Research | 1:10-1:20 | |
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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 | 1:20-1:25 | |||
| Title TBA | TBD | TBD | 1:25-1:50 | |
| Integrating T‑Cell Engagers: Evolution, Preclinical safety packages in Oncology | Nirav Patel | AstraZeneca | 1:50-2:15 | |
| Title TBA | Sophie Tourdot | Pfizer | 2:15-2:40 | |
| Break | 2:40-3:00 | |||
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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 | 3:00-3:05 | |||
| Title TBA | Russ Naven | Novartis | 3:05-3:30 | |
| Title TBA | Matt Wagoner | Takeda | 3:30-3:55 | |
| Title TBA | TBD | TBD | 3:55-4:20 | |
| Title TBA | Runxi Shen | Broad Institute | 4:20-4:45 | |
| Day 1 Closing Remarks | 4:45-4:50 | |||
| DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 6, 2026 | ||||
| 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 - 9:30 | |
| Use of NAMs to Support Early Safety Assessment in Drug Development | Rebecca Kohnken | AbbVie | 9:30 - 9:55 | |
| Title TBA | TBD | TBD | 9:55 - 10:20 | |
| Break | 10:20 - 10:40 | |||
| 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 | 10:40-10:45 | |||
| Title TBA | Zhechu Peng | AstraZeneca | 10:45-11:10 | |
| Title TBA | TBD | FDA | 11:10-11:35 | |
| In vitro Developmental Toxicity Testing of PROteolysis-TArgeting Chimeras (PROTACs) | Giel Hendriks | Toxys Netherlands | 11:35-12:00 | |
| Lunch | 12:00-1:15 | |||
| Workshop Introduction and Speaker Introduction | 1:15-1:25 | |||
| Plenary Lecture: Title TBA | Ron Wange | Aclairo Pharmaceutical Development Group/former FDA | 1:25 - 2:05 | |
| Vendor Talk: Benefits of Early In Vitro Screening for Seizure Liability in Problem Solving and Decision Making | Kim Rockley | AconiX | 2:05-2:30 | |
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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 | 2:30-2:35 | |||
| Alternative Approaches During T Cell Engager Development: Regulatory Interactions, Scientific Rigor and Reduced NHP Usage | Petra Lutterbuese | Amgen | 2:35-3:00 | |
| IQ Survey - Strategies to Reduce NHP Use in the Nonclinical Development of Oncology Therapeutics | Kaushik Datta | Merck | 3:00-3:25 | |
| Title TBA | Marie Lemper | USB | 3:25-3:55 | |
| Reception | 3:55-5:10 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 7, 2026 | ||||
| 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 | |
| Title TBA | 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 |
J & J Novartis |
9:55 - 10:25 | |
| Vendor Talk: Title TBA | TBD | Evotec | 10:25-10:45 | |
| AM Break | 10:45-11:05 | |||
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Session VI: Targeted Protein Degraders & Degrader Antibody Conjugates (DAC's) Moderators: Jon Maher, Pliant, Christine Mollica, Amgen, and Daniella Pizzurro, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 11:05-11:10 | |||
| Title TBA | Rhiannon Harwick | BMS | 11:10-11:35 | |
| Title TBA | Matt Lalonde | Kymera Therapeutics | 11:35-12:00 | |
| Title TBA | Lise Loberg | AbbVie | 12:00-12:35 | |
| Conference Closing | 12:25-12:30 | |||