APT 2023 AGENDA
| May 16, 2023 | Discovery Toxicology |
| May 17, 2023 morning | Discovery Toxicology |
| May 17, 2023 afternoon | Development Toxicology |
| May 18, 2023 | Development Toxicology |
Note: Times listed are Pacific Time
Agenda Updated 05/04/2023 - Download Program Guide
| DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 16, 2023 | ||||
| Session | Topic | Speaker | Company | Time |
| Registration | 12:00 - 1:00 | |||
| Conference Opening and Plenary Speaker Introduction |
Rama Pai, Merck & Connie Wu, Genentech |
1:00 - 1:10 | ||
| Plenary Lecture: Safety Considerations for Selection and Development of Combination Therapies for Tuberculosis | Monicah Otieno | Bill and Melinda Gates Medical Research Institute | 1:10 - 1:55 | |
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Session I: Alternative Models Chairs: Jodi Goodwin, Takeda & Jon Heyen, Pfizer |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 1:55-2:00 | |||
| Utility of Zebrafish for Detecting Mitochondrial and Biliary Toxicities in Preclinical Safety | Steven Cassar | AbbVie | 2:00-2:30 | |
| ID.Flow: A Physiologically Relevant Test System for Nonclinical Safety Assessment of Different Drug Modalities | Erika Fletcher | Immuneed | 2:30-3:00 | |
| Vendor Talk - Human Intestinal Organoid Culture System for Drug-Induced Gastrointestinal Toxicity Screening | Martin Stahl & Danny Leung |  |
3:00-3:25 | |
| Break | 3:25-3:50 | |||
| Leveraging Organoids and Organs-on-Chip in Drug Development | Kim Homan | Genentech | 3:50-4:20 | |
| Vendor Talk- ReachBio Acquired by Discovery Life Sciences, Expanding Toxicology Solutions |
Marcela Alomia & Emer Clarke |
 |
4:20-4:30 | |
| Preclinical Safety Evaluation of mRNA Cancer Therapeutics: A Platform Approach | Anuhar Chaturvedi | BioNTech SE | 4:30-5:00 | |
| Poster Session and Reception | 5:00-6:30 | |||
| DISCOVERY TOXICOLOGY WORKSHOP- WEDNESDAY MAY 17, 2023 | ||||
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Session II: Understanding Unwanted Pharmacology Chairs: Jon Maher, Pliant Therapeutics & Yoav Timsit, Blueprint Medicines |
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| Registration and Breakfast | 7:00 - 8:00 | |||
| Session Introduction | 8:00 - 8:05 | |||
| Elucidating On and Off-target Effects of Protein Degraders Through Quantitative Proteomics | Joel Federspiel | Pfizer | 8:05 - 8:35 | |
| Current Strategies in Secondary Pharmacology and its Impact on the Safety of New Medicines | Yoav Timsit | Blueprint Medicines | 8:35 - 9:05 | |
| Screening of Antibody, Protein, and Cell Therapeutics for Potential Off-targets Using Human Cell Microarray Technology | Diogo Rodrigues Ferreirinha | Charles River Laboratories | 9:05 - 9:35 | |
| Break | 9:35 - 9:55 | |||
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Session III: In Vitro and In Silico Predictive Immunogenicity Chair: Prathap Mahalingaiah, AbbVie & Darcey Clark, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:55-10:00 | |||
| Systems Biology Approaches to Understand Immunologic Response/Precision Medicine to Improve Vaccines in Young and Elderly | Ofer Levy | Boston Children's Hospital | 10:00 - 10:30 | |
| Preclinical Immunogenicity Risk Assessment Approaches for Traditional Biologics and Next Generation Novel Modalities | Vibha Jawa | BMS | 10:30-11:00 | |
| Advancement in Translational In Vitro Models for Preclinical Immunogenicity and Immunosafety Risk Assessment | Ruchi Srivastava | AbbVie | 11:00-11:30 | |
| Vendor Talk - Liver Spheroid Models for Predictive and Investigative Toxicology | Bruno Filippi |  |
11:30-11:55 | |
| Lunch | 11:55 - 1:15 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 17, 2023 | ||||
| Workshop Introduction and Speaker Introduction | Edward Dere | Genentech | 1:15- 1:25 | |
| Plenary Lecture: A Stem Cell-Derived Implant for Dry Age-related Macular Degeneration | Dennis Clegg | UCSB | 1:25 - 2:05 | |
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Session IV: An Eye on the Eye! Chairs: Edward Dere, Genentech & Christine Mollica, Amgen |
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| Session Introduction | 2:05 - 2:10 | |||
| Ocular Inflammation in Non-clinical Ocular Toxicity Studies - An Evolution Understanding, Approaches, and Impact | Helen Booler | Novartis, Basel | 2:10 - 2:40 | |
| The Bigger Picture of Inflammation | Nora Denk | Roche, Basel | 2:40 - 3:10 | |
| Break | 3:10 - 3:30 | |||
| Vendor Talk: Nonclinical Safety Evaluation of Nanolipid Particles | Renzong Xie |  |
3:30 - 3:40 | |
| Looking to the Future: Evolving Considerations for Intravitreal (Ocular) Biologics Combination Toxicity Studies | Rachel Andrews | Genentech | 3:40 - 4:10 | |
| Poster Session and Reception | 4:10 - 5:25 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 18, 2023 | ||||
| Breakfast | 7:00 - 8:00 | |||
| Workshop Opening and Plenary Speaker Introduction | 8:00 - 8:05 | |||
| Plenary Lecture: BARDA, Medical Countermeasure Development, and the Animal Rule | Paul Roney | BARDA | 8:05 - 8:45 | |
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Session V: ABC's of ADC's Chairs: Michael Santostefano, Merck & Jairo Nunes, Novartis |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 8:45 - 8:50 | |||
| Current Strategies of Lead Op for Existing and Novel Conjugates | Melissa Schutten |
Seagen |
8:50 - 9:20 | |
| The Ultra-fast Journey of First Merck ADC | Cuixian (Trisha) Yang | Merck | 9:20 - 9:50 | |
| Engineering Antibody-Drug Conjugates for Solid Tumors | Ian Nessler | AbbVie | 9:50 - 10:20 | |
| Break | 10:20-10:40 | |||
| Vendor Talk: In vivo Neuropathology: Detecting the Neurotoxicity of Candidate Drugs during Early Drug Discovery | Craig Ferris |  |
10:40-11:05 | |
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Session VI: Nitrosamine Impurities Chairs: Betty Pettersen, Pfizer, Paul Cornwell, Eli Lilly, and Joe Cichocki, Vertex |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 11:05-11:10 | |||
| Nitrosamine SAR: I'll Show You a Read-across | Kevin Cross | Instem | 11:10-11:40 | |
| I've Got a Nitrosamine Impurity: What Now? | Joel Bercu | Gilead Sciences | 11:40-12:10 | |
| Schrödinger's Cat is Dead, but Not from Nitrosamine Exposure...Probably | Robert Jolly | Eli Lilly | 12:10-12:40 | |
| Conference Closing | 12:40-12:45 | |||