APT 2024 AGENDA
| May 14, 2024 | Discovery Toxicology |
| May 15, 2024 morning | Discovery Toxicology |
| May 15, 2024 afternoon | Development Toxicology |
| May 16, 2024 | Development Toxicology |
Agenda Updated 04/22/2024
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Download APT 2024 Program Guide Here DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 14, 2024 |
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| Session | Topic | Speaker | Company | Time |
| Registration | 8:00 - 9:00 | |||
| Conference Opening and Plenary Speaker Introduction |
Connie Wu |
Genentech | 9:00 - 9:10 | |
| Plenary Lecture: Bench to Bedside: Nonclinical Considerations for First in Human Dosing for Novel Gene Therapies | Justine Cunningham | RegenX Bio | 9:10 - 9:50 | |
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Session I: Discovery Toxicology in New Modalities Employing Cutting-Edge Assay Systems/Emerging Technologies Moderators: Yoav Timsit, Novartis & Jodi Goodwin, Takeda |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:50-9:55 | |||
| Intestinal Organoids as Models to Predict and Evaluate Toxicity | Michael Beshiri | AstraZeneca | 9:55-10:25 | |
| Molecular Mapping of Heterogeneous Organs with Spatial Transcriptomics | Laura Armstrong | BMS | 10:25-10:55 | |
| Break | 10:55-11:15 | |||
| New Approach Methodologies for In Vitro Safety Assessment of Cell Therapies & Engagers | Taylor Hickman | Takeda | 11:15-11:45 | |
| Vendor Talk: Models and Imaging of The Blood-brain Barrier in Health and Disease |
Roger D. Kamm |
MIT | 11:45-12:10 | |
| Lunch | 12:10-1:25 | |||
| Vendor Talk - Preclinical Safety Evaluation for Antibody Drug Conjugates (ADCs) | Qingcong Lin | Medicilon | 1:25-1:35 | |
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Session II: Mastering Discovery Toxicology: Case Studies & Strategies Moderators: Jon Maher, Pliant Therapeutics & Prathap Kumar Mahalingaiah, AbbVie |
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| Session Introduction | 1:35 - 1:40 | |||
| An Introduction to Ocular Oligonucleotide Therapies: In-Life Observations and Associated Pathology | Krishna Yekkala | Johnson & Johnson | 1:40 - 2:10 | |
| Using Human Liver-on-a-Chip to Predict and De-Risk LNP and mRNA Toxicities | Samantha Atkins | Moderna | 2:10 - 2:40 | |
| Break | 2:40 - 3:00 | |||
| Evaluation of Drug-Induced Toxicity of Specific Cell Lineages in Rodent Bone Marrow via Transcriptional Biomarkers of Hematopoietic Cell Subpopulations | Keith Tanis | Merck | 3:00 - 3:30 | |
| No Panic All Disco: De-Risking Pre-Clinical Toxicity with a Potential First-In-Class TRPA1 Antagonist GDC-6599 for Respiratory Disease | Satoko Kakiuchi-Kiyota | Genentech | 3:30 - 4:00 | |
| Rapid Fire Poster Presentations | 4:00 - 4:40 | |||
| DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 15, 2024 | ||||
| Registration | 8:00 - 9:00 | |||
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Session III: Unpacking T-Cell Engagers Safety Assessment - Case Examples Moderators: Rama Pai, Merck & Darcey Clark, Merck |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:00 - 9:05 | |||
| Know Your Target: Unexpected Safety Findings with a T-cell Dependent Bispecific Antibody for Solid Tumors | Liz Tonkin | Genentech | 9:05 - 9:35 | |
| Unique Aspects for Building a Cell Therapy Nonclinical Safety Strategy | Tynisha Glover | Janssen | 9:35-10:05 | |
| Evaluation of Safety and Efficacy of Antibody Therapies in PBMC Humanized Mice | Li-Chin Yao | The Jackson Laboratory | 10:05-10:35 | |
| Break | 10:35-10:55 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 15, 2024 | ||||
| Workshop Introduction and Speaker Introduction | Daniella Pizzurro | Merck | 10:55- 11:05 | |
| Plenary Lecture: Application of AI on Drug Development and Regulatory Decision | Menglun Wang (in person) & Qi Liu (virtual) | FDA | 11:05-11:45 | |
| Vendor Talk: Metabolism Dependent Xenobiotic Toxicity Detected with Co-Cultured Hepatocytes and CD34+ Hematopoietic Stem Cells (HSC) | Albert Li | Discovery Life Sciences | 11:45-12:10 | |
| Lunch | 12:10-1:40 | |||
| Vendor Talk: RepliGut® StemTox™ Assay: A Human Primary Stem Cell-Based in vitro Assay for Predicting the Gastrointestinal Toxicity Risk of Therapeutic Agents | Maureen Bunger | Altis Biosystems | 1:40-1:50 | |
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Session I: Occupational Exposure Guidance & Learnings for New Modalities Moderators: Michael Santostefano, Merck & Betty Pettersen, Alexion |
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| Session Introduction | 1:50 - 1:55 | |||
| Health Based-Exposure Limits (OELs, PDEs) for New Modalities: How are they calculated, and for which type of modalities are they needed? | Claudia Sehner | Boehringer Ingelheim | 1:55 - 2:15 | |
| Adapting Occupational Toxicology to Navigate a New Modality Landscape – How Hazard Assessment Considerations are Evolving Alongside our Pipelines | Elizabeth Vancza | Merck | 2:15 - 2:35 | |
| Evaluating and Controlling Biologically-Derived Materials | Stephen Nowakowski | SafeBridge Regulatory & Life Sciences Group, Trinity Consultants, Inc. | 2:35 - 2:55 | |
| Biologics and Advanced Therapies Manufacturing: Employing Biorisk Management and Occupational Toxicology in CDMO Operations | AJ Troiano | FUJIFILM Diosynth Biotechnologies | 2:55 - 3:15 | |
| Panel Discussion - Session IV Speakers | 3:15 - 3:30 | |||
| Break | 3:30 - 3:50 | |||
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Session II: New Approaches for Non-clinical Safety Evaluation Moderators: Yuan Lu, CinRx Pharma & Christine Mollica, Amgen |
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| Session Introduction | 3:50 - 3:55 | |||
| Development of Novel Human-Specific Therapeutics with Only Partial or No Cross-Reactivity to Standard Toxicology Species: Case Examples | Oliver Thomas | Amgen | 3:55 - 4:25 | |
| Drug Safety Risk Mitigation with Organoid-Based Approach | Tada Shinozawa | Takeda | 4:25 - 4:55 | |
| Oral Poster Presentation | 4:55 - 5:05 | |||
| Reception | 5:05 - 6:20 | |||
| DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 16, 2024 | ||||
| Breakfast | 8:00 - 9:00 | |||
| Plenary Speaker Introduction | 9:00 - 9:05 | |||
| Plenary Lecture: Perspectives from a Mom-cologist | Courtney Horvath | Novartis | 9:05 - 9:45 | |
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Session III: The Tides Have Turned: Updates on Development of Oligonucleotide-Based Therapeutics Moderators: Joe Cichocki, Vertex |
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| Session | Topic | Speaker | Company | Time |
| Session Introduction | 9:45-9:50 | |||
| Non-clinical Development of Oligonucleotides: Opportunities, Challenges, and the Balancing Act Between the Two | Michael Templin | CRL | 9:50-10:20 | |
| Break | 10:20 - 10:40 | |||
| Development of Novel siRNAs: General Paradigm and Case Study of an siRNA for Treatment of Chronic Hepatitis B | Dinah Misner | Aligos Therapeutics | 10:40-11:10 | |
| Key Considerations for DART Assessment of Oligonucleotides | Bethany Hannas | Eli Lilly | 11:10-11:40 | |
| Conference Closing | 11:40-11:45 | |||