May 14, 2024 Discovery Toxicology
May 15, 2024 morning Discovery Toxicology
May 15, 2024 afternoon Development Toxicology
May 16, 2024 Development Toxicology

Download APT 2024 Program Guide Here


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

Session I:  Discovery Toxicology in New Modalities Employing Cutting-Edge Assay Systems/Emerging Technologies

Moderators:  Yoav Timsit, Novartis & Jodi Goodwin, Takeda

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

Session II: Mastering Discovery Toxicology: Case Studies & Strategies

Moderators:  Jon Maher, Pliant Therapeutics & Prathap Kumar Mahalingaiah, AbbVie

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
Registration     8:00 - 9:00

Session III: Unpacking T-Cell Engagers Safety Assessment - Case Examples

Moderators: Rama Pai, Merck & Darcey Clark, Merck

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
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

Session I: Occupational Exposure Guidance & Learnings for New Modalities

Moderators: Michael Santostefano, Merck & Betty Pettersen, Alexion

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

Session II: New Approaches for Non-clinical Safety Evaluation

Moderators: Yuan Lu, CinRx Pharma & Christine Mollica, Amgen

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
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

Session III: The Tides Have Turned: Updates on Development of Oligonucleotide-Based Therapeutics

Moderators: Joe Cichocki, Vertex

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





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May 14-15, 2024 Discovery Toxicology

May 15-16, 2024 Development Toxicology

Merck Research Laboratories, Boston, MA


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