May 13, 2025 Discovery Toxicology
May 14, 2025 morning Discovery Toxicology
May 14, 2025 afternoon Development Toxicology
May 15, 2025 Development Toxicology
 

DISCOVERY TOXICOLOGY WORKSHOP - TUESDAY MAY 13, 2025

Session Topic Speaker Company Time
Registration and Lunch     12:00-1:00
Conference Opening and Plenary Speaker Introduction

 Jodi Goodwin

 Takeda 1:00-1:10
Plenary Lecture: Integrating Generative AI with Active Learning to Power Next Generation Drug Discovery Richard Bonneau Genentech 1:10-1:55

Session I:  Digital Pathology & Spatial Transcriptomics (Applications)

Moderators:  Yoav Timsit, Novartis, Darcy Clark, Merck & Jodi Goodwin, Takeda

Session Topic Speaker Company Time
Session Introduction     1:55-2:00
Comparison of Supervised and Unsupervised Machine Learning Scoring of Histology Images Tom Forest Merck 2:00-2:30
Model Detection of the Seen and Unseen: A Multi-paradigm Approach to Histologic Anomaly Detection Fangyao Hu Genentech 2:30-3:00
Vendor Talk: h-VIOS: A Human-relevant Drug Discovery and Development  Platform Using Bioprinted Tissues Taci Pereira 3:00-3:25
Break       3:25-3:50
Computational Pathology Applied to Toxicologic Pathology Byunghak (BK) Kang Novartis

3:50-4:20

Context-specific Applications Across Spatial Transcriptomic Platform David Gallegos Takeda 4:20-4:50

Rapid Fire Poster Presentations:

1. Logan Porter, Lena Biosciences,

2. Maria Walczak, Jagielllonian Univ. Medical College, Poland  

3. Julia Co, Genentech

4:50-5:10
Day 1 Closing Remarks     5:10-5:15
DISCOVERY TOXICOLOGY WORKSHOP - WEDNESDAY MAY 14, 2025
Registration and Breakfast  7:00-8:00

Session II: Traditional & New Modalities - Case Studies

Moderators:  Connie Wu, Genentech, Jonathan Heyen, Treeline Bio & Helen Yu, Vertex

Session Introduction      8:00 - 8:05
Safety Considerations for Developing Molecular Glues and other Targeted Protein Degraders Jessica Sims Genentech 8:05 - 8:35
Global Off-Target Profiling of Targeted Protein Degraders with a Cell-Based Proteomics Platform Xiaoting Wang Amgen 8:35 - 9:05
Oligonucleotides in Discovery: A Case Study of an siRNA for the Treatment of Chronic Hepatitis B Virus Infection Dinah Misner Aligos Therapeutics 9:05 - 9:35
Vendor Talk: TBA   TBA 9:35-9:50
Break       9:50 - 10:10

Session III: 4th Generation of ADC's

Moderators: Rama Pai, Merck & Prathap Kumar Mahalingaiah, AstraZeneca

Session Topic Speaker Company Time
Session Introduction     10:10 - 10:15
Nonclinical Safety Assessment of Antibody-Oligo Conjugates from IND-enabling through Late-Stage Clinical Trials Laura Leung Avidity Biosciences 10:15 - 10:40
The Use of In Vitro Assays for Novel Payload Selection in New-Generation ADCs Diana Lac Genentech 10:40 - 11:05
Opportunities and Challenges for Preclinical Assessment of Next Generation ADCs Haley Neff-LaFord Pfizer 11:05 - 11:30
Integrating PKPD Modeling and Clinical Toxicity Meta-Analysis towards Therapeutic Index prediction for Antibody-Drug Conjugate Mahua Roy AstraZeneca 11:30 - 11:55
Vendor Talk: An AI Approach to Drug-Induced Liver Injury Risk: Prediction of Safe Maximum Doses from Toxicogenomic Profile Chris Strock 11:55-12:20
Lunch   12:20-1:40
DEVELOPMENT TOXICOLOGY WORKSHOP- WEDNESDAY MAY 14, 2025
Workshop Introduction and Speaker Introduction     1:40 - 1:50
Plenary Lecture: Harnessing Generative AI in Nonclinical Safety Evaluation Zhichao Liu Boehringer Ingelheim 1:50 - 2:30

Session IV: Revolutionizing Toxicology: Virtual Controls, Digital Pathology, NAMs, and Species Alternatives in Drug Development

Moderators: Betty Pettersen, Alexion, Yuan Lu, CinRx Pharma & Surekha Akella, AbbVie

Session Introduction      2:30 - 2:35
Opportunities and Insights From Pharma On the Use of NAMs to Replace Large Animal Studies in Nonclinical Safety Assessments for Biotherapeutics Kim Homan Genentech 2:35 - 3:05
Advancing Pre-Clinical Safety Assessment with Advanced Cell Models Nataha Bohin AstraZeneca 3:05 - 3:35
Break   3:35 - 3:55
Leveraging the Proteome: Harnessing in vitro NAMs to Understand Human and Non-Human Protein Binding Profiles for Therapeutics Nick Brown Charles River Laboratories 3:55 - 4:25
Insights into Building a Robust Virtual Control Database and Selection Methods for Use on Retrospective Analysis of Nonclinical Safety Assessment Studies Jillian Wendel LabCorp 4:25 - 4:55
Poster Session and Reception     4:55 - 6:10
DEVELOPMENT TOXICOLOGY WORKSHOP-THURSDAY MAY 15, 2025
Breakfast  7:00 - 8:00
Workshop Introduction     8:00 - 8:05

Session V: New Generations ADC's ( Antibody-siRNA-Conjugates (ARC), Peptide-drug Conjugates (PDC)

Moderators: Christine Mollica, Amgen, Ed Dere, Genentech, Daniella Pizarro, Merck & Pia Kasperkovitz, Bright Peak Therapeutics

Session Introduction       8:05 - 8:10
Nonclinical Safety Strategies for ADC Development - Looking Back to Move Forward Christina de Zafra Merck 8:10 - 8:35
Unique Platform Toxicities of ADCs - Learnings Over the Last Decade Magali Guffroy AbbVie 8:35 - 9:00
Case Study: Regulatory Interactions and Path to IND for a Novel Antibody-Protein Conjugate Pia Kasperkovitz Bright Peak Therapeutics 9:00 - 9:25
AM Break     9:25 - 9:45

Session VI: Pioneering Cell and Gene Therapies: Expanding Horizons Beyond CAR-T

Moderators: Heather Kowalski, BlueRock Therapeutics, Joe Cichocki, Vertex & Michael Santostefano, Merck

Session Topic Speaker Company Time
 Session Introduction      9:45 - 9:50
Protecting Allogeneic Transplants from Immune Rejection is the Key to Bringing Cell-Based Therapies to Patients Sonja Schrepfer Sana Biotechnology 9:50 - 10:15
Supporting Clinical Trials for Non-Cancer Cell Therapies - From Patient and Treatment Plans, Backwards Lauren Black CRL 10:15 - 10:40
Modeling Approaches to Support Dose Selection for Cell and Gene Therapies Raibatak Das Quantilogix, LLC 10:40 - 11:05
Conference Closing     11:05 - 11:10

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May 13-14, 2025 Discovery Toxicology

May 14-15, 2025 Development Toxicology

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