| October 6, 2025 | Regulated Bioanalysis Workshop | |
| October 7, 2025 | Discovery Bioanalysis and New Technologies Workshop | |
| October 8, 2025 | Mechanistic ADME Workshop |
DOWNLOAD 2025 APA PROGRAM GUIDE HERE
Regulated Bioanalysis Workshop - Monday, October 6, 2025
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction. |
Nevena Mollova |
Gilead |
8:30 - 8:40 |
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Session I: Precision Strategies in Regulated BA & Biomarker Validation |
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Session Introduction: Darshana Jani, Moderna; Ang Liu, Johnson & Johnson; Nevena Mollova, Gilead |
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8:40 - 8:45 |
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PK Cross Validation: Past, Present, Future |
Patrick Breslin |
J & J |
8:45 - 9:05 |
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Metabolite Bioanalysis in Drug Development: Recommendations From the IQ Consortium Metabolite Bioanalysis Working Group |
Wenkui Liu |
Novartis |
9:05 - 9:25 |
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Oversight of Bioavailability and Bioequivalence Studies in Support of New and Generic Drugs and Therapeutic Biologics |
Sean Kassim |
FDA |
9:25 - 9:45 |
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Biomarker Validation in Clinical Drug Development 2025 |
Lindsay King |
Pfizer |
9:45 - 10:05 |
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Panel Discussion |
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10:05 - 10:20 |
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AM Break & Exhibits |
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10:20 - 10:40 |
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Sponsor Presentation: Application of LC-MS/MS Methods for Characterization of Low-abundance Peptides, Proteins, and Biomarkers in Biological Samples |
Jason Hamilton |
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10:40 - 10:50 |
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Session II: Analytical Innovations in Emerging Modalities & Nucleic Acid-Based Therapies |
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Session Introduction: Seema Kumar, Flagship & Jennifer Cunliffe, Novartis |
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10:50 - 10:55 |
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Identification of Critical Reagents for Novel Biotherapeutic Modalities: Considerations and Case Studies |
Krisna Duong-Ly |
Merck |
10:55 - 11:20 |
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Characterization of Critical Reagents with Different New Modalities |
Rosmery Lawrence-Henderson |
Pfizer |
11:20 - 11:45 |
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Unraveling xRNA Immunogenicity: Insights and Future Horizons |
Maria Jadhav |
Novartis |
11:45 - 12:10 |
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Lunch, Exhibits, and Poster Viewing (1:10 pm - 1:30 pm) |
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12:10 - 1:20 |
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Vendor Presentation: Leveraging Orthogonal Platforms to Address the Bioanalysis Needs of New Modalities in Drug R&D |
Benjamin Wei |
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1:20 - 1:30 |
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Session III: Immunogenicity Matters: Advances in ADA Assay Development and Monitoring |
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Session Introduction: Fumin Li, Unitides Bioanalytical Lab & James Schiller, Merck |
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1:30 - 1:35 |
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Signal-to-Noise Ratio: A Streamlined Alternative to Titer for Anti-Drug Antibody Assessment |
Amy Li |
Genentech |
1:35 - 2:00 |
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Bioanalytical Immunogenicity Strategy for the Clesrovimab Program: A Case Study |
Brad Roadcap |
Merck |
2:00 - 2:25 |
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When Singlicate and Duplicate Diverge: Evaluating Risk, Performance, and Feasibility in Ligand Binding Assays |
Douglas Donaldson |
Moderna |
2:25 - 2:50 |
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Clinical Immunogenicity Monitoring of an Fc Fusion Protein Drug with Two Endogenous Counterparts: From Screening to Domain Specificity and Cross-Reactivity |
Jinsong Yang |
Keros |
2:50 - 3:15 |
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PM Break & Exhibits |
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3:15 - 3:35 |
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Session IV: Beyond Buzzwords: Real-World AI and ML Applications in Bioanalysis |
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Session Introduction: Yongjun Xue, BMS & Erik Burns, Alturas Analytics |
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3:35 - 3:40 |
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Machine Learning Guided Selection of Chiral Supercritical Fluid Chromatography Conditions |
Kiyoto Tanemura |
BMS |
3:40 - 4:00 |
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Leveraging AI in Bioanalysis: Real-World Applications of Large Language Models |
Stephanie Pasas-Farmer |
BioData Solutions |
4:00 - 4:20 |
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Exploration of AI and ML-Powered Models for Predicting Immunogenicity in Preclinical Tox Studies |
Afsana Trini |
BMS |
4:20 - 4:40 |
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Intelligent BioAnalysis (iBA) System: Pioneering the Future of Bioanalysis |
Andreas Luippold | Boehringer Ingelheim | 4:40 - 5:05 |
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Session VI: Rapid Fire Poster Presentations |
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Session Introduction: Ying Zhang, Bicycle Therapeutics & Brendan Tierney, Pfizer |
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5:05 - 5:10 |
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Poster Presenters: 1. Margarita Semis, Amgen - Development & Implementation of a 6-plex Hybrid LC-MS/MS Method for Quantitative BA of CDH3 MSLN T cell engager (TCE) 2. Tilak Chandrasekaran, Sciex - Rapid and Sensitive Analytical Method for Amylin Analogs in Bood Sugar Regulation Therapeutics 3. Sarah Hwang, Sanofi - Evaluation of the MSD S-Plex Neuropanel 1 Multiplex Assay for Neurlogical Biomarkers |
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5:10 - 5:25 |
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Sciex's User Meeting & Reception Tatjana Talamantes, Senior Product Manager, HR Accurate Mass Unlocking Sensitivity and Selectivity: ZenoTOF 8600 for BioA, DMPK, and Beyond |
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5:25 - 6:25 | |
Discovery Bioanalysis and New Technologies Workshop - Tuesday, October 7, 2025
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction |
Yu Tian |
AbbVie |
8:30 - 8:35 |
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Session I: Bioanalytical Challenges and Approaches for Oligonucleotides in Therapeutic Development |
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Session Introduction: Jing Tu, GSK; Linlin Dong, Takeda; Hongying Gao, Innovo Bioanalysis |
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8:35 - 8:40 |
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LC-MS Bioanalytical Support for Oligonucleotide PK/PD Studies |
John Chen |
NovaBio Assays |
8:40 - 9:05 |
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Bridging HELISA and LC-MS for Quantification of siRNA and Its Metabolite in Preclinical Studies |
Yunlin Fu |
Novartis |
9:05 - 9:30 |
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From Brain to Biofluids: Translational Readouts of Target Engagement for Tau-Lowering C16-siRNA |
Diana Cha |
Alnylam |
9:30 - 9:55 |
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Sponsor Presentation: Integrating New Approaches Methods into Drug Discovery and Development |
Paige Vinson |
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9:55 - 10:05 |
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AM Break & Exhibits |
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10:05 - 10:35 |
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Session II: Immunogenicity & ADA Assessment |
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Session Introduction: John Williams, Vertex & Ju Liu, Eli Lilly |
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10:35 - 10:40 |
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MHC-associated Peptide Proteomics (MAPPS) Assay for Characterization of Presented Peptide Epitopes |
Emilee Knowlton |
PepImmune |
10:40 - 11:05 |
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Integrated Immunogenicity Risk Assessment in Protein-based Biotherapeutic Drug Development |
Xiaobin Zhang |
Takeda |
11:05 - 11:30 |
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Overcoming Challenges Associated with Anti-drug Antibody (ADA) Assay Development for Antisense Oligonucleotides (ASOs) |
Brittany Youngs |
Stoke Therapeutics |
11:30 - 11:55 |
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In Silico Immunogenicity Risk Assessments: AI- Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax’s ISPRI Toolkit |
Aimee Mattei |
EpiVax |
11:55 - 12:20 |
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Lunch, Exhibits, and Poster Viewing (1:00 - 1:35 pm) |
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12:20 - 1:35 |
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Sponsor Presentation: Build Resilience and Maintain Unparalleled Sensitivity for Long-term Bioanalysis |
Matthew Stone |
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1:35 - 1:45 |
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Session III: AI & Machine Learning in Bioanalysis and Drug Discovery |
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Session Introduction: Yu Tian, AbbVie & Zachary Parsons, BMS |
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1:45 - 1:50 |
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Plenary Talk: AI/ML - From Hype to Preclinical Integration. How to Deliver Impact |
Gary Jenkins |
AbbVie |
1:50 - 2:30 |
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Basics of Machine Learning and Its Applications in Drug Discovery |
Reilly Eason |
Merck |
2:30 - 2:55 |
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Leveraging AI in Computational Toxicology |
Wei Liang |
AbbVie |
2:55 - 3:20 |
| PM Break & Exhibits | 3:20 - 3:40 | ||
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Session IV: Complex Biologics & Bioanalytical Strategies & Biomarker Analysis and Applications in Drug Development |
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Session Introduction: Jonathan Joseph & Paddy Eangoor, Sanofi |
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3:40 - 3:45 |
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A Two-Cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues |
Yipei Zhang |
Takeda |
3:45 - 4:10 |
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Strategic Bioanalytical Approaches for Complex Biologics: Tools and Case Studies |
Paddy Eangoor |
Sanofi |
4:10 - 4:35 |
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Rapid- Fire Poster Presentation 1. Marissa Mitola, Moderna - Development of Multiplex RT-qPCR Assay for Highly Similar mRNA Sequences 2. Aihua Liu, Resolian - Advanced LC-MS/MS Assay for the Quantitation of Novel Therapeutic Oligonucleotides in Human Plasma: Case Study 3. Lu Tan, Alnylam - Bioanalytical Strategies for Developing Surrogate Matrix to Quantify CNS 4. Pavithra Krishnaswami, Sanofi - Proteomic Signatures of Gaucher Disease Type 3 Reveal Response to Venglustat and Imiglucerase Combination Therapy Using Olink Explore HT |
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4:35 - 4:55 |
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Reception & Exhibits |
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4:55 - 6:10 |
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Mechanistic ADME Workshop - Wednesday, October 8, 2025
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Title |
Speaker |
Company |
Time |
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Registration, Breakfast, Exhibits |
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7:30 - 8:30 |
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Workshop Introduction |
Donglu Zhang |
Genentech |
8:30 - 8:40 |
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Plenary Talk - Human Mass Balance and Metabolite Profiling Studies: Regulatory Guidance, Technical Approaches and Clinical Implications |
Chandra Prakash |
Agios |
8:40 - 9:20 |
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Session I: PROTACs and Molecular Glues with respect to ADME challenges and human PK/dose projection; Early dose prediction strategies |
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Session Introduction: Raman Sharma, Pfizer; Sara Shum, City Therapeutics & Hongbin Yu, Boehringer-Ingelheim |
9:20 - 9:25 |
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Bridging Traditional and Novel Compounds in Discovery: Permeability and ADME Challenges with Protacs |
Mark Niosi |
Pfizer |
9:25 - 9:50 |
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ADME profiling of clinical stage PROTACs |
Jesse Yu |
Relay Therapeutics |
9:50 - 10:15 |
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Mathematical Modeling for Human Dose Prediction of Degraders |
Jan Elias |
Boehringer-Ingelheim |
10:15 - 10:40 |
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AM Break & Exhibits |
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10:40 - 11:05 |
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Rapid Fire Poster Presentations 1. Frank Scheffler, Hypha Discovery - Scalable In Vitro Methods for Accessing Major Human Metabolites of Structurally Complex Drugs using PolyCYPs and PolyUGT Enzymes 2. Shengsheng Xu, JnJ - An Optimized Approach for Simultaneous Quantification of Total Antibody-Conjugated Payload Using Immunocapture LC-MS/MS 3. Yinzheng Guan, Sanofi - Development of Sensitive Intact Assays for Evaluating Molecular Stability and Pharmacokinetics of Protein Oligonucleotide Conjugate 4. Taeseok (Sammy) Oh, Resolian - In Vitro Reaction Phenotyping of Carboxylesterase Isoforms Using Supersomes: Method Development and Optimization to Assess Enzyme Contributions to Metabolic Clearance |
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11:05 - 11:25 |
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Session II: Use of AI & ML for Early Dose Prediction and ADME Properties |
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Session Introduction: Christopher Kochansky, Exelixis; Donglu Zhang, Genentech & April Chen, AstraZeneca |
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11:25 - 11:30 |
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Human Dose Projection at the Point of Design |
Kaushik Mitra |
J & J |
11:30 - 11:55 |
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Scoring Success in Molecule Making - From Idea Generation to PK Candidate Selection |
Fabio Broccatelli |
Altos Labs |
11:55 - 12:20 |
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AI-aided drug design from drug metabolism perspectives |
Lionel Cheruzel |
Genentech |
12:20 - 12:45 |
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Lunch, Exhibits, and Poster Viewing (1:30 - 2:00 pm) |
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12:45 - 2:00 |
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Session III: New Insights on the Discovery and Characterization of Covalent Inhibitors |
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Session Introduction: Benjamin Johnson, BMS & David Stresser, AbbVie |
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2:00 - 2:05 |
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DMPK Considerations for the Development of Targeted Covalent Inhibitor Drugs: An IQ Consortium Assessment |
Martin Dowty |
AbbVie |
2:05 - 2:30 |
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Analytical Strategies for Covalent Drug Discovery - Targeting Residues Beyond Cysteine |
Lyn Jones |
Harvard University |
2:30 - 3:05 |
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PM Break & Exhibits |
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3:05 - 3:25 |
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GSH Conjugation in a Covalent Drug Discovery Paradigm: The Untold GST Story |
Cody Fullendwider |
Vividion Therapeutics |
3:25 - 3:50 |
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Session IV: Recent Progress on Understanding Mechanisms of Hepatotoxicity |
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Session Introduction: James Driscoll; Nagendra Chemuturi, Eli Lilly & Eric Ballard, Takeda |
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3:50 - 3:55 |
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Covalent Protein Modifications By Reactive Metabolites: Evidence For Drug-Induced Liver Toxicity |
Qinying Yu |
Genentech |
3:55 - 4:20 |
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Covalent Binding & TAK-994 Drug-Induced Liver Injury |
Matthew Wagoner |
Takeda |
4:20 - 4:45 |
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Conference Closing Remarks |
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4:45- 4:50 |
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