| October 6, 2025 | Regulated Bioanalysis Workshop | |
| October 7, 2025 | Discovery Bioanalysis and New Technologies Workshop | |
| October 8, 2025 | Mechanistic ADME Workshop |
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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recommendations on cross-validation experiment design from bioanalytical and clinical pharmacology perspective - Title TBA |
Patrick Breslin |
J & J |
8:45 - 9:05 |
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metabolite bioanalysis on behalf of IQ consortium - Title TBA |
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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TBA |
TBA |
TBA |
10:05 - 10:25 |
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AM Break & Exhibits |
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10:25 - 10:45 |
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Sponsor Presentation: Title TBA |
TBA |
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10:45 - 11:00 |
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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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11:00 - 11:05 |
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Identification of Critical Reagents for Novel Biotherapeutic Modalities: Considerations and Case Studies |
Krisna Duong-Ly |
Merck |
11:05 - 11:30 |
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Characterization of Critical Reagents with Different New Modalities |
Rosmery Lawrence-Henderson |
Pfizer |
11:30 - 11:55 |
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Unraveling xRNA Immunogenicity: Insights and Future Horizons |
Maria Jadhav |
Novartis |
11:55 - 12:20 |
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Lunch, Exhibits, and Poster Viewing (1:10 pm - 1:30 pm) |
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12:30 - 1:30 |
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Vendor Presentation: Title TBA |
TBA |
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1:30 - 1:45 |
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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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1:45 - 1:50 |
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Signal-to-Noise Ratio: A Streamlined Alternative to Titer for Anti-Drug Antibody Assessment |
Amy Li |
Genentech |
1:50 - 2:15 |
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Bioanalytical Immunogenicity Strategy for the Clesrovimab Program: A Case Study |
Brad Roadcap |
Merck |
2:15 - 2:40 |
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Anti drug antibody assay singlicate vs duplicate sample testing - Title TBA |
Douglas Donaldson |
Moderna |
2:40 - 3:05 |
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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 |
3:05 - 3:30 |
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PM Break & Exhibits |
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3:30 - 3:50 |
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Session IV: Beyond Buzzwords: Real-World AI and ML Applications in Bioanalysis |
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Session Introduction: |
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3:50 - 3:55 |
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Machine Learning Guided Selection of Chiral Supercritical Fluid Chromatography Conditions |
Kiyoto Tanemura |
BMS |
3:55 - 4:15 |
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Leveraging AI in Bioanalysis: Real-World Applications of Large Language Models |
Stephanie Pasas-Farmer |
BioData Solutions |
4:15 - 4:35 |
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Title TBA |
Afsana Trini |
BMS |
4:35 - 4:55 |
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Session V: Innovation Junction: Bridging Science and Solutions in Pharma |
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Sponsor Showcase: TBA |
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4:55 - 5:15 |
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Session VI: Rapid Fire Poster Presentations |
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Session Introduction: |
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5:15 - 5:20 |
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Poster Presenters: 1. TBD 2. TBD 3. TBD 4. TBD |
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5:20 - 5:40 |
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 |
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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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Novel LBA Methodology for Bioanalysis of Antibody-siRNA Drug Conjugates |
Diana Cha |
Alnylam |
8:40 - 9:05 |
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LC-MS Bioanalytical Support for Oligonucleotide PK/PD Studies |
John Chen |
NovaBioAssays |
9:05 - 9:30 |
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Bridging HELISA and LC-MS for Quantification of siRNA and Its Metabolite in Preclinical Studies |
Yunlin Fu |
Novartis |
9:30 - 9:55 |
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Sponsor Presentation: Title TBA |
TBA |
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9:55 - 10:10 |
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AM Break & Exhibits |
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10:10 - 10:40 |
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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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10:40 - 10:45 |
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MHC-associated Peptide Proteomics (MAPPS) Assay for Characterization of Presented Peptide Epitopes |
Emilee Knowlton |
PepImmune |
10:45 - 11:10 |
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Immunogenicity Risk Assessment at the pre-IND Stage: Integrated Immunogenicity Risk Assessment in Protein-based Biotherapeutic Drug Development |
Xiaobin Zhang |
Takeda |
11:10 - 11:35 |
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Overcoming Challenges Associated with Anti-drug Antibody (ADA) Assay Development for Antisense Oligonucleotides (ASOs) |
Brittany Youngs |
Stoke Therapeutics |
11:35 - 12:00 |
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In Silico Immunogenicity Risk Assessments: AI- Enhanced Prediction of Clinical Immunogenicity Outcomes with EpiVax’s ISPRI Toolkit |
Aimee Mattei |
EpiVax |
12:00 - 12:25 |
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Lunch, Exhibits, and Poster Viewing |
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12:25 - 1:40 |
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Sponsor Presentation: Title TBA |
TBA |
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1:40 - 1:50 |
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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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1:50 - 1:55 |
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Plenary Talk: Title TBA |
Gary Jenkins |
AbbVie |
1:55 - 2:35 |
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AI/ML applications in drug discovery - Title TBA |
Reilly Eason |
Merck |
2:35 - 3:00 |
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Leveraging AI in Computational Toxicology |
Wei Liang |
AbbVie |
3:00 - 3:25 |
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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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3:25 - 3:30 |
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A Two-Cycle Immunoaffinity Enrichment Strategy with Acid Treatment to Enhance Biotherapeutics Assay Sensitivity in Tissues |
Yipei Zhang |
Takeda |
3:30 - 4:00 |
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PM Break & Exhibits |
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4:00 - 4:20 |
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Strategic Bioanalytical Approaches for Complex Biologics: Tools and Case Studies |
Paddy Eangoor |
Sanofi |
4:20 - 4:50 |
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Rapid Fire Talks |
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4:50 - 5:15 |
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Reception & Exhibits |
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5:15 - 6:30 |
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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 |
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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 |
9:40 - 9:25 |
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Title TBA |
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. TBD 2. TBD 3. TBD 4. TBD |
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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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Title TBA |
Kaushik Mitra |
J & J |
11:30 - 11:55 |
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Title TBA |
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 |
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12:45 - 2:00 |
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Session III: Building Reliable Screening Funnels for Targeted Covalent Binders |
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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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Title TBA |
TBA |
TBA |
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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Title TBA |
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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