| September 14, 2026 | Regulated Bioanalysis Workshop | |
| September 15, 2026 | Discovery Bioanalysis and New Technologies Workshop | |
| September 16, 2026 | Mechanistic ADME Workshop |
Regulated Bioanalysis Workshop - Monday, September 14, 2026
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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. |
Jeongsup Shim |
Genentech |
8:30 - 8:40 |
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Session I: Regulatory & Agency Perspectives |
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Session Introduction: Ryan Lo, Moderna; Aihua Liu, Resolian; Nevena Mollova, Gilead & Ying Zhang, Bicycle Therapeutics |
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8:40 - 8:45 |
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Oversight of Bioavailability and Bioequivalence Studies in Support of New and Generic Drugs and Therapeutic Biologics |
Sean Kassim |
FDA |
8:45 - 9:05 |
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Evaluating Partial Bioanalytical Method Validations in ANDAs Under ICH M10 Guidance |
Yang Lu |
FDA |
9:05 - 9:25 |
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Common Biomarker Challenges Encountered in Clinical Development |
Heather Myler |
Takeda |
9:25 - 9:45 |
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Plenary Talk: Challenges and Opportunities in Biomarker Bioanalysis |
Chongwoo Yu |
FDA |
9:45 - 10:20 |
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Panel Discussion: Sean Kassim, FDA; Yang Lu, FDA; Heather Myler, Takeda; Chongwoo Yu, FDA; Sarah Bean, Charles River Laboratories |
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10:20 - 10:40 |
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AM Break & Exhibits |
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10:40 - 11:10 |
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Sponsor Presentation: Title TBA |
Matthew Stone |
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11:10- 11:20 |
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Session II: Emerging Technologies in BA & Next Gen. Modalities |
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Session Introduction: Yongjun Xue, BMS; Darshana Jani, Moderna; Seema Kumar, Flagship & Yeongsup Shim, Genentech |
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11:20 - 11:25 |
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Emerging Hybrid LC-HRMS Assays for In Vivo DAR Shift Bioanalysis of ADCs |
Joshua Powers |
BMS |
11:25 - 11:45 |
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Simplifying PK and Biomarker Analysis: High-Sensitivity Single-Dilution Assays with the NULISA Platform |
Yeongsup Shim |
Genentech |
11:50 - 12:15 |
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Bioanalytical and Translational Considerations for Therapeutic siRNA and ASOs: Industry Practices and IQ Consortium Recommendations |
Guangnong (Sunny) Zhang |
Novo Nordisk |
12:15 - 12:40 |
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Lunch, Exhibits, and Poster Viewing (1:10- 2:00 PM) |
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12:40 - 2:00 |
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Rapid-Fire Poster Presentations Moderator: Brendan Tierney, Pfizer 1. Richard Dambra, Boehringer Ingelheim -Development and Validation of A Clinical nAb Assay For A Replicating Oncolytic Virus 2. Andy (Hongfang) Xue, Resolian - A Novel LC-MS/MS Strategy for Quantification of TGW101 Conjugated Payload in Human Plasma via Chemically Controlled Release of a Click-to-Release ADC Linker |
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2:00 - 2:10 |
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Session III: Immunogenicity & ADA in Regulated Context |
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Session Introduction: Jenifer Vija, Ajivia, LLC; Fumin Li, Unitides Bioanalytical Lab & James Schiller, Merck |
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2:10 - 2:15 |
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Insights into Immunogenicity Testing of Contemporary Peptide Therapeutics |
Ron Bowsher |
B2S Labs |
2:15 - 2:40 |
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Immunogenicity Risk Prediction and Mitigation - talk title tba |
Vibha Jawa |
EpiVax,Inc. |
2:40 - 3:05 |
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Implementing Streamlined Immunogenicity Assessment: From Analysis to Submission |
Jenny Valentine |
Regeneron |
3:05 - 3:30 |
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PM Break & Exhibits |
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3:30 - 4:00 |
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Session IV: AI/ML in Regulated Bioanalysis |
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Session Introduction: Niketa Jani, Novartis; Ang Liu, Johnson and Johnson & Erik Burns, Alturas Analytics |
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4:00 - 4:05 |
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Title TBA |
Michelle Groff |
Johnson & Johnson |
4:05 - 4:30 |
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Enabling the AI-Ready Bioanalytical Lab: Adoption, Governance, and Scale |
Jason DelCarpini |
Moderna |
4:30 - 4:55 |
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Artificial Intelligence in Regulated Science: Defining the Standards Before They Define Us |
Jera Kantz & Sara Underwood |
Alturas Analytics |
4:55 - 5:20 |
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Workshp Closing Comments |
Jinsong Yang |
Keros Therpeutics |
5:20 - 5:25 |
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Reception & Sciex's Mixer Event - Shane Needham, Veloxity Labs
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5:25 - 6:40 | |
Discovery Bioanalysis and New Technologies Workshop - Tuesday, September 15, 2026
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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 Approaches and Strategies for Therapeutic and Conjugated Oligonucleotides |
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Session Introduction: Ju Liu, Eli Lilly; Linlin Dong, Takeda & Hongying Gao, Innovo Bioanalysis |
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8:35 - 8:40 |
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qPCR-Based Quantification of siRNA Therapeutics in Plasma and Tissues: Bioanalytical Considerations for Pharmacokinetic and Biodistribution Studies |
Irina Laczkovich |
Takeda |
8:40 - 9:05 |
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Overview of Hybridization ELISA for Oligonucleotide Quantitation |
Sarah Dicker |
Eli Lilly |
9:05 - 9:30 |
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Quantitative Bioanalysis of Antibody-Oligonucleotide Conjugates: Challenges, Strategies, and Emerging Solutions |
Long Yuan |
Biogen |
9:30 - 9:55 |
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Beyond GalNAc-siRNA: Bioanalytical Strategy for bispecific siRNA, Aptamer-Drug Conjugate and ADA |
Min Meng |
Resolian |
9:55 - 10:20 |
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Sponsor Presentation: Title TBA |
Jason Hamilton |
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10:20 - 10:30 |
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AM Break & Exhibits |
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10:30 - 11:00 |
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Session II: Bioanalysis Hot Topics |
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Session Introduction: Paddy Eangoor, Sanofi & Jonathan Joseph, Takeda |
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11:00 - 11:05 |
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Rapid Fire Poster Presentations 1. Xien Yu Chua, Alnylam - Observation of a Single-Stranded Lipophilic siRNA Metabolite in Plasma 2. Yipei Zhang, Takeda - A Nove Immunoaffinity Nano-LC/MS Workflow to Assess Linker Integrity and In Vivo Activation of a Complex Conditional Bispecific T Cell Engager 3. Wenchun Ma, Medicilon - Active-Learning-Guided Optimization of a Picogram-Level LC-MS Method for Quantification of Structurally Similar Cyclic Tetrapeptides in Preclinical DMPK 4. Dennis Van De Goor, Sanofi - AI-Assisted Development of a Bi-active Ligand Binding Assay for Pharmacokinetic Assessment of Monoclonal Antibodies 5. Kristina Shqillo, Novartis - Advancing Platform-Based Bioanalytical Assay Development Across Drug Programs and Endpoints Through Shared Generic Antibody Tools |
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11:05 - 11:30 |
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Digital or Quantitative? Choosing the right PCR Platform for Bioanalytical Applications |
Amanda Hayes |
Bioagilytix |
11:30 - 11:55 |
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Implementing a generic ADA assay strategy to measure free and complexed ADA that can efficiently address TK and safety‑related ADA considerations in a preclinical setting |
Rodd Polsky |
GSK |
11:55 - 12:20 |
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Rapid-Fire Poster Presentations 1. Yinzheng Guan, Sanofi 2. David Zuluaga-Rave, Resolian 3. Shamael Dastagir, Sanofi 4. Mark Wissel, Eurofins 5. Prakash Bhosale, IQVIA |
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12:20 - 12:45 |
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Lunch, Exhibits, and Poster Viewing (1:20 - 2:00 pm) |
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12:45 - 2:00 |
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Sponsor Presentation: SMab™ Technology for Bioanalytical Critical Reagent Discovery |
Hao Cheng |
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2:00 - 2:10 |
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Session III: Biomarkers & Multi-Omics in Discovery |
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Session Introduction: Catherine Vrentas, Alnylam & Yu Tian, AbbVie |
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2:10 - 2:15 |
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Leveraging Multidimensional Spatial-Omics Tools To Empower Our Understanding of Disease Pathobiology and Target Validation in the Industry Setting |
Silva Siso |
AbbVie |
2:15 - 2:40 |
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Integrating Advanced Cell Models, Multiomics, and AI for Safety Prediction |
Jurre Kamphorst |
AstraZeneca |
2:40 - 3:05 |
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From Spatial Biomarkers to Development Decisions: Practical Applications Across Preclinical and Clinical Drug Development |
Corinne Ramos |
Aliri |
3:05 - 3:30 |
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PM Break and Exhibits |
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3:30 - 3:50 |
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Session IV: Case Studies on Novel Technologies & Implementation |
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Session Introduction: Zachary Parsons, BMS & Maria Myzithras, Boehringer-Ingelheim |
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3:50 - 3:55 |
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Plenary Talk: Harnessing AI for Bridging Translational Gaps in Drug Discovery |
Lei Xie |
Northeastern Univeristy |
3:55 - 4:35 |
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Intramolecular Reactions and Chemical Degradation as Drivers of Apparent Biotransformation Pathways in a Series of SYK Inhibitors |
Ujjal Sarkar |
AbbVie |
4:35 - 5:00 |
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Ex vivo Biotransformations Masquerading as Bioanalytical Method Anomalies |
Zach Parsons |
BMS |
5:00 - 5:20 |
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Networking Reception and Exhibits |
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5:20 - 6:35 |
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Mechanistic ADME Workshop - Wednesday, September 16, 2026
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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 - Applications of Complex in vitro Models of the Kidney and Intestine in Modeling Drug Disposition |
Edward Kelly |
University of Washington |
8:40 - 9:20 |
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Session I: New Approach Methodologies for Drug Metabolism & Toxicity |
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Session Introduction: Raman Sharma, Pfizer; Chandra Prakash, Agios Pharmaceuticals & David Stresser, AbbVie |
9:20 - 9:25 |
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Pharmaceutical Industry Perspective on Opportunities and Considerations for NAMs in Drug Discovery |
Patrick Devine |
BMS |
9:25 - 9:50 |
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Human Organ Chips in Toxicology: From Model Establishment to Validation |
Haiqing Bai |
Xellar Bio |
9:50 - 10:15 |
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Mind the Gap: In Silico ADME as a New Approach Methodology for Human Prediction |
Michael McCoy |
Takeda |
10:15 - 10:40 |
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AM Break & Exhibits |
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10:40 - 11:10 |
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Sponsor Presentation |
TBA |
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11:10 - 11:25 |
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Session II: Metabolism, Metabolites & Alternate Models - Mechanistic Insights into Drug Metabolism, Human Metabolites, and Predictive Models |
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Session Introduction: Eric Ballard, Takeda & James Driscoll, Kardigan Bio |
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11:25 - 11:30 |
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A Comparison of In Vitro and In Vivo Metabolite Profiles: How Quantitatively Predictive are Our In Vitro Assays? |
Matt Cerney |
Pfizer |
11:30 - 11:55 |
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In Vitro-In Vivo Extrapolation Inaccuracy: The CYP3A4 Anomaly In Vitro and Utilizing PBPK Modeling to Understand CYP3A4/P-gp Interplay |
Christine Bowman |
Genentech |
11:55 - 12:20 |
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Combining MetID, Quantitative Enzymology, and In Vitro Ames to Profile the Potential Bioactivation and Genotoxicity Risks for N-nitroso Paroxetine |
Carley Heck |
Pfizer |
12:20 - 12:45 |
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Lunch, Exhibits, and Poster Viewing (1:15 - 1:45 pm) |
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12:45 - 1:45 |
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Rapid-Fire Poster Presentations Moderator: Eric Ballard, Takeda 1. Jaimie Townsend, Novartis - Advancing Human-Relevant Prediction of Complex CYP3A4 DDIs: Insights From 8HUM Mice and Microfluidic Liver-On-Chip Technologies 2. Kari Martyniak, Pfizer - Comparative Temporal Proteomic Profiling of Primary Hepatocytes Cultures From Preclinical Species and Humans |
1:45 - 1:55 | ||
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Session III: Mechanistic ADME of Beyond the Rule of 5 (BRo5) Molecules |
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Session Introduction: Christopher Kochansky, Exelixis; Nagendra Chemuturi, Lilly & April Chen, AstraZeneca |
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1:55 - 2:00 |
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Beyond Rule-of-5: ADME Challenges and Opportunities for Oral and CNS-Active Targeted Protein Degraders |
Ritu Singh |
C4 Therapeutics |
2:00 - 2:25 |
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Allometric Scaling as a Viable and Practical Approach for Peptide PK Prediction |
Ryota Kikuchi |
AbbVie |
2:25 - 3:00 |
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PM Break & Exhibits |
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3:00 - 3:20 |
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ADME and PKPD Consideration in the Discovery of RAS(ON) Tri-complex Inhibitors: Daraxonrasib and Elironrasib as Examples |
Zhican Wang |
Revolution Medicine |
3:20 - 3:45 |
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Session IV: PK/PD Strategies From Preclinical Discovery to Human Dose Projection |
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Session Introduction: Sara Shum, City Therapeutics, Donglu Zhang, Genentech; & Hongbin Yu, Boehringer-Ingelheim |
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3:45 - 3:50 |
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Preclinical PK/PD: Translational Considerations for Human Dose Prediction in Drug Discovery |
Niklas Kroemer |
Boehringer-Ingelheim, Germany |
3:50 - 4:15 |
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Driving Targeted Protein Degrader Discovery Through Quantitative PK/PD Modeling |
Valerie Kramlinger |
Amgen |
4:15 - 4:40 |
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Conference Closing Remarks |
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4:40- 4:45 |
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