| October 7, 2024 | Regulated Bioanalysis Workshop | |
| October 8, 2024 | Discovery Bioanalysis and New Technologies Workshop | |
| October 9, 2024 | Mechanistic ADME Workshop |
Regulated Bioanalysis Workshop - Monday, October 7, 2024
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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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Session I: Regulatory Audits and Industry Perspectives on Audits |
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Session Introduction: Nevena Mollova, Gilead; Jay, ?? & Joseph Tweed, Bicycle Therapeutics |
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8:40 - 8:45 |
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Recent Data Integrity Findings in Bioresearch Monitoring |
Yi-Ying Chen |
FDA |
8:45 - 9:10 |
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Title TBA |
TBA |
TBA |
9:10 - 9:35 |
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Title TBA |
Faye Vazvaei |
Merck |
9:35 - 10:00 |
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Plenary Talk - Title TBA |
TBA |
TBA |
10:00 - 10:35 |
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AM Break & Exhibits |
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10:35 - 10:55 |
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Session II: Advances in Sampling Strategies and Drug Delivery Innovations |
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Session Introduction: Lori Payne, Alturas Analytics & Jeongsup Shim, Genentech |
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10:55 - 11:00 |
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Implementation of Low Volume Sampling Technologies for PK and Biomarker Analysis: Technical and Logistical Challenges and Solutions |
Xiaoyun Yang |
Genentech |
11:00 - 11:25 |
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Space - The Final Microsampling Frontier"/ Mitra Device /Part II |
Lori Payne |
Alturas |
11:25 - 11:45 |
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Accelerator Mass Spectrometry (AMS) Applications for Supporting Clinical Development |
Xiaomin Wang |
BMS |
11:45 - 12:10 |
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Sponsor Presentation:TBD |
TBD |
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12:10 - 12:25 |
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Lunch, Exhibits, and Poster Viewing |
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12:25 - 1:40 |
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Title TBA |
TBD |
Pharmaron |
1:40 - 2:05 |
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Session III: Advances in Drug Modalities and Emerging Technologies for Characterization |
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Session Introduction: Ang Liu, Daiichi Sankyo; Fumin Li, Unitides Bioanalytical Lab & Yongjun Xue, BMS |
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2:05 - 2:10 |
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Plenary Talk - Application of AI in Drug Development |
Joe Rajaro |
Accenture |
2:10 - 2:50 |
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A Novel Hybridization LC-MS/MS Methodology for Bioanalysis of siRNA |
Long Yuan |
Biogen |
2:50 - 3:15 |
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Sponsor Showcase |
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3:15 - 3:35 |
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Title TBA |
Jason DelCarpini |
Moderna |
3:35 - 4:00 |
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PM Break & Exhibits |
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4:00 - 4:20 |
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Development of Nonclinical Total Anti-Drug Antibody (ADA) Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies |
Audrey Arjomandi |
Genentech |
4:20 - 4:45 |
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RT-qPCR Method Development and Validation for mRNA Analysis |
Nazneen Bano |
Merck |
4:45 - 5:10 |
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Session IV: Rapid Fire Poster Presentations |
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Session Introduction: Joeseph Tweed, Bicycle Therapeutics |
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5:10 - 5:15 |
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Poster Presenters: |
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5:15 - 5:35 |
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Reception, Exhibits, and Poster Viewing |
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5:35 - 6:35 |
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Discovery Bioanalysis and New Technologies Workshop - Tuesday, October 8, 2024
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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 |
Hiroshi Sugimoto |
Takeda |
8:30 - 8:40 |
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Session I: Emerging Analytical & Bioanalytical Platform Technology |
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Session Introduction: Hiroshi Sugimoto, Takeda & Zack Parsons, BMS |
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8:40 - 8:45 |
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Plenary Talk - Understanding the tumor microenvironment using multi-omics and spatial omics - Title TBA |
William Hwang |
Harvard |
8:40 - 9:20 |
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Subcellular PK/PD Analysis Using Spatial Transcriptomics Technology |
Quishi Liu |
Takeda |
9:20 - 9:50 |
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Bio-Digital Transformation of Proteomic Analysis |
Yohei Kosugi |
Takeda |
9:50 - 10:20 |
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AM Break & Exhibits |
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10:20 - 10:50 |
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Basics of Machine Learning and Its Applications in Drug Discovery |
Reilly Eason |
Merck |
10:50 - 11:20 |
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Session II: Novel Strategy to Advance Biotherapeutic Development |
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Session Introduction: Yu Tian, AbbVie & Ju Liu, Eli Lilly |
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11:20 - 11:25 |
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Measuring Endogenous and Transgene-Expressed Protein Levels in Gene Therapy Bioanalytical and Biomarker Studies - tentative title |
Li Chin Wong |
Eli Lilly |
11:25 - 11:55 |
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Domain Specificity in the Tiered Approach: Never Too Late for Immunogenicity Characterization of Multi-Domain Therapeutics |
Richard Hughes |
Resolian |
11:55 - 12:25 |
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Title TBD |
TBD |
TBD |
12:25 - 12:55 |
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Lunch, Exhibits, and Poster Viewing |
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12:55 - 2:10 |
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Sponsor Presentation: Title TBD |
TBD |
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2:10 - 2:30 |
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Session III: Latest Advances: Elisa/Cell-based Assays/Hepatocytes tissue |
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Session Introduction: Hongying Gao, Innovo Bioanalysis LLC & Christopher Kochansky, Exelixis |
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2:30 - 2:35 |
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Title TBA |
TBD |
TBD |
2:35 - 3:05 |
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Session IV: Recent Case Study to Support New Modalities (oligonucleotides/C>)/bioanalytical |
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Session Introduction: John Wiliams, Vertex, Jonathan Josephs, Genentech & Jing Tu, Resolian |
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3:05 - 3:10 |
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non-vial gene therapies - Title TBA |
Nag Chemuturi |
Eli Lilly |
3:10 - 3:40 |
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PM Break & Exhibits |
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3:40 - 4:00 |
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The Challenges and Solutions in Developing Ultra-Sensitive LC-MS Bioanalytical Assay for Oligonucleotides |
Aihua Liu |
Resolian |
4:00 - 4:30 |
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Title TBA |
TBA |
TBA |
4:30 - 5:00 |
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Reception and Poster Viewing |
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5:00 - 6:15 |
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Mechanistic ADME Workshop - Wednesday, October 9, 2024
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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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Session I: Role of NonCYP Enzymes in DDI |
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Session Introduction: Raman Sharma, Pfizer & Nagendra Chemuturi, Eli Lilly |
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8:40 - 8:45 |
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Uncertainties and Opportunities in Predicting Non-CYP Mediated Drug Metabolism |
Sandhya Subash |
WSU |
8:45 - 9:10 |
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Title TBA |
TBA |
TBA |
9:10 - 9:35 |
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recent developments in predicting CYP-independent metabolism - Title TBA |
Jasleen Sodhiei |
Septerna |
9:35 - 10:00 |
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AM Break & Exhibits |
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10:00 - 10:25 |
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Sponsor Showcase and Rapid Fire Poster Presentations |
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10:25 - 10:45 |
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Session II: PK/PD Challenges of New Modalities: ADCs, in vivo Gene Therapies, and PROTACs |
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Session Introduction: Sara Shum, Renegade & Hongbin Yu, Boehringer Ingelheim |
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10:45 - 10:50 |
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PK/PD of ADC - title TBA |
Minu Pilvankar |
Boehringer Ingelheim |
10:50 - 11:15 |
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In vivo CRISPR therapeutics - title TBA |
Adam Amaral |
Intellia |
11:15 - 11:40 |
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Title TBA |
Stefanus Steyn |
Pfizer |
11:40 - 12:05 |
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Lunch, Exhibits, and Poster Viewing |
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12:05 - 1:20 |
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Plenary Speaker Introduction |
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1:20 - 1:25 |
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Plenary Talk - Prospects for New Approach Methodologies and Complex In Vitro Models to Reduce, Refine and Replace Animals in Drug Safety Testing |
Terry Van Vleet |
AbbVie |
1:25 - 2:05 |
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Session III: The importance of tracking missing metabolites/new technologies (covalent drugs) |
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Session Introduction: Eric Ballard, Takeda & Donglu Zhang, Genetech |
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2:05 - 2:10 |
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A "Missing” Trazpiroben Metabolite Observed as the Most Abundant Metabolite in Human Plasma and Urine |
Sean Zhu |
Takeda |
2:10 - 2:35 |
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Title TBA |
TBA |
TBA |
2:35 - 3:00 |
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PM Break & Exhibits |
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3:00 - 3:20 |
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impacts of mitigating missing metabolites for lead optimization in drug discovery - Title TBA |
Joyce Liu |
Genentech |
3:20 - 3:45 |
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Session IV: New Approaches to in Vitro ADME Assays for Improved Drug-Drug-Interaction and Clearance Predictions |
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Session Introduction: Benjamin Johnson, BMS |
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3:45 - 3:50 |
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translation of metabolic clearance for aldehyde oxidase substrates - title TBA |
Prakash Bolleddula |
EMD Serono |
3:50 - 4:15 |
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prediction of drug-drug interactions involving time-dependent P450 inhibitors - title TBA |
Elaine Tseng |
Pfizer |
4:15 - 4:40 |
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Hepatocyte Uptake and Loss Assay (HUpLA): Proof-of-Concept of an All-in-One System for Same Day Measuring Hepatic Influx, Egress, and Metabolic Clearance Based on the Extended Clearance Concept |
Julia Pauly |
AbbVie |
4:40 - 5:05 |
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Conference Closing Remarks |
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5:05- 5:10 |
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