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Tuesday, July 23, 2024
7:00 AM – 8:00 AM
CST
Continental Breakfast
7:00 AM – 8:00 AM
CST
Continental Breakfast
Location: Salon 1B
7:00 AM – 4:00 PM
CST
Registration Open
7:00 AM – 4:00 PM
CST
Registration Open
Location: Ballroom Foyer
7:00 AM – 5:00 PM
CST
Exhibit Hall Open
7:00 AM – 5:00 PM
CST
Exhibit Hall Open
Location: Salon 1B
8:00 AM – 10:05 AM
CST
Bioanalytical Strategies for New Modalities - Part 1
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
8:00 AM – 10:05 AM
CST
Bioanalytical Strategies for New Modalities - Part 1
Location: Salon II
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
8:05 AM – 8:35 AM
CST
Development of siRNA Therapeutics: What Data are Needed for PK and ADA Assessment
Location: Salon II
Speaker:
An Zhao, PhD
– Regeneron Pharmaceuticals, Inc.
Bioanalytical
8:35 AM – 9:05 AM
CST
Investigation of Antibody Drug Conjugate’s Fast Clearance: Assay or Biology?
Location: Salon II
Speaker:
Cynthia M. Chavez-Eng, PhD
– Merck & Co., Inc.
Bioanalytical
9:05 AM – 9:35 AM
CST
ADCs – LBA vs Hybrid: Hybrid LC-MS/MS Technology vs LBA for the Bioanalysis of Antibody-Drug-Conjugates Examples and Case Studies for Hybrid
Location: Salon II
Speaker:
Dawn Dufield, PhD
– KCAS Bio
Bioanalytical
9:35 AM – 10:05 AM
CST
Impact of Soluble Target on Clinical ADA Assessment
Location: Salon II
Speaker:
Karen Liao, MD
– Merck & Co., Inc.
Bioanalytical
8:00 AM – 10:05 AM
CST
Nitrosamine Analysis and Control
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
8:00 AM – 10:05 AM
CST
Nitrosamine Analysis and Control
Location: Salon III
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
8:05 AM – 8:35 AM
CST
Perspectives on Acceptable Intakes for Nitrosamines
Location: Salon III
Speaker:
Leonardo Allain, PhD (he/him/his)
– Merck & Co., Inc.
Pharmaceutical Analysis
8:35 AM – 9:05 AM
CST
Predicting Nitrosamine Formation in Drug Products
Location: Salon III
Speaker:
Eric J. Munson, PhD, FAAPS
– Purdue University/Industrial and Physical Pharmacy
Pharmaceutical Analysis
9:05 AM – 9:35 AM
CST
Accuracy Challenges in Nitrosamine Analysis
Location: Salon III
Speaker:
Qiyao Li, PhD (she/her/hers)
– United States Pharmacopeia
Pharmaceutical Analysis
9:35 AM – 10:05 AM
CST
Navigating the Complexity of LC-MS Method Development for NDSRI Analysis - Case Studies
Location: Salon III
Speaker:
Jan Yang, PhD
– US FDA
Pharmaceutical Analysis
10:05 AM – 10:25 AM
CST
Morning Break
10:05 AM – 10:25 AM
CST
Morning Break
Location: Salon 1B
10:25 AM – 11:30 AM
CST
Bioanalytical Strategies for New Modalities - Part 1 Continued
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
10:25 AM – 11:30 AM
CST
Bioanalytical Strategies for New Modalities - Part 1 Continued
Location: Salon II
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
10:25 AM – 10:55 AM
CST
Peptide BA Strategies: PK and ADA
Location: Salon II
Speaker:
Jo Goodman (she/her/hers)
– Celerion
Bioanalytical
10:55 AM – 11:25 AM
CST
FDA guidance on ADC BA: What to Measure at Different Clinical Stages
Location: Salon II
Speaker:
Atiya Taqui (she/her/hers)
– Gilead Sciences, Inc.
Bioanalytical
10:25 AM – 11:30 AM
CST
Nitrosamine Analysis and Control - Continued
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
10:25 AM – 11:30 AM
CST
Nitrosamine Analysis and Control - Continued
Location: Salon III
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
10:25 AM – 10:55 AM
CST
Application of Structure-Activity Relationship (SAR) Modeling to Nitrosamine Impurities in Pharmaceuticals
Location: Salon III
Speaker:
Naomi Kruhlak, PhD (she/her/hers)
– US Food and Drug Administration
Pharmaceutical Analysis
10:55 AM – 11:25 AM
CST
Nitrosamine Analysis and Control Panel Discussion
Location: Salon III
Speaker:
Leonardo Allain, PhD (he/him/his)
– Merck & Co., Inc.
Speaker:
Eric J. Munson, Ph.D.
– Purdue University
Speaker:
Qiyao Li, PhD (she/her/hers)
– United States Pharmacopeia
Speaker:
Jan Yang, PhD
– US FDA
Speaker:
Naomi Kruhlak, PhD (she/her/hers)
– US Food and Drug Administration
Pharmaceutical Analysis
11:30 AM – 12:00 PM
CST
Advances in Accelerated Quantification of Oligo Therapies with Automated, Microfluidic Methods
11:30 AM – 12:00 PM
CST
Advances in Accelerated Quantification of Oligo Therapies with Automated, Microfluidic Methods
Location: Salon II
Partner Presenter:
Manny Lozano
– Gyros Protein Technologies
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
Sponsored By
11:30 AM – 12:00 PM
CST
Practical Approaches to Characterizing Charged Variants
11:30 AM – 12:00 PM
CST
Practical Approaches to Characterizing Charged Variants
Location: Salon III
Partner Presenter:
Shawn Fitzgibbons, MS Chemistry (he/him/his)
– Catalent Pharma Solutions
Pharmaceutical Analysis
Sponsored By
12:00 PM – 1:30 PM
CST
Lunch
12:00 PM – 1:30 PM
CST
Lunch
Location: Salon 1B
1:30 PM – 3:10 PM
CST
Bioanalytical Strategies for New Modalities - Part 2
Moderator:
Linlin Luo, Dr. (she/her/hers)
– Merck & Co., Inc.
Bioanalytical
1:30 PM – 3:10 PM
CST
Bioanalytical Strategies for New Modalities - Part 2
Location: Salon II
Moderator:
Linlin Luo, Dr. (she/her/hers)
– Merck & Co., Inc.
Bioanalytical
1:35 PM – 2:05 PM
CST
Cell-Based Therapies: Adaptations and Considerations for Global Bioanalysis
Location: Salon II
Speaker:
Thanh-Long Nguyen, PhD (he/him/his)
– ICON plc
Bioanalytical
2:05 PM – 2:35 PM
CST
Leveraging Learnings from Ligand-Binding and LCMS Methodologies for ARC Bioanalysis
Location: Salon II
Speaker:
Catherine L. Brockus, PhD (she/her/hers)
– Eli Lilly and Company
Bioanalytical
2:35 PM – 3:05 PM
CST
Enhancing Cellular Immunogenicity Assessment Through Elispot Testing: Leveraging Advances and Resources
Location: Salon II
Speaker:
Sylvia Janetzki, MD (she/her/hers)
– ZellNet Consulting, Inc.
Bioanalytical
1:30 PM – 3:10 PM
CST
Stuck in the Middle - Methodologies for Oligonucleotides, Peptides and Other Medium-Sized Molecules
Moderator:
Eric J. Munson, PhD, FAAPS
– Purdue University/Industrial and Physical Pharmacy
Pharmaceutical Analysis
1:30 PM – 3:10 PM
CST
Stuck in the Middle - Methodologies for Oligonucleotides, Peptides and Other Medium-Sized Molecules
Location: Salon III
Moderator:
Eric J. Munson, PhD, FAAPS
– Purdue University/Industrial and Physical Pharmacy
Pharmaceutical Analysis
1:35 PM – 2:05 PM
CST
Expanding the Characterization Capability of Therapeutic LNPs
Location: Salon III
Speaker:
Jiawei Gong, PhD (she/her/hers)
– Bristol Myers Squibb
Pharmaceutical Analysis
2:05 PM – 2:35 PM
CST
Design and Implementation of a Platform Analytical Characterization Strategy for Rapid Candidate Screening and the study of Degradation Mechanism Pathways of Synthetic Macrocyclic Peptide Therapeutics
Location: Salon III
Speaker:
Sam Yang
Pharmaceutical Analysis
2:35 PM – 3:05 PM
CST
Analytical Comparability of a Complex Medium-Sized Biotherapeutic
Location: Salon III
Speaker:
Mark Chipley, MS
– Pfizer
Pharmaceutical Analysis
3:10 PM – 3:30 PM
CST
Afternoon Break
3:10 PM – 3:30 PM
CST
Afternoon Break
Location: Salon 1B
3:30 PM – 4:00 PM
CST
Bioanalysis Essentials: Case Studies on mAb Quantification and M10 Validation
3:30 PM – 4:00 PM
CST
Bioanalysis Essentials: Case Studies on mAb Quantification and M10 Validation
Location: Salon II
Partner Presenter:
Prajita Pandey, PhD
– Emery Pharma
Moderator:
Dominic Warrino, PhD
– KCAS Bio
Bioanalytical
Sponsored By
3:30 PM – 4:15 PM
CST
Rapid Fire Presentations: Pharmaceutical Analysis
Rapid Fire Moderator:
Jeff Patrick, PhD
– BioAgilytix Labs
Pharmaceutical Analysis
3:30 PM – 4:15 PM
CST
Rapid Fire Presentations: Pharmaceutical Analysis
Location: Salon III
Rapid Fire Moderator:
Jeff Patrick, PhD
– BioAgilytix Labs
Pharmaceutical Analysis
3:30 PM – 3:45 PM
CST
Advancing Quality Control for CRISPR-Cas9 Systems: Separation of CRISPR Components using Ion Exchange Chromatography
Location: Salon III
Rapid Fire Presenter:
Rachel Ginther, PhD (she/her/hers)
– MRIGlobal
Pharmaceutical Analysis
3:45 PM – 4:00 PM
CST
Size Exclusion Chromatography for LNP Analysis: Strategies for Dealing with Method Development Challenges
Location: Salon III
Rapid Fire Presenter:
Abraham S. Finny, PhD, PChem
– Waters Corporation
Pharmaceutical Analysis
4:00 PM – 4:15 PM
CST
Implications of Draft FDA Guidance on Potency Assays for G&CT
Location: Salon III
Rapid Fire Presenter:
Manoj Baskaran, MS (he/him/his)
– BioAgilytix Labs
Pharmaceutical Analysis
4:00 PM – 4:45 PM
CST
Rapid Fire Presentations: Bioanalytical
Rapid Fire Moderator:
Dominic Warrino, PhD
– KCAS Bio
Bioanalytical
4:00 PM – 4:45 PM
CST
Rapid Fire Presentations: Bioanalytical
Location: Salon II
Rapid Fire Moderator:
Dominic Warrino, PhD
– KCAS Bio
Bioanalytical
4:00 PM – 4:15 PM
CST
Hybridization LC-MS for Bioanalysis of Oligonucleotides
Location: Salon II
Rapid Fire Presenter:
Brendan Powers, PhD (he/him/his)
– LabCorp Drug Development - Bioanalytical Services
Bioanalytical
4:15 PM – 4:30 PM
CST
Screening Non-Neutralizing Anti-Idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay
Location: Salon II
Rapid Fire Presenter:
Yong Jiang, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytical
4:30 PM – 4:45 PM
CST
DMPK of Gefitinib & Gefitinib-3-PROTAC Following Subcutaneous Administration to the Rat Using Micro Sampling and UPLC-MS/MS
Location: Salon II
Rapid Fire Presenter:
Andrew Leightner, BS
– Waters Corporation
Bioanalytical
6:15 PM – 8:15 PM
CST
Networking Reception: Guided Lab Tours at KCAS Bio followed by a BBQ Dinner Reception
6:15 PM – 8:15 PM
CST
Networking Reception: Guided Lab Tours at KCAS Bio followed by a BBQ Dinner Reception
Location: KCAS Bio: 10830 S. Clay Blair Blvd., Olathe, KS 66061
Sponsored By
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