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Tuesday, Jul 23rd
8:00 AM – 10:05 AM
CST
Bioanalytical Strategies for New Modalities - Part 1
Location: Salon II
Moderator:
Brad Roadcap
– Merck & Co., Inc.
Bioanalytical
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
10:25 AM – 10:55 AM
CST
Peptide BA Strategies: PK and ADA
Location: Salon II
Speaker:
Jo Goodman (she/her/hers)
– Celerion
Bioanalytical
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
4:00 PM – 4:45 PM
CST
Rapid Fire Presentations: Bioanalytical
Location: Salon II
Rapid Fire Moderator:
Dominic Warrino, PhD
– KCAS Bio
Bioanalytical
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Tuesday, Jul 23rd
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
Wednesday, Jul 24th
8:00 AM – 10:05 AM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 1
Location: Salon II
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
Wednesday, Jul 24th
8:05 AM – 8:35 AM
CST
Navigating the Future: AI in Pharma and Regulatory Roadmap
Location: Salon II
Speaker:
Stephanie A. Pasas-Farmer, PhD
– Ariande Software
Bioanalytical
Wednesday, Jul 24th
8:35 AM – 9:05 AM
CST
Microsampling of Liquid Plasma and Dry Milk in Pre-Clinical and Clinical Studies
Location: Salon II
Speaker:
Ming Wang, MA (he/him/his)
– Merck & Co., Inc.
Bioanalytical
Wednesday, Jul 24th
9:05 AM – 9:35 AM
CST
Putting Cell Counting in Context (of use): Analytical Measurements Supporting Cellular Therapies
Location: Salon II
Speaker:
Virginia Litwin, PhD (she/her/hers)
– Eurofins Clinical Trial Solutions
Bioanalytical
Wednesday, Jul 24th
9:35 AM – 10:05 AM
CST
RNASeq: Illuminating Biomarker Landscapes for Precision Medicine - A Comparative Exploration of Multiplex Gene Profiling Technologies
Location: Salon II
Speaker:
Kirthi Kutumbaka, PhD (he/him/his)
– Eurofins Viracor BioPharma Services
Bioanalytical
Wednesday, Jul 24th
10:25 AM – 11:30 AM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 1 Continued
Location: Salon II
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
Wednesday, Jul 24th
10:25 AM – 10:55 AM
CST
Single-Cell Proteomics Analysis of Clinical Samples by IsoLight
Location: Salon II
Speaker:
Stephen McCarthy
– KCAS Bio-Philadelphia
Bioanalytical
Wednesday, Jul 24th
10:55 AM – 11:25 AM
CST
Organoids/Organ-On-Chip Models to Assess ADME-Tox at Early Stages of Development
Location: Salon II
Speaker:
Rodrigo Cristofoletti, PhD (he/him/his)
– University of Florida
Bioanalytical
Wednesday, Jul 24th
11:30 AM – 12:00 PM
CST
HRMS as a Tool for Targeted Stabilization and Improved LLOD
Location: Salon II
Partner Presenter:
Nicholas Ingram, BS (he/him/his)
– Q Squared Solutions
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
Sponsored By
Wednesday, Jul 24th
12:00 PM – 12:30 PM
CST
Bioanalytical Strategies for Immunogenicity Assessment of ASOs
Location: Salon II
Partner Presenter:
Andrea Sequeira
– BioAgilytix
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
Sponsored By
Wednesday, Jul 24th
1:30 PM – 3:10 PM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 2
Location: Salon II
Moderator:
Mark C. Wissel, PhD
– Eurofins-Viracor
Bioanalytical
Wednesday, Jul 24th
1:35 PM – 2:05 PM
CST
Multiple Automation Approaches for Increased Bioanalytical Laboratory Efficiency
Location: Salon II
Speaker:
Enoch Shum, MSCS
– Regeneron Pharmaceuticals
Bioanalytical
Wednesday, Jul 24th
2:05 PM – 2:35 PM
CST
AAV-Vector Derived Gene Therapy Safety and Efficacy Assays: Platform Selection
Location: Salon II
Speaker:
Yanshan Dai, PhD (he/him/his)
– Bristol Myers Squibb
Bioanalytical
Wednesday, Jul 24th
2:35 PM – 3:05 PM
CST
Validation Best Practices: PCR Case Studies in Shedding
Location: Salon II
Speaker:
Bryan M. Gullick, PhD
– BioAgilytix Labs, LLC.
Bioanalytical
Wednesday, Jul 24th
3:30 PM – 4:00 PM
CST
Rapid Fire Presentations: Bioanalytical
Location: Salon II
Rapid Fire Moderator:
Xiuli Li (she/her/hers)
– Hikma Pharmaceuticals
Bioanalytical
Wednesday, Jul 24th
3:30 PM – 3:45 PM
CST
Identification and Impact Assessment of Matrix Effect for Protein Biomarkers Analyzed by Liquid Chromatography-Mass Spectrometry
Location: Salon II
Rapid Fire Presenter:
Mackenzie Bentley, MBA (she/her/hers)
– ICON Plc
Bioanalytical
Wednesday, Jul 24th
3:45 PM – 4:00 PM
CST
PK Parameters are a Single API Call Away
Location: Salon II
Rapid Fire Presenter:
Nathan Teuscher, MS, PhD (he/him/his)
– Aplos Analytics, Inc.
Bioanalytical
Thursday, Jul 25th
8:00 AM – 10:40 AM
CST
Challenges in Analytical Method Validations and Transfers: Bio and Pharm Joint Session
Location: Salon II
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
8:05 AM – 8:35 AM
CST
Strategies for Overcoming Challenges with Bioanalytical Method Transfers
Location: Salon II
Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
8:35 AM – 9:05 AM
CST
Strategies for the Modernization of Legacy Transfer Methods
Location: Salon II
Speaker:
Erik Jerks, B.S.
– Eurofins Pharma Bioanalytics Services, LLC
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
9:05 AM – 9:35 AM
CST
Risk Assessment for Lab Training and Readiness Prior to Method Transfer
Location: Salon II
Speaker:
Joselito Gonzalez, MS Quality Engineering (he/him/his)
– Organon
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
9:35 AM – 10:05 AM
CST
Lessons Learned from Registrational Analytical Methods Transfer and Validation at External CMOs in Support of Drug Substance Processes
Location: Salon II
Speaker:
Peter I. Tattersall, PhD (he/him/his)
– Analytical Strategy & Operations / Bristol Myers Squibb
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
10:05 AM – 10:35 AM
CST
Joint Session: Panel Discussion
Location: Salon II
Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Speaker:
Erik Jerks, B.S.
– Eurofins Pharma Bioanalytics Services, LLC
Speaker:
Joselito Gonzalez, MS Quality Engineering (he/him/his)
– Organon
Speaker:
Peter I. Tattersall, PhD (he/him/his)
– Analytical Strategy & Operations / Bristol Myers Squibb
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Bioanalytical
Pharmaceutical Analysis
Thursday, Jul 25th
10:35 AM – 10:40 AM
CST
Closing Remarks
Location: Salon II
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
Pharmaceutical Analysis