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Wednesday, July 24, 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 – 5:00 PM
CST
Registration Open
7:00 AM – 5:00 PM
CST
Registration Open
Location: Ballroom Foyer
7:00 AM – 5:15 PM
CST
Exhibit Hall Open
7:00 AM – 5:15 PM
CST
Exhibit Hall Open
Location: Salon 1B
8:00 AM – 10:05 AM
CST
Analytical Methods for Complex and Novel Formulations
Moderator:
Nathan Contrella, PhD (he/him/his)
– Merck Research Laboratories
Pharmaceutical Analysis
8:00 AM – 10:05 AM
CST
Analytical Methods for Complex and Novel Formulations
Location: Salon III
Moderator:
Nathan Contrella, PhD (he/him/his)
– Merck Research Laboratories
Pharmaceutical Analysis
8:05 AM – 8:35 AM
CST
Detecting Crystallinity at Extremely Low Levels by Nonlinear Optical Spectroscopy
Location: Salon III
Speaker:
Garth Simpson, PhD
– Purdue University
Pharmaceutical Analysis
8:35 AM – 9:05 AM
CST
Challenges of Gel-Based Formulation Analysis
Location: Salon III
Speaker:
Adam Socia, PhD
– Organon
Pharmaceutical Analysis
9:05 AM – 9:35 AM
CST
Characterization of Complex Drug Product using Asymmetrical Flow Field Flow Fractionation (AF4): Challenges and Opportunities
Location: Salon III
Speaker:
Haiou Qu, PhD (he/him/his)
– US Food and Drug Administration
Pharmaceutical Analysis
9:35 AM – 10:05 AM
CST
New Analytical Frameworks to Accelerate Method Development of Vaccine Adjuvants across Complex Formulations
Location: Salon III
Speaker:
Caleb Kinsey (he/him/his)
– Merck
Pharmaceutical Analysis
8:00 AM – 10:05 AM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 1
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
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
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
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
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
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
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
Analytical Methods for Complex and Novel Formulations - Continued
Moderator:
Nathan Contrella, PhD (he/him/his)
– Merck Research Laboratories
Pharmaceutical Analysis
10:25 AM – 11:30 AM
CST
Analytical Methods for Complex and Novel Formulations - Continued
Location: Salon III
Moderator:
Nathan Contrella, PhD (he/him/his)
– Merck Research Laboratories
Pharmaceutical Analysis
10:25 AM – 10:55 AM
CST
Dissolution Method Development of a Parenteral Formulation
Location: Salon III
Speaker:
Limin Zhang, MS (she/her/hers)
– Bristol-Myers Squibb
Pharmaceutical Analysis
10:55 AM – 11:25 AM
CST
New USP General Chapters for the Complex Injectables (Microspheres and Iron Colloidals) and Drug-Device Combination Products
Location: Salon III
Speaker:
Prabhakar R. Gruddanti, MS, PhD (he/him/his)
– United States Pharmacopeia
Pharmaceutical Analysis
10:25 AM – 11:30 AM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 1 Continued
Moderator:
Lynn Kamen, PhD
– BioAgilytix Labs
Bioanalytical
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
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
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
11:30 AM – 12:00 PM
CST
HRMS as a Tool for Targeted Stabilization and Improved LLOD
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
11:30 AM – 1:30 PM
CST
Lunch
11:30 AM – 1:30 PM
CST
Lunch
Location: Salon 1B
12:00 PM – 12:30 PM
CST
Bioanalytical Strategies for Immunogenicity Assessment of ASOs
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
1:30 PM – 3:10 PM
CST
Challenges in Analytical Method Validations and Transfers
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Pharmaceutical Analysis
1:30 PM – 3:10 PM
CST
Challenges in Analytical Method Validations and Transfers
Location: Salon III
Moderator:
Landon Greene, PhD (he/him/his)
– Vertex Pharmaceuticals
Pharmaceutical Analysis
1:35 PM – 2:05 PM
CST
Pitfalls in Underpowered and Poorly Designed Validation Studies
Location: Salon III
Speaker:
Steven Walfish, MA MBA (he/him/his)
– Statistical Outsourcing Services
Pharmaceutical Analysis
2:05 PM – 2:35 PM
CST
Transferring an AAV Genome Titer Method - Lessons and Keys to Success
Location: Salon III
Speaker:
Sabine Wenzel, PhD (she/her/hers)
– Eli Lilly
Pharmaceutical Analysis
2:35 PM – 3:05 PM
CST
Transfer of Analytical Procedures as Part of the Method Lifecycle: USP Chapters <1224> and <1220>
Location: Salon III
Speaker:
Margareth R. Marques, MS, PhD (she/her/hers)
– U. S. Pharmacopeia
Pharmaceutical Analysis
1:30 PM – 3:10 PM
CST
Emerging Novel Technologies in the Bioanalytical Field - Part 2
Moderator:
Mark C. Wissel, PhD
– Eurofins-Viracor
Bioanalytical
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
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
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
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
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
Rapid Fire Presentations: Bioanalytical
Rapid Fire Moderator:
Xiuli Li (she/her/hers)
– Hikma Pharmaceuticals
Bioanalytical
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
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
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
3:30 PM – 4:15 PM
CST
Rapid Fire Presentations: Pharmaceutical Analysis
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
3:30 PM – 4:15 PM
CST
Rapid Fire Presentations: Pharmaceutical Analysis
Location: Salon III
Moderator:
Sachin Lohani, Ph.D.
– Merck & Co., Inc.
Pharmaceutical Analysis
3:30 PM – 3:45 PM
CST
Global Harmonization of PCR: An Initial Study with Six World Health Organization Reference Strains
Location: Salon III
Rapid Fire Presenter:
Sharon J. Manley, PhD
– Eurofins Viracor Biopharma Services
Pharmaceutical Analysis
3:45 PM – 4:00 PM
CST
Transfer and Validation of Flow Cytometry Assay Across Platforms and Labs
Location: Salon III
Rapid Fire Presenter:
Manoj Baskaran, MS (he/him/his)
– BioAgilytix Labs
Pharmaceutical Analysis
4:00 PM – 4:15 PM
CST
Stability Study and Beyond-Use Date Determination of a Compounded Labetalol Suspension
Location: Salon III
Rapid Fire Presenter:
Busayo O. Akodu, Bpharm. (he/him/his)
– School of Pharmacy, Southern Illinois University, Edwardsville.
Pharmaceutical Analysis
4:00 PM – 5:15 PM
CST
Closing Reception
4:00 PM – 5:15 PM
CST
Closing Reception
Location: Salon 1B
Sponsored By
5:15 PM – 6:00 PM
CST
Exhibitor Move-Out
5:15 PM – 6:00 PM
CST
Exhibitor Move-Out
Location: Salon 1B
