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Monday, Nov 10th
9:00 AM - 11:00 AM
CT
Symposium: AI/ML in Bioanalysis
Location: 221 CD
Moderator:
Sanjeev Bhardwaj, PhD (he/him/his)
– Moderna Therapeutics
Bioanalytics
Monday, Nov 10th
9:00 AM - 11:00 AM
CT
Symposium: Changing Landscape of Regulated Bioanalysis
Location: 221 AB
Moderator:
Ang Liu, PhD (she/her/hers)
– Johnson & Johnson
Bioanalytics
Monday, Nov 10th
9:00 AM - 9:30 AM
CT
Machine Learning to Streamline Chiral SFC Method Development
Location: 221 CD
Speaker:
Ines Santos, PhD (she/her/hers)
– Bristol-Myers Squibb
Bioanalytics
Monday, Nov 10th
9:00 AM - 9:30 AM
CT
Remembering the Bioanalytical Lessons Learned from Regulatory Submissions
Location: 221 AB
Speaker:
Chongwoo Yu, Ph.D.
– US Food and Drug Administration
Bioanalytics
Monday, Nov 10th
9:30 AM - 10:00 AM
CT
AI/ML Used in Predictive Maintenance to Enhance Laboratory Efficiency
Location: 221 CD
Speaker:
Kim Huynh-Ba, M.S., PMP, FAAPS (she/her/hers)
– Pharmalytik
Bioanalytics
Monday, Nov 10th
9:30 AM - 10:00 AM
CT
In vitro Bioequivalence - Trends in Regulatory Review and Inspections
Location: 221 AB
Speaker:
Tahseen Mirza, Ph.D., MBA
– US Food and Drug Administration
Bioanalytics
Monday, Nov 10th
10:00 AM - 10:30 AM
CT
Regulated Bioanalysis in China, a 15-Year Retrospective
Location: 221 AB
Speaker:
Eric J. Woolf, PhD, FAAPS (he/him/his)
– Beyond M10 Bioanalytical Consulting
Bioanalytics
Monday, Nov 10th
10:00 AM - 10:30 AM
CT
Regulatory-Ready AI: Applying Large Language Models to Bioanalytical Workflows
Location: 221 CD
Speaker:
Stephanie A. Pasas-Farmer, PhD (she/her/hers)
– BioData Solutions LLC
Bioanalytics
Monday, Nov 10th
10:30 AM - 11:00 AM
CT
Accelerating Mass Spectrometry Imaging Using Deep Learning
Location: 221 CD
Speaker:
Mithunjha Anandakumar (she/her/hers)
– University of Illinois Urbana Champaign
Bioanalytics
Monday, Nov 10th
10:30 AM - 11:00 AM
CT
Immunogenicity Assessment: Can We Harmonize Immunogenicity Assays?
Location: 221 AB
Speaker:
Gregor Jordan, M.Eng.
– Roche Diagnostics GmbH
Bioanalytics
Monday, Nov 10th
9:30 AM - 10:15 AM
CT
Rigorous Critical Reagent Characterization: A Key to Sustaining BioA Programs
Location: Spotlight Stage A, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Adam S. Kinne, MS (he/him/his)
– B2S Life Sciences
Bioanalytics
Sponsored By
Monday, Nov 10th
9:30 AM - 10:30 AM
CT
Navigating New Modalities: Tackling Biotransformation and Bioanalytical Challenges
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker:
Hong Zhang, PhD (he/him/his)
– WuXi AppTec
Partner Presentation Speaker:
Peiwen Zhang, PhD
– WuXi AppTec
Bioanalytics
Sponsored By
Monday, Nov 10th
10:30 AM - 11:30 AM
CT
Plan Early to Ensure a Successful ADA Assessment
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker:
Ha Bruno, PhD
– Certara
Partner Presentation Speaker:
Elliot Offman, BSc Pharm, MSc, PhD
– Certara
Bioanalytics
Sponsored By
Monday, Nov 10th
11:00 AM - 12:00 PM
CT
To Hybridize or Not to Hybridize: That is the Question
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker:
Elizabeth C. Dodson, PhD
– IQVIA Labs
Bioanalytics
Sponsored By
Monday, Nov 10th
11:15 AM - 12:00 PM
CT
Accelerating Clinical Bioanalysis: Transforming the Industry with Automation and Tech First Approaches
Location: Spotlight Stage A, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Ely Porter, PhD
– Dash Bio, Inc
Bioanalytics
Sponsored By
Monday, Nov 10th
1:30 PM - 2:30 PM
CT
Extractables and Leachables for Biologic Drug Forms
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker:
Eric Hill, MS MBA
– BA Sciences
Bioanalytics
Sponsored By
Monday, Nov 10th
1:30 PM - 2:30 PM
CT
Keynote: From Algorithms to Action: Harnessing Predictive Models in the Era of Precision Medicine
Location: 221 CD
Keynote Speaker:
Anna G. Kondic, PhD, MBA
– BMS
Moderator:
Jim Shen, PhD
– Bristol Myers Squibb
Bioanalytics
Monday, Nov 10th
1:30 PM - 2:30 PM
CT
Keynote: Reflections on Transformations in Drug Development, Bioanalysis and Regulations
Location: 221 AB
Keynote Speaker:
Mark E. Arnold, PhD
– Bioanalytical Solution Integration
Moderator:
Faye Vazvaei, M.S.
– Merck & Co., Inc.
Bioanalytics
Monday, Nov 10th
2:00 PM - 3:00 PM
CT
Bioanalytics of New Drug Modalities and Cell/Gene Therapies
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker:
Daniel Sikkema
– Labcorp
Bioanalytics
Sponsored By
Monday, Nov 10th
3:00 PM - 4:00 PM
CT
Rapid Fires: AI/ML in Bioanalysis
Location: 221 CD
Rapid Fire Moderator:
Steve Lowes, PhD (he/him/his)
– IQVIA Laboratories
Bioanalytics
Monday, Nov 10th
3:00 PM - 4:00 PM
CT
Rapid Fires: Changing Landscape of Regulated Bioanalysis
Location: 221 AB
Rapid Fire Moderator:
Manish Kumar, PhD (he/him/his)
– Daiichi Sankyo
Bioanalytics
Monday, Nov 10th
3:00 PM - 3:15 PM
CT
Improving Ex-vivo Stimulation Assays for Robust Bioanalysis
Location: 221 AB
Rapid Fire Speaker:
Tyler Moore, PhD (he/him/his)
– Celerion
Bioanalytics
Monday, Nov 10th
3:00 PM - 3:15 PM
CT
Innovating Bioanalytical Reporting: Assessing Piloted AI Reporting Tools at Celerion
Location: 221 CD
Rapid Fire Speaker:
Mark Campbell
– Celerion
Bioanalytics
Monday, Nov 10th
3:15 PM - 3:30 PM
CT
Assessing Risk for the IVDR Application
Location: 221 AB
Rapid Fire Speaker:
Joleen T. White, PhD (she/her/hers)
– BioData Solutions LLC
Bioanalytics
Monday, Nov 10th
3:15 PM - 3:30 PM
CT
Transforming Data Strategy for Advanced Analytics and Automation
Location: 221 CD
Rapid Fire Speaker:
Andy Waters, MBA, MSBA
– IQVIA Laboratories
Bioanalytics
Monday, Nov 10th
3:30 PM - 3:45 PM
CT
Agentic AI Bioanalysis of Personalized Cancer Neoantigen Vaccine Based Trials
Location: 221 CD
Rapid Fire Speaker:
Yongzhong Zhao, PhD
– Frontage Labs
Bioanalytics
Monday, Nov 10th
3:30 PM - 3:45 PM
CT
Bioanalytical Challenges and Strategies for Antibody–Drug Conjugates
Location: 221 AB
Rapid Fire Speaker:
Peiwen Zhang, PhD
– WuXi AppTec
Bioanalytics
Monday, Nov 10th
3:45 PM - 4:00 PM
CT
Innovating Compliantly: Automating Workflows Within Regulatory Guidance Using ChatGPT
Location: 221 CD
Rapid Fire Speaker:
Quentin Burke (he/him/his)
– Moderna Inc.
Bioanalytics
Monday, Nov 10th
3:45 PM - 4:00 PM
CT
SEC-MALS for Peptide and ADC Characterization: Precision in Bioanalysis
Location: 221 AB
Rapid Fire Speaker:
Subathra Ramamoorthy, MS, RPh
– Veranova
Bioanalytics
Tuesday, Nov 11th
9:00 AM - 10:00 AM
CT
Complex Complexities: Insights into the Method Development and Binding Tendencies of Hemoproteins and their Heme-Bound Complexes.
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker:
Joey Campbell, Ph.D.
– Prolytix
Bioanalytics
Sponsored By
Tuesday, Nov 11th
9:00 AM - 11:00 AM
CT
Symposium: Biomarker, Platform and Support
Location: 221 AB
Moderator:
Shoshana Oberstein (she/her/hers)
– Takeda
Bioanalytics
Tuesday, Nov 11th
9:00 AM - 11:00 AM
CT
Symposium: Using Mass Spec to Support PD/PK
Location: 221 CD
Moderator:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
Bioanalytics
Tuesday, Nov 11th
9:00 AM - 9:30 AM
CT
Bioanalytical Assays for Gene Therapy Shedding Studies: Platforms and Validation
Location: 221 AB
Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Bioanalytics
Tuesday, Nov 11th
9:00 AM - 9:30 AM
CT
Measuring Receptor Occupancy in Peripheral Blood Cells Using Mass Spectrometry
Location: 221 CD
Speaker:
Joseph M. Eckenrode, PhD
– Merck & Co, Inc - Rahway, NJ
Bioanalytics
Tuesday, Nov 11th
9:30 AM - 10:00 AM
CT
Composite Non-Invasive Testing Biomarker Enrichment in HBV-aHCC with Poor Prognosis
Location: 221 AB
Speaker:
Bin Ye, PhD.
– Huahui Health Biotech
Bioanalytics
Tuesday, Nov 11th
9:30 AM - 10:00 AM
CT
Uncover the Power of Mass Spectrometry Imaging (MSI) for Spatially Resolved Analysis of Biological Tissues
Location: 221 CD
Speaker:
Erin H. Seeley, PhD (she/her/hers)
– MD Anderson Cancer Center
Bioanalytics
Tuesday, Nov 11th
10:00 AM - 10:30 AM
CT
Best Practice of Regulated Flow Cytometry by Chinese Bioanalysis Forum
Location: 221 AB
Speaker:
Jing Shi, PhD
– InnoStar
Bioanalytics
Tuesday, Nov 11th
10:00 AM - 10:30 AM
CT
MS and Stable-Isotope Kinetic Methods for Target Biology & Biomarker Strategies
Location: 221 CD
Speaker:
Stephen F. Previs, PhD
– PharmaCadence Analytical Services, LLC
Bioanalytics
Tuesday, Nov 11th
10:30 AM - 11:00 AM
CT
Advancing AAV Standards in Gene Therapy
Location: 221 AB
Speaker:
Ben Clarke, PhD
– United States Pharmacopeia
Bioanalytics
Tuesday, Nov 11th
10:30 AM - 11:00 AM
CT
Innovative Mass Spectrometry Strategies for Clinical Bioanalysis and Monitoring
Location: 221 CD
Speaker:
Robin Kemperman, PhD (he/him/his)
– Children's Hospital of Philadelphia
Bioanalytics
Tuesday, Nov 11th
10:30 AM - 11:30 AM
CT
Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward
Location: 220
Hot Topic Moderator:
Carmen Fernandez-Metzler, PhD
– PharmaCadence
Hot Topic Speaker:
Steven P. Piccoli, PhD (he/him/his)
– SPARC
Hot Topic Speaker:
Lauren Stevenson, PhD (she/her/hers)
– Immunologix
Hot Topic Speaker:
Karen J. Quadrini, PhD
– Prothena Biosciences
Hot Topic Speaker:
Lakshmi Amaravadi, PhD (she/her/hers)
– AstraZeneca
Bioanalytics
Tuesday, Nov 11th
12:00 PM - 1:00 PM
CT
Elevating Analytical Excellence: RNA Extraction and Singlicate Use in LBA
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker:
Ruwini D. Rajapaksha, PhD, PMP (she/her/hers)
– Lovelace Biomedical
Bioanalytics
Sponsored By
Tuesday, Nov 11th
1:30 PM - 2:30 PM
CT
Keynote: Harnessing MALDI Mass Spectrometry Imaging for Biomarker Development in Hepatocellular Carcinoma Diagnosis and Prognosis
Location: 221 CD
Keynote Speaker:
Anand Mehta, DPhil (he/him/his)
– Medical University of South Carolina
Moderator:
Ryan De Palma
Bioanalytics
Tuesday, Nov 11th
1:30 PM - 2:30 PM
CT
Keynote: Navigating the Biomarker Spectrum: From Pharmacokinetics to Companion Diagnostics in a Complex Regulatory World
Location: 221 AB
Keynote Speaker:
Sarah Hersey, MS, MBA, RAC (she/her/hers)
– Bristol Myers Squibb
Moderator:
Lina Luo, MS (she/her/hers)
– Bristol-Myers Squibb Company
Bioanalytics
Tuesday, Nov 11th
3:00 PM - 4:00 PM
CT
Rapid Fires: Biomarker, Platform and Support
Location: 221 AB
Rapid Fire Moderator:
Christopher Sucato, PhD
– Novartis
Bioanalytics
Tuesday, Nov 11th
3:00 PM - 4:00 PM
CT
Rapid Fires: Using Mass Spec to Support PD/PK
Location: 221 CD
Rapid Fire Moderator:
Qian Veronica Qin, PhD
– Amgen
Bioanalytics
Tuesday, Nov 11th
3:00 PM - 3:15 PM
CT
Biomarker Challenges: Spiked Quality Controls, Can They Bias your Results?
Location: 221 AB
Rapid Fire Speaker:
Marc-Olivier Pepin, BSc
– Charles River
Bioanalytics
Tuesday, Nov 11th
3:00 PM - 3:15 PM
CT
Linker-Cleavage Enzyme Comparison for Hybrid LC-MS Analysis of Antibody-Drug Conjugates
Location: 221 CD
Rapid Fire Speaker:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson
Bioanalytics
Tuesday, Nov 11th
3:15 PM - 3:30 PM
CT
A Streamlined, Rapid End-to-End Workflow for Discovery Bioanalysis Laboratories
Location: 221 CD
Rapid Fire Speaker:
Nikunj Tanna, MS (he/him/his)
– Waters Corporation
Bioanalytics
Tuesday, Nov 11th
3:15 PM - 3:30 PM
CT
Practical Management of Conjugates for ADA and NAb Assays
Location: 221 AB
Rapid Fire Speaker:
Kuiyi Xing, Ph.D. (he/him/his)
– Celerion
Bioanalytics
Tuesday, Nov 11th
3:30 PM - 3:45 PM
CT
Innovative Approaches to Micro-Sampling/Patient-Centric Sampling in Regulated Bioanalysis
Location: 221 AB
Rapid Fire Speaker:
Lina Luo, MS (she/her/hers)
– Bristol-Myers Squibb Company
Bioanalytics
Tuesday, Nov 11th
3:30 PM - 3:45 PM
CT
Mass Spectrometry-Imaging to Determine Drug Disposition Using Targeted Cell-Based Carriers
Location: 221 CD
Rapid Fire Speaker:
Ishwor Poudel, PhD (he/him/his)
– University of Washington
Bioanalytics
Tuesday, Nov 11th
3:45 PM - 4:00 PM
CT
A Validated Assay for LC-MS/MS Analysis of an siRNA Therapeutic Drug Using Microsampling Devices
Location: 221 AB
Rapid Fire Speaker:
Todd Lusk, BS
– IQVIA Laboratories
Bioanalytics
Tuesday, Nov 11th
3:45 PM - 4:00 PM
CT
LC-MS Quantification of an ASO Drug Candidate in Human Plasma
Location: 221 CD
Rapid Fire Speaker:
Xuejun Sun, PhD (she/her/hers)
– Novartis Biomedical Research
Bioanalytics
Tuesday, Nov 11th
3:30 PM - 4:30 PM
CT
Bioanalytical Strategies for Therapeutic Drugs and Their Conjugates (ADCs, Oligos, siRNA, ASOs and AOCs/ARCs) by QqQ/HRMS. Strategies and Case Studies
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker:
Dawn Dufield, PhD
– KCAS Bio
Bioanalytics
Sponsored By
Wednesday, Nov 12th
9:00 AM - 10:00 AM
CT
Hot Topic: Key Considerations: Implementing ML and LLM-Based Research to Regulatory Applications
Location: 220
Hot Topic Speaker:
Shraddha Thakkar, PhD (she/her/hers)
– US Food and Drug Administration
Hot Topic Speaker:
Weida Tong, PhD (he/him/his)
– National Center for Toxicological Research, FDA
Hot Topic Speaker:
Michael Renaudin, PhD, MBA
– Swiss Medic 4.0
Hot Topic Moderator:
Raja B. Velagapudi, PhD (he/him/his)
– Tolmar Inc
Bioanalytics
Wednesday, Nov 12th
9:00 AM - 11:00 AM
CT
Symposium: Novel Instrumentations in Bioanalysis
Location: 221 CD
Moderator:
Mohamed I. Gadallah, MSc (he/him/his)
– University of Texas at Austin
Bioanalytics
Wednesday, Nov 12th
9:00 AM - 11:00 AM
CT
Symposium: Oligo Bioanalysis, Platforms and Methods
Location: 221 AB
Moderator:
Long Yuan, PhD
– Biogen Inc.
Bioanalytics
Wednesday, Nov 12th
9:00 AM - 9:30 AM
CT
Bioanalysis of Emerging Modality Therapeutics Using Novel Mass Spectrometry Approaches
Location: 221 CD
Speaker:
Rachel Shi
– Genentech
Bioanalytics
Wednesday, Nov 12th
9:00 AM - 9:30 AM
CT
Comparison of Bioanalytical Assay Platforms for Oligonucleotide Quantitation
Location: 221 AB
Speaker:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson
Bioanalytics
Wednesday, Nov 12th
9:30 AM - 10:00 AM
CT
Comparison of Three LC-MS Platforms for Oligonucleotide Therapeutic Quantification
Location: 221 AB
Speaker:
Troy Voelker, PhD (he/him/his)
– Aliri Bioanalysis
Bioanalytics
Wednesday, Nov 12th
9:30 AM - 10:00 AM
CT
Ion Mobility Spectrometry (IMS) and its Integration with Mass Spectrometry
Location: 221 CD
Speaker:
Brandon Ruotolo, PhD (he/him/his)
– University of Michigan
Bioanalytics
Wednesday, Nov 12th
10:00 AM - 10:30 AM
CT
Advancing High-Resolution Ion Mobility-Mass Spectrometry for Bioanalysis and Drug Applications
Location: 221 CD
Speaker:
Christopher D. Chouinard, PhD
– Clemson University
Bioanalytics
Wednesday, Nov 12th
10:00 AM - 10:30 AM
CT
Comparison of Two Hybridization LBA Platforms for Oligonucleotide Therapeutic Quantification
Location: 221 AB
Speaker:
Liz Nolff, M.S. (she/her/hers)
– BioAgilytix
Bioanalytics
Wednesday, Nov 12th
10:30 AM - 11:00 AM
CT
Minimizing Immunogenicity Testing for Development of Oligonucleotide Therapeutics: Risk-Based Strategy
Location: 221 AB
Speaker:
An Zhao, PhD (she/her/hers)
– Regeneron Pharmaceuticals
Bioanalytics
Wednesday, Nov 12th
10:30 AM - 11:00 AM
CT
SampleStream Technology for Automated Analysis of Biotherapeutic Samples
Location: 221 CD
Speaker:
Philip D. Compton, PhD (he/him/his)
– Integrated Protein Technologies, Inc.
Bioanalytics
Wednesday, Nov 12th
1:30 PM - 2:30 PM
CT
Keynote: New Frontiers in High Performance Mass Spectrometry for Bioanalysis of Therapeutics
Location: 221 CD
Keynote Speaker:
Jennifer Brodbelt, PhD (she/her/hers)
– University of Texas at Austin
Moderator:
Scott Robotham, PhD (he/him/his)
– Bristol Myers Squibb Company
Bioanalytics
Wednesday, Nov 12th
1:30 PM - 2:30 PM
CT
Keynote: The Evolving Bioanalytical Strategies and Considerations for Advancing Gene and Cell Therapy Drug Development
Location: 221 AB
Keynote Speaker:
Yanmei Lu, PhD (she/her/hers)
– Sangamo Therapeutics
Moderator:
Honglue (Holly) Shen, PhD
– Merck
Bioanalytics
Wednesday, Nov 12th
3:00 PM - 4:00 PM
CT
Rapid Fires: Novel Instrumentations in Bioanalysis/Oligo Bioanalysis, Platforms and Methods
Location: 221 AB
Rapid Fire Moderator:
Bryan M. Gullick, PhD
– BioAgilytix Labs, LLC.
Bioanalytics
Wednesday, Nov 12th
3:00 PM - 3:15 PM
CT
Capillary Assisted Vitrification: Stabilizing Critical Reagents and Biospecimens for Storage at Room Temperature
Location: 221 AB
Rapid Fire Speaker:
Jorge Becerra, PhD
– Ambient Biosciences
Bioanalytics
Wednesday, Nov 12th
3:15 PM - 3:30 PM
CT
Qualifying scRNA-seq Assay for Profiling Leukocytes from Human Blood Samples
Location: 221 AB
Rapid Fire Speaker:
Suresh Peddigari, PhD (he/him/his)
– Moderna Therapeutics
Bioanalytics
Wednesday, Nov 12th
3:30 PM - 3:45 PM
CT
The Tale of Two Methods: Charge Heterogeneity of Stressed Biotherapeutics
Location: 221 AB
Rapid Fire Speaker:
Michael J. Grasso, PhD
– Merck
Bioanalytics
Wednesday, Nov 12th
3:45 PM - 4:00 PM
CT
Taming SEC columns: A Journey Through HMW Recovery
Location: 221 AB
Rapid Fire Speaker:
Qian Veronica Qin, PhD
– Amgen
Bioanalytics