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ON DEMAND
Prologue: Biomarker and Omics Approaches
Location: On Demand
Prologue Speaker: Robert Dodge, PhD – Novartis
Bioanalytics
Monday, Oct 23rd
9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis
Location: 311 EF West
Moderator: Shefali Patel, BSc., MLT – Janssen Research and Development, LLC
Bioanalytics
Monday, Oct 23rd
9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 2
Location: 311 GH West
Moderator: Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc.
Bioanalytics
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
Low Volume Sampling Technologies Versus Venipuncture in a Clinical Study
Location: 311 EF West
Speaker: Saloumeh K. Fischer, PhD – Genentech Inc
Bioanalytics
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
Metabolomics in Drug Discovery & Precision Diagnostics, and the Importance of Context-of-Use
Location: 311 GH West
Speaker: Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc.
Bioanalytics
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Mitigation Strategies for Batch-Effects in Biomarker Data in Long-Term Studies
Location: 311 GH West
Speaker: Jihee Sohn, PhD (she/her/hers) – Biogen
Bioanalytics
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Multi-Omics Microsampling for Dynamic Health Monitoring and Biomarker Discovery
Location: 311 EF West
Speaker: Michael Snyder – Stanford University
Bioanalytics
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
A Novel Method to Overcome ADA Interference in PK Assay
Location: 311 GH West
Speaker: Saleem Shaik, PhD – Takeda Pharmaceuticals
Bioanalytics
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
Advance Clinical Studies with Patient Centric Sampling: Opportunities and Challenges
Location: 311 EF West
Speaker: Zhuo Chen, PhD (he/him/his) – GSK
Bioanalytics
Monday, Oct 23rd
10:30 AM – 11:00 AM ET
Investigation of Patient Centric Sampling Solutions for Routine Clinical Measurements
Location: 311 EF West
Speaker: Bradley Collier, PhD – Labcorp
Bioanalytics
Monday, Oct 23rd
10:30 AM – 11:00 AM ET
Stability and Method Performance Considerations for Bioanalytical Enzymatic Activity Assays
Location: 311 GH West
Speaker: Christian Duke, MBA (he/him/his) – PPD, part of Thermo Fisher Scientific
Bioanalytics
Monday, Oct 23rd
11:00 AM – 12:00 PM ET
Unleash Small and Large Molecule Solutions for Biologics and Gene-Therapy
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Andre Mueller, PhD (he/him/his) – Unchained Labs
Partner Presentation Speaker: Del Ray Jackson, PhD – Unchained Labs
Partner Presentation Speaker: Ben Knappett, PhD – Unchained Labs
Bioanalytics
Presented By
Monday, Oct 23rd
12:30 PM – 1:15 PM ET
Application of Accurate Mass Spectrometry for Nitrosamine Impurities in Metformin
Location: Spotlight Stage B Exhibit Hall West A4-B3
Chalk Talk Presenter: Dan Safarpour, PhD (he/him/his) – Symbiotic Research, LLC
Bioanalytics
Sponsored By
Monday, Oct 23rd
12:30 PM – 1:15 PM ET
Challenges and Opportunities for Bioanalytical Support of New Drug Modalities
Location: Spotlight Stage A Exhibit Hall West A4-B3
Chalk Talk Presenter: Daniel Sikkema, PhD – Labcorp
Bioanalytics
Presented By Labcorp
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: Patient Centricity: One Blood Draw at a Time
Location: 311 EF West
Keynote Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
Moderator: Catherine L. Brockus, PhD (she/her/hers) – Eli Lilly and Company
Bioanalytics
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: The Bioanalytical Program: From Strategy to Implementation –Current State and Additional Considerations
Location: 311 GH West
Keynote Speaker: Jad Zoghbi, MS – Biogen
Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company
Bioanalytics
Monday, Oct 23rd
2:30 PM – 3:30 PM ET
Speaker Spotlight: Single-Cell Multi-Omics for Cell and Gene Therapies
Location: Spotlight Stage A Exhibit Hall West A4-B3
Spotlight Speaker: Priya S. Chockalingam, PhD (she/her/hers) – Beam Therapeutics
Moderator: Karen J. Quadrini, PhD – Passage Bio, Inc
Bioanalytics
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 1
Location: 311 EF West
Rapid Fire Moderator: Linlin Luo, Ph.D. – Merck & Co., Inc.
Bioanalytics
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 2
Location: 311 GH West
Rapid Fire Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals
Bioanalytics
Monday, Oct 23rd
3:00 PM – 3:15 PM ET
ADA and NAb Assays with Distinct Formats Determined by Biologics
Location: 311 EF West
Rapid Fire Speaker: Yongzhong Zhao, PhD – Frontage Laboratories, Inc.
Bioanalytics
Monday, Oct 23rd
3:00 PM – 3:15 PM ET
Investigation of Compound-A Rat Exposure Bias Observed in Toxicological Studies
Location: 311 GH West
Rapid Fire Speaker: Rajesh B. Desai, M.S. – Merck and Co Inc
Bioanalytics
Monday, Oct 23rd
3:15 PM – 3:30 PM ET
Bead-Based NAb Assay with High Drug Tolerance for A Bispecific
Location: 311 EF West
Rapid Fire Speaker: Megan Schnarr, MS – Janssen
Bioanalytics
Monday, Oct 23rd
3:15 PM – 3:30 PM ET
Use of AI to Guide Immunoassay Development
Location: 311 GH West
Rapid Fire Speaker: Mark Ma, MD (he/him/his) – Biotech
Bioanalytics
Monday, Oct 23rd
3:30 PM – 3:45 PM ET
Novel Approaches and Troubleshooting for Developing High-Throughput Oligonucleotide LC-MS Method
Location: 311 GH West
Rapid Fire Speaker: Changhong Yun, PhD – Merck & Co.
Bioanalytics
Monday, Oct 23rd
3:30 PM – 3:45 PM ET
Utilization of Quality-by-Design/Design-of-Experiment(s) for Optimization of Flow Cytometric Wet-Lab Methods
Location: 311 EF West
Rapid Fire Speaker: Stefanie Biedermann, MS (she/her/hers) – Miltenyi Biotec B.V. & Co. KG
Bioanalytics
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Platform Methods: Universal Immunoaffinity-LCMS Bioanalytical Methods for Drug Development Platforms
Location: 311 GH West
Rapid Fire Speaker: Ben Nie, PhD (he/him/his) – BioAgilytix
Bioanalytics
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Quantification of mRNA from mRNA-LNP Therapeutics by RT-qPCR
Location: 311 EF West
Rapid Fire Speaker: Suresh Peddigari, PhD (he/him/his) – Moderna Therapeutics
Bioanalytics
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 1
Location: 311 EF West
Moderator: HsinPin Ho, Ph.D. – Bristol Myers Squibb Company
Bioanalytics
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 2
Location: 311 GH West
Moderator: Troy Voelker, PhD – Aliri Bioanalysis
Bioanalytics
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
A Hybridization Approach to Oligonucleotide Sample Extraction and LC/MS Analysis
Location: 311 GH West
Speaker: Troy Voelker, PhD – Aliri Bioanalysis
Bioanalytics
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
Advances in Regulated Bioanalytical Strategies Supporting Quantitation of Protein Degraders
Location: 311 EF West
Speaker: Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations
Bioanalytics
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
Amplicon-Based Next-Generation Sequencing Nonclinical Assay Validation
Location: 311 GH West
Speaker: Kelly S. Colletti, PhD, MBA (she/her/hers) – Beam Therapeutics
Bioanalytics
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
Quantitation of Oligonucleotides – LC-HRMS or LC-MS/MS, Which is Better?
Location: 311 EF West
Speaker: Zamas Lam, PhD (he/him/his) – QPS
Bioanalytics
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
High Content Biomarkers: Application of High Parameter Flow Cytometry for Single-Cell Analysis in Clinical Trials
Location: 311 GH West
Speaker: Michelle Graham, PhD (she/her/hers) – AbbVie
Bioanalytics
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
Hybridization LC-MS/MS Bioanalysis of Oligonucleotides to Support PET Imaging Study
Location: 311 EF West
Speaker: Di Jiang, PhD (she/her/hers) – Biogen Inc.
Bioanalytics
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
Developing a Semi-Quantitative LBA LC-MS Assay for Anti-Drug Antibody Isotypes
Location: 311 EF West
Speaker: Paige A. Malec, PhD (she/her/hers) – Labcorp Drug Development
Bioanalytics
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
Scientific Challenges Developing Bioanalytical Assays for Novel Modalities: Car-T
Location: 311 GH West
Speaker: Mark Blimline, MS (he/him/his) – Navigate Biopharma
Bioanalytics
Tuesday, Oct 24th
9:30 AM – 10:30 AM ET
Leverage Bioanalysis Outsourcing Partnerships to Support Complex Clinical Trials
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Joe Marino (he/him/his) – LabConnect
Bioanalytics
Presented By
Tuesday, Oct 24th
9:30 AM – 10:30 AM ET
Speaker Spotlight: Targeted vs Untargeted Workflows to Quantify Oligonucleotide Therapeutics by High Resolution Mass Spectrometry
Location: Spotlight Stage A Exhibit Hall West A4-B3
Spotlight Speaker: Ryan Hill (he/him/his) – Drug Disposition/ADME/Eli Lilly and Company
Moderator: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
Bioanalytics
Tuesday, Oct 24th
11:15 AM – 12:00 PM ET
Revolutionize Critical Reagent Development with Rabbit Single B-Cell Technology
Location: Spotlight Stage B Exhibit Hall West A4-B3
Chalk Talk Presenter: Hao Cheng, PhD (he/him/his) – Yurogen Biosystems
Bioanalytics
Presented By
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current Research
Location: 311 GH West
Keynote Speaker: Michelle Lynn Hall, PhD (she/her/hers) – Eli Lilly
Moderator: Yan G. Ni, PhD – Passage Bio
Bioanalytics
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: New Era of Bioanalysis Post Covid-19 Pandemic
Location: 311 EF West
Keynote Speaker: Qin Ji, PhD – AbbVie
Moderator: Long Yuan, PhD – Biogen Inc.
Bioanalytics
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Approaches for Emerging Modalities and Complex Studies 1
Location: 311 EF West
Rapid Fire Moderator: Heather A. Myler, PhD – Takeda
Bioanalytics
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Approaches for Emerging Modalities and Complex Studies 2
Location: 311 GH West
Rapid Fire Moderator: Sanjeev Bhardwaj, PhD – Janssen BioTherapeutics
Bioanalytics
Tuesday, Oct 24th
3:00 PM – 3:15 PM ET
Clinical Bioanalysis of AMG 133, a Bispecific Molecule for Obesity
Location: 311 GH West
Rapid Fire Speaker: Omar S. Barnaby, PhD (he/him/his) – Amgen
Bioanalytics
Tuesday, Oct 24th
3:00 PM – 3:15 PM ET
Measuring and Understanding the Relevance of Cellular-Immune Responses to CAR-T-Cells
Location: 311 EF West
Rapid Fire Speaker: Madhan Masilamani, PhD – Bristol Myers Squibb
Bioanalytics
Tuesday, Oct 24th
3:15 PM – 3:30 PM ET
Innovative Immunogenicity Strategies for New Modalities
Location: 311 EF West
Rapid Fire Speaker: Heather A. Myler, PhD – Takeda
Bioanalytics
Tuesday, Oct 24th
3:15 PM – 3:30 PM ET
The Bioanalytical Profile for a DARPin Therapeutic: Pharmacokinetics and Immunogenicity.
Location: 311 GH West
Rapid Fire Speaker: Robert Dodge, PhD – Novartis
Bioanalytics
Tuesday, Oct 24th
3:30 PM – 3:45 PM ET
ADA Strategies to Address Potential Target Interference in Support of a FIH Study Sprays
Location: 311 EF West
Rapid Fire Speaker: Linlin Luo, Ph.D. – Merck & Co., Inc.
Bioanalytics
Tuesday, Oct 24th
3:30 PM – 3:45 PM ET
Hybridization LC-MS/MS for Oligonucleotide Quantification: When Specificity Meets Sensitivity
Location: 311 GH West
Rapid Fire Speaker: Kevork Mekhssian, MSc – Altasciences
Bioanalytics
Tuesday, Oct 24th
3:45 PM – 4:00 PM ET
Immunocapture-LC/MS Investigation of a mAb Glycosylation Pattern in Human Plasma
Location: 311 GH West
Rapid Fire Speaker: Wei Wei, PhD (she/her/hers) – Boehringer Ingelheim
Bioanalytics
Tuesday, Oct 24th
3:45 PM – 4:00 PM ET
Risk-Based Bioanalytical Strategy for AAV Gene Therapy for Cardiac Delivery
Location: 311 EF West
Rapid Fire Speaker: Kun Yang, PhD – Bristol Myers Squibb
Bioanalytics
Tuesday, Oct 24th
3:30 PM – 4:30 PM ET
Hot Topic: ICH M10 Bioanalytical Method Validation Guidance-1 year Later
Location: 308 CD West
Hot Topic Speaker: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc
Hot Topic Speaker: Faye Vazvaei-Smith, M.S. – Merck & Co.
Hot Topic Speaker: Chongwoo Yu, Ph.D. – US Food and Drug Administration
Hot Topic Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
Hot Topic Moderator: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc
Bioanalytics
Wednesday, Oct 25th
9:00 AM – 11:00 AM ET
Symposium: The Bioanalytical Lab of the Future 1
Location: 311 EF West
Moderator: Nanda Balasubramanian, MSc, PhD (he/him/his) – Bristol Myers Squibb
Bioanalytics
Wednesday, Oct 25th
9:00 AM – 11:00 AM ET
Symposium: The Bioanalytical Lab of the Future 2
Location: 311 GH West
Moderator: Robert Dodge, PhD – Novartis
Bioanalytics
Wednesday, Oct 25th
9:00 AM – 9:30 AM ET
Analytical Quality-by-Design: Analytical Comparability Assessment and Bioanalysis of Biosimilars by LC-MS Approaches
Location: 311 EF West
Speaker: Jinhui Zhang, PhD (he/him/his) – US Food and Drug Administration
Bioanalytics
Wednesday, Oct 25th
9:00 AM – 9:30 AM ET
Metabolomics in the Clinic: Technical Hurdles and Success Stories
Location: 311 GH West
Speaker: Anne M. Evans, PhD (she/her/hers) – Metabolon
Bioanalytics
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
Advancing Drug Development Through Data-Independent Acquisition Mass Spectrometry for Biomarker Discovery and Development
Location: 311 GH West
Speaker: Veronica Anania, PhD – Genentech
Bioanalytics
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
Integrated Immunogenicity Strategies Support Value-Driven Clinical Development
Location: 311 EF West
Speaker: Devangi Mehta, PhD – Immunologix Laboratories
Bioanalytics
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
Novel Technical Breakthrough: qPCR Sensitivity LLOQ of 8 Copies/ug DNA
Location: 311 GH West
Speaker: Bin Xu, PhD (he/him/his) – Accurant Biotech
Bioanalytics
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
qPCR and dPCR Assay Validations for Cell and Gene Therapies
Location: 311 EF West
Speaker: Wendy O. Adamowicz, MS (she/her/hers) – PPD Clinical Research, Thermo Fisher Scientific
Bioanalytics
Wednesday, Oct 25th
10:30 AM – 11:00 AM ET
LCMS Approaches for Discovery and Quantitation of Biomarkers for Target Engagement and Pathway Modulation
Location: 311 GH West
Speaker: Faizan Zubair, PhD – Takeda Pharmaceuticals
Bioanalytics
Wednesday, Oct 25th
10:30 AM – 11:00 AM ET
Utility of TAb vs.NAb Assays as Prescreen for Gene-Therapy Trials
Location: 311 EF West
Speaker: Renuka Pillutla, PhD (she/her/hers) – SparkTx
Bioanalytics
Wednesday, Oct 25th
10:00 AM – 11:00 AM ET
Speaker Spotlight: The Power of Hybrid LC-MS/MS: Case Studies from Simple to More Complex Biotherapeutic Modalities
Location: Spotlight Stage A Exhibit Hall West A4-B3
Moderator: James Huleatt, PhD (he/him/his) – Bill & Melinda Gates Medical Research Institute
Spotlight Speaker: Dawn Dufield, PhD – KCAS
Bioanalytics
Wednesday, Oct 25th
12:00 PM – 1:00 PM ET
New Considerations for LC-Based Characterization and Quantitation of Oligonucleotide Therapeutics
Location: 360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: Matthew Lauber, PhD – Waters Corporation
Bioanalytics
Presented By
Wednesday, Oct 25th
12:30 PM – 1:30 PM ET
Getting Your Research Right with Open Source Visual Programming
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Martyna Pawletta, MA – KNIME
Partner Presentation Speaker: Corey Weisinger – KNIME
Bioanalytics
Presented By
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: Advancing Clinical Translation: An Automated Platform for Massively Scalable Preclinical Human Testing
Location: 311 GH West
Keynote Speaker: Anthony Bahinski, MBA, PhD – Vivodyne, Inc.
Moderator: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC
Bioanalytics
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: When Companion Diagnostics Met Bioanalysis: The Roles of Companion Diagnosis and Bioanalysis in Guiding Treatment Selection and Monitoring Drug Response
Location: 311 EF West
Keynote Speaker: Mark Ma, MD (he/him/his) – Biotech
Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company
Bioanalytics
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: The Bioanalytical Lab of the Future 1
Location: 311 EF West
Rapid Fire Moderator: Robert Dodge, PhD – Novartis
Bioanalytics
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: The Bioanalytical Lab of the Future 2
Location: 311 GH West
Rapid Fire Moderator: Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations
Bioanalytics
Wednesday, Oct 25th
3:00 PM – 3:15 PM ET
Bioanalysis and Pharmacokinetic-Modelling Considerations for Antisense Oligonucleotides Targeting CNS Diseases
Location: 311 GH West
Rapid Fire Speaker: Susovan Mohapatra, PhD (he/him/his) – Stoke Therapeutics, Inc.
Bioanalytics
Wednesday, Oct 25th
3:00 PM – 3:15 PM ET
Therapeutic Drug Monitoring: Opportunities and Technical Considerations
Location: 311 EF West
Rapid Fire Speaker: Michael Partridge, PhD – Regeneron
Bioanalytics
Wednesday, Oct 25th
3:15 PM – 3:30 PM ET
Epitope Specific Concentration Analysis of Recombinant Calibrators for Biomarker LBAs
Location: 311 EF West
Rapid Fire Speaker: Jonathan R. Haulenbeek, PhD – Bristol-Myers Squibb/Translational Sciences
Bioanalytics
Wednesday, Oct 25th
3:15 PM – 3:30 PM ET
Physiologically Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays
Location: 311 GH West
Rapid Fire Speaker: Steven Chopski, PhD (he/him/his) – US Food and Drug Administration
Bioanalytics
Wednesday, Oct 25th
3:30 PM – 3:45 PM ET
Biomarker Challenges: Dilution Linearity or Parallelism?
Location: 311 EF West
Rapid Fire Speaker: Marc-Olivier Pepin, BSc – Charles River Laboratories
Bioanalytics
Wednesday, Oct 25th
3:30 PM – 3:45 PM ET
Monoclonal Antibody Blood Bioanalysis - Keeping the Goal in Mind
Location: 311 GH West
Rapid Fire Speaker: James Huleatt, PhD (he/him/his) – Bill & Melinda Gates Medical Research Institute
Bioanalytics
Wednesday, Oct 25th
3:45 PM – 4:00 PM ET
Microsampling Device Considerations and Workflows Supporting Regulated Bioanalysis
Location: 311 GH West
Rapid Fire Speaker: Jeff Plomley, M.Sc. – Altasciences Clinical Research
Bioanalytics
Wednesday, Oct 25th
3:45 PM – 4:00 PM ET
Parallelism for Biomarker Assays Best Practice
Location: 311 EF West
Rapid Fire Speaker: Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc
Bioanalytics