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  • On Demand
    Prologue:  Applying Machine Learning to the Laboratory: How AI Can Help Us Innovate
    Location: Online Only
    Prologue Speaker: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
    Bioanalytics
  • On Demand
    Prologue:  Challenges in Bioanalysis
    Location: Online Only
    Prologue Speaker: Catherine Vrentas, PhD, MBA, MPH (she/her/hers) – Booz Allen Hamilton
    Bioanalytics
  • On Demand
    Prologue: Regulatory Implications: from Immunogenicity to Diagnostics
    Location: Online Only
    Prologue Speaker: Weifeng Xu, PhD – Merck & Co.
    Bioanalytics
  • On Demand
    Prologue:  Regulatory Implications: From Immunogenicity to Diagnostics
    Location: Online Only
    Prologue Speaker: Mohsen Rajabi, Ph.D. – US Food and Drug Administration
    Bioanalytics
  • On Demand
    Prologue:  Understanding HRMS in Regulated Bioanalysis, with Applications for ADCs
    Location: Online Only
    Prologue Speaker: William R. Mylott, Jr., BS Chemistry – Thermo Fisher Scientific
    Bioanalytics
  • Monday, Oct 21st
    9:00 AM – 11:00 AM MT
    Symposium: Bioanalytical Lab Innovations 1
    Location: 150 DEFG
    Moderator: Amy Lavelle, PhD (she/her/hers) – Thermo Fisher Scientific
    Bioanalytics
  • Monday, Oct 21st
    9:00 AM – 11:00 AM MT
    Symposium: Bioanalytical Lab Innovations 2
    Location: 151 ABCG
    Moderator: Lynn Kamen, Ph.D. – BioAgilytix
    Bioanalytics
  • Monday, Oct 21st
    9:00 AM – 9:30 AM MT
    Balancing Innovation with Responsibility: Governance Strategies for AI in Pharmaceuticals
    Location: 150 DEFG
    Speaker: Stephanie A. Pasas-Farmer, PhD (she/her/hers) – BioData Solutions LLC
    Bioanalytics
  • Monday, Oct 21st
    9:00 AM – 9:30 AM MT
    Recommended Practices in Enzymatic Assay Design, Validation, and Long-Term Maintenance to Support Bioanalysis
    Location: 151 ABCG
    Speaker: Catherine Vrentas, PhD, MBA, MPH (she/her/hers) – Booz Allen Hamilton
    Bioanalytics
  • Monday, Oct 21st
    9:30 AM – 10:00 AM MT
    Enhanced Structure-Based Prediction of Chiral Stationary Phases for Chromatographic Enantioseparation from 3D Molecular Conformations
    Location: 151 ABCG
    Speaker: Christopher Welch, PhD – ICASE
    Bioanalytics
  • Monday, Oct 21st
    9:30 AM – 10:00 AM MT
    Home-Brew Multiplex Assay on MSD Platform for I-O Drug Development
    Location: 150 DEFG
    Speaker: Catherine Zhang, MSc – ABBVIE
    Bioanalytics
  • Monday, Oct 21st
    10:00 AM – 10:30 AM MT
    Development of Novel Cis-Receptor Occupancy Method for Bispecific Antibodies
    Location: 150 DEFG
    Speaker: Pu Fang, PhD – Johnson & Johnson
    Bioanalytics
  • Monday, Oct 21st
    10:00 AM – 10:30 AM MT
    Leveraging Machine Learning for ADME and Bioanalysis: Working Smarter, not Harder
    Location: 151 ABCG
    Speaker: Estelle M. Maes, PhD – AbbVie
    Bioanalytics
  • Monday, Oct 21st
    10:30 AM – 11:00 AM MT
    AI/ML for Personalized Medicine
    Location: 150 DEFG
    Speaker: Corinne Ramos, PhD (she/her/hers) – Aliri Bioanalysis
    Bioanalytics
  • Monday, Oct 21st
    10:30 AM – 11:00 AM MT
    From LLM to Robots, a Vision of the AI Labs of the future
    Location: 151 ABCG
    Speaker: Jim X. Shen, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • Monday, Oct 21st
    9:30 AM – 10:30 AM MT
    Continuous Improvement (CI) in Bioanalytical Laboratories: Challenges and Success Stories
    Location: 360 Stage #4, Exhibit Hall
    Partner Presentation Speaker: Jayaprakash Kotha, MBBS, Ph.D (he/him/his) – Worldwide Clinical Trials
    Bioanalytics
    Sponsored By 
  • Monday, Oct 21st
    10:00 AM – 11:00 AM MT
    Hot Topic: FDA Laboratory Developed Test Proposed Rule and Biomarker Testing
    Location: 250 ABC
    Hot Topic Speaker: Steven P. Piccoli, PhD (he/him/his) – Sun Pharma Advanced Research
    Hot Topic Speaker: Patrice Hugo, PhD (he/him/his) – IQVIA Laboratories
    Hot Topic Moderator: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Hot Topic Speaker: Mark Ma, PhD (he/him/his) – Biotech
    Bioanalytics
  • Monday, Oct 21st
    11:00 AM – 12:00 PM MT
    Integrated Bioanalysis and Biotransformation Strategies for Antibody-Drug Conjugates
    Location: 360 Stage #4, Exhibit Hall
    Partner Presentation Speaker: Li Qu, Ph.D – WuXi AppTec
    Partner Presentation Speaker: Peng Li, PhD (he/him/his) – WuXi AppTec
    Bioanalytics
    Sponsored By 
  • Monday, Oct 21st
    11:15 AM – 12:00 PM MT
    Bioanalytical Strategies, Innovations, and Future Considerations for ADCs
    Location: Spotlight Stage A, Aisle 1100, Exhibit Hall
    Chalk Talk Presenter: Eric Thomas, PhD (he/him/his) – Labcorp
    Chalk Talk Presenter: Eric Bonner – Labcorp
    Bioanalytics
    Sponsored By 
  • Monday, Oct 21st
    1:30 PM – 2:30 PM MT
    Keynote: Applying AI/ML Methodologies Within Regulated Bioanalysis
    Location: 150 DEFG
    Keynote Speaker: Mary Belfast (she/her/hers) – Teva Branded Pharmaceutical Products, Inc.
    Moderator: Joe Rajarao, PhD, MBA (he/him/his) – Accenture
    Bioanalytics
  • Monday, Oct 21st
    1:30 PM – 2:30 PM MT
    Keynote: Bioanalytical Lab in the Era of AI and Revolutionary Technologies
    Location: 151 ABCG
    Keynote Speaker: Mark Ma, PhD (he/him/his) – Biotech
    Moderator: Honglue Shen, PhD – Merck & Co., Inc.
    Bioanalytics
  • Monday, Oct 21st
    2:30 PM – 3:30 PM MT
    Speaker Spotlight: Automation in Regulated Bioanalysis
    Location: Spotlight Stage A, Aisle 1100, Exhibit Hall
    Spotlight Speaker: Chad J. Briscoe, PhD (he/him/his) – Celerion
    Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals
    Bioanalytics
  • Monday, Oct 21st
    3:00 PM – 3:45 PM MT
    Rapid Fires: Bioanalytical Lab Innovations 1
    Location: 150 DEFG
    Rapid Fire Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • Monday, Oct 21st
    3:00 PM – 3:15 PM MT
    Cell-Based NAB Assays: Aligning Cell Models with Drug MOA
    Location: 150 DEFG
    Rapid Fire Speaker: Yongzhong Zhao, PhD – Frontage Laboratories, Inc.
    Bioanalytics
  • Monday, Oct 21st
    3:15 PM – 3:30 PM MT
    Non-Specific Binding of Antibodies Induces Immunogenicity via Unintended Immune Activation
    Location: 150 DEFG
    Rapid Fire Speaker: Eiichi Hashimoto, PhD – Chugai Pharmaceutical Co., LTD.
    Bioanalytics
  • Monday, Oct 21st
    3:30 PM – 3:45 PM MT
    Preclinical Immunogenicity Support for IND Enabling Studies and S6 Guidance Alignment
    Location: 150 DEFG
    Rapid Fire Speaker: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
    Bioanalytics
  • Monday, Oct 21st
    3:00 PM – 4:00 PM MT
    Affinity Capture-High Resolution Mass Spectrometry (AC-MS) for Bioanalysis of Pharmacodynamic Biomarkers and Therapeutics
    Location: 360 Stage #3, Exhibit Hall
    Partner Presentation Speaker: Hemanth Akkiraju – IQVIA Laboratories
    Partner Presentation Speaker: Prakash Bhosale, PhD – IQVIA Laboratories
    Bioanalytics
    Sponsored By 
  • Monday, Oct 21st
    3:00 PM – 4:00 PM MT
    Rapid Fires: Bioanalytical Lab Innovations 2
    Location: 151 ABCG
    Rapid Fire Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • Monday, Oct 21st
    3:00 PM – 3:15 PM MT
    Investigating Apparent Accumulation of Therapeutic A Upon Repeat Dosing
    Location: 151 ABCG
    Rapid Fire Speaker: Habib Sistani, PhD (he/him/his) – Merck & Co, Inc
    Bioanalytics
  • Monday, Oct 21st
    3:15 PM – 3:30 PM MT
    Developing Validated, Multiplexed, LC-MS Biomarker Assays for Accelerated Drug Development
    Location: 151 ABCG
    Rapid Fire Speaker: Ben Gonzales, MBA – Inoviv
    Bioanalytics
  • Monday, Oct 21st
    3:30 PM – 3:45 PM MT
    Supercritical Fluid Chromatography for the Quantitation of CYP3A DDI Biomarkers
    Location: 151 ABCG
    Rapid Fire Speaker: Ines Santos, PhD (she/her/hers) – Bristol-Myers Squibb
    Bioanalytics
  • Monday, Oct 21st
    3:45 PM – 4:00 PM MT
    Optimizing Sample Preparation Approaches for Quantification of PROTACs
    Location: 151 ABCG
    Rapid Fire Speaker: Nikunj Tanna, MS (he/him/his) – Waters Corporation
    Bioanalytics
  • Tuesday, Oct 22nd
    9:00 AM – 11:00 AM MT
    Symposium: Current Challenges in Bioanalytical Labs
    Location: 151 ABCG
    Moderator: Jason Pennucci, MS (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • Tuesday, Oct 22nd
    9:00 AM – 11:00 AM MT
    Symposium: High Resolution Mass Spectrometry for Regulated Bioanalysis, Quo Vadis?
    Location: 150 DEFG
    Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • Tuesday, Oct 22nd
    9:00 AM – 9:30 AM MT
    CRO Perspectives on the Use of HRMS in Regulated Bioanalysis
    Location: 150 DEFG
    Speaker: Eric Thomas, PhD (he/him/his) – Labcorp
    Bioanalytics
  • Tuesday, Oct 22nd
    9:00 AM – 9:30 AM MT
    Multiple Strategies for Mitigating Immunogenicity Assay Interferences
    Location: 151 ABCG
    Speaker: Lisette Fred Lucena, PhD (she/her/hers) – Immunologix Laboratories
    Bioanalytics
  • Tuesday, Oct 22nd
    9:30 AM – 10:00 AM MT
    Bioanalytical Development: Anti-Polyethylene Glycol IgE Detection in Human Sera
    Location: 151 ABCG
    Speaker: Javier Aguilera, PhD – Moderna
    Bioanalytics
  • Tuesday, Oct 22nd
    9:30 AM – 10:00 AM MT
    Role(s) of HRMS in the Modern Bioanalytical Toolbox
    Location: 150 DEFG
    Speaker: Steve Lowes, PhD (he/him/his) – IQVIA Laboratories
    Bioanalytics
  • Tuesday, Oct 22nd
    10:00 AM – 10:30 AM MT
    Current Regulatory Guidelines for Using HRMS in Bioanalytical Studies
    Location: 150 DEFG
    Speaker: John A. Kadavil, PhD – USFDA
    Bioanalytics
  • Tuesday, Oct 22nd
    10:00 AM – 10:30 AM MT
    Low Blood Volume Alternative to Monitor Antigen-Specific Cellular Immune Responses
    Location: 151 ABCG
    Speaker: Sivasankar Baalasubramanian, PhD (he/him/his) – ImmunitasBio Private Limited
    Bioanalytics
  • Tuesday, Oct 22nd
    10:30 AM – 11:00 AM MT
    Effective Clinical ADA Monitoring for High-Dose Biologic Therapies
    Location: 151 ABCG
    Speaker: Maria Jadhav, PhD – Novartis Institutes for BioMedical Research, Inc.
    Bioanalytics
  • Tuesday, Oct 22nd
    10:30 AM – 11:00 AM MT
    Role of HRMS in ADC Drug Development for Stability and Biotransformation Studies
    Location: 150 DEFG
    Speaker: Keyang Xu, PhD (he/him/his) – Genentech Inc
    Bioanalytics
  • Tuesday, Oct 22nd
    10:00 AM – 11:00 AM MT
    Hot Topic: Bioanalytics
    Location: 250 ABC
    Hot Topic Moderator: Ines Santos, PhD (she/her/hers) – Bristol-Myers Squibb
    Bioanalytics
  • Tuesday, Oct 22nd
    10:00 AM – 10:30 AM MT
    An Innovative Approach to Quantifying a Serum Biomarker in the Presence of Endogenous Interferences
    Location: 250 ABC
    Hot Topic Speaker: Manuel Montalban (he/him/his) – Denali Therapeutics
    Bioanalytics
  • Tuesday, Oct 22nd
    10:30 AM – 11:00 AM MT
    Considerations for Development of Protein and Enzymatic Assays for Transgene Proteins
    Location: 250 ABC
    Hot Topic Speaker: Xiaojiao Xue, PhD – Regeneron
    Bioanalytics
  • Tuesday, Oct 22nd
    11:00 AM – 12:00 PM MT
    Overcoming Global Analytical Challenges with Scientific Central Lab Expertise
    Location: 360 Stage #4, Exhibit Hall
    Partner Presentation Speaker: Stacy Kirn-Barker, MLS(ASCP) – LabConnect
    Bioanalytics
    Sponsored By 
  • Tuesday, Oct 22nd
    11:15 AM – 12:00 PM MT
    Choosing Suitable Extraction Platforms for Bioanalytical qPCR
    Location: Spotlight Stage A, Aisle 1100, Exhibit Hall
    Chalk Talk Presenter: Mark C. Wissel, MB(ASCP) – Eurofins Viracor BioPharma Services
    Bioanalytics
    Sponsored By 
  • Tuesday, Oct 22nd
    12:30 PM – 1:15 PM MT
    Ensuring Patient Safety by Chemical Assessment of the Container Closure Material and Drug Product - Container Interactions
    Location: Spotlight Stage C, Aisle 2800, Exhibit Hall
    Chalk Talk Presenter: Frank de smedt, PhD (he/him/his) – Nelson Labs
    Bioanalytics
    Sponsored By 
  • Tuesday, Oct 22nd
    12:30 PM – 1:30 PM MT
    Bioanalytical Methods/Platforms for PK and Immunogenicity of ADCs and Other Conjugated Therapeutics
    Location: 360 Stage #2, Exhibit Hall
    Partner Presentation Speaker: Dawn Dufield, PhD – KCAS Bio
    Partner Presentation Speaker: Dominic Warrino, PhD – KCAS Bio
    Bioanalytics
    Sponsored By 
  • Tuesday, Oct 22nd
    1:30 PM – 2:30 PM MT
    Keynote: ADC: Drug Development Challenges- What We are Measuring and What Does it Matter?
    Location: 150 DEFG
    Keynote Speaker: Malaz Abutarif, PhD – DSI
    Moderator: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
    Bioanalytics
  • Tuesday, Oct 22nd
    1:30 PM – 2:30 PM MT
    Keynote: Purposeful Bioanalysis: Ask the Why and What Questions
    Location: 151 ABCG
    Keynote Speaker: Boris Gorovits, PhD – Regeneron
    Moderator: Jim X. Shen, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • Tuesday, Oct 22nd
    2:30 PM – 3:30 PM MT
    Speaker Spotlight: A Slice of the Immunerdy Pecan Pie- Regulatory Stakeholders in CDER’s Integrative Immunogenicity Review of Therapeutic Proteins and Peptides
    Location: Spotlight Stage A, Aisle 1100, Exhibit Hall
    Spotlight Speaker: Joao Pedras-Vasconcelos, PhD (he/him/his) – U.S. Food and Drug Administration
    Moderator: Troy Voelker, PhD (he/him/his) – Aliri Bioanalysis
    Bioanalytics
  • Tuesday, Oct 22nd
    3:00 PM – 4:00 PM MT
    Enhancing Communication with your CRO to Improve Scientific Collaboration
    Location: 360 Stage #3, Exhibit Hall
    Partner Presentation Speaker: Sara Underwood – Alturas Analytics, Inc.
    Partner Presentation Speaker: Jennifer Zimmer, PhD – Alturas Analytics, Inc.
    Bioanalytics
    Sponsored By 
  • Tuesday, Oct 22nd
    3:00 PM – 4:00 PM MT
    Rapid Fires: Current Challenges in Bioanalytical Labs 1
    Location: 150 DEFG
    Rapid Fire Moderator: Shoshana Oberstein (she/her/hers) – Takeda
    Bioanalytics
  • Tuesday, Oct 22nd
    3:00 PM – 4:00 PM MT
    Rapid Fires: Current Challenges in Bioanalytical Labs 2
    Location: 151 ABCG
    Rapid Fire Moderator: Joanne Goodman (she/her/hers) – Celerion
    Bioanalytics
  • Tuesday, Oct 22nd
    3:00 PM – 3:15 PM MT
    Comparative Assessment of RT-dPCR and RT-qPCR in mRNA Therapeutics Bioanalysis
    Location: 151 ABCG
    Rapid Fire Speaker: Zhihua Jiang, PhD – Pfizer
    Bioanalytics
  • Tuesday, Oct 22nd
    3:00 PM – 3:15 PM MT
    Validations of Three LC-MS/MS Bioanalytical Assays to Support ADC Development
    Location: 150 DEFG
    Rapid Fire Speaker: Jian Chen, PhD (he/him/his) – BMS
    Bioanalytics
  • Tuesday, Oct 22nd
    3:15 PM – 3:30 PM MT
    Advanced LCMS Strategies for Both Antibody and Payload Bioanalysis
    Location: 150 DEFG
    Rapid Fire Speaker: Aihua Liu, PhD – Resolian
    Bioanalytics
  • Tuesday, Oct 22nd
    3:15 PM – 3:30 PM MT
    Advancing Peripheral Blood Mononuclear Cells Isolation: Strategies for Analytical Outcomes
    Location: 151 ABCG
    Rapid Fire Speaker: Teresa Urlacher, PhD (she/her/hers) – Celerion
    Bioanalytics
  • Tuesday, Oct 22nd
    3:30 PM – 3:45 PM MT
    Development, Comparison of Quantitative Analytical Methods Evaluating Antibody-Drug-Conjugates in Plasma
    Location: 150 DEFG
    Rapid Fire Speaker: Ning Ren, MS (she/her/hers) – WuXi AppTec Co., Ltd./ DMPK (NJ, USA)
    Bioanalytics
  • Tuesday, Oct 22nd
    3:30 PM – 3:45 PM MT
    Overcoming Challenges: ctDNA Liquid Biopsies in Early Phase Clinical Trials
    Location: 151 ABCG
    Rapid Fire Speaker: John J. Bauer – LabConnect
    Bioanalytics
  • Tuesday, Oct 22nd
    3:45 PM – 4:00 PM MT
    In-vitro Stability Assay Translatability for Predicting Biotransformation of Evolving Biologics
    Location: 150 DEFG
    Rapid Fire Speaker: John Tran, PhD – Genentech, Inc.
    Bioanalytics
  • Tuesday, Oct 22nd
    3:45 PM – 4:00 PM MT
    MSD Based ADA Assay for CAR-T Cell Therapy
    Location: 151 ABCG
    Rapid Fire Speaker: Shixue Shen, PhD (he/him/his) – Janssen Research & Development, LLC
    Bioanalytics
  • Wednesday, Oct 23rd
    9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 2
    Location: 151 ABCG
    Moderator: Darshana Jani, Ph.D. – Moderna Therapeutics
    Bioanalytics
  • Wednesday, Oct 23rd
    9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 1
    Location: 150 DEFG
    Moderator: Manish Kumar, PhD (he/him/his) – Daiichi Sankyo
    Bioanalytics
  • Wednesday, Oct 23rd
    9:00 AM – 9:30 AM MT
    Comparison of Different Platforms for Evaluating Cellular and Humoral Immunogenicity
    Location: 150 DEFG
    Speaker: Yanshan Dai, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • Wednesday, Oct 23rd
    9:00 AM – 9:30 AM MT
    Unraveling CGTP Compliance: Part 1- Biomarker Assay Selection and Pitfalls
    Location: 151 ABCG
    Speaker: Stephanie A. Pasas-Farmer, PhD (she/her/hers) – BioData Solutions LLC
    Bioanalytics
  • Wednesday, Oct 23rd
    9:30 AM – 10:00 AM MT
    Challenging Current Immunogenicity Assessment: Clinical Case Studies for 1-Tiered Approach
    Location: 150 DEFG
    Speaker: Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc
    Bioanalytics
  • Wednesday, Oct 23rd
    9:30 AM – 10:00 AM MT
    Unraveling CGTP Compliance: Part 2- Comparative Study Fabry Associated Biomarkers
    Location: 151 ABCG
    Bioanalytics
  • Wednesday, Oct 23rd
    10:00 AM – 10:30 AM MT
    Collaborative Training Initiatives for Strengthening Regulatory and Laboratory Systems
    Location: 150 DEFG
    Speaker: Chaitanya K. Koduri, MTech (he/him/his) – US Pharmacopeia
    Bioanalytics
  • Wednesday, Oct 23rd
    10:00 AM – 10:30 AM MT
    NAb Assays for ADC: Killing or Not Killing?
    Location: 151 ABCG
    Speaker: Weifeng Xu, Ph.D. – Merck & Co., Inc.
    Bioanalytics
  • Wednesday, Oct 23rd
    10:30 AM – 11:00 AM MT
    How Would the European In Vitro Diagnostic Regulation 2017/746 (EU IVDR) Impact Regulated Bioanalysis?
    Location: 151 ABCG
    Speaker: Don (Zhandong) Zhong, PhD (he/him/his) – Denali Therapeutics
    Bioanalytics
  • Wednesday, Oct 23rd
    10:30 AM – 11:00 AM MT
    The Road to IVD Companion Diagnostics – Pathways to IDE
    Location: 150 DEFG
    Speaker: Luke Armstrong, PhD (he/him/his) – BioAgilytix
    Bioanalytics
  • Wednesday, Oct 23rd
    10:00 AM – 11:00 AM MT
    Speaker Spotlight: Optimizing CAR T Cell Trials: Guidance on Developing and Validating Flow Cytometry Assays for Pharmacokinetics in Clinical Trials
    Location: Spotlight Stage A, Aisle 1100, Exhibit Hall
    Spotlight Speaker: Kevin Lang, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific
    Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • Wednesday, Oct 23rd
    1:30 PM – 2:30 PM MT
    Keynote: Impact of Immunogenicity on Gene Therapy Development – Science, Regulatory and Patients
    Location: 150 DEFG
    Keynote Speaker: Jim McNally, PhD – BioAgilytix
    Moderator: Maria Jadhav, PhD – Novartis Institutes for BioMedical Research, Inc.
    Bioanalytics
  • Wednesday, Oct 23rd
    1:30 PM – 2:30 PM MT
    Keynote: Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry
    Location: 151 ABCG
    Keynote Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Moderator: Chad J. Briscoe, PhD (he/him/his) – Celerion
    Bioanalytics
  • Wednesday, Oct 23rd
    3:00 PM – 4:00 PM MT
    Rapid Fires: Regulatory Implications for Bioanalysis 1
    Location: 150 DEFG
    Rapid Fire Moderator: Jim X. Shen, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • Wednesday, Oct 23rd
    3:00 PM – 4:00 PM MT
    Rapid Fires: Regulatory Implications for Bioanalysis 2
    Location: 151 ABCG
    Rapid Fire Moderator: Mahadevan (Maha) Lakshminarasimhan, PhD (he/him/his) – Merck & Co., Inc.
    Bioanalytics
  • Wednesday, Oct 23rd
    3:00 PM – 3:15 PM MT
    Bioanalytical Cross-Validation: Application of ICH M10 Guidance in Data Analysis
    Location: 150 DEFG
    Rapid Fire Speaker: Mianzhi Gu, PhD (she/her/hers) – GSK
    Bioanalytics
  • Wednesday, Oct 23rd
    3:00 PM – 3:15 PM MT
    Problematic Aggregation of Biotinylated and Sulfo-Tagged Proteins in Immunoassays
    Location: 151 ABCG
    Rapid Fire Speaker: Bao Lam, PhD (he/him/his) – Resolian
    Bioanalytics
  • Wednesday, Oct 23rd
    3:15 PM – 3:30 PM MT
    Biomarker Challenges: How to Deal with Lack of Parallelism?
    Location: 150 DEFG
    Rapid Fire Speaker: Marc-Olivier Pepin, BSc – Charles River
    Bioanalytics
  • Wednesday, Oct 23rd
    3:15 PM – 3:30 PM MT
    Leveraging HRMS to Characterize Critical Reagents for Biologics Drug Development
    Location: 151 ABCG
    Rapid Fire Speaker: Mahadevan (Maha) Lakshminarasimhan, PhD (he/him/his) – Merck & Co., Inc.
    Bioanalytics
  • Wednesday, Oct 23rd
    3:30 PM – 3:45 PM MT
    Challenges in Critical Reagents and ADA Assays for Cell Therapy
    Location: 151 ABCG
    Rapid Fire Speaker: Kun Yang, PhD – Bristol Myers Squibb
    Bioanalytics
  • Wednesday, Oct 23rd
    3:30 PM – 3:45 PM MT
    Utilizing Natural Language Processing to Author Bioanalytical SOPs
    Location: 150 DEFG
    Rapid Fire Speaker: Joe Rajarao, PhD, MBA (he/him/his) – Accenture
    Bioanalytics
  • Wednesday, Oct 23rd
    3:45 PM – 4:00 PM MT
    LC-MS/MS Quantitation of Therapeutic Proteins in Tasso-M20 Dried Blood Samples
    Location: 150 DEFG
    Rapid Fire Speaker: Margarita Semis, PhD (she/her/hers) – Amgen Inc
    Bioanalytics
  • Wednesday, Oct 23rd
    3:45 PM – 4:00 PM MT
    Model Informed Assay Development Improves Understanding of ADA Assay Results
    Location: 151 ABCG
    Rapid Fire Speaker: Gregor Jordan, M.Eng. – Roche Diagnostics GmbH
    Bioanalytics