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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
Speaker:
Josephine Y. Fang, PhD (she/her/hers)
– Takeda
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