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Bioanalytics

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Saturday, Nov 3
1:00 pm

SC4 - Introduction of Team and Objectives

Location: 146 A, WEWCC
Heather A. Myler, PhD – PPD
Saturday, Nov 3
1:00 pm

SC4 - Short Course: A Harmonized Strategy for the Regulatory Submission of Immunogenicity Validation Data

Location: 146 A, WEWCC
Heather A. Myler, PhD – PPD; An Song, PhD – Genentech; Joao Pedras-Vasconcelos, PhD – FDA-CDER-OPQ-OBP-DBRR3
Saturday, Nov 3
1:10 pm

SC4 - OBP Immunogenicity Review Challenges and Solutions

Location: 146 A, WEWCC
Joao Pedras-Vasconcelos, PhD – FDA-CDER-OPQ-OBP-DBRR3
Saturday, Nov 3
1:30 pm

SC4 - Cut Point Considerations

Location: 146 A, WEWCC
Viswanath Devanarayan, PhD, FAAPS – Charles River Laboratories
Saturday, Nov 3
3:15 pm

SC4 - Defining Assay Sensitivity

Location: 146 A, WEWCC
Kelli R. Phillips, PhD, MBA – PPD
Saturday, Nov 3
3:35 pm

SC4 - Defining Assay Drug Tolerance

Location: 146 A, WEWCC
Marta Manning, PhD – Amgen
Saturday, Nov 3
3:55 pm

SC4 - FDA Perspective on Assay Sensitivity and Drug Tolerance

Location: 146 A, WEWCC
Haoheng Yan, MD, Ph.D – FDA
Saturday, Nov 3
4:15 pm

SC4 - Defining Assay Domain Specificity/ Selectivity

Location: 146 A, WEWCC
Shobha Purushothama, Scientist – Biogen
Sunday, Nov 4
9:00 am

SC7 - Short Course: Immunogenicity Data Evaluations and Clinical Interpretation

Location: 146 A, WEWCC
Viswanath Devanarayan, PhD, FAAPS – Charles River Laboratories
Sunday, Nov 4
9:00 am

WS2 - Workshop: Bioanalytical Method Validation: The Finalized Guidance

Location: 146 C, WEWCC
Brian Booth, Ph.D.
Monday, Nov 5
8:30 am

Prologue: Bioanalytical Solutions Driving the Development of Novel Therapeutic Modalities

Location: 151 B, WEWCC
Jaya Goyal, PhD – Wave Life Sciences
Monday, Nov 5
8:30 am

Prologue: Novel Protein Modalities – Bioanalytical Challenges and Solutions

Location: 151 A, WEWCC
Yan Zhang, PhD – Bristol-Myers Squibb Company
Monday, Nov 5
9:00 am

Novel Protein Modalities – Bioanalytical Challenges and Solutions

Location: 151 A, WEWCC
Alexander Kozhich, PhD – Bristol-Myers Squibb Company
Monday, Nov 5
9:30 am

Bioanalytical Strategies for Bi-specific and Multi-specific Biologics

Location: 151 A, WEWCC
Dong Geng, PhD – Legend Biotech
Monday, Nov 5
10:00 am

Protein Misfolding and its Role in Prion Disease Expansion

Location: 151 A, WEWCC
Philip R. Oldfield, DPhil CSci CChem FRSC(UK) – Philip Oldfield Bioanalytical Consulting
Monday, Nov 5
10:30 am

Vaccine Clinical Assays: What Can We Adopt to Support Emerging Modalities?

Location: 151 A, WEWCC
Huaping Tang, PhD – Merck
Monday, Nov 5
9:00 am

LCMS/Hybridization ELISA Approaches for Bioanalysis of Stereopure Oligonucleotides

Location: 151 B, WEWCC
Susovan Mohapatra, PhD – Wave Life Sciences
Monday, Nov 5
9:00 am

Novel Therapeutic Modalities – Chemical

Location: 151 B, WEWCC
Jaya Goyal, PhD – Wave Life Sciences
Monday, Nov 5
9:30 am

Bioanalytical Challenges and Opportunities in Development of RNAi Therapeutics

Location: 151 B, WEWCC
Valerie Clausen – Alnylam Pharmaceuticals Inc.
Monday, Nov 5
10:00 am

Bioanalytical Strategies and Considerations for the Bioanalysis of Liposomal Drugs

Location: 151 B, WEWCC
Aaron Ledvina, PhD – Covance Laboratories, Inc.
Monday, Nov 5
10:30 am

Meeting Bioanalytical Challenges of Protein-Drug Conjugates with Improved Efficiency using Multiplexed Hybrid LBA-LC-MS/MS Assays

Location: 151 B, WEWCC
Morse Faria, B.Pharm., M. Pharm., PhD – PPD
Monday, Nov 5
1:30 pm

Keynote: The Expanding Frontier of Bioanalysis: New Modalities

Location: 207 B, WEWCC
Binodh DeSilva, PhD – Bristol-Myers Squibb; Brian Booth, Ph.D.
Monday, Nov 5
3:00 pm

Fighting Cancers with Oncolytic Viruses: Bioanalytical Considerations

Location: 207 A, WEWCC
LaKenya Williams, PhD – Bristol-Myers Squibb
Monday, Nov 5
3:00 pm

Immuno-Oncology: Advancement from Infancy to Products - Bioanalytical

Location: 207 A, WEWCC
Boris Gorovits – Pfizer Inc.
Monday, Nov 5
3:30 pm

Clinical Bioanalytical Strategy Consideration for Cell Therapies

Location: 207 A, WEWCC
Dong Geng, PhD – Legend Biotech
Monday, Nov 5
4:00 pm

Bi-specific T-cell Redirector PK/ADA/NAB Strategy

Location: 207 A, WEWCC
Ying Wang, Ph.D – Pfizer
Monday, Nov 5
4:30 pm

Bi-specific T-cell Redirectors: Receptor Occupancy Strategy

Location: 207 A, WEWCC
Adrienne Clements-Egan, PhD – Janssen Biotherapeutics, Janssen R&D, LLC
Monday, Nov 5
3:00 pm

Turning Multiple Assays into One: Strategic LC-MS Data Acquisition for Antibody Drug Conjugates

Location: 207 B, WEWCC
John F. Kellie, PhD, Chemistry – GSK
Monday, Nov 5
3:00 pm

Rapid and Cost-Effective Delivery of New Drugs to Patients - Bioanalytical

Location: 207 B, WEWCC
Mark E. Arnold, PhD – Covance Inc.
Monday, Nov 5
3:30 pm

Maximizing PK and PD Information from Discovery Samples

Location: 207 B, WEWCC
Timothy V. Olah, PhD – Bristol Myers Squibb Company
Monday, Nov 5
4:00 pm

Advancing Microsampling for Biomarker Analysis with Lessons Learned from Clinical Chemistry

Location: 207 B, WEWCC
Russell p. Grant, PhD – Laboratory Corporation of America
Monday, Nov 5
4:30 pm

Building Confidence in Patient Focused Precision Medicine with LC-MS Based Biomarkers and Metabolomics

Location: 207 B, WEWCC
Matthew Blatnik, PhD – Pfizer Inc.
Tuesday, Nov 6
8:30 am

Prologue: ABIRISK: Europe's IMI Immunogenicity Consortium

Location: 151 A, WEWCC
Susan M. Richards, PhD – Sanofi; Timothy Hickling
Tuesday, Nov 6
8:30 am

Prologue: New Technology and Solutions in Bioanalysis

Location: 151 B, WEWCC
Kevin Bateman, PhD – Merck & Co., Inc.; Anahita Keyhani, Ph.D. – Altasciences
Tuesday, Nov 6
9:00 am

What Could be an Achievable LC-MS/MS Sensitivity Level: Theoretical Considerations

Location: 151 B, WEWCC
Shaolian Zhou – Roche
Tuesday, Nov 6
9:00 am

New Technology and New Applications of Existing Technology - Chemical

Location: 151 B, WEWCC
Kevin Bateman, PhD – Merck & Co., Inc.; Anahita Keyhani, Ph.D. – Altasciences
Tuesday, Nov 6
9:30 am

Towards Highly Sensitive and Accurate Analysis of Novel Biotherapeutics in Tissues

Location: 151 B, WEWCC
Jun Qu, PhD – SUNY-Buffalo
Tuesday, Nov 6
10:00 am

Intact LC/MS Analysis of Peptides and Biotherapetuics for Pharmacokinetics Study

Location: 151 B, WEWCC
Naidong Weng, PhD – Janssen
Tuesday, Nov 6
10:30 am

Evaluation of Volumetric Absorptive Microsampling and its Bioanalytical Challenges

Location: 151 B, WEWCC
Jeff Plomley, M.Sc. – Altasciences Clinical Research
Tuesday, Nov 6
9:00 am

Overview of the Consortium and Major Findings

Location: 151 A, WEWCC
Marc J. Pallardy, PharmD PhD – Team leader INSERM UMR 996 Research Unit, on "Inflammation, Chemokines, & Immunopathology"
Tuesday, Nov 6
9:00 am

New Technology and New Applications of Existing Technology – Biomolecular

Location: 151 A, WEWCC
Susan M. Richards, PhD – Sanofi; Timothy Hickling
Tuesday, Nov 6
9:30 am

Understanding Mechanism of Immunogenicity including the Identification of Early Signature of ADA Response

Location: 151 A, WEWCC
Elizabeth Jury, PhD – University College London
Tuesday, Nov 6
10:00 am

Characteristics of ADA and Production of ADA Assay Standards

Location: 151 A, WEWCC
vincent Mikol, Ph.D – Sanofi
Tuesday, Nov 6
10:30 am

Clinical Observations and Genetic Associations

Location: 151 A, WEWCC
Philippe Broet, MD,PhD – University Paris-Sud/Paris-Saclay, CESP, Paris
Tuesday, Nov 6
1:30 pm

Keynote: Mass Spec Technology

Location: 151 B, WEWCC
Nathan A. Yates, PhD – University of Pittsburgh; Shaolian Zhou – Roche
Tuesday, Nov 6
1:30 pm

Keynote: State of the Art and Future Perspectives on the Predictive Immunogenicity

Location: 151 A, WEWCC
Bernard Maillère, PhD – CEA; Timothy Hickling
Wednesday, Nov 7
8:30 am

Prologue: Regulations and Science in PK, PD and ADA Analysis of Biologic Therapeutics

Location: 151 A, WEWCC
Heather A. Myler, PhD – PPD; Mark H. Ma – Alexion Pharma
Wednesday, Nov 7
8:30 am

Prologue: The Regulatory Landscape & Its Bearing on Bioanalysis

Location: 151 B, WEWCC
Mark E. Arnold, PhD – Covance Inc.; Jianing Zeng – Bristol-Myers Squibb; Faye Vazvaei, MS – Roche
Wednesday, Nov 7
9:00 am

Systematic Approaches in Investigation of Failed Bio-comparability Study

Location: 151 A, WEWCC
Mark H. Ma – Alexion Pharma
Wednesday, Nov 7
9:00 am

Emerging Regulations Impacting Bioanalysis – Biomolecular

Location: 151 A, WEWCC
Heather A. Myler, PhD – PPD; Mark H. Ma – Alexion Pharma
Wednesday, Nov 7
9:30 am

Considerations for Establishing Biosimilarity for Compounds with Observed Biotransformation

Location: 151 A, WEWCC
Kelli R. Phillips, PhD, MBA – PPD
Wednesday, Nov 7
10:00 am

Technical Approaches in Pre-study Method Validation and Sample Analysis to Minimize Bioanalytical Bias

Location: 151 A, WEWCC
Theingi Thway, PhD – FDA
Wednesday, Nov 7
10:30 am

Panel Discussion: Bioanalytical Investigation of Failed Bio-comparability Studies

Location: 151 A, WEWCC
Mark H. Ma – Alexion Pharma; Theingi Thway, PhD – FDA; Sophia Xu – BMS
Wednesday, Nov 7
9:00 am

LC-MS/MS Biomarker Assay Validation Considerations from the New Guidance: Discussion of the Upcoming AAPS Whitepaper Recommendations

Location: 151 B, WEWCC
Carmen Fernandez-Metzler, PhD – PharmaCadence Analytical Services, LLC
Wednesday, Nov 7
9:00 am

Emerging Regulations Impacting Bioanalysis – Chemical

Location: 151 B, WEWCC
Jianing Zeng – Bristol-Myers Squibb; Faye Vazvaei, MS – Roche
Wednesday, Nov 7
9:30 am

Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices

Location: 151 B, WEWCC
Afshin Safavi, PhD – BioAgilytix; Steven P. Piccoli, PhD – GlaxoSmithKline
Wednesday, Nov 7
10:00 am

ICH M10 Update and the New FDA Guidance

Location: 151 B, WEWCC
Brian Booth, Ph.D.
Wednesday, Nov 7
10:30 am

Panel Discussion: Emerging Regulations Impacting Bioanalysis

Location: 151 B, WEWCC
Brian Booth, Ph.D.; Afshin Safavi, PhD – BioAgilytix; Carmen Fernandez-Metzler, PhD – PharmaCadence Analytical Services, LLC; Steven P. Piccoli, PhD – GlaxoSmithKline
Wednesday, Nov 7
1:30 pm

Keynote: Evolving Regulatory Landscape in Bioanalysis of Biologics; Immunogenicity and Biosimilars

Location: 151 A, WEWCC
Joao Pedras-Vasconcelos, PhD – FDA-CDER-OPQ-OBP-DBRR3; Boris Gorovits – Pfizer Inc.; Heather A. Myler, PhD – PPD
Wednesday, Nov 7
1:30 pm

Keynote: The Evolving Regulatory Landscape in Bioanalysis and Bioanalytical Method Validation--PK and Biomarkers

Location: 151 B, WEWCC
John Kadavil, PhD – USFDA; Faye Vazvaei, MS – Roche
Monday, Nov 5
3:00 pm

Rapid Fire Presentations: Bioanalytics – Biomolecular

Location: 151 A, WEWCC
Sumit Kar – Celerion; Ashley Lay-Fortenbery – University of Kentucky; Abhisheak Sharma, M. Pharm, PhD – University of Florida
Monday, Nov 5
3:00 pm

Rapid Fire Presentations: Bioanalytics – Chemical

Location: 151 B, WEWCC
Jenny Patel – The University of Tennessee at Knoxville; Zaneera Hassan – Virginia Commonwealth University; Amr Hassan, PhD – Virginia Commonwealth University
Tuesday, Nov 6
3:00 pm

Rapid Fire Presentations: Bioanalytics – Biomolecular

Location: 151 A, WEWCC
Sreedhar Reddy Suthe – Texas Tech University Health Sciences Center; Mitchel Ruigrok, M.Sc. – University of Groningen; Amr Hassan, PhD – Virginia Commonwealth University
Tuesday, Nov 6
3:00 pm

Rapid Fire Presentations: Bioanalytics – Chemical

Location: 151 B, WEWCC
Sumit Kar – Celerion; Swetha Thiyagarajan – North Dakota State University; Zaneera Hassan – Virginia Commonwealth University
Wednesday, Nov 7
3:00 pm

Rapid Fire Presentations: Bioanalytics – Biomolecular

Location: 151 A, WEWCC
Darshana Shah, Doctoral Student – St. John's University; Christopher Jay – Virginia Commonwealth University; Sreedhar Reddy Suthe – Texas Tech University Health Sciences Center
Wednesday, Nov 7
3:00 pm

Rapid Fire Presentations: Bioanalytics – Chemical

Location: 151 B, WEWCC
Laxmishanthi Chede, Ph.D student – University of Iowa; Sweilem Rihani