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PRE-RECORDED
Prologue: Opportunities and Implications for Using AI/ML in Bioanalytical Assay Development
Location: Online Only
Prologue Speaker: Joe Rajarao, PhD (he/him/his) – Accenture
Novel Strategies to Advance Biotherapeutic Development
PRE-RECORDED
Prologue: Patient Centric Sampling for Clinical Drug Development
Location: Online Only
Prologue Speaker: Melanie Anderson, MS (she/her/hers) – Merck & Co., Inc.
Novel Strategies to Advance Biotherapeutic Development
PRE-RECORDED
Prologue: Technology Advances in Vaccine Research
Location: Online Only
Prologue Speaker: Andrea Bertolotti-Ciarlet, PhD (she/her/hers) – Takeda
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
9:30 AM – 11:00 AM PT
Symposium: Development Strategy for Novel Targeted Therapeutic Delivery
Location: Plaza A
Moderator: Lynn Kamen, PhD – BioAgilytix Labs
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
9:30 AM – 10:00 AM PT
An Ultra-Sensitive Human pS413 Tau Assay in Cerebrospinal Fluid
Location: Plaza A
Speaker: Xuemei Zhao, PhD – Merck
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
10:00 AM – 10:30 AM PT
The Advancement of High-Plex Bioanalytical Technology and its Data Integration
Location: Plaza A
Speaker: Tomoki Yamashita, PhD (he/him/his) – Takeda Pharmaceutical Company Limited
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
10:30 AM – 11:00 AM PT
Hybrid LBA LC-MS Assay: Does One Size Fit All?
Location: Plaza A
Speaker: Jinhui Zhang, PhD (he/him/his) – US Food and Drug Administration
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
10:15 AM – 11:00 AM PT
High Resolution Accurate Mass Analysis: Addressing Sensitivity and Specificity
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Prakash Bhosale, PhD – Q Squared Solutions
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
11:15 AM – 12:00 PM PT
High-Speed Microdroplet Reactions for Faster Therapeutic Protein Analysis
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Krishna D.B Anapindi, PhD (he/him/his) – Gilead Sciences
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
12:15 PM – 1:00 PM PT
Mass Photometry – an Analytical Technology for Biomolecular Characterization
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Gabriella Kiss, PhD (she/her/hers) – Refeyn Inc.
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
1:00 PM – 2:00 PM PT
Keynote: Using Biomarkers to Accelerate Development of Disease Modifying Therapies for Rare Disease
Location: Plaza A
Keynote Speaker: Emil Kakkis, MD, PhD (he/him/his) – Ultragenyx
Moderator: Karen J. Quadrini, PhD – Prothena Biosciences
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
1:30 PM – 2:15 PM PT
Advances in Accelerated Quantification of Oligonucleotides with Automated, Microfluidic Methods
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Jasmine Singh, MS – Gyros Protein Technologies
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
2:30 PM – 3:30 PM PT
Rapid Fire: Development Strategy for Novel Targeted Therapeutic Delivery
Location: Plaza A
Rapid Fire Moderator: Wei Wei, PhD (she/her/hers) – Boehringer Ingelheim
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
2:30 PM – 2:45 PM PT
Advanced ADA-Domain-Characterization for T-cell-Engager-Drugs to Understand Exposure and Activity Impact
Location: Plaza A
Rapid Fire Speaker: Gregor P. Lotz, PhD (he/him/his) – Roche Diagnostics GmbH
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
2:30 PM – 3:30 PM PT
Hot Topic: Biomarkers and Accelerated Approval for Advanced Therapy
Location: Yosemite A
Hot Topic Speaker: Celia W. Witten, MD, PhD – Center for Biologics Evaluation and Research,FDA
Hot Topic Speaker: Yan G. Ni, PhD – Passage Bio
Hot Topic Moderator: Yan G. Ni, PhD – Passage Bio
Hot Topic Speaker: Emil Kakkis, MD, PhD (he/him/his) – Ultragenyx
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
2:45 PM – 3:00 PM PT
Spectral Unmixing Impact Comparison Across Immunophenotyping Panels and Matrices
Location: Plaza A
Rapid Fire Speaker: Nassouh Mourabet, MS (he/him/his) – KCAS Bio
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
3:00 PM – 3:15 PM PT
Identifying Inflammatory Biomarkers in Small-Cell Lung Cancer Using Olink Assays
Location: Plaza A
Rapid Fire Speaker: Jeff Chen, PhD – AstraZeneca
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
3:15 PM – 3:30 PM PT
High-Dimensional Immunophenotyping Panel to Characterize Chimeric-Antigen-Receptor T Cells in Clinical-Trials
Location: Plaza A
Rapid Fire Speaker: Rohini Emani, PhD (she/her/hers) – Astrazeneca
Novel Strategies to Advance Biotherapeutic Development
Tuesday, May 14th
3:30 PM – 4:15 PM PT
Immunogenicity Assessment and Target Binding Reagents Beyond Antibodies
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Emilee Knowlton, PhD (she/her/hers) – ProImmune, Inc.
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
9:30 AM – 11:00 AM PT
Symposium: Advances in Analytical and Bioanalytical Platform Technology
Location: Plaza A
Moderator: Shoshana Oberstein (she/her/hers) – PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
9:30 AM – 10:00 AM PT
Personalizing Clinical Immunogenicity Risk Through HLA DR Alleles Associations
Location: Plaza A
Speaker: SURENDRAN RAJENDRAN, PhD (he/him/his) – Bristol-Myers Squibb
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:00 AM – 10:30 AM PT
Unique Clinical Pharmacology Considerations for Allogeneic Cell Therapies
Location: Plaza A
Speaker: Dhruvitkumar Sutaria, PhD (he/him/his) – Genentech
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:30 AM – 11:00 AM PT
Methodologies for Biotherapeutic Biotransformation Studies
Location: Plaza A
Speaker: Anton Rosenbaum – AstraZeneca
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:00 AM – 11:00 AM PT
Hot Topic: Applications of qPCR/dPCR in Cell and Gene Therapies; Case Studies
Location: Yosemite A
Hot Topic Moderator: Jacqueline Murphy, MS – Janssen
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:00 AM – 10:10 AM PT
Introduction to PCR Assay Development and Validation
Location: Yosemite A
Hot Topic Speaker: Timothy L. Lochmann, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:10 AM – 10:20 AM PT
A Case Study in AAV Gene Therapy Viral Shedding
Location: Yosemite A
Hot Topic Speaker: Mitra Azadeh, PhD (she/her/hers) – Ultragenyx
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:20 AM – 10:30 AM PT
A Case study in Cell Therapy Persistence by qPCR
Location: Yosemite A
Hot Topic Speaker: Kate B. Herr, M.S. (she/her/hers) – Johnson & Johnson
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:30 AM – 10:40 AM PT
A Case Study in Cell Therapy Persistence by ddPCR
Location: Yosemite A
Hot Topic Speaker: Nanda Balasubramanian, PhD (he/him/his) – Bristol-Myers Squibb Company
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
10:40 AM – 11:00 AM PT
Panel Discussion
Location: Yosemite A
Hot Topic Speaker: Mitra Azadeh, PhD (she/her/hers) – Ultragenyx
Hot Topic Speaker: Timothy L. Lochmann, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific
Hot Topic Speaker: Nanda Balasubramanian, PhD (he/him/his) – Bristol-Myers Squibb Company
Hot Topic Speaker: Kate B. Herr, M.S. (she/her/hers) – Johnson & Johnson
Hot Topic Moderator: Jacqueline Murphy, MS – Janssen
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
11:30 AM – 12:30 PM PT
Special Poster Collection
Location: Grand Ballroom AB, Poster Forum 1
Poster Collection Host: Katie F. Maass, Ph.D. (she/her/hers) – Genentech, Inc.
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
12:15 PM – 1:00 PM PT
From ASO to mRNA—Oligonucleotide Therapeutics Separation and Characterization Using LC/MS
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Suraj Dhungana, PhD, MBA (he/him/his) – Waters Corporation
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
1:00 PM – 2:00 PM PT
Keynote: Development of Oligonucleotide Therapeutics
Location: Plaza A
Keynote Speaker: Raman Bahal
Moderator: Linzhi Chen, PhD (he/him/his) – Boehringer Ingelheim Pharmaceuticals, Inc.
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
2:30 PM – 3:30 PM PT
Rapid Fire: Advances in Analytical and Bioanalytical Platform Technology
Location: Plaza A
Rapid Fire Moderator: Nancy Yu (she/her/hers) – Genentech, Inc
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
2:30 PM – 2:45 PM PT
Metabolite identification and Profiling Methodology - Application for GalNAc Conjugated Oligonucleotides
Location: Plaza A
Rapid Fire Speaker: Asa Walander, M.S., PhD (she/her/hers) – Ionis Pharmaceuticals
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
2:45 PM – 3:00 PM PT
Highly-Sensitive Hybridization ELISA Development for Oligonucleotide Quantitation at Picogram Levels
Location: Plaza A
Rapid Fire Speaker: Eric F. Tewalt, PhD – PPD, Part of Thermo Fisher Scientific
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
3:00 PM – 3:15 PM PT
Comparison of Four Bioanalytical Assay Platforms for siRNA Therapeutic Quantitation
Location: Plaza A
Rapid Fire Speaker: Karan Agrawal, PhD (he/him/his) – Janssen Research and Development
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
3:15 PM – 3:30 PM PT
Bioanalytical Strategy for Pharmacokinetic Characterization of Oligonucleotide-Protein Conjugates
Location: Plaza A
Rapid Fire Speaker: Babak Basiri, PhD (he/him/his) – Dyne Therapeutics
Novel Strategies to Advance Biotherapeutic Development
Wednesday, May 15th
3:30 PM – 4:15 PM PT
Bioanalytical Strategy for Quantitation of GLP-1 Analogs
Location: Learning Lab, Grand Ballroom AB
Partner Presentation Speaker: Ebru S. Selen, PhD (she/her/hers) – SCIEX
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
9:30 AM – 11:00 AM PT
Symposium: High Content Bioanalysis
Location: Plaza A
Moderator: Eric Thomas, PhD – LabCorp
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
9:30 AM – 10:00 AM PT
AAV8 Shedding Assay to Support Gene Therapy Clinical Trials
Location: Plaza A
Speaker: Johannes Stanta, PhD – Celerion
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
10:00 AM – 10:30 AM PT
Companion Diagnostics for AAV-Mediated Gene Therapy: Recent Developments and Challenges
Location: Plaza A
Speaker: Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics, Inc
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
10:30 AM – 11:00 AM PT
Comparability Assessment Regulatory Considerations of Cell and Gene Therapy Products
Location: Plaza A
Speaker: Mo Heidarian, PhD – Cellx Inc. Consulting
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
12:30 PM – 1:30 PM PT
Keynote: Getting Up Close and Personal: Can Understanding the Pharmacogenetic Determinants of Immunogenicity Help in the Design of Safer Biologics?
Location: Plaza A
Keynote Speaker: Zuben E. Sauna, PhD (he/him/his) – U.S. Food and Drug Administration
Moderator: Arkadeep Sinha, PhD (he/him/his) – Upstream BIo
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:00 PM – 3:00 PM PT
Rapid Fire: High Content Bioanalysis
Location: Plaza A
Rapid Fire Moderator: Devangi Mehta, PhD – Immunologix Laboratories
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:00 PM – 2:15 PM PT
Modeling Strategy to Inform Antibody Binding Affinity for Soluble Targets
Location: Plaza A
Rapid Fire Speaker: Kazi Tasneem, PhD – Genentech - South San Francisco, CA
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:00 PM – 3:00 PM PT
Hot Topic: Navigating the New FDA Immunogenicity Labelling Guidance
Location: Yosemite A
Hot Topic Speaker: Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech
Hot Topic Speaker: Ching-Ha (Vicky) Lai, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc
Hot Topic Speaker: Will Williams, MS (he/him/his) – BioAgilytix
Hot Topic Moderator: Steve J. Swanson, PhD, FAAPS (he/him/his) – Genentech
Hot Topic Speaker: Yow-Ming Wang, PhD – US FDA, CDER., Office of Clinical Pharmacology
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:15 PM – 2:30 PM PT
Bioanalytical Functional Activity Measurement in Support of AAV Gene Therapy
Location: Plaza A
Rapid Fire Speaker: Sayali Saykhedkar, Dr. (she/her/hers) – Spark Therapeutics
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:30 PM – 2:45 PM PT
Bioanalytical Strategies, Challenges, and Solutions During PEGylated Drug Development
Location: Plaza A
Rapid Fire Speaker: Emma (Yanqiu) Liu, PhD – Genentech
Novel Strategies to Advance Biotherapeutic Development
Thursday, May 16th
2:45 PM – 3:00 PM PT
Longitudinal Multi-Omics Characterization of Propyl Gallate-Mediated Nephrotoxicity in Beagles
Location: Plaza A
Rapid Fire Speaker: Nathaly Reyes Garces, PhD (she/her/hers) – AstraZeneca
Novel Strategies to Advance Biotherapeutic Development