Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Browse by Track

Type here to filter the list

Advances in Discovery, Formulation, and Delivery of New Modalities

PRE-RECORDED

Prologue: Advancements in Immuno-Oncology : mAbs to Novel Modalities

Location: Online Only

Prologue Speaker: – Bristol Myers Squibb

Advances in Discovery, Formulation, and Delivery of New Modalities

PRE-RECORDED

Prologue: AI/ML in Drug Manufacturing: Use Cases and Areas of Consideration

Location: Online Only

Prologue Speaker: – US Food and Drug Administration

Advances in Discovery, Formulation, and Delivery of New Modalities

PRE-RECORDED

Prologue: Opportunities and Challenges for Lipid-Based Drug Delivery Systems for Biopharmaceuticals

Location: Online Only

Prologue Speaker: – HTD Biosystems Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

9:30 AM – 11:00 AM PT

Symposium: Preformulation and Formulation Approaches for Biologics and New Modalities

Location: Yosemite BC

Moderator: – Teva Pharmaceuticals

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

9:30 AM – 10:00 AM PT

Novel Approaches to Cancer Immunotherapy: a Strategic Overview

Location: Yosemite BC

Speaker: – Teva Pharmaceuticals

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:00 AM – 10:30 AM PT

High-Throughput Screening and Structural Characterization for Oligonucleotide LNP

Location: Yosemite BC

Speaker: – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:30 AM – 11:00 AM PT

Structure-Function Relationships in Lyophilized Biologics for Stability Prediction

Location: Yosemite BC

Speaker: – Purdue University/Industrial and Physical Pharmacy

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:00 AM – 11:00 AM PT

Hot Topic: Particle Safety and Size Threshold for Particle Visibility Revisited

Location: Yosemite A

Hot Topic Moderator: – Takeda

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:00 AM – 10:20 AM PT

Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

Location: Yosemite A

Hot Topic Speaker: – Genentech

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:20 AM – 10:40 AM PT

Silicone Oil Particles in Protein Drug Product – Are These a Significant Immunogenicity Risk Factor?

Location: Yosemite A

Hot Topic Speaker: – Amgen

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

10:40 AM – 11:00 AM PT

Panel Discussion

Location: Yosemite A

Hot Topic Speaker: – Genentech

Hot Topic Speaker: – Spyre Therapeutics

Hot Topic Speaker: – Amgen

Hot Topic Moderator: – Takeda

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

11:30 AM – 12:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: – BioAgilytix

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

1:00 PM – 2:00 PM PT

Keynote: Crafting Complex Biologics: A Fusion of Art and Science?

Location: Yosemite BC

Keynote Speaker: – Merck & Co, Inc.

Moderator: – Merck & Co., Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

2:30 PM – 3:15 PM PT

Formulation Development of sa-RNA Lipid Nanoparticles and Adjuvants for Regulating Immune Response

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Labcorp

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

2:30 PM – 3:30 PM PT

Rapid Fire: Preformulation and Formulation Approaches for Biologics and New Modalities

Location: Yosemite BC

Rapid Fire Moderator: – SynerG Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

2:30 PM – 2:45 PM PT

Atomic Level Characterization of Excipient Interactions with Monoclonal Antibodies

Location: Yosemite BC

Rapid Fire Speaker: – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

2:45 PM – 3:00 PM PT

Using Artificial Extracellular Matrices in Injectable Formulation Development

Location: Yosemite BC

Rapid Fire Speaker: – Pion Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

3:00 PM – 3:15 PM PT

Beyond mRNA and Lipid Nanoparticles: Formulation and Process Innovations

Location: Yosemite BC

Rapid Fire Speaker: – Landmark Bio

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

3:15 PM – 3:30 PM PT

Cell Therapy CMC Case Studies

Location: Yosemite BC

Rapid Fire Speaker: – Syner-G Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

9:30 AM – 11:00 AM PT

Symposium: Drug Delivery for New Modalities and Therapies

Location: Yosemite BC

Moderator: – SMC Ltd.

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

9:30 AM – 10:00 AM PT

Enabling Lipid Chemistry & Nanoparticle Surface Modification for Cytosolic Delivery

Location: Yosemite BC

Speaker: – University of Connecticut

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

10:00 AM – 10:30 AM PT

Auto-Mode Biomimicry: A Versatile Theranostic Model for Efficient Tumor Targeting

Location: Yosemite BC

Speaker: – University of the Punjab

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

10:30 AM – 11:00 AM PT

Novel Engineering and Formulation Based Approaches for Delivery of CART to Solid Tumors

Location: Yosemite BC

Speaker: – Consultant

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

10:15 AM – 11:00 AM PT

The Impact of Polysorbate Quality/Grade on Biopharmaceutical Formulations

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Croda, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

11:15 AM – 12:00 PM PT

Recombinant Human Hyaluronidase Facilitated Subcutaneous Drug Delivery Using a 10mL High-Volume Auto-Injector

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – Halozyme Therapeutics Inc

Partner Presentation Speaker: – Halozyme Therapeutics, Inc

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

1:00 PM – 2:00 PM PT

Keynote: In vivo Delivery of mRNAs for Anti-Aging Applications: Potential and Challenges

Location: Yosemite BC

Keynote Speaker: – Stanford University and Turn Biotechnologies

Moderator: – St. John's University

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

1:15 PM – 3:00 PM PT

PCR Assay Recommendations for Cell and Gene Therapies: Insights from an Industry Panel

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: – BioAgilytix

Partner Presentation Speaker: – Eurofins Viracor BioPharma

Partner Presentation Speaker: – Beam Therapeutics

Partner Presentation Speaker: – BioMarin Pharmaceutical, Inc.

Moderator: – AAPS

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

2:30 PM – 3:30 PM PT

Rapid Fire: Drug Delivery for New Modalities and Therapies

Location: Yosemite BC

Rapid Fire Moderator: – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

2:30 PM – 2:45 PM PT

Dry Powders for the Delivery of Biopharmaceuticals to the Nose

Location: Yosemite BC

Rapid Fire Speaker: – Harro Höfliger

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

2:30 PM – 3:30 PM PT

Hot Topic: Prior Knowledge Integration in Product Development

Location: Yosemite A

Hot Topic Speaker: – Pfizer Inc.

Hot Topic Moderator: – US Food and Drug Administration

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

2:45 PM – 3:00 PM PT

Development of an Inhalable and Temperature-Stable COVID-19 Liposomal Vaccine

Location: Yosemite BC

Rapid Fire Speaker: – St. Johns University

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

3:00 PM – 3:15 PM PT

What Does “Biorelevant” Mean for Oral Peptides?

Location: Yosemite BC

Rapid Fire Speaker: – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Wednesday, May 15th

3:15 PM – 3:30 PM PT

Molecular Investigation on Permeation-Enhancer Assisted Oral Peptide Delivery in Lipid-Bilayers

Location: Yosemite BC

Rapid Fire Speaker: – Merck

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

9:30 AM – 11:00 AM PT

Symposium: AI/ML in Drug Discovery and Development

Location: Yosemite BC

Moderator: – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

9:30 AM – 10:00 AM PT

ML Enhanced DLS for Rapid Characterization of mAb Aggregation

Location: Yosemite BC

Speaker: – Indian Insitute of Technology Delhi

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:00 AM – 10:30 AM PT

Harnessing Artificial Intelligence for Classifying Free-Fatty Acid Particles in Biopharmaceuticals

Location: Yosemite BC

Speaker: – Clear Solutions Laboratories AG

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:30 AM – 11:00 AM PT

Assessing Immunogenicity Risk of Biologics: Prediction Tools, and Case Studies

Location: Yosemite BC

Speaker: – AbbVie

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:00 AM – 11:00 AM PT

Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New Era

Location: Yosemite A

Hot Topic Moderator: – Saliogen Therapeutics

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:00 AM – 10:20 AM PT

Machine Learning-Guided Design of Polymer Nanoparticles for In Vivo Gene Therapies

Location: Yosemite A

Hot Topic Speaker: – Nanite Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:20 AM – 10:40 AM PT

The Quest for Next Generation Lipid Nanoparticles for Cell-Specific Delivery of mRNA

Location: Yosemite A

Hot Topic Speaker: – Oregon State University

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

10:40 AM – 11:00 AM PT

Panel Discussion

Location: Yosemite A

Hot Topic Moderator: – Saliogen Therapeutics

Hot Topic Speaker: – Nanite Inc.

Hot Topic Speaker: – Oregon State University

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

12:30 PM – 1:30 PM PT

Keynote: Artificial Intelligence for Drug Discovery (AIDD)-Are We There Yet? How AI is Transforming the Drug Discovery Process

Location: Yosemite BC

Keynote Speaker: – Howard University

Moderator: – HTD Biosystems

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

2:00 PM – 2:45 PM PT

Rapid Fire: AI/ML in Drug Discovery and Development

Location: Yosemite BC

Rapid Fire Moderator: – AbbVie

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

2:00 PM – 2:15 PM PT

Data Quality and Data Integrity Considerations for Applying AI/ML as Part of Process/Product Development

Location: Yosemite BC

Rapid Fire Speaker: – Pharmatech Associates

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

2:15 PM – 2:30 PM PT

Optimizing for Failure - Survivorship Bias in AI

Location: Yosemite BC

Rapid Fire Speaker: – ERA Sciences

Advances in Discovery, Formulation, and Delivery of New Modalities

Thursday, May 16th

2:30 PM – 2:45 PM PT

Mechanistic Insight into the Physical Stability of Oligonucleotides

Location: Yosemite BC

Rapid Fire Speaker: – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

Executive Track

Novel Strategies to Advance Biotherapeutic Development

PRE-RECORDED

Prologue: Opportunities and Implications for Using AI/ML in Bioanalytical Assay Development

Location: Online Only

Prologue Speaker: – Accenture

Novel Strategies to Advance Biotherapeutic Development

PRE-RECORDED

Prologue: Patient Centric Sampling for Clinical Drug Development

Location: Online Only

Prologue Speaker: – Merck & Co., Inc.

Novel Strategies to Advance Biotherapeutic Development

PRE-RECORDED

Prologue: Technology Advances in Vaccine Research

Location: Online Only

Prologue Speaker: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – Ultragenyx

Moderator: – 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: – 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: – 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: – 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: – Center for Biologics Evaluation and Research,FDA

Hot Topic Speaker: – Passage Bio

Hot Topic Moderator: – Passage Bio

Hot Topic Speaker: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – Ultragenyx

Hot Topic Speaker: – PPD, part of Thermo Fisher Scientific

Hot Topic Speaker: – Bristol-Myers Squibb Company

Hot Topic Speaker: – Johnson & Johnson

Hot Topic Moderator: – 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: – 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: – 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:

Moderator: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – 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: – U.S. Food and Drug Administration

Moderator: – 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: – 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: – 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: – Genentech

Hot Topic Speaker: – Regeneron Pharmaceuticals Inc

Hot Topic Speaker: – BioAgilytix

Hot Topic Moderator: – Genentech

Hot Topic Speaker: – 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: – 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: – 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: – AstraZeneca

Novel Strategies to Advance Biotherapeutic Development