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Coffee Break

Tuesday, May 14th

10:00 AM – 11:00 AM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

Tuesday, May 14th

2:00 PM – 2:30 PM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

Wednesday, May 15th

10:00 AM – 11:00 AM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

Wednesday, May 15th

2:00 PM – 2:30 PM PT

Coffee Break in the Solution Center

Location: Grand Ballroom AB

Thursday, May 16th

9:00 AM – 10:00 AM PT

Coffee Break

Location: Yosemite Foyer

Thursday, May 16th

1:30 PM – 2:00 PM PT

Coffee Break

Location: Yosemite Foyer

Community Event

Tuesday, May 14th

8:30 AM – 9:30 AM PT

AAPS Bioanalytical Community Membership Meeting

Location: Yosemite A

Community Leader: Daniel S. Spellman, PhD – Merck Research Laboratories

Wednesday, May 15th

8:30 AM – 9:30 AM PT

AAPS Biomarkers and Precision Medicine Community Membership Meeting

Location: Yosemite A

Community Leader: Karen J. Quadrini, PhD – Prothena Biosciences

Wednesday, May 15th

4:00 PM – 5:00 PM PT

AAPS Gene and Cell Therapy Products Community Membership Meeting

Location: Yosemite A

Community Leader: Yan G. Ni, PhD – Passage Bio

Executive Track

Tuesday, May 14th

9:30 AM – 11:00 AM PT

Executive Track - Cell and Gene Therapies at the Intersection of Business and Science

Location: Franciscan A&B

Moderator: Praveen Tyle, PhD – Potens Pharmaceuticals

Executive Education Speaker: Jason Bock, Ph.D. – CTMC

Executive Education Speaker: Kimberley Buytaert-Hoefen, Ph.D. – QPS

Executive Education Speaker: Nianwei Lin, PhD (he/him/his) – iXCells Biotechnologies

Executive Education Speaker: Hari Pujar, Ph.D. – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics

Executive Track

Happy Hour

Tuesday, May 14th

3:30 PM – 4:30 PM PT

Happy Hour Sponsored by Aragen Lifesciences Ltd

Location: Booth #208, Grand Ballroom AB

Wednesday, May 15th

3:30 PM – 4:30 PM PT

Happy Hour Sponsored by INTERPHEX

Location: Booth #805, Grand Ballroom AB

Hot Topic

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: Nazila Miller, PhD (she/her/hers) – 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: Miguel Saggu, PhD (he/him/his) – 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: Kimya Nourbakhsh, PhD (she/her/hers) – 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: Miguel Saggu, PhD (he/him/his) – Genentech

Hot Topic Speaker: Tapan K. Das, PhD, FAAPS – Spyre Therapeutics

Hot Topic Speaker: Kimya Nourbakhsh, PhD (she/her/hers) – Amgen

Hot Topic Moderator: Nazila Miller, PhD (she/her/hers) – Takeda

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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

2:30 PM – 3:30 PM PT

Hot Topic: Prior Knowledge Integration in Product Development

Location: Yosemite A

Hot Topic Speaker: Parag Kolhe, PhD – Pfizer Inc.

Hot Topic Moderator: Ping Ji, PhD – US Food and Drug Administration

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: Sandeep Nema, PhD (he/him/his) – 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: Shashi Murthy, PhD – 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: Gaurav Sahay, PhD – 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: Sandeep Nema, PhD (he/him/his) – Saliogen Therapeutics

Hot Topic Speaker: Shashi Murthy, PhD – Nanite Inc.

Hot Topic Speaker: Gaurav Sahay, PhD – Oregon State University

Advances in Discovery, Formulation, and Delivery of New Modalities

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

Keynote

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: Yongchao Su, PhD – Merck & Co, Inc.

Moderator: Elizabeth Thoryk – Merck & Co., Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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

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: Vittorio Sebastiano, PhD (he/him/his) – Stanford University and Turn Biotechnologies

Moderator: Nitesh Kunda, PhD – St. John's 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: Simon Wang, PhD (he/him/his) – Howard University

Moderator: Mitra Mosharraf, M Pharm, PhD, MBA – HTD Biosystems

Advances in Discovery, Formulation, and Delivery of New Modalities

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

Partner Presentation

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

1:30 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 – 3:15 PM PT

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

Location: Learning Lab, Grand Ballroom AB

Partner Presentation Speaker: Adam R. Nasar (he/him/his) – Labcorp

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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: Sreejit Menon, PhD – 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: David W. Kang – Halozyme Therapeutics Inc

Partner Presentation Speaker: Michael Travanty – Halozyme Therapeutics, Inc

Advances in Discovery, Formulation, and Delivery of New Modalities

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

1:15 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: Amanda L. Hays, PhD – BioAgilytix

Partner Presentation Speaker: Mark C. Wissel, PhD – Eurofins Viracor BioPharma

Partner Presentation Speaker: Kelly S. Colletti, PhD, MBA (she/her/hers) – Beam Therapeutics

Partner Presentation Speaker: Russell K. Soon, Jr. (he/him/his) – BioMarin Pharmaceutical, Inc.

Moderator: Tina S. Morris, PhD – AAPS

Advances in Discovery, Formulation, and Delivery of New Modalities

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

Plenary Session

Monday, May 13th

3:00 PM – 4:30 PM PT

Opening Plenary with Hari Pujar, Ph.D.

Location: Imperial Ballroom

Plenary Speaker: Hari Pujar, Ph.D. – Operating Partner at Flagship Pioneering and Chief Operating Officer of Tessera Therapeutics

Thursday, May 16th

3:15 PM – 4:30 PM PT

Closing Plenary with Dr. Peter Lee

Location: Imperial Ballroom

Plenary Speaker: Peter Lee, Ph.D.

Prologue

PRE-RECORDED

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

Location: Online Only

Prologue Speaker: Ankit D. Kanthe, PhD – 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: Thomas O'Connor, PhD (he/him/his) – 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: Rajiv Nayar, PhD – HTD Biosystems Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

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

Rapid Fire

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 – 3:30 PM PT

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

Location: Yosemite BC

Rapid Fire Moderator: Scott Rudge, PhD (he/him/his) – SynerG Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

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 – 2:45 PM PT

Atomic Level Characterization of Excipient Interactions with Monoclonal Antibodies

Location: Yosemite BC

Rapid Fire Speaker: Anupreet Kaur (she/her/hers) – 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

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

2:45 PM – 3:00 PM PT

Using Artificial Extracellular Matrices in Injectable Formulation Development

Location: Yosemite BC

Rapid Fire Speaker: Conor Gomes, Ph.D. (he/him/his) – 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: Rob Delong, PhD (he/him/his) – Landmark Bio

Advances in Discovery, Formulation, and Delivery of New Modalities

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

Cell Therapy CMC Case Studies

Location: Yosemite BC

Rapid Fire Speaker: Stacy Plum, PhD – Syner-G Biopharma Group

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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 – 3:30 PM PT

Rapid Fire: Drug Delivery for New Modalities and Therapies

Location: Yosemite BC

Rapid Fire Moderator: Karthik Nagapudi, PhD – 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: Irene Rossi, PhD – Harro Höfliger

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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

Location: Yosemite BC

Rapid Fire Speaker: Apoorva Daram (she/her/hers) – St. Johns University

Advances in Discovery, Formulation, and Delivery of New Modalities

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

3:00 PM – 3:15 PM PT

What Does “Biorelevant” Mean for Oral Peptides?

Location: Yosemite BC

Rapid Fire Speaker: Tahnee J. Dening, PhD (she/her/hers) – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

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

3:15 PM – 3:30 PM PT

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

Location: Yosemite BC

Rapid Fire Speaker: Jing Ling, PhD – Merck

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: Swati Gupta, PhD (she/her/hers) – 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: Bikash Chatterjee (he/him/his) – 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: Andrew O'Connor, BSc (Hons) – 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: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

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

2:15 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

Reception

Monday, May 13th

4:30 PM – 6:00 PM PT

Welcome Reception in the Solution Center

Location: Grand Ballroom AB

Tuesday, May 14th

5:00 PM – 6:30 PM PT

Sustaining Partner Reception (by invitation only)

Location: Vista Lounge (45th Floor)

Wednesday, May 15th

5:00 PM – 6:30 PM PT

Women in Biotech Reception Sponsored by AstraZeneca

Location: Vista Lounge (45th Floor)

Special Poster Collection

Tuesday, May 14th

11:30 AM – 12:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: Amanda L. Hays, PhD – BioAgilytix

Advances in Discovery, Formulation, and Delivery of New Modalities

Tuesday, May 14th

3:30 PM – 4:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: Gopi Shankar, Ph.D., M.B.A., FAAPS – Larimartx

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

3:30 PM – 4:30 PM PT

Special Poster Collection

Location: Grand Ballroom AB, Poster Forum 1

Poster Collection Host: Russ S. Weiner, Ph.D., FAAPS – Takeda

Symposium

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 – 11:00 AM PT

Symposium: Preformulation and Formulation Approaches for Biologics and New Modalities

Location: Yosemite BC

Moderator: Haichen Nie, PhD – Teva Pharmaceuticals

Advances in Discovery, Formulation, and Delivery of New Modalities

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

9:30 AM – 10:00 AM PT

Novel Approaches to Cancer Immunotherapy: a Strategic Overview

Location: Yosemite BC

Speaker: Steffen Nock, PhD (he/him/his) – 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: Chunwan Yen, PhD (she/her/hers) – Genentech, Inc.

Advances in Discovery, Formulation, and Delivery of New Modalities

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

10:30 AM – 11:00 AM PT

Structure-Function Relationships in Lyophilized Biologics for Stability Prediction

Location: Yosemite BC

Speaker: Eric J. Munson, PhD, FAAPS – Purdue University/Industrial and Physical Pharmacy

Advances in Discovery, Formulation, and Delivery of New Modalities

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 – 11:00 AM PT

Symposium: Drug Delivery for New Modalities and Therapies

Location: Yosemite BC

Moderator: Asmita Khanolkar, MS – 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: Xiuling Lu, Ph.D., FAAPS (she/her/hers) – University of Connecticut

Advances in Discovery, Formulation, and Delivery of New Modalities

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

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

Location: Yosemite BC

Speaker: Imran Tariq, PhD – University of the Punjab

Advances in Discovery, Formulation, and Delivery of New Modalities

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

10:30 AM – 11:00 AM PT

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

Location: Yosemite BC

Speaker: Robert Dodge, PhD – Consultant

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: Maxwell Korang-Yeboah, PhD – FDA/CDER/OPQ/OPQR

Advances in Discovery, Formulation, and Delivery of New Modalities

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

9:30 AM – 10:00 AM PT

ML Enhanced DLS for Rapid Characterization of mAb Aggregation

Location: Yosemite BC

Speaker: Anurag S. Rathore, Ph.D. – Indian Insitute of Technology Delhi

Advances in Discovery, Formulation, and Delivery of New Modalities

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

10:00 AM – 10:30 AM PT

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

Location: Yosemite BC

Speaker: Filip M. Fedorowicz, MS (he/him/his) – 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: Swati Gupta, PhD (she/her/hers) – AbbVie

Advances in Discovery, Formulation, and Delivery of New Modalities

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