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Pre-Recorded
Mon, May 13
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Wed, May 15
Thu, May 16
Full Schedule
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Thursday, May 16, 2024
8:30 AM – 2:00 PM
PT
Registration Hours
8:30 AM – 2:00 PM
PT
Registration Hours
Location: Yosemite Foyer
8:30 AM – 2:30 PM
PT
Speaker Ready Room
8:30 AM – 2:30 PM
PT
Speaker Ready Room
Location: Executive Boardroom
9:00 AM – 10:00 AM
PT
Coffee Break
9:00 AM – 10:00 AM
PT
Coffee Break
Location: Yosemite Foyer
9:30 AM – 11:00 AM
PT
Symposium: AI/ML in Drug Discovery and Development
Moderator:
Maxwell Korang-Yeboah, PhD
– FDA/CDER/OPQ/OPQR
Advances in Discovery, Formulation, and Delivery of New Modalities
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
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
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
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
9:30 AM – 11:00 AM
PT
Symposium: High Content Bioanalysis
Moderator:
Eric Thomas, PhD
– LabCorp
Novel Strategies to Advance Biotherapeutic Development
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
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
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
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
10:00 AM – 11:00 AM
PT
Hot Topic: Advances in in-vivo Therapeutic Nucleic Acid Delivery: Ushering New Era
Hot Topic Moderator:
Sandeep Nema, PhD (he/him/his)
– Saliogen Therapeutics
Advances in Discovery, Formulation, and Delivery of New Modalities
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
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
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
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
11:00 AM – 12:30 PM
PT
Networking Lunch
11:00 AM – 12:30 PM
PT
Networking Lunch
Location: Franciscan ABCD
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
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
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?
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
1:30 PM – 2:00 PM
PT
Coffee Break
1:30 PM – 2:00 PM
PT
Coffee Break
Location: Yosemite Foyer
2:00 PM – 2:45 PM
PT
Rapid Fire: AI/ML in Drug Discovery and Development
Rapid Fire Moderator:
Swati Gupta, PhD (she/her/hers)
– AbbVie
Advances in Discovery, Formulation, and Delivery of New Modalities
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
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
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
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
2:00 PM – 3:00 PM
PT
Hot Topic: Navigating the New FDA Immunogenicity Labelling Guidance
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
2:00 PM – 3:00 PM
PT
Rapid Fire: High Content Bioanalysis
Rapid Fire Moderator:
Devangi Mehta, PhD
– Immunologix Laboratories
Novel Strategies to Advance Biotherapeutic Development
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
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
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
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
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
3:15 PM – 4:30 PM
PT
Closing Plenary with Dr. Peter Lee
Plenary Speaker:
Peter Lee, Ph.D.
3:15 PM – 4:30 PM
PT
Closing Plenary with Dr. Peter Lee
Location: Imperial Ballroom
Plenary Speaker:
Peter Lee, Ph.D.
