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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
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
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
10:30 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
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
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
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
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
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
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
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
3:15 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
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
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
10:30 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
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
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
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
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 – 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
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
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
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
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 – 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
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
10:00 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
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
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