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Pre-Recorded
Prologue: Inspiring Innovation in Formulation, Bioprocessing & Drug Delivery: Novel Development of Biologics for Newer and Established Modalities
Location: Online Only
Prologue Speaker: Amardeep S. Bhalla, PhD (he/him/his) – Regeneron Pharmaceuticals
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Pre-Recorded
Prologue: Integrating Modern Tools for Biologics Development: Innovating Traditional and Emerging Modalities
Location: Online Only
Prologue Speaker: Parag Kolhe, PhD – Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Pre-Recorded
Prologue: Intravitreal Drug Delivery: Overcoming Formulation and Device Challenges
Location: Online Only
Prologue Speaker: Andrea Allmendinger, Prof Dr (she/her/hers) – ten23 health AG
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
9:30 AM – 11:00 AM ET
Symposium: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
Location: Webster
Moderator: Sheetal S. Pai-Wechsung, PhD (she/her/hers) – Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
9:30 AM – 10:00 AM ET
RNA-LNP Drug Product: Lipid Stability, RNA Impurities and Particle Characterization
Location: Webster
Speaker: Nejc Pavlin, PhD (he/him/his) – Sartorius BIA Separations
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:00 AM – 10:30 AM ET
Leveraging Prior Knowledge to Accelerate Drug Product Formulation and Process Development
Location: Webster
Speaker: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:30 AM – 11:00 AM ET
Resolving the Complexity of Combination Drug Product Design
Location: Webster
Speaker: Allen Templeton, PhD – Merck & Co, Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:00 AM – 11:00 AM ET
Hot Topic: Progress in mRNA LNP Understanding to Enable Refrigerated Long-Term Storage
Location: Otis
Hot Topic Moderator: Ruchi Shah, PhD – GSK
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:00 AM – 10:15 AM ET
Out of Deep Freeze: A Patient-Centric Approach in Enhancing mRNA/LNP Drug Products
Location: Otis
Hot Topic Speaker: Ramin Darvari, PhD – Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:15 AM – 10:30 AM ET
Considerations and Challenges in Early LNP Development for NVGT
Location: Otis
Hot Topic Speaker: Yuefei Shen, PhD – Sanofi
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:30 AM – 10:45 AM ET
Bridging the Gap: Developing Solutions for Efficient mRNA-LNP Process Tech Transfer
Location: Otis
Hot Topic Speaker: Michael Newton, MS (he/him/his) – AstraZeneca
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:45 AM – 11:00 AM ET
Panel Discussion
Location: Otis
Hot Topic Speaker: Ramin Darvari, PhD – Pfizer Inc.
Hot Topic Speaker: Yuefei Shen, PhD – Sanofi
Hot Topic Speaker: Michael Newton, MS (he/him/his) – AstraZeneca
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
10:15 AM – 11:00 AM ET
Improved Methods for Antibody Purification
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Alistair Hurst – emp BIOTECH LLC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Monday, May 5th
1:00 PM – 2:00 PM ET
Keynote: Challenges in Characterization and Comparability of Advanced Therapies
Location: Webster
Keynote Speaker: Phillip Ramsey, MS, MBA (he/him/his) – Sangamo Therapeutics
Moderator: Sheetal S. Pai-Wechsung, PhD (she/her/hers) – Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
1:30 PM – 2:15 PM ET
Novel Pharma Excipient: Hyaluronic Acid Nanogel for Sustained Release and Solubility Enhancement of Biologics
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Yoshiyuki Nakagawa, PhD (he/him/his) – Asahi Kasei Corporation
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Monday, May 5th
2:30 PM – 3:30 PM ET
Rapid Fire: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
Location: Webster
Rapid Fire Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
2:30 PM – 2:45 PM ET
Optimization mRNA Lipid Nanoparticles for Macrophage Transfection in Lung Disease
Location: Webster
Rapid Fire Speaker: Asma M. Alterawi, MSc PharmTech PhD (Expected 2025) (she/her/hers) – Virginia Commonwealth University
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
2:45 PM – 3:00 PM ET
Could a Blue-Green Algae Be An Efficient Vaccine Adjuvant?
Location: Webster
Rapid Fire Speaker: Bernadette DSouza, PhD, MEd (she/her/hers) – Samford University
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
3:00 PM – 3:15 PM ET
Increasing Tumor Penetration with Heavy Chain Antibody Drug Conjugates
Location: Webster
Rapid Fire Speaker: Molly Major (she/her/hers) – University of Utah, College of Pharmacy
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Monday, May 5th
3:15 PM – 3:30 PM ET
Folate Conjugated Carfilzomib Loaded Lactoferrin Nanoparticles as Biotherapeutics for Cancer
Location: Webster
Rapid Fire Speaker: Drishti Panjwani, PhD (she/her/hers) – Institute of Pharmaceutical Sciences, Faculty of Pharmacy Parul University
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
9:30 AM – 11:00 AM ET
Symposium: Bioprocessing, Characterization & Comparability for Complex Biologics
Location: Webster
Moderator: Sheetal S. Pai-Wechsung, PhD (she/her/hers) – Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
9:30 AM – 10:00 AM ET
Evaluating a Bayesian Hierarchical Model for Predicting Biopharmaceutical Shelf-Life: Multivalent Vaccine
Location: Webster
Speaker: Jordan Berger, PhD – Merck
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
10:00 AM – 10:30 AM ET
Comparability Studies to Support Manufacturing Process Change
Location: Webster
Speaker: Wenqin Ni, PhD (she/her/hers) – Pfizer
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
10:30 AM – 11:00 AM ET
Accelerating High Concentration Formulation Development with Big Data-Driven High-Throughput Technologies
Location: Webster
Speaker: Lun Xin, MS (he/him/his) – Wuxi Biologics
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
11:15 AM – 12:00 PM ET
Accelerate Development of AAV-based Gene Therapies with Automated Viral Vector Titer and Impurity Analysis
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Noah Kopcho, PhD – Gyros Protein Technologies
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Tuesday, May 6th
12:15 PM – 1:00 PM ET
Comprehensive Analytical Workflows for Characterization & Quality Control of mRNA-LNP Therapeutics
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Christopher M. Colangelo, PhD – Agilent Technologies
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Tuesday, May 6th
1:00 PM – 2:00 PM ET
Keynote: Harnessing Bioinspiration for the Delivery of Protein and Nucleic Acid-Based Biotherapeutics
Location: Webster
Keynote Speaker: Stephen T. Buckley, PhD (he/him/his) – Novo Nordisk A/S
Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
1:30 PM – 2:15 PM ET
Advanced Structural Characterization of Lipid Nanoparticles Using Calorimetry and Light Scattering Technologies
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Jonathan Mehtala, PhD – Malvern Panalytical Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Tuesday, May 6th
2:30 PM – 3:15 PM ET
Benefiting from Understanding the Quality and Cell Distribution of PBMCs
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker: Larissa Walker, MS (she/her/hers) – ODIN Bioscience
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sponsored By
Tuesday, May 6th
2:30 PM – 3:30 PM ET
Rapid Fire: Bioprocessing, Characterization & Comparability for Complex Biologics
Location: Webster
Rapid Fire Moderator: Lindsey Crawford, PhD – Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
2:30 PM – 2:45 PM ET
Versatile In-Line Cytometry Probe for Continuous Process Monitoring and Analysis
Location: Webster
Rapid Fire Speaker: Grace Cai, PhD (she/her/hers) – Physical Sciences Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
2:45 PM – 3:00 PM ET
Online Deformulation Liquid Chromatography Analysis of LNP mRNA Drug Products
Location: Webster
Rapid Fire Speaker: Matthew Lauber, PhD – Waters Corporation
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:00 PM – 3:15 PM ET
Delivering on the Future of Bio-Manufacturing with Intensification, Integration, and Continuous Bioprocessing
Location: Webster
Rapid Fire Speaker: Jeff Salm, PhD – Pfizer
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:15 PM – 3:30 PM ET
Expanding Therapeutic Reach: Antibody-Conjugated Lipid Nanoparticles to Enhance Extrahepatic Nucleic Acid Delivery
Location: Webster
Rapid Fire Speaker: Bei Cheng, PhD (she/her/hers) – Astrazeneca
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:00 PM – 4:00 PM ET
Hot Topic: AI/ML + FDA: Best Practices, Themes & Considerations for Regulatory Success in Drugs, Diagnostics, & Devices
Location: Otis
Hot Topic Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:00 PM – 3:10 PM ET
Evolving Role of AI/ML in Drug Development
Location: Otis
Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:10 PM – 3:30 PM ET
Regulatory Expectations and Best Practices in FDA Engagement for AI/ML Products
Location: Otis
Hot Topic Speaker: Alex Cadotte, PhD – MCRA, and IQVIA company
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Tuesday, May 6th
3:30 PM – 4:00 PM ET
Future Directions: Harmonizing Innovation with Regulation – Panel Discussion
Location: Otis
Hot Topic Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC
Hot Topic Speaker: Alex Cadotte, PhD – MCRA, and IQVIA company
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
9:30 AM – 11:00 AM ET
Symposium: Patient-Centric Product Design and Precision Medicine
Location: Webster
Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
9:30 AM – 10:00 AM ET
Formulating the Interplay of Protein and Device for Combination Drug Product
Location: Webster
Speaker: Yongchao Su, PhD – Merck & Co, Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
10:00 AM – 10:30 AM ET
Deliverability Assessment of Combination Product Development: Integrating Stability, Performance, and Patient Experience
Location: Webster
Speaker: Galen Shi, PhD – Eli Lilly
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
10:30 AM – 11:00 AM ET
Characterizing Silicone Oil-Induced Protein Aggregation in Pre-Filled Syringes with Stimulated Raman Scattering
Location: Webster
Speaker: Dan Fu, PhD (he/him/his) – Department of Chemistry, University of Washington
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
10:00 AM – 11:00 AM ET
Hot Topic: Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Location: Otis
Hot Topic Moderator: Lindsey Crawford, PhD – Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
10:00 AM – 10:30 AM ET
Advancing Patient-Centric Pharmaceutical Design: Aligning Therapeutics with Individual Needs
Location: Otis
Hot Topic Speaker: Nélio Drumond, PharmD, PhD – The Pharma xCentric
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
10:30 AM – 11:00 AM ET
Combination Product Solutions Towards Optimized Drug Delivery and Patient Experience
Location: Otis
Hot Topic Speaker: Asmita Khanolkar, MS, Materials Science and Engineering – SMC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
12:30 PM – 1:30 PM ET
Keynote: Predict and Overcome Developability Challenges in High-Concentration Formulations Through Machine Learning
Location: Webster
Keynote Speaker: Pin-Kuang Lai, PhD (he/him/his) – Stevens Institute of Technology
Moderator: Yongchao Su, PhD – Merck & Co, Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
2:00 PM – 3:00 PM ET
Rapid Fire: Patient-Centric Product Design and Precision Medicine
Location: Webster
Rapid Fire Moderator: Sheetal S. Pai-Wechsung, PhD (she/her/hers) – Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
2:00 PM – 2:15 PM ET
Alignment Strategies for a Patient-Centric Focus in Drug Product Development
Location: Webster
Rapid Fire Speaker: Lindsey Crawford, PhD – Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
2:15 PM – 2:30 PM ET
Predicting Subvisible Particle Formation of Monoclonal Antibodies
Location: Webster
Rapid Fire Speaker: Indira Prajapati, PhD – AstraZeneca
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
2:30 PM – 2:45 PM ET
Design of Experiments to Accelerate Formulation Development of Complex Modalities
Location: Webster
Rapid Fire Speaker: Mitra Mosharraf, M Pharm, PhD, MBA (she/her/hers) – HTD Biosystems Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Wednesday, May 7th
2:45 PM – 3:00 PM ET
Hyaluronic Acid Nanogel: A Versatile Nano-Carrier for Long-Acting Biologics
Location: Webster
Rapid Fire Speaker: Toru Katsumata, PhD – Asahi KASEI Corporation
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery