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Tuesday, May 6, 2025
7:30 AM – 3:30 PM
ET
Registration Hours
7:30 AM – 3:30 PM
ET
Registration Hours
Location: Elm Foyer
8:30 AM – 3:30 PM
ET
Speaker Ready Room
8:30 AM – 3:30 PM
ET
Speaker Ready Room
Location: Revere
9:30 AM – 11:00 AM
ET
Symposium: Bioprocessing, Characterization & Comparability for Complex Biologics
Moderator:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
9:30 AM – 11:00 AM
ET
Symposium: Bioprocessing, Characterization & Comparability for Complex Biologics
Location: Stone
Moderator:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
9:30 AM – 10:00 AM
ET
Evaluating a Bayesian Hierarchical Model for Predicting Biopharmaceutical Shelf-Life: Multivalent Vaccine
Location: Stone
Speaker:
Jordan Berger, PhD (he/him/his)
– Merck & Co, Inc - Rahway, NJ
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
10:00 AM – 10:30 AM
ET
Comparison of AI/ML and Novel Characterization Methods on ASOs Aggregation
Location: Stone
Speaker:
Xiangyi Dong, Ph.D.
– US Food and Drug Administration
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
10:30 AM – 11:00 AM
ET
Accelerating High Concentration Formulation Development with Big Data-Driven High-Throughput Technologies
Location: Stone
Speaker:
Steven Ren, PhD (he/him/his)
– WuXi Biologics US
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
9:30 AM – 11:00 AM
ET
Symposium: Managing Global Clinical Trials and Crises in Sample Logistics
Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 11:00 AM
ET
Symposium: Managing Global Clinical Trials and Crises in Sample Logistics
Location: Webster
Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 10:00 AM
ET
Using Artificial Intelligence to Evaluate Potential Clinical Study Sites
Location: Webster
Speaker:
Jerry L. Chapman, BS (he/him/his)
– REDICA Systems
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 10:30 AM
ET
Bioanalytical Challenges in the Use of Biosimilars as Co-Medications
Location: Webster
Speaker:
Johanna R. Mora, PhD
– Bristol-Myers Squibb
From Bench to Bedside: Bioanalysis and Translational Science
10:30 AM – 11:00 AM
ET
A Nine-Year Case Study: What Did ISR Tell Us?
Location: Webster
Speaker:
Stacey Shank (she/her/hers)
– Regeneron Pharmaceuticals
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 11:00 AM
ET
Coffee Break in the Solution Center
10:00 AM – 11:00 AM
ET
Coffee Break in the Solution Center
Location: Grand Ballroom / Pavilion
10:00 AM – 11:00 AM
ET
Hot Topic: Industry Discussions on Companion Diagnostics for AAV-Mediated Gene Therapy
10:00 AM – 11:00 AM
ET
Hot Topic: Industry Discussions on Companion Diagnostics for AAV-Mediated Gene Therapy
Location: Otis
Hot Topic Speaker:
Yanmei Lu, PhD (she/her/hers)
– Sangamo Therapeutics
Hot Topic Speaker:
Jim McNally, PhD
– BioAgilytix
Hot Topic Speaker:
Manuela Braun, PhD (she/her/hers)
– Bayer
Hot Topic Speaker:
Amanda L. Hays, PhD
– BioAgilytix
Hot Topic Moderator:
Francis Wolenski
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 4:30 PM
ET
Coffee Station
10:00 AM – 4:30 PM
ET
Coffee Station
Location: Booth #308
Sponsored By
10:00 AM – 4:30 PM
ET
Solution Center Hours & Poster Presentations
10:00 AM – 4:30 PM
ET
Solution Center Hours & Poster Presentations
Location: Grand Ballroom / Pavilion
11:00 AM – 1:00 PM
ET
Dedicated Solution Center Hours
11:00 AM – 1:00 PM
ET
Dedicated Solution Center Hours
Location: Grand Ballroom / Pavilion
11:30 AM – 1:00 PM
ET
Lunch in the Solution Center
11:30 AM – 1:00 PM
ET
Lunch in the Solution Center
Location: Grand Ballroom / Pavilion
1:00 PM – 2:00 PM
ET
Keynote: Harnessing Bioinspiration for the Delivery of Protein and Nucleic Acid-Based Biotherapeutics
Keynote Speaker:
Stephen T. Buckley, PhD (he/him/his)
– Novo Nordisk A/S
Moderator:
Jing Ling, Ph.D.
– Merck & Co., Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
1:00 PM – 2:00 PM
ET
Keynote: Harnessing Bioinspiration for the Delivery of Protein and Nucleic Acid-Based Biotherapeutics
Location: Stone
Keynote Speaker:
Stephen T. Buckley, PhD (he/him/his)
– Novo Nordisk A/S
Moderator:
Jing Ling, Ph.D.
– Merck & Co., Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
1:00 PM – 2:00 PM
ET
Keynote: Where the Patients Are: Bioanalytical Strategies Enabling Global Clinical Trials
Keynote Speaker:
Joleen T. White, PhD (she/her/hers)
– Gates Medical Research Institute
Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
1:00 PM – 2:00 PM
ET
Keynote: Where the Patients Are: Bioanalytical Strategies Enabling Global Clinical Trials
Location: Webster
Keynote Speaker:
Joleen T. White, PhD (she/her/hers)
– Gates Medical Research Institute
Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 2:30 PM
ET
Coffee Break in the Solution Center
2:00 PM – 2:30 PM
ET
Coffee Break in the Solution Center
Location: Grand Ballroom / Pavilion
2:30 PM – 3:30 PM
ET
Rapid Fire: Bioprocessing, Characterization & Comparability for Complex Biologics
Rapid Fire Moderator:
Vivek Agrahari, PhD (he/him/his)
– CONRAD
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
2:30 PM – 3:30 PM
ET
Rapid Fire: Bioprocessing, Characterization & Comparability for Complex Biologics
Location: Stone
Rapid Fire Moderator:
Vivek Agrahari, PhD (he/him/his)
– CONRAD
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
2:30 PM – 2:45 PM
ET
Versatile In-Line Cytometry Probe for Continuous Process Monitoring and Analysis
Location: Stone
Rapid Fire Speaker:
Grace Cai, PhD (she/her/hers)
– Physical Sciences Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
2:45 PM – 3:00 PM
ET
Online Deformulation Liquid Chromatography Analysis of LNP mRNA Drug Products
Location: Stone
Rapid Fire Speaker:
Matthew Lauber, PhD
– Waters Corporation
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
3:00 PM – 3:15 PM
ET
Delivering on the Future of Bio-Manufacturing with Intensification, Integration, and Continuous Bioprocessing
Location: Stone
Rapid Fire Speaker:
Jeff Salm
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
3:15 PM – 3:30 PM
ET
Expanding Therapeutic Reach: Antibody-Conjugated Lipid Nanoparticles to Enhance Extrahepatic Nucleic Acid Delivery
Location: Stone
Rapid Fire Speaker:
Bei Cheng, PhD (she/her/hers)
– Astrazeneca
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
2:30 PM – 3:30 PM
ET
Rapid Fire: Managing Global Clinical Trials and Crises in Sample Logistics
Rapid Fire Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 3:30 PM
ET
Rapid Fire: Managing Global Clinical Trials and Crises in Sample Logistics
Location: Webster
Rapid Fire Moderator:
Steven W. Louie, M.S. (he/him/his)
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Impact of Serum Omission on Clinical ELISpot Assays
Location: Webster
Rapid Fire Speaker:
Xinyuan Li, PhD
– Johnson & Johnson
From Bench to Bedside: Bioanalysis and Translational Science
2:45 PM – 3:00 PM
ET
Single-Cell Multiomics: Unveiling Cell-Type-Specific Insights for Clinical and Therapeutic Research
Location: Webster
Rapid Fire Speaker:
Desiree Jacqueline Wendering
– CheckImmune GmbH
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 3:15 PM
ET
ddPCR-Based Genomic Assay in Cell, Gene Therapies and Biomarker Research
Location: Webster
Rapid Fire Speaker:
Jing Mo
– Takeda
From Bench to Bedside: Bioanalysis and Translational Science
3:15 PM – 3:30 PM
ET
Immune Cell Profiling in Human Skin for Clinical Applications
Location: Webster
Rapid Fire Speaker:
Sandra Jagdmann, PhD (she/her/hers)
– CheckImmune GmbH
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 4:00 PM
ET
Hot Topic: AI/ML + FDA: Best Practices, Themes & Considerations for Regulatory Success in Drugs, Diagnostics, & Devices
Hot Topic Moderator:
Rikhav Gala
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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 Gala
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
3:30 PM – 4:00 PM
ET
Future Directions: Harmonizing Innovation with Regulation – Panel Discussion
Location: Otis
Hot Topic Moderator:
Rikhav Gala
Hot Topic Speaker:
Eric Luellen, Msc, MPH (he/him/his)
– Turing Biosciences LLC
Hot Topic Speaker:
Alex Cadotte
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
4:30 PM – 8:00 PM
ET
Exhibitor Move-Out
4:30 PM – 8:00 PM
ET
Exhibitor Move-Out
Location: Grand Ballroom / Pavilion
5:00 PM – 6:30 PM
ET
Women in Biotech Reception
5:00 PM – 6:30 PM
ET
Women in Biotech Reception
Location: Sauciety
