Skip to main content
Toggle navigation
Login
Search
Home
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Full Schedule
Home
Full Schedule
All Days
Cancelled
Sun, May 4
Mon, May 5
Tue, May 6
Wed, May 7
Full Schedule
Type here to filter the list
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
8:00 AM – 9:00 AM
ET
AAPS Bioanalytical Community Membership Meeting
Community Leader:
Lauren Stevenson, PhD (she/her/hers)
– Immunologix Laboratories
8:00 AM – 9:00 AM
ET
AAPS Bioanalytical Community Membership Meeting
Location: Otis
Community Leader:
Lauren Stevenson, PhD (she/her/hers)
– Immunologix Laboratories
8:00 AM – 9:00 AM
ET
AAPS Biomarkers and Precision Medicine Community Membership Meeting
Community Leader:
Amanda L. Hays, PhD
– BioAgilytix
8:00 AM – 9:00 AM
ET
AAPS Biomarkers and Precision Medicine Community Membership Meeting
Location: Webster
Community Leader:
Amanda L. Hays, PhD
– BioAgilytix
8:30 AM – 3:30 PM
ET
Speaker Ready Room
8:30 AM – 3:30 PM
ET
Speaker Ready Room
Location: Revere
9:00 AM – 4:30 PM
ET
Solution Center Hours & Poster Presentations
9:00 AM – 4:30 PM
ET
Solution Center Hours & Poster Presentations
Location: Grand Ballroom / Pavilion
9:15 AM – 10:00 AM
ET
Molecular Bioanalysis Considerations for Transitioning from Pre-clinical to the Clinical Space
9:15 AM – 10:00 AM
ET
Molecular Bioanalysis Considerations for Transitioning from Pre-clinical to the Clinical Space
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Keith Rennier, PhD
– Labcorp
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
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: Webster
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: Webster
Speaker:
Jordan Berger, PhD
– Merck
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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)
– Medicilon -US Corp
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: Commonwealth Ballroom
Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
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: Commonwealth Ballroom
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: Commonwealth Ballroom
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: Commonwealth Ballroom
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:
Manuela Braun, PhD (she/her/hers)
– Bayer
Hot Topic Moderator:
Francis Wolenski, PhD DABT FellowATS
– Keros Therapeutics
Hot Topic Speaker:
Vibha Jawa, PhD, FAAPS
– Bristol-Myers Squibb Company
Hot Topic Speaker:
Amanda L. Hays, PhD
– BioAgilytix
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
10:15 AM – 11:00 AM
ET
Case Studies: Accelerating Bioanalytical Method Development with Simulation and Modeling
10:15 AM – 11:00 AM
ET
Case Studies: Accelerating Bioanalytical Method Development with Simulation and Modeling
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Rafiq Islam, MSc
– Somru BioScience USA Inc
Partner Presentation Speaker:
Mohammed Moin
– Somru BioScience USA Inc
Partner Presentation Speaker:
wildemar Carvalho, PhD (he/him/his)
– Somru BioScience Inc
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
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
11:15 AM – 12:00 PM
ET
Accelerate Development of AAV-based Gene Therapies with Automated Viral Vector Titer and Impurity Analysis
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
11:30 AM – 12:25 PM
ET
Special Poster Collection
11:30 AM – 12:25 PM
ET
Special Poster Collection
Location: Poster Forum #1, Pavilion
Poster Collection Host:
Russ S. Weiner, Ph.D., FAAPS
– Takeda
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
12:15 PM – 1:00 PM
ET
Comprehensive Analytical Workflows for Characterization & Quality Control of mRNA-LNP Therapeutics
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
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:
Rikhav P. Gala, PhD, M.Sc.
– Pfizer 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: 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
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)
– BioData Solutions LLC
Moderator:
Vibha Jawa, PhD, FAAPS
– Bristol-Myers Squibb Company
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: Commonwealth Ballroom
Keynote Speaker:
Joleen T. White, PhD (she/her/hers)
– BioData Solutions LLC
Moderator:
Vibha Jawa, PhD, FAAPS
– Bristol-Myers Squibb Company
From Bench to Bedside: Bioanalysis and Translational Science
1:30 PM – 2:15 PM
ET
Advanced Structural Characterization of Lipid Nanoparticles Using Calorimetry and Light Scattering Technologies
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
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 – 3:15 PM
ET
Benefiting from Understanding the Quality and Cell Distribution of PBMCs
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
2:30 PM – 3:30 PM
ET
Rapid Fire: Bioprocessing, Characterization & Comparability for Complex Biologics
Rapid Fire Moderator:
Lindsey Crawford, PhD
– Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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
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
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
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)
– Medicilon -US Corp
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: Commonwealth Ballroom
Rapid Fire Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Impact of Serum Omission on Clinical ELISpot Assays
Location: Commonwealth Ballroom
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: Commonwealth Ballroom
Rapid Fire Speaker:
Levent Akyuez (he/him/his)
– 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: Commonwealth Ballroom
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: Commonwealth Ballroom
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 P. Gala, PhD, M.Sc.
– Pfizer INC
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 P. Gala, PhD, M.Sc.
– Pfizer INC
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, PhD
– MCRA, and IQVIA company
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 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
3:30 PM – 4:15 PM
ET
Conjugation of AAV for Ligand Binding Assays: Challenges and Lessons
3:30 PM – 4:15 PM
ET
Conjugation of AAV for Ligand Binding Assays: Challenges and Lessons
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Alyssa Cieslak
– B2S Life Sciences
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
3:30 PM – 4:25 PM
ET
Special Poster Collection
3:30 PM – 4:25 PM
ET
Special Poster Collection
Location: Poster Forum #1, Pavilion
Poster Collection Host:
Amanda L. Hays, PhD
– BioAgilytix
3:30 PM – 4:30 PM
ET
Happy Hour Sponsored by EMD Serono
3:30 PM – 4:30 PM
ET
Happy Hour Sponsored by EMD Serono
Location: Grand Ballroom / Pavilion
Sponsored By
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
Sponsored By
.png)
.png)
.png)
.png)
.png)
.png)
.png)
