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Monday, May 5, 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 Gene and Cell Therapy Products Community Membership Meeting
Community Leader:
Prathap Nagaraja Shastri, PhD
– Johnson and Johnson
8:00 AM – 9:00 AM
ET
AAPS Gene and Cell Therapy Products Community Membership Meeting
Location: Webster
Community Leader:
Prathap Nagaraja Shastri, PhD
– Johnson and Johnson
8:00 AM – 9:30 AM
ET
Executive Track: Developability and Due Diligence: How to Assess, Draw, and Sometimes End the Road(map) for New and Unusual Modalities
8:00 AM – 9:30 AM
ET
Executive Track: Developability and Due Diligence: How to Assess, Draw, and Sometimes End the Road(map) for New and Unusual Modalities
Location: Otis
Moderator:
Jef Akst, MS (she/her/hers)
– BioSpace
Executive Education Speaker:
Rick Pierce (he/him/his)
– Decoy Therapeutics, Inc.
Executive Education Speaker:
Andrew W. Lo, PhD (he/him/his)
– MIT Sloan School of Management
Executive Education Speaker:
Fran Brown, Ph.D.
– Certara
Executive Track
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
Advanced Multiplexing and Quantification Techniques for Biomarkers and Proteins Using HRMS/NanoLC
9:15 AM – 10:00 AM
ET
Advanced Multiplexing and Quantification Techniques for Biomarkers and Proteins Using HRMS/NanoLC
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Hemanth Akkiraju, PhD (he/him/his)
– IQVIA Laboratories
Partner Presentation Speaker:
Prakash Bhosale, PhD, MBA (he/him/his)
– IQVIA Laboratories
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
9:30 AM – 11:00 AM
ET
Symposium: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
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: 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
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
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
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
9:30 AM – 11:00 AM
ET
Symposium: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
Moderator:
Varun Ramani, Master of Science (he/him/his)
– Inhibrx, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 11:00 AM
ET
Symposium: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
Location: Commonwealth Ballroom
Moderator:
Varun Ramani, Master of Science (he/him/his)
– Inhibrx, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 10:00 AM
ET
Bridging the Gap Between Promise and Execution: Revolutionizing Bioanalytical Workflows with AI and Natural Language Processing
Location: Commonwealth Ballroom
Speaker:
Robert Dodge, PhD
– Independent
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 10:30 AM
ET
Implementing a Risk-Based Immunogenicity Strategy to Accelerate ASO Drug Development
Location: Commonwealth Ballroom
Speaker:
Christopher Stebbins, PhD (he/him/his)
– Immunologix Labs
From Bench to Bedside: Bioanalysis and Translational Science
10:30 AM – 11:00 AM
ET
Measuring Antibody Drug Concentrations in Presence of a Reversal Drug
Location: Commonwealth Ballroom
Speaker:
Mu Chen, PhD (he/him/his)
– 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
Sponsored By
10:00 AM – 11:00 AM
ET
Hot Topic: Progress in mRNA LNP Understanding to Enable Refrigerated Long-Term Storage
Hot Topic Moderator:
Ruchi Shah, PhD
– GSK
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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
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
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
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
Improved Methods for Antibody Purification
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
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
PK & ADA Bioanalysis Support for ARCs/siRNA: Case Studies
11:15 AM – 12:00 PM
ET
PK & ADA Bioanalysis Support for ARCs/siRNA: Case Studies
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Dawn Dufield, PhD
– KCAS Bio
Partner Presentation Speaker:
LIndsay Rutherford, PhD
– KCAS Bio
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
11:30 AM – 12:30 PM
ET
Special Poster Collection
11:30 AM – 12:25 PM
ET
Special Poster Collection
Location: Poster Forum #1, Pavilion
Poster Collection Host:
Adeola O. Coker, Ph.D. (she/her/hers)
– University of the Incarnate Word
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
Creating Enhanced and In-Depth Characterization of Biotherapeutics Using the Latest Tools from Waters
12:15 PM – 1:00 PM
ET
Creating Enhanced and In-Depth Characterization of Biotherapeutics Using the Latest Tools from Waters
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
samuel seal
– Waters Corporation
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
1:00 PM – 2:00 PM
ET
Keynote: Challenges in Characterization and Comparability of Advanced Therapies
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
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
1:00 PM – 2:00 PM
ET
Keynote: Delivering Biotherapeutics to the CNS via Different Routes of Administration: State-of-the-Art
Keynote Speaker:
Robert G. Thorne, PhD (he/him/his)
– Denali Therapeutics & University of Minnesota
Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
From Bench to Bedside: Bioanalysis and Translational Science
1:00 PM – 2:00 PM
ET
Keynote: Delivering Biotherapeutics to the CNS via Different Routes of Administration: State-of-the-Art
Location: Commonwealth Ballroom
Keynote Speaker:
Robert G. Thorne, PhD (he/him/his)
– Denali Therapeutics & University of Minnesota
Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
From Bench to Bedside: Bioanalysis and Translational Science
1:30 PM – 2:15 PM
ET
Novel Pharma Excipient: Hyaluronic Acid Nanogel for Sustained Release and Solubility Enhancement of Biologics
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
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
Immunogenicity Assessment for Biotherapeutics and Target Binding Reagents Beyond Antibodies
2:30 PM – 3:15 PM
ET
Immunogenicity Assessment for Biotherapeutics and Target Binding Reagents Beyond Antibodies
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Andrew Isidoridy, PhD
– ProImmune Inc.
From Bench to Bedside: Bioanalysis and Translational Science
Sponsored By
2:30 PM – 3:30 PM
ET
Rapid Fire: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
Rapid Fire Moderator:
Rikhav P. Gala, PhD, M.Sc.
– Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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 (she/her/hers)
– Samford University
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
2:30 PM – 3:30 PM
ET
Rapid Fire: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
Rapid Fire Moderator:
Francis Wolenski, PhD DABT FellowATS
– Keros Therapeutics
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 3:30 PM
ET
Rapid Fire: Breaking Barriers: Bioanalytical Innovation for Complex Biologics
Location: Commonwealth Ballroom
Rapid Fire Moderator:
Francis Wolenski, PhD DABT FellowATS
– Keros Therapeutics
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Coupling Unique Therapeutic Features with Emerging Bioanalytical Tools: Application to Radioligand Therapies
Location: Commonwealth Ballroom
Rapid Fire Speaker:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
2:45 PM – 3:00 PM
ET
Supporting Development of RNA Therapies with Novel Flow-Cytometry Methodologies
Location: Commonwealth Ballroom
Rapid Fire Speaker:
Sachith Gallolu, PhD
– Pfizer Inc
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 3:15 PM
ET
Antibody Drug Conjugates and Antibody RNA Conjugates: Similarities and Differences
Location: Commonwealth Ballroom
Rapid Fire Speaker:
Nagendra Chemuturi, PhD, EMBA
– Eli Lilly
From Bench to Bedside: Bioanalysis and Translational Science
3:15 PM – 3:30 PM
ET
Simplified and Streamlined Bioanalytical Strategy for Developing Preclinical ADC-PK Assays
Location: Commonwealth Ballroom
Rapid Fire Speaker:
Madhan Masilamani, PhD
– Bristol Myers Squibb
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 4:00 PM
ET
Hot Topic: Panel Discussion on Neutralizing Antibody Sample Testing and Report Harmonization
Hot Topic Speaker:
Darshana Jani, Ph.D.
– Moderna
Hot Topic Speaker:
Jason Pennucci
– Moderna Therapeutics
Hot Topic Speaker:
Susan Irvin, PhD, PMP (she/her/hers)
– Regeneron Pharmaceuticals
Hot Topic Moderator:
Varun Ramani, Master of Science (he/him/his)
– Inhibrx, Inc.
Hot Topic Speaker:
Amanda L. Hays, PhD
– BioAgilytix
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 4:00 PM
ET
Hot Topic: Panel Discussion on Neutralizing Antibody Sample Testing and Report Harmonization
Location: Otis
Hot Topic Speaker:
Darshana Jani, Ph.D.
– Moderna
Hot Topic Speaker:
Jason Pennucci
– Moderna Therapeutics
Hot Topic Speaker:
Susan Irvin, PhD, PMP (she/her/hers)
– Regeneron Pharmaceuticals
Hot Topic Moderator:
Varun Ramani, Master of Science (he/him/his)
– Inhibrx, Inc.
Hot Topic Speaker:
Amanda L. Hays, PhD
– BioAgilytix
From Bench to Bedside: Bioanalysis and Translational Science
3:30 PM – 4:15 PM
ET
Successful Nucleic Acid Extraction – The Linchpin for PCR Bioanalysis
3:30 PM – 4:15 PM
ET
Successful Nucleic Acid Extraction – The Linchpin for PCR Bioanalysis
Location: Learning Lab in the Grand Ballroom
Partner Presentation Speaker:
Mark Wissel, PhD
– Eurofins Clinical Trial Solutions
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:
Gopi Shankar, Ph.D., M.B.A., FAAPS
– Larimartx
5:00 PM – 6:30 PM
ET
Sustaining Partner Reception (by invitation only)
5:00 PM – 6:30 PM
ET
Sustaining Partner Reception (by invitation only)
Location: Sauciety
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