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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 – 9:30 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
Speaker:
Rick Pierce (he/him/his)
– Decoy Therapeutics, Inc.
Speaker:
Andrew W. Lo, PhD
– MIT Sloan School of Management
Executive Track
8:30 AM – 3:30 PM
ET
Speaker Ready Room
8:30 AM – 3:30 PM
ET
Speaker Ready Room
Location: Revere
9:30 AM – 11:00 AM
ET
Symposium: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
Moderator:
Rikhav Gala
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: Stone
Moderator:
Rikhav Gala
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: Stone
Speaker:
Andreja Livk
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
10:00 AM – 10:30 AM
ET
Benchmark Glycan Profile in FDA-Approved Therapeutic Monoclonal Antibodies
Location: Stone
Speaker:
Baolin Zhang, PhD (he/him/his)
– US Food and Drug Administration
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
10:30 AM – 11:00 AM
ET
Resolving the Complexity of Combination Drug Product Design
Location: Stone
Speaker:
Allen Templeton
– 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, PMP (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: Webster
Moderator:
Varun Ramani, Master of Science, PMP (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: Webster
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: Webster
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: Webster
Speaker:
Mu Chen, Ph.D.
– 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: Progress in mRNA LNP Understanding to Enable Refrigerated Long-Term Storage
Hot Topic Speaker:
Himanshu Bhattacharjee, PhD
– GlaxoSmithKline
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 Speaker:
Himanshu Bhattacharjee, PhD
– GlaxoSmithKline
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
– 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
– 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
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
10:45 AM – 11:00 AM
ET
Panel Discussion
Location: Otis
Hot Topic Moderator:
Himanshu Bhattacharjee, PhD
– GlaxoSmithKline
Hot Topic Speaker:
Ramin Darvari
– Pfizer Inc.
Hot Topic Speaker:
Yuefei Shen
– Sanofi
Hot Topic Speaker:
Michael Newton
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
10:00 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: Challenges in Characterization and Comparability of Advanced Therapies
Keynote Speaker:
Phillip Ramsey, MS, MBA
– Sangamo Therapeutics
Moderator:
Vivek Agrahari, PhD (he/him/his)
– CONRAD
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: Stone
Keynote Speaker:
Phillip Ramsey, MS, MBA
– Sangamo Therapeutics
Moderator:
Vivek Agrahari, PhD (he/him/his)
– CONRAD
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)
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: Webster
Keynote Speaker:
Robert G. Thorne, PhD (he/him/his)
– Denali Therapeutics & University of Minnesota
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: Accelerating Novel Formulation Development of Biologics for Newer and Established Modalities
Rapid Fire Moderator:
Jing Ling, Ph.D.
– Merck & Co., 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: Stone
Rapid Fire Moderator:
Jing Ling, Ph.D.
– Merck & Co., 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: Stone
Rapid Fire Speaker:
Asma Alterawi
– Virginia Commonwealth University
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
2:45 PM – 3:00 PM
ET
Macromolecule Delivery Across the Intestinal Epithelium: A Novel Transport Mechanism
Location: Stone
Rapid Fire Speaker:
Kyungbo Kim, PhD (he/him/his)
– BioMed X
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: Stone
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: Stone
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
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: Webster
Rapid Fire Moderator:
Francis Wolenski
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Analytical Innovations to Transform Workflows in mRNA Product Development
Location: Webster
Rapid Fire Speaker:
Kanwal Gill
– Pfizer, 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: Webster
Rapid Fire Speaker:
Sachith Gallolu, PhD
– Pfizer Inc
From Bench to Bedside: Bioanalysis and Translational Science
3:00 PM – 3:15 PM
ET
SARS-CoV-2 Binding Affects the Neonatal Fc Receptor (FcRn)-Mediated IgG Transcytosis
Location: Webster
Rapid Fire Speaker:
Sharon Vijayanand
– US Food and Drug Administration
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: Webster
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:
Daniela Verthelyi, Ph.D.
– US Food and Drug Administration
Hot Topic Speaker:
Jason Pennucci, MS (he/him/his)
– Moderna Therapeutics
Hot Topic Speaker:
Susan Irvin, PhD (she/her/hers)
– Regeneron Pharmaceuticals
Hot Topic Moderator:
Varun Ramani, Master of Science, PMP (he/him/his)
– Inhibrx, Inc.
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:
Daniela Verthelyi, Ph.D.
– US Food and Drug Administration
Hot Topic Speaker:
Jason Pennucci, MS (he/him/his)
– Moderna Therapeutics
Hot Topic Speaker:
Susan Irvin, PhD (she/her/hers)
– Regeneron Pharmaceuticals
Hot Topic Moderator:
Varun Ramani, Master of Science, PMP (he/him/his)
– Inhibrx, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
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
