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Wednesday, May 7, 2025
8:00 AM – 9:30 AM
ET
Career Objectives Workshop: Define Your Path to Success
8:00 AM – 9:30 AM
ET
Career Objectives Workshop: Define Your Path to Success
Location: Otis
Career Center Speaker:
Sarah Cardozo-Duncan
– Career Strategist
Career Development
8:30 AM – 2:00 PM
ET
Registration Hours
8:30 AM – 2:00 PM
ET
Registration Hours
Location: Elm Foyer
8:30 AM – 2:00 PM
ET
Speaker Ready Room
8:30 AM – 2:00 PM
ET
Speaker Ready Room
Location: Revere
9:00 AM – 10:00 AM
ET
Coffee Break
9:00 AM – 10:00 AM
ET
Coffee Break
Location: Meeting Room Foyer
9:30 AM – 11:00 AM
ET
Symposium: Patient-Centric Product Design and Precision Medicine
Moderator:
Rikhav P. Gala, PhD, M.Sc.
– Pfizer INC
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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
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
9:30 AM – 11:00 AM
ET
Symposium: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 11:00 AM
ET
Symposium: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
Location: Stone
Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
9:30 AM – 10:00 AM
ET
Cell-ing Harmony: Towards a Unified Quantitative Framework for T-Cell Therapies
Location: Stone
Speaker:
Peter Ashcroft, PhD (he/him/his)
– Novartis Biomedical Research
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 10:30 AM
ET
Predicting Immunogenity of Genetic Medicine Using In Vitro Translational Models
Location: Stone
Speaker:
Swati Gupta
– AbbVie Inc.
From Bench to Bedside: Bioanalysis and Translational Science
10:30 AM – 11:00 AM
ET
Using Organ-on-a-Chip Technology to Model CAR-T Cell Therapies and Bi-Specific Antibodies
Location: Stone
Speaker:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
10:00 AM – 11:00 AM
ET
Hot Topic: Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Hot Topic Moderator:
Lindsey Crawford, PhD
– Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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
10:30 AM – 2:30 PM
ET
On-Site Career Coaching with Sarah Cardozo-Duncan
10:30 AM – 2:30 PM
ET
On-Site Career Coaching with Sarah Cardozo-Duncan
Location: Paine
Career Center Speaker:
Sarah Cardozo-Duncan
– Career Strategist
Career Development
11:00 AM – 12:30 PM
ET
Networking Lunch
11:00 AM – 12:30 PM
ET
Networking Lunch
Location: Pavilion
12:30 PM – 1:30 PM
ET
Keynote: Bench to Bedside Translation of Newer Modalities Using Quantitative Models: State-of-the-Art
Keynote Speaker:
Dhaval K. Shah, PhD (he/him/his)
– University at Buffalo
Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
12:30 PM – 1:30 PM
ET
Keynote: Bench to Bedside Translation of Newer Modalities Using Quantitative Models: State-of-the-Art
Location: Stone
Keynote Speaker:
Dhaval K. Shah, PhD (he/him/his)
– University at Buffalo
Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
12:30 PM – 1:30 PM
ET
Keynote: Predict and Overcome Developability Challenges in High-Concentration Formulations Through Machine Learning
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
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
2:00 PM – 3:00 PM
ET
Hot Topic: Role of Model-Informed Drug Development in Cell and Gene Therapies
Hot Topic Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 3:00 PM
ET
Hot Topic: Role of Model-Informed Drug Development in Cell and Gene Therapies
Location: Otis
Hot Topic Moderator:
Rodrigo Cristofoletti, PhD
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 2:30 PM
ET
Systems Modelling for CRISPR Cas9 and RNAi Therapeutics
Location: Otis
Hot Topic Speaker:
Devam A. Desai, MS (he/him/his)
– University of Florida
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Role of Model‑Informed Drug Development in Cell and Gene Therapies
Location: Otis
Hot Topic Speaker:
Johannes Stanta, PhD (he/him/his)
– Celerion
From Bench to Bedside: Bioanalysis and Translational Science
2:45 PM – 3:00 PM
ET
Advancing Oligonucleotide Therapeutics from Bench to Bedside Through Quantitative Pharmacology & Model-Informed Development
Location: Otis
Hot Topic Speaker:
Vivaswath Ayyar, PhD
– GSK
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 3:00 PM
ET
Rapid Fire: Patient-Centric Product Design and Precision Medicine
Rapid Fire Moderator:
Sheetal S. Pai-Wechsung, PhD (she/her/hers)
– Pfizer Inc
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
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
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
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
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
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
2:00 PM – 3:00 PM
ET
Rapid Fire: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
Rapid Fire Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 3:00 PM
ET
Rapid Fire: Preclinical and Clinical PK/PD, Safety Translation of Newer Modalities
Location: Stone
Rapid Fire Moderator:
Steven W. Louie, M.S. (he/him/his)
– Medicilon -US Corp
From Bench to Bedside: Bioanalysis and Translational Science
2:00 PM – 2:15 PM
ET
Informing Pre-Clinical-to-Clinical Translation and Derisking of Biotherapeutics with Cell-Based Analysis
Location: Stone
Rapid Fire Speaker:
Zhiheng He, PhD (he/him/his)
– Pfizer, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
2:15 PM – 2:30 PM
ET
mRNA Nanoparticle Engineering of Macrophages for Lung Disease Immunotherapy
Location: Stone
Rapid Fire Speaker:
Raneem Aldaqqa, PharmD (she/her/hers)
– Virginia Commonwealth University
From Bench to Bedside: Bioanalysis and Translational Science
2:30 PM – 2:45 PM
ET
Enhancing Lipopolymer Efficiency for Extrahepatic Delivery of Therapeutic Nucleic Acids
Location: Stone
Rapid Fire Speaker:
Mohammad Nasrullah, MS
– University of Alberta
From Bench to Bedside: Bioanalysis and Translational Science
2:45 PM – 3:00 PM
ET
Proximity Extension Assay for Pharmacodynamics and Biomarker-Profiling in Clinical Studies
Location: Stone
Rapid Fire Speaker:
Toralf Roch, PhD (he/him/his)
– CheckImmune GmbH
From Bench to Bedside: Bioanalysis and Translational Science
3:15 PM – 4:15 PM
ET
Closing Plenary with Dr. Andrew Lo
Plenary Speaker:
Andrew W. Lo, PhD (he/him/his)
– MIT Sloan School of Management
3:15 PM – 4:15 PM
ET
Closing Plenary with Dr. Andrew Lo
Location: Commonwealth Ballroom
Plenary Speaker:
Andrew W. Lo, PhD (he/him/his)
– MIT Sloan School of Management
