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Prologue: AI Solutions for Dose and Dosage Form Selection in Drug Clinical Development
Prologue Speaker:
Sruthi Sarvepalli, MS, PhD (she/her/hers)
– St. John's University
From Bench to Bedside: Bioanalysis and Translational Science
Prologue: AI Solutions for Dose and Dosage Form Selection in Drug Clinical Development
Location: Online Only
Prologue Speaker:
Sruthi Sarvepalli, MS, PhD (she/her/hers)
– St. John's University
From Bench to Bedside: Bioanalysis and Translational Science
Prologue: Complex Biologics Attempt to Stymie Bioanalysts… Challenge Accepted
Prologue Speaker:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
Prologue: Complex Biologics Attempt to Stymie Bioanalysts… Challenge Accepted
Location: Online Only
Prologue Speaker:
Jennifer Cunliffe, PhD (she/her/hers)
– Novartis Institutes for BioMedical Research, Inc.
From Bench to Bedside: Bioanalysis and Translational Science
Prologue: Inspiring Innovation in Formulation, Bioprocessing & Drug Delivery: Novel Development of Biologics for Newer and Established Modalities
Prologue Speaker:
Amardeep S. Bhalla, PhD (he/him/his)
– Regeneron Pharmaceuticals
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Prologue: Inspiring Innovation in Formulation, Bioprocessing & Drug Delivery: Novel Development of Biologics for Newer and Established Modalities
Location: Online Only
Prologue Speaker:
Amardeep S. Bhalla, PhD (he/him/his)
– Regeneron Pharmaceuticals
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Prologue: Integrating Modern Tools for Biologics Development: Innovating Traditional and Emerging Modalities
Prologue Speaker:
Parag Kolhe, PhD
– Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Prologue: Integrating Modern Tools for Biologics Development: Innovating Traditional and Emerging Modalities
Location: Online Only
Prologue Speaker:
Parag Kolhe, PhD
– Pfizer Inc.
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Prologue: Intravitreal Drug Delivery: Overcoming Formulation and Device Challenges
Prologue Speaker:
Andrea Allmendinger, Prof Dr (she/her/hers)
– ten23 health AG
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Prologue: Intravitreal Drug Delivery: Overcoming Formulation and Device Challenges
Location: Online Only
Prologue Speaker:
Andrea Allmendinger, Prof Dr (she/her/hers)
– ten23 health AG
Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery
Sunday, May 4, 2025
7:30 AM – 6:00 PM
ET
Registration Hours
7:30 AM – 6:00 PM
ET
Registration Hours
Location: Elm Foyer
8:00 AM – 3:00 PM
ET
Exhibitor Move-In
8:00 AM – 3:00 PM
ET
Exhibitor Move-In
Location: Grand Ballroom / Pavilion
12:00 PM – 3:00 PM
ET
Speaker Ready Room
12:00 PM – 3:00 PM
ET
Speaker Ready Room
Location: Revere
3:00 PM – 4:30 PM
ET
Opening Plenary with Dr. Nikhil Munshi
Plenary Speaker:
Nikhil C. Munshi, MD
– Dana-Farber Cancer Institute
3:00 PM – 4:30 PM
ET
Opening Plenary with Dr. Nikhil Munshi
Location: Commonwealth Ballroom
Plenary Speaker:
Nikhil C. Munshi, MD
– Dana-Farber Cancer Institute
4:30 PM – 6:00 PM
ET
Welcome Reception in the Solution Center
4:30 PM – 6:00 PM
ET
Welcome Reception in the Solution Center
Location: Grand Ballroom / Pavilion
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
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
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
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