Full Schedule

8:30 AM – 2:00 PM ET

Registration Hours

Location: Elm Foyer

8:30 AM – 2:00 PM ET

Speaker Ready Room

Location: Revere

9:30 AM – 11:00 AM ET

Symposium: Patient-Centric Product Design and Precision Medicine

Location: Stone

Moderator: – Merck & Co., 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: Stone

Speaker: – 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: Stone

Speaker: – 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: Stone

Speaker: – 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

Location: Webster

Moderator: – 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: Webster

Speaker: – 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: Webster

Speaker: – AbbVie

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: Webster

Speaker: – 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

Location: Otis

Hot Topic Moderator: – CONRAD

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:

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: – SMC

Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery

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

Location: Webster

Keynote Speaker: – University at Buffalo

Moderator: – 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

Location: Stone

Keynote Speaker: – Stevens Institute of Technology

Moderator: – 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

Location: Otis

Hot Topic Moderator: – 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: – University of Florida

From Bench to Bedside: Bioanalysis and Translational Science

2:30 PM – 2:45 PM ET

Development and Application of Quantitative Systems Pharmacology Models for Cell Therapies in Oncology and Autoimmune Disorders

Location: Otis

Hot Topic Speaker: – Takeda

From Bench to Bedside: Bioanalysis and Translational Science

2:45 PM – 3:00 PM ET

Mechanistic Pharmacokinetics and Pharmacodynamics of GalNAc-siRNA: Translational Model Involving Competitive Receptor-Mediated Disposition and RISC-Dependent Gene Silencing

Location: Otis

Hot Topic Speaker: – Johnson & Johnson

From Bench to Bedside: Bioanalysis and Translational Science

2:00 PM – 3:00 PM ET

Rapid Fire: Patient-Centric Product Design and Precision Medicine

Location: Stone

Rapid Fire Moderator: – 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: Stone

Rapid Fire Speaker: – 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: Stone

Rapid Fire Speaker:

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: Stone

Rapid Fire Speaker: – 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: Stone

Rapid Fire Speaker: – 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

Location: Webster

Rapid Fire Moderator:

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: Webster

Rapid Fire Speaker: – 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: Webster

Rapid Fire Speaker: – 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: Webster

Rapid Fire Speaker: – Faculty of Pharmacy and Pharmaceutical Sciences, 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: Webster

Rapid Fire Speaker: – CheckImmune GmbH

From Bench to Bedside: Bioanalysis and Translational Science

3:00 PM – 4:00 PM ET

Closing Plenary

Location: Commonwealth Ballroom