Full Schedule

7:30 AM - 5:00 PM CT

Registration Hours

Location: Lobby Registration

8:00 AM - 5:00 PM CT

Exhibitor Move-In

Location: Exhibit Halls 2-4

7:30 AM - 7:00 PM CT

Registration Hours

Location: Lobby Registration

8:00 AM - 5:00 PM CT

Exhibitor Move-In

Location: Exhibit Halls 2-4

12:00 PM - 4:00 PM CT

Speaker Ready Room

Location: 305

5:00 PM - 6:30 PM CT

Opening Plenary with Dr. Richard T. Thakor

Location: Lila Cockrell Theatre

Plenary Speaker: – University of Minnesota, Carlson School of Management

6:30 PM - 8:00 PM CT

Welcome Reception

Location: Lone Star Ballroom, Grand Hyatt San Antonio

Sponsored By

7:30 AM - 5:00 PM CT

Registration Hours

Location: Lobby Registration

7:30 AM - 5:00 PM CT

Speaker Ready Room

Location: 305

8:30 AM - 2:00 PM CT

Guest Tour: River Barge & San Antonio Icons Experience (additional fee required)

Location: Meet at the Grand Hyatt San Antonio at 8:30 am

8:30 AM - 4:30 PM CT

Free Professional Headshots

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 4:30 PM CT

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 4:30 PM CT

Mock Interviews

Location: Careers 360, Exhibit Hall

Career Development

8:30 AM - 5:00 PM CT

Solution Center Hours & Poster Presentations

Location: Exhibit Halls 2-4

9:00 AM - 10:00 AM CT

Who's Reading Your Resume? Ask Me Anything

Location: Careers 360, Exhibit Hall

Career Center Speaker: – Recruitomics Consulting and The Collaboratory Career Hub

Career Center Moderator: – AAPS

Career Center Speaker: – Reliant Life Sciences

Career Development

9:00 AM - 11:00 AM CT

Symposium: Advances and Case Examples of In Silico Modeling for Drug Development

Location: 225 CD

Moderator: – Smithers - Pharmaceutical Development Services

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Leveraging Mechanistic Static Models for DDI Waivers and Regulatory Approval

Location: 225 CD

Speaker: – Boehringer Ingelheim Pharma GmbH & Co

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Where Are We for Successful Modeling for Oral Macrocyclic Peptide?

Location: 225 CD

Speaker: – Certara Plc

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Mechanistic PBPK Modelling for the Locally Acting GIT Drug: Mesalamine

Location: 225 CD

Speaker: – Certara Predictive Technologies, Certara UK Limited

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Perspectives on PCR-Based Cellular Kinetics and Biodistribution in Cell Therapy

Location: 225 CD

Speaker: – BMS

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Advancements in Manufacturing and Characterization of Pharmaceuticals/ Biopharmaceuticals 1

Manufacturing and Analytical Characterization

Location: 301 ABC

Moderator: – Gilead Sciences

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Applied Solutions to Overcome the Challenge of Dosing Particle-Engineered Powders

Location: 301 ABC

Speaker: – Harro Hoefliger

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

Formulating High Drug Load Amorphous Dispersions Through Co-Precipitation

Location: 301 ABC

Speaker: – University of Iowa

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

Lifecycle Management Strategies – Rethinking Product Development Through Lipid-Based Formulations

Location: 301 ABC

Speaker: – Evolve Consulting

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Advanced Characterization of Polymorphic Diastereoisomers for Robust Crystallization Control

Location: 301 ABC

Speaker: – Bristol-Myers Squibb

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Advancements in Manufacturing and Characterization of Pharmaceuticals/ Biopharmaceuticals 2

Location: 302 ABC

Moderator: – AbbVie Inc.

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Addressing Practical Challenges in CM via Novel Hardware and Automation

Location: 302 ABC

Speaker: – Hovione

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

Develop, Scale-Up, and Clinical Study High-Drug-Loading Nano for BCS IV

Location: 302 ABC

Speaker: – AbbVie, Inc.

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

Drug-Polymer Nanoparticle Formation by “Flash Precipitation” Process

Location: 302 ABC

Speaker: – Chemical and Biological Engineering, Princeton University

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Twin-Screw Extruders Prepare High Drugload Nanosized Dispersible Amorphous Solid Dispersions

Location: 302 ABC

Speaker: – Queen's University Belfast

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: AI/ML in Bioanalysis

Location: 221 CD

Moderator: – Moderna Therapeutics

Bioanalytics

9:00 AM - 9:30 AM CT

Machine Learning to Streamline Chiral SFC Method Development

Location: 221 CD

Speaker: – Bristol-Myers Squibb

Bioanalytics

9:30 AM - 10:00 AM CT

AI/ML Used in Predictive Maintenance to Enhance Laboratory Efficiency

Location: 221 CD

Speaker: – Pharmalytik

Bioanalytics

10:00 AM - 10:30 AM CT

Regulatory-Ready AI: Applying Large Language Models to Bioanalytical Workflows

Location: 221 CD

Speaker: – BioData Solutions LLC

Bioanalytics

10:30 AM - 11:00 AM CT

Accelerating Mass Spectrometry Imaging Using Deep Learning

Location: 221 CD

Speaker: – University of Illinois Urbana Champaign

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Changing Landscape of Regulated Bioanalysis

Location: 221 AB

Moderator: – Johnson & Johnson

Bioanalytics

9:00 AM - 9:30 AM CT

Remembering the Bioanalytical Lessons Learned from Regulatory Submissions

Location: 221 AB

Speaker: – US Food and Drug Administration

Bioanalytics

9:30 AM - 10:00 AM CT

In vitro Bioequivalence - Trends in Regulatory Review and Inspections

Location: 221 AB

Speaker: – US Food and Drug Administration

Bioanalytics

10:00 AM - 10:30 AM CT

Regulated Bioanalysis in China, a 15-Year Retrospective

Location: 221 AB

Speaker: – Beyond M10 Bioanalytical Consulting

Bioanalytics

10:30 AM - 11:00 AM CT

Immunogenicity Assessment: Can We Harmonize Immunogenicity Assays?

Location: 221 AB

Speaker: – Roche Diagnostics GmbH

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: New Frontiers of Drug Development Through the Use of Non-Animal Models and Imaging

Location: 225 AB

Moderator:

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Organoids Unleashed: Engineering Mini-Organs in a Dish to Accelerate Veterinary and Comparative Pharmaceutical Research

Location: 225 AB

Speaker: – College of Veterinary Medicine/University of Georgia

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Advancing Drug Development and Regulatory Toxicology with AI-Supported PBPK, IVIVE, and Computational Modeling

Location: 225 AB

Speaker: – Physicians Committee for Responsible Medicine

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Testing and Qualification of the Microphysiological Systems Through an Academia-Industry-Government Collaboration

Location: 225 AB

Speaker: – College of Veterinary Medicine and Biomedical Sciences/Texas A&M

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Pursuing the Holy Grail of Predicting Human Tissue Drug Concentrations

Location: 225 AB

Speaker: – University of Washington

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Out-of-the-Box Approaches for Innovation

Location: 303 AB

Moderator: – University of Washington

Discovery and Basic Research

9:00 AM - 9:30 AM CT

Advanced Dendritic Cell Therapy: Evolution Toward a Cell-Free Approach

Location: 303 AB

Speaker: – University of Illinois Chicago

Discovery and Basic Research

9:30 AM - 10:00 AM CT

Innovative Radiopharmaceutical Therapy for Metastatic Cancers

Location: 303 AB

Speaker: – University of Connecticut

Discovery and Basic Research

10:00 AM - 10:30 AM CT

Structure and Dynamics of Lipid-Stabilized Amyloid Beta Aβ1–42 Oligomers

Location: 303 AB

Speaker: – University of Central Florida College of Sciences

Discovery and Basic Research

10:30 AM - 11:00 AM CT

Metabolite-Based Nanoparticles for Macrophage Reprogramming in Inflammatory Disease Treatment

Location: 303 AB

Speaker: – University of Maryland Baltimore

Discovery and Basic Research

9:00 AM - 11:00 AM CT

Symposium: Patient-Centric Formulation Development: Implications on Performance and Stability

Location: Stars at Night B2/B3

Moderator:

Formulation and Delivery

9:00 AM - 9:30 AM CT

Patient-Centric Insights into Clinical In-Use Stability of Protein Drug Products

Location: Stars at Night B2/B3

Speaker: – Teva Pharmaceuticals

Formulation and Delivery

9:30 AM - 10:00 AM CT

mRNA/Lipid Nanoparticle (LNP) Formulation Considerations Under Stress Stimuli

Location: Stars at Night B2/B3

Speaker: – Pfizer

Formulation and Delivery

10:00 AM - 10:30 AM CT

CAPS: A Novel Co-Processing Approach to Enhance ASD Properties

Location: Stars at Night B2/B3

Speaker: – Boehringer Ingelheim Pharma GmbH

Formulation and Delivery

10:30 AM - 11:00 AM CT

Performance Evaluation of Amorphous Solid Dispersions of Model PROTAC Compounds

Location: Stars at Night B2/B3

Speaker: – AstraZeneca Pharmaceuticals

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Through Peaks and Valleys: Advancing the Frontiers of Long-Acting Therapies

Location: Stars at Night B1

Moderator: – Queen's University Belfast

Formulation and Delivery

9:00 AM - 9:30 AM CT

Injectable Nanosuspensions Enabling Long-Acting Delivery of Small Molecules and Prodrugs

Location: Stars at Night B1

Speaker: – University of Liverpool

Formulation and Delivery

9:30 AM - 10:00 AM CT

Implants – Evolving Beyond Contraceptives to Deliver Long-Acting Medications

Location: Stars at Night B1

Speaker:

Formulation and Delivery

10:00 AM - 10:30 AM CT

A Dynamic Duo: Nanocrystals and Microneedles for Long-Acting Drug Delivery

Location: Stars at Night B1

Speaker: – Queen's University Belfast

Formulation and Delivery

10:30 AM - 11:00 AM CT

Biodegradable Particles Facilitating Durable Expression of Genetic Therapies

Location: Stars at Night B1

Speaker: – University of Groningen

Formulation and Delivery

9:30 AM - 10:00 AM CT

Coffee Break in the Solution Center

Location: Exhibit Halls 2-4

9:30 AM - 10:30 AM CT

Hot Topic: Rise of Machines and Biosensors in Drug Delivery

Location: 220

Hot Topic Speaker: – Southern Methodist University

Hot Topic Speaker: – Persist AI Formulations Corp

Formulation and Delivery

10:30 AM - 11:30 AM CT

LinkedIn: Your Essential Tool for Career Success

Location: Careers 360, Exhibit Hall

Career Center Moderator: – Bristol-Myers Squibb

Career Center Speaker: – Next Success

Career Development

11:00 AM - 12:00 PM CT

To Hybridize or Not to Hybridize: That is the Question

Location: 360 Stage #4, Exhibit Hall

Partner Presentation Speaker: – IQVIA Labs

Bioanalytics

Sponsored By

11:00 AM - 1:30 PM CT

Dedicated Solution Center Hours

Location: Exhibit Halls 2-4

12:00 PM - 1:00 PM CT

Upskill your AI Game for Job Search & Professional Growth

Location: Careers 360, Exhibit Hall

Career Center Moderator: – Pfizer.Inc

Career Center Speaker: – Mix Talent

Career Center Speaker: – Persist AI Formulations Corp

Career Center Speaker:

Career Development

12:30 PM - 1:15 PM CT

The Flexibility Factor: Adaptive Formulation Strategies That Drive Clinical Success

Location: Spotlight Stage C, Aisle 3800, Exhibit Hall

Partner Presentation Speaker: – Altasciences

Formulation and Delivery

Sponsored By

1:30 PM - 2:30 PM CT

Keynote: Drug Delivery Systems for Translational Immunotherapy

Location: 303 AB

Keynote Speaker: – University of Michigan

Moderator: – University of Washington

Discovery and Basic Research

1:30 PM - 2:30 PM CT

Keynote: From Algorithms to Action: Harnessing Predictive Models in the Era of Precision Medicine

Location: 221 CD

Keynote Speaker:

Moderator: – Bristol Myers Squibb

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: High Concentration Biologic Products: Manufacturing Challenges and Mitigation Strategies

Location: 302 ABC

Keynote Speaker: – Merck & Co.

Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Human Organ Chips as Tools for Clinical Mimicry

Location: 225 AB

Keynote Speaker: – Wyss Institute at Harvard University

Moderator: – Pfizer Inc

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Ionic Liquids for Formulation and Delivery of Biologics

Location: Stars at Night B1

Keynote Speaker: – Harvard University

Moderator: – Boehringer Ingelheim Pharmaceutical Inc

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Lipid Nanoparticles for Overcoming Biological Barriers to mRNA Delivery

Location: Stars at Night B2/B3

Keynote Speaker: – University of Pennsylvania

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Manufacturing Innovations in Oral Solids and Inhaled Products - Current Status and Future Vision

Location: 301 ABC

Keynote Speaker: – National University of Singapore

Moderator: – BioDuro

Manufacturing & Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Reflections on Transformations in Drug Development, Bioanalysis and Regulations

Location: 221 AB

Keynote Speaker: – Bioanalytical Solution Integration

Moderator: – Merck & Co., Inc.

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: The Evolution of PK/PD Models for Clinical Practice and Drug Development

Location: 225 CD

Keynote Speaker: – Learn & Confirm, Inc.

Moderator: – Neurocrine

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Small Size, Big Impact: Advancing Patient-Centric Care With Minitablets

Location: 360 Stage #1, Exhibit Hall

Partner Presentation Speaker: – Adare Pharma Solutions

Formulation and Delivery

Sponsored By

2:00 PM - 3:00 PM CT

Hot Topic: Emerging Role of Nanomaterials in Medicine

Location: 220

Hot Topic Moderator: – Butler University

Discovery and Basic Research

2:00 PM - 2:15 PM CT

The Critical Role of Buffer Composition on the Performance of mRNA-Lipid Nanoparticles

Location: 220

Speaker: – The University of Texas At Austin

Discovery and Basic Research

2:15 PM - 2:30 PM CT

A Predictive In Vitro Platform for Comprehensive Assessment of Lipid Nanoparticle Performance

Location: 220

Hot Topic Speaker: – Genentech, Inc.

Discovery and Basic Research

2:30 PM - 2:45 PM CT

Engineering Hydrophobicity to Modulate Nano-Bio Interface and Tissue-Selective mRNA Delivery

Location: 220

Hot Topic Speaker: – University of Florida

Discovery and Basic Research

2:45 PM - 3:00 PM CT

Engineered Nano-Prodrug for Microbial Metabolites Delivery and Immune Modulation

Location: 220

Hot Topic Speaker: – University of Washington

Discovery and Basic Research

2:30 PM - 3:00 PM CT

Coffee Break in the Solution Center

Location: Exhibit Halls 2-4

3:00 PM - 4:00 PM CT

Happy Hour Sponsored by INTERPHEX

Location: Booth #2651

Sponsored By

3:00 PM - 4:00 PM CT

Happy Hour Sponsored by ROQUETTE

Location: Booth #3335

Sponsored By

3:00 PM - 4:00 PM CT

How to Connect, Convey, and Convince When You Converse

Location: Careers 360, Exhibit Hall

Career Center Speaker: – Speaking of Solutions, LLC

Career Development

3:00 PM - 4:00 PM CT

Rapid Fires: AI/ML in Bioanalysis

Location: 221 CD

Rapid Fire Moderator: – IQVIA Laboratories

Bioanalytics

3:00 PM - 3:15 PM CT

Innovating Bioanalytical Reporting: Assessing Piloted AI Reporting Tools at Celerion

Location: 221 CD

Rapid Fire Speaker: – Celerion

Bioanalytics

3:15 PM - 3:30 PM CT

Mapping Protein Dynamics to Decode Excipient Effects in Formulation Development

Location: 221 CD

Rapid Fire Speaker: – Institute for Bioscience and Biotechnology Research, National Institute of Standards and Technology & University of Maryland

Bioanalytics

3:30 PM - 3:45 PM CT

Agentic AI Bioanalysis of Personalized Cancer Neoantigen Vaccine Based Trials

Location: 221 CD

Rapid Fire Speaker: – Frontage Labs

Bioanalytics

3:45 PM - 4:00 PM CT

Innovating Compliantly: Automating Workflows Within Regulatory Guidance Using ChatGPT

Location: 221 CD

Rapid Fire Speaker: – Moderna Inc.

Bioanalytics

3:00 PM - 4:00 PM CT

Rapid Fires: Changing Landscape of Regulated Bioanalysis

Location: 221 AB

Rapid Fire Moderator: – Daiichi Sankyo

Bioanalytics

3:00 PM - 3:15 PM CT

Improving Ex-vivo Stimulation Assays for Robust Bioanalysis

Location: 221 AB

Rapid Fire Speaker: – Celerion

Bioanalytics

3:15 PM - 3:30 PM CT

Assessing Risk for the IVDR Application

Location: 221 AB

Rapid Fire Speaker: – BioData Solutions LLC

Bioanalytics

3:30 PM - 3:45 PM CT

Bioanalytical Challenges and Strategies for Antibody–Drug Conjugates

Location: 221 AB

Rapid Fire Speaker: – WuXi AppTec (Shanghai) Co., Ltd.

Bioanalytics

3:45 PM - 4:00 PM CT

SEC-MALS for Peptide and ADC Characterization: Precision in Bioanalysis

Location: 221 AB

Rapid Fire Speaker: – Veranova

Bioanalytics

3:00 PM - 4:00 PM CT

Rapid Fires: Deep Dive: Characterization, Regulation & Innovation in Advanced Therapeutics

Rapid Fire Manufacturing & Bioprocessing

Location: 302 ABC

Rapid Fire Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

3:00 PM - 3:15 PM CT

Distinguishing Excipient Functionality of Lubricants and Anti-Adherents

Location: 302 ABC

Rapid Fire Speaker: – Purdue University

Manufacturing & Analytical Characterization

3:15 PM - 3:30 PM CT

Hypoxia-Mimetic and Pulsed-Electrical Stimulation Amplify NK-Exosome Manufacturing and Immunomodulatory Activity

Location: 302 ABC

Rapid Fire Speaker: – Florida A&M University

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Regulatory and Analytical Considerations for PFAS Testing in Pharmaceutical Industry

Location: 302 ABC

Rapid Fire Speaker: – SGS Phama

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Probing Protein-Protein Interactions in High-Concentration mAb-Formulations to Navigate Viscosity Challenges

Location: 302 ABC

Rapid Fire Speaker: – Pfizer Inc.

Manufacturing & Analytical Characterization

3:00 PM - 4:00 PM CT

Rapid Fires: Manufacturing Evolved: Continuous Processes, Precision Analytics & Complex Formulations

Location: 301 ABC

Rapid Fire Moderator: – Duquesne University School of Pharmacy - Graduate School of Pharmaceutical Scien

Manufacturing & Analytical Characterization

3:00 PM - 3:15 PM CT

Novel Purification Methods for Manufacturing of Complex Lipid Nanoparticle Formulations

Location: 301 ABC

Rapid Fire Speaker: – Sartorius BIA Separations

Manufacturing & Analytical Characterization

3:15 PM - 3:30 PM CT

Continuous ASD Tablet Manufacturing: Integrating Hot Melt Extrusion & Compaction

Location: 301 ABC

Rapid Fire Speaker: – RCPE GmbH

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Development of Continuous Twin Screw Wet Granulation and Drying

Location: 301 ABC

Rapid Fire Speaker: – Abbvie

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Comparison of Time-Gated and Traditional Raman Spectroscopy in Upstream Bioprocess

Location: 301 ABC

Rapid Fire Speaker: – Duquesne University School of Pharmacy - Graduate School of Pharmaceutical Scien

Manufacturing & Analytical Characterization

3:00 PM - 4:00 PM CT

Rapid Fires: Novel In Silico and In Vitro Approaches in Drug Development 1

Location: 225 AB

Rapid Fire Moderator: – The University of Texas Medical Branch

Preclinical, Clinical, and Translational Sciences

3:00 PM - 3:15 PM CT

Virtual Cells in Drug Discovery: A Physics-to-Intelligence Journey

Location: 225 AB

Rapid Fire Speaker: – Revilico Inc

Preclinical, Clinical, and Translational Sciences

3:15 PM - 3:30 PM CT

Cellular Mechanisms Underlying Species-Related Differences in LNP-mRNA Delivery

Location: 225 AB

Rapid Fire Speaker: – Pfizer, Inc.

Preclinical, Clinical, and Translational Sciences

3:30 PM - 3:45 PM CT

Enhancing Biorelevance: Unveiling Enzymatic Impact on Simulated GI Dissolution

Location: 225 AB

Rapid Fire Speaker: – Hovione

Preclinical, Clinical, and Translational Sciences

3:45 PM - 4:00 PM CT

In vitro + In Silico: Advanced Tools for Absorption Prediction

Location: 225 AB

Rapid Fire Speaker: – Pion Inc.

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

Rapid Fires: Novel In Silico and In Vitro Approaches in Drug Development 2

Location: 225 CD

Rapid Fire Moderator: – University of Washington

Preclinical, Clinical, and Translational Sciences

3:00 PM - 3:15 PM CT

Bridging In Vitro to In Vivo: Preclinical In Vitro Models for Characterizing Oligonucleotide Metabolism

Location: 225 CD

Rapid Fire Speaker: – WuXi AppTec

Preclinical, Clinical, and Translational Sciences

3:15 PM - 3:30 PM CT

Human Brain-on-Chip Powering a Preclinical Pipeline of Discovery through Delivery

Location: 225 CD

Rapid Fire Speaker: – Harvard Medical School, Massachusetts General Brigham

Preclinical, Clinical, and Translational Sciences

3:30 PM - 3:45 PM CT

Poloxamer-Coated Camel Milk Exosomes for Oral Cannabidiol Delivery: A Triad of In-Silico, In-Vitro, and In-Vivo Insights

Location: 225 CD

Rapid Fire Speaker: – FLORIDA A&M UNIVERSITY

Preclinical, Clinical, and Translational Sciences

3:45 PM - 4:00 PM CT

Advancing In Vitro Methods for Nose to Brain Delivery - Current Prospects and Future Possibilities

Location: 225 CD

Rapid Fire Speaker: – Bayer Healthcare LLC

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

Rapid Fires: Out-of-the-Box Approaches for Innovation

Location: 303 AB

Rapid Fire Moderator:

Discovery and Basic Research

3:00 PM - 3:15 PM CT

Tumor-Specific Radionuclide Therapy and Immunomodulation for Treating Metastatic Peritoneal Cancer

Location: 303 AB

Rapid Fire Speaker: – University of Connecticut

Discovery and Basic Research

3:15 PM - 3:30 PM CT

Selenium-Functionalized Synthetic Glycosaminoglycans to Treat Resistance and Metastasis in Solid Tumors

Location: 303 AB

Rapid Fire Speaker: – University of Utah, College of Pharmacy

Discovery and Basic Research

3:30 PM - 3:45 PM CT

Bugs as Drugs: Engineered Microbes for Cancer and Vaccine Therapy

Location: 303 AB

Rapid Fire Speaker: – University of Mississippi

Discovery and Basic Research

3:45 PM - 4:00 PM CT

Physiologically-Based Modeling and Immunomodulatory Effects of Microbial Metabolite-Delivering Polymeric Nano-Prodrugs

Location: 303 AB

Rapid Fire Speaker: – University of Washington

Discovery and Basic Research

3:00 PM - 4:00 PM CT

Rapid Fires: Patient-Centric Formulation and Personalized Drug Delivery Strategies 1

Location: Stars at Night B1

Rapid Fire Moderator: – Eli Lilly and Company

Formulation and Delivery

3:00 PM - 3:15 PM CT

Model-Informed Personalized Solid Dosage Formulation via Novel Additive Manufacturing Approach

Location: Stars at Night B1

Rapid Fire Speaker: – University of Puerto Rico

Formulation and Delivery

3:15 PM - 3:30 PM CT

Unlocking the Science of Terminal Sterilization for Long Acting Injectables

Location: Stars at Night B1

Rapid Fire Speaker: – Gilead Sciences

Formulation and Delivery

3:30 PM - 3:45 PM CT

Non-Invasive Intranasal Gels for Brain Delivery in Neurodegenerative Disorders

Location: Stars at Night B1

Rapid Fire Speaker: – St. John's University

Formulation and Delivery

3:45 PM - 4:00 PM CT

Biorelevant Imaging and Release Prediction to Rapidly Assess Long-Acting Injectables

Location: Stars at Night B1

Rapid Fire Speaker: – DigiM Solution LLC

Formulation and Delivery

3:00 PM - 4:00 PM CT

Rapid Fires: Patient-Centric Formulation and Personalized Drug Delivery Strategies 2

Location: Stars at Night B2/B3

Rapid Fire Moderator: – Purdue University

Formulation and Delivery

3:00 PM - 3:15 PM CT

Innovative Imaging Techniques Unraveling Needle Clogging Mechanisms in Pre-Filled Syringes

Location: Stars at Night B2/B3

Rapid Fire Speaker: – Merck

Formulation and Delivery

3:15 PM - 3:30 PM CT

Mucoadhesive Microparticle Shuttles for Targeted Nose-to-Brain Drug Delivery

Location: Stars at Night B2/B3

Rapid Fire Speaker: – Duquesne University

Formulation and Delivery

3:30 PM - 3:45 PM CT

SynBiosys®-Based Subcutaneous Implants: Customizable Drug Release via Dual Extruder 3D-Printing

Location: Stars at Night B2/B3

Rapid Fire Speaker: – RCPE GmbH

Formulation and Delivery

3:45 PM - 4:00 PM CT

Long-Acting Intradermal Drug Delivery

Location: Stars at Night B2/B3

Rapid Fire Speaker: – Queen's University Belfast

Formulation and Delivery

3:00 PM - 5:00 PM CT

Margarita Station Sponsored by Worldwide Clinical Trials

Location: Booth #2535

Sponsored By

3:30 PM - 4:30 PM CT

Hot Topic: CMC and Manufacturing Strategies for Lipid Nano-Particles Enabled Medicines

Location: 220

Hot Topic Moderator:

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Blueprint to Engineering and Scaling LNPs for Clinical Development

Location: 220

Hot Topic Speaker: – AstraZeneca

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Manufacturing Considerations for mRNA LNP-Based Drug Products

Location: 220

Hot Topic Speaker: – Pfizer

Manufacturing & Analytical Characterization

4:00 PM - 4:15 PM CT

Next Generation LNP Pharmaceuticals Analytics: Intact Chromatography for Comprehensive Characterization

Location: 220

Hot Topic Speaker: – Sartorius BIA Separations

Manufacturing & Analytical Characterization

4:15 PM - 4:30 PM CT

Strategies for Manufacturing and Analysis of Lipid-Based Nanomedicines and Vaccines

Location: 220

Hot Topic Speaker: – HTD Biosystems Inc

Manufacturing & Analytical Characterization

4:00 PM - 4:30 PM CT

David P. Otey, MA, MBA, Book Signing and Meet and Greet

Location: Careers 360, Exhibit Hall

Career Development

4:00 PM - 5:00 PM CT

Happy Hour Sponsored by Agilent Technologies

Location: Booth #2524

Sponsored By

4:00 PM - 5:00 PM CT

Happy Hour Sponsored by Celerion

Location: Booth #3019

Sponsored By Celerion

5:00 PM - 7:00 PM CT

KU Pharm Chem Alumni Reception (Invited Guests Only)

Location: Seguin A, Grand Hyatt San Antonio

5:30 PM - 7:00 PM CT

Minnesota Alumni Reception

Location: Lone Star C Ballroom, Grand Hyatt San Antonio

5:30 PM - 7:30 PM CT

UT Austin College of Pharmacy Alumni and Friends Reception

Location: Travis, San Antonio Marriott Riverwalk

6:00 PM - 7:30 PM CT

St. John's University Alumni & Friends Reception (Invited Guests Only)

Location: Lone Star B, Grand Hyatt San Antonio

6:00 PM - 8:00 PM CT

University of Iowa College of Pharmacy Alumni and Friends Reception

Location: Travis AB, Grand Hyatt San Antonio

6:00 PM - 8:30 PM CT

SCIEX Mixer – Meet the New ZenoTOF 8600 System - Invited Guests Only

Location: Bowie ABC, Grand Hyatt San Antonio

7:00 AM - 8:30 AM CT

Mentor Breakfast

Location: Stars at Night Prefunction

Career Development

Sponsored By

7:30 AM - 5:00 PM CT

Speaker Ready Room

Location: 305

8:00 AM - 2:30 PM CT

Industry Tour: BioConnect San Antonio Industry Immersion Experience (additional fee required)

Location: Meet at the Henry B. Gonzalez Convention Center at 7:30 am

8:00 AM - 5:00 PM CT

Registration Hours

Location: Lobby Registration

8:30 AM - 4:30 PM CT

Free Professional Headshots

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 4:30 PM CT

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 4:30 PM CT

Mock Interviews

Location: Careers 360, Exhibit Hall

Career Development

8:30 AM - 5:00 PM CT

Solution Center Hours & Poster Presentations

Location: Exhibit Halls 2-4

9:00 AM - 10:00 AM CT

Complex Complexities: Insights into the Method Development and Binding Tendencies of Hemoproteins and their Heme-Bound Complexes.

Location: 360 Stage #3, Exhibit Hall

Partner Presentation Speaker: – Prolytix

Bioanalytics

Sponsored By

9:00 AM - 10:00 AM CT

Hot Topic: Predictive Scale-Up/Scale-Down for Pharmaceuticals/Biopharmaceuticals

Location: 220

Hot Topic Moderator: – Pfizer Inc

Hot Topic Speaker: – Pfizer

Hot Topic Speaker: – Procegence

Hot Topic Speaker:

Hot Topic Speaker: – AbbVie Inc.

Manufacturing & Analytical Characterization

9:00 AM - 10:00 AM CT

Negotiating Your Contract -- Ask Me Anything

Location: Careers 360, Exhibit Hall

Career Development

9:00 AM - 11:00 AM CT

Symposium: Biomarker, Platform and Support

Location: 221 AB

Moderator: – Takeda

Bioanalytics

9:00 AM - 9:30 AM CT

Bioanalytical Assays for Gene Therapy Shedding Studies: Platforms and Validation

Location: 221 AB

Speaker: – BioAgilytix

Bioanalytics

9:30 AM - 10:00 AM CT

Composite Non-Invasive Testing Biomarker Enrichment in HBV-aHCC with Poor Prognosis

Location: 221 AB

Speaker: – Huahui Health Biotech

Bioanalytics

10:00 AM - 10:30 AM CT

Best Practice of Regulated Flow Cytometry by Chinese Bioanalysis Forum

Location: 221 AB

Speaker: – InnoStar

Bioanalytics

10:30 AM - 11:00 AM CT

Advancing AAV Standards in Gene Therapy

Location: 221 AB

Speaker: – United States Pharmacopeia

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Clinical Trials for Pediatric Populations

Location: 225 CD

Moderator: – Ernest Mario School of Pharmacy

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Model-Informed Drug-Drug Interaction Assessment in Pediatric Populations

Location: 225 CD

Speaker: – CTI Laboratories

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Clinical Study Design and Effective Study in Pediatric Population

Location: 225 CD

Speaker: – Hospital for Sick Children

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

What Should Consider for the Drug Development in Pediatric Populations

Location: 225 CD

Speaker: – FDA

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

The Effect of Formulation Excipients for Oral Absorption in Pediatrics

Location: 225 CD

Speaker: – Ono Pharmaceutical

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Emerging Technology as a Game Changer in Drug Discovery

Location: 303 AB

Moderator: – University Of Texas At Austin

Discovery and Basic Research

9:00 AM - 9:30 AM CT

Circular Single-Stranded DNA-Mediated Genomic Integration

Location: 303 AB

Speaker: – Full Circles Therapeutics

Discovery and Basic Research

9:30 AM - 10:00 AM CT

Organoid-Derived Small Intestinal Monolayers as a Novel Lymphatic Transport Model

Location: 303 AB

Speaker: – Northeastern University

Discovery and Basic Research

10:00 AM - 10:30 AM CT

GEMclear Elevates Accuracy of Spatial Proteomics for Drug Target Discovery

Location: 303 AB

Speaker: – University of California, Irvine

Discovery and Basic Research

10:30 AM - 11:00 AM CT

The Airway Revolution: Proteins and Probiotics in Pulmonary Drug Delivery

Location: 303 AB

Speaker: – University of Parma

Discovery and Basic Research

9:00 AM - 11:00 AM CT

Symposium: Enabling Technologies and Materials for Formulation Innovation 1

Location: Stars at Night B1

Moderator: – Teva Pharmaceuticals

Formulation and Delivery

9:00 AM - 9:30 AM CT

Carbohydrate-Driven Control of Respirable Protein Powder Surfaces and Performance

Location: Stars at Night B1

Speaker: – University of Michigan

Formulation and Delivery

9:30 AM - 10:00 AM CT

How to Resolve Dilemma of Selecting Excipients for Pediatric Products?

Location: Stars at Night B1

Speaker: – Novo Nordisk

Formulation and Delivery

10:00 AM - 10:30 AM CT

H-Bonded Organic Frameworks as Ultrasound-Programmable Delivery Platform

Location: Stars at Night B1

Speaker: – University of Texas At Austin

Formulation and Delivery

10:30 AM - 11:00 AM CT

Innovative Pathways: Trends in IND Studies for Nanomedicines

Location: Stars at Night B1

Hot Topic Speaker: – Auburn University, Dept Drug Disocvery and Development

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Enabling Technologies and Materials for Formulation Innovation 2

Location: Stars at Night B2/B3

Moderator: – Cybernax Bio

Formulation and Delivery

9:00 AM - 9:30 AM CT

Lipids Evaluation in RNA-LNPs: Enhancing Endosomal Escape and Extrahepatic Delivery

Location: Stars at Night B2/B3

Speaker: – Regeneron Pharmaceuticals

Formulation and Delivery

9:30 AM - 10:00 AM CT

Novel Biodegradable Class of Ionizable Lipids for Efficient RNA Delivery

Location: Stars at Night B2/B3

Speaker: – Millennium: The Takeda Oncology Company

Formulation and Delivery

10:00 AM - 10:30 AM CT

Designing Lipid Nanoparticle Formulations for Pulmonary Delivery of Nucleic Acids

Location: Stars at Night B2/B3

Speaker: – University of Texas at Austin

Formulation and Delivery

10:30 AM - 11:00 AM CT

AI-Driven Development of Next Generation Lipid Nanoparticles for mRNA Delivery

Location: Stars at Night B2/B3

Speaker: – University of Toronto/Department of Pharmaceutical Sciences

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 1

Location: 301 ABC

Moderator: – Bristol Myers Squibb

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Analytical Insights into Bispecific Antibodies Manufactured Through Co-Culture/Column-based Redox

Location: 301 ABC

Speaker: – Pfizer

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

Navigating Challenges of High Concentration Protein Therapeutics: Advanced Analytical Approaches

Location: 301 ABC

Speaker: – Merck and Co Inc

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

Recommendations for Biosimilar Manufacturers on Analytical and Functional Comparability Assessments

Location: 301 ABC

Speaker: – Indian Insitute of Technology Delhi

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Overcoming Challenges in Characterizing (Degraded) Surfactants through Advanced Chromatographic Methods

Location: 301 ABC

Speaker: – Coriolis Pharma Research GmbH

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 2

Location: 302 ABC

Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Extrusion-Based 3D Printing Approaches for Rapid Prototyping of Orodispersible Films

Location: 302 ABC

Speaker: – Auburn University

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

A Novel Laboratory-Scale Pneumatic Tube System (PTS) to Assess the Impact of Hospital PTS Transportation on the Product Quality of Therapeutic Monoclonal Antibodies

Location: 302 ABC

Speaker: – GSK

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

Case Study on Manufacturing Scalability: Gelation Impact on Lyophilization

Location: 302 ABC

Speaker: – University of Iowa, Pharmaceuticals

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Analytical Control Strategy for Half-Life Extension Features of Biotherapeutics

Location: 302 ABC

Speaker: – Merck Research Laboratories

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Special Considerations for Patient Populations in Clinical Trials

Location: 225 AB

Moderator: – Simulations Plus, Inc.

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Hepatic Impairment and the Differential Effects on Drug Clearance Mechanisms

Location: 225 AB

Speaker: – Pfizer Inc

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

AI in Designing and Delivering Clinical Trials for Specific Populations

Location: 225 AB

Speaker: – Tolmar Inc

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Trial Design for Obese: Right Compound, Right Dose, Right Patient

Location: 225 AB

Speaker: – Simulations Plus, Inc.

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Model-Informed Design of Clinical Trial in Patients with Renal Impairment

Location: 225 AB

Speaker: – Simulations Plus, Inc.

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Using Mass Spec to Support PD/PK

Location: 221 CD

Moderator: – Novartis Institutes for BioMedical Research, Inc.

Bioanalytics

9:00 AM - 9:30 AM CT

Measuring Receptor Occupancy in Peripheral Blood Cells Using Mass Spectrometry

Location: 221 CD

Speaker: – Merck & Co, Inc - Rahway, NJ

Bioanalytics

9:30 AM - 10:00 AM CT

Uncover the Power of Mass Spectrometry Imaging (MSI) for Spatially Resolved Analysis of Biological Tissues

Location: 221 CD

Speaker: – University of Texas at Austin

Bioanalytics

10:00 AM - 10:30 AM CT

MS and Stable-Isotope Kinetic Methods for Target Biology & Biomarker Strategies

Location: 221 CD

Speaker: – PharmaCadence Analytical Services, LLC

Bioanalytics

10:30 AM - 11:00 AM CT

Innovative Mass Spectrometry Strategies for Clinical Bioanalysis and Monitoring

Location: 221 CD

Speaker: – Children's Hospital of Philadelphia

Bioanalytics

9:00 AM - 4:00 PM CT

Career Connections

Location: Careers 360, Exhibit Hall

Career Development

9:30 AM - 10:00 AM CT

Coffee Break in the Solution Center

Location: Exhibit Halls 2-4

10:30 AM - 11:30 AM CT

Bridging Science and Business: Essential Knowledge for the Modern Scientist

Location: Careers 360, Exhibit Hall

Career Center Moderator: – Pharmalytik

Career Center Speaker: – Merck

Career Development

10:30 AM - 11:30 AM CT

Hot Topic: 2025 FDA Guidance BMV for Biomarkers: Impact and Path Forward

Location: 220

Hot Topic Speaker: – SPARC

Hot Topic Speaker: – Immunologix

Hot Topic Speaker: – Prothena Biosciences

Hot Topic Moderator: – PharmaCadence

Hot Topic Speaker: – AstraZeneca

Bioanalytics

11:00 AM - 1:30 PM CT

Dedicated Solution Center Hours

Location: Exhibit Halls 2-4

12:00 PM - 1:00 PM CT

Elevating Analytical Excellence: RNA Extraction and Singlicate use in LBA

Location: 360 Stage #1, Exhibit Hall

Partner Presentation Speaker: – Lovelace Biomedical

Bioanalytics

Sponsored By

12:00 PM - 1:00 PM CT

Know Your IP and How to Protect It

Location: Careers 360, Exhibit Hall

Career Center Speaker: – KATRINA ROGERS CONSULTING LLC

Career Development

1:00 PM - 3:00 PM CT

Smoothie Station Sponsored by Eurofins Clinical Trial Solutions

Location: Booth #2729

Sponsored By

1:30 PM - 2:30 PM CT

Keynote: Creating Community Connections to Enhance Clinical Research

Location: 225 CD

Keynote Speaker: – RTI International

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Designing, Formulating, and Manufacturing Molecules for Long-Acting Therapies

Location: 302 ABC

Keynote Speaker: – Gilead Sciences

Moderator: – Gilead Sciences

Manufacturing & Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Evolving Decentralized Clinical Research: Lessons from Five Years of Progress

Location: 225 AB

Keynote Speaker: – Eli Lilly and Company

Moderator: – Eli Lilly and Company

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Excipient Phase Behavior in Frozen and Freeze-Dried Systems – Potential Implications on Drug Stability

Location: Stars at Night B1

Keynote Speaker: – University of Minnesota

Moderator: – Simtra BioPharma Solutions

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Harnessing MALDI Mass Spectrometry Imaging for Biomarker Development in Hepatocellular Carcinoma Diagnosis and Prognosis

Location: 221 CD

Keynote Speaker:

Moderator:

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Illuminating Dynamic Architecture of Living Systems to Discover Biology and Identify Therapeutics

Location: 303 AB

Keynote Speaker: – University of California, San Francisco

Moderator: – University Of Texas At Austin

Discovery and Basic Research

1:30 PM - 2:30 PM CT

Keynote: Lipid Nanoparticles-Based mRNA Delivery for the Treatment of Genetic Diseases

Location: Stars at Night B2/B3

Keynote Speaker: – Oregon State University

Moderator: – University of Toronto/Department of Pharmaceutical Sciences

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Navigating the Biomarker Spectrum: From Pharmacokinetics to Companion Diagnostics in a Complex Regulatory World

Location: 221 AB

Keynote Speaker:

Moderator: – Bristol Myers Squibb

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Pharmaceutical Novel Modalities: Opportunities and Challenges

Location: 301 ABC

Keynote Speaker: – Novo Nordisk

Moderator: – Bristol Myers Squibb

Manufacturing & Analytical Characterization

1:30 PM - 2:30 PM CT

The Changing Landscape of the Pharmaceutical Industry

Location: Careers 360, Exhibit Hall

Career Center Speaker: – Bristol Myers Squibb

Career Center Speaker: – Astellas Pharma

Career Development

2:30 PM - 3:00 PM CT

Coffee Break in the Solution Center

Location: Exhibit Halls 2-4

2:30 PM - 3:30 PM CT

2025 AAPS High Impact Manuscript Award Rapid Fire Presentations

Location: Spotlight Stage A, Aisle 2500, Exhibit Hall

2:30 PM - 3:30 PM CT

Hot Topic: New Technologies and Approaches for Translation to Clinical Practice

Location: 220

Hot Topic Moderator: – Rutgers - The State University of New Jersey

Hot Topic Speaker: – Amgen

Hot Topic Speaker: – University of Florida

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

How to Become A Successful Consultant

Location: Careers 360, Exhibit Hall

Career Center Speaker: – SJTPharm LLC

Career Center Speaker: – JSM Pharmaceutical Consulting, LLC

Career Center Speaker: – Allucent

Career Center Moderator:

Career Development

3:00 PM - 4:00 PM CT

Rapid Fires: Biomarker, Platform and Support

Location: 221 AB

Rapid Fire Moderator:

Bioanalytics

3:00 PM - 3:15 PM CT

Biomarker Challenges: Spiked Quality Controls, Can They Bias your Results?

Location: 221 AB

Rapid Fire Speaker: – Charles River

Bioanalytics

3:15 PM - 3:30 PM CT

Practical Management of Conjugates for ADA and NAb Assays

Location: 221 AB

Rapid Fire Speaker: – Celerion

Bioanalytics

3:30 PM - 3:45 PM CT

Innovative Approaches to Micro-Sampling/Patient-Centric Sampling in Regulated Bioanalysis

Location: 221 AB

Rapid Fire Speaker: – Bristol Myers Squibb

Bioanalytics

3:45 PM - 4:00 PM CT

A Validated Assay for LC-MS/MS Analysis of an siRNA Therapeutic Drug Using Microsampling Devices

Location: 221 AB

Rapid Fire Speaker: – IQVIA Laboratories

Bioanalytics

3:00 PM - 4:00 PM CT

Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 1

Location: 225 AB

Rapid Fire Moderator: – Takeda

Preclinical, Clinical, and Translational Sciences

3:00 PM - 3:15 PM CT

Emerging Trends for FIH Studies Over the Last 4 Years

Location: 225 AB

Rapid Fire Speaker: – Quotient Sciences

Preclinical, Clinical, and Translational Sciences

3:15 PM - 3:30 PM CT

Translational Pharmaceutics to Support Clinical Trials for Orphan/ Rare Diseases

Location: 225 AB

Rapid Fire Speaker: – Quotient Sciences

Preclinical, Clinical, and Translational Sciences

3:30 PM - 3:45 PM CT

Advancing Inclusive Research: Thinking End-to-End and Starting Early in Development

Location: 225 AB

Rapid Fire Speaker: – Roche

Preclinical, Clinical, and Translational Sciences

3:45 PM - 4:00 PM CT

Nemolizumab: Pediatric Extrapolation to Waive Placebo-Controlled Studies in Atopic Dermatitis

Location: 225 AB

Rapid Fire Speaker: – Galderma R&D

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 2

Location: 225 CD

Rapid Fire Moderator: – Takeda

Preclinical, Clinical, and Translational Sciences

3:00 PM - 3:15 PM CT

Multiplexed Targeted Proteomics for Translating Research Discoveries into Clinical Utility

Location: 225 CD

Rapid Fire Speaker: – Bristol Myers Squibb

Preclinical, Clinical, and Translational Sciences

3:15 PM - 3:30 PM CT

Iberdomide Biopharmaceutical Risk Assessment Using Model Informed Drug Development Approach

Location: 225 CD

Rapid Fire Speaker: – Bristol Myers Squibb

Preclinical, Clinical, and Translational Sciences

3:30 PM - 3:45 PM CT

Novel Oral Molecules: Preclinical to Clinical Translation of Absorption-Disposition

Location: 225 CD

Rapid Fire Speaker: – Genentech, Inc.

Preclinical, Clinical, and Translational Sciences

3:45 PM - 4:00 PM CT

AAV-Based Gene Therapy Shedding Study Design in Clinical Trials

Location: 225 CD

Rapid Fire Speaker: – Lilly

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

Rapid Fires: Emerging Technology as a Game Changer in Drug Discovery

Location: 303 AB

Rapid Fire Moderator: – WuXi AppTec

Discovery and Basic Research

3:00 PM - 3:15 PM CT

Discovery of Ionizable Lipids for Organ-Specific Targeting Using Machine Learning

Location: 303 AB

Rapid Fire Speaker: – Argonne National Laboratory

Discovery and Basic Research

3:15 PM - 3:30 PM CT

Manifold Kernelization of Molecule's Quantum Information for AI-powered Drug Discovery

Location: 303 AB

Rapid Fire Speaker: – Purdue University

Discovery and Basic Research

3:30 PM - 3:45 PM CT

How Artificial Intelligence Can Progress Organoid Intelligence Towards New Treatments

Location: 303 AB

Rapid Fire Speaker: – University of Mississippi

Discovery and Basic Research

3:45 PM - 4:00 PM CT

Rational Discovery and Design of Membrane-Permeable Endolysins Against Gram-Negative Bacteria

Location: 303 AB

Rapid Fire Speaker: – Chinese University of Hong Kong

Discovery and Basic Research

3:00 PM - 4:00 PM CT

Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 1

Location: Stars at Night B1

Rapid Fire Moderator: – St. John's University

Formulation and Delivery

3:00 PM - 3:15 PM CT

Room Temperature Aerosol Dehydration for Innovative Thermostable Formulations of Biologics

Location: Stars at Night B1

Rapid Fire Speaker: – Inaedis, Inc.

Formulation and Delivery

3:15 PM - 3:30 PM CT

Hydroxypropyl-ꞵ-Cyclodextrin and Trehalose for Improved Stability of Spray-Dried Monoclonal Antibody

Location: Stars at Night B1

Rapid Fire Speaker: – Genentech, Inc.

Formulation and Delivery

3:30 PM - 3:45 PM CT

Protein-Surfactant Interactions at Solid-Liquid Interfaces of Primary Packaging Materials

Location: Stars at Night B1

Rapid Fire Speaker: – BASF Corporation

Formulation and Delivery

3:45 PM - 4:00 PM CT

Enhancing BCS II & IV Drugs Bioavailability with Lipid Formulations

Location: Stars at Night B1

Rapid Fire Speaker: – Catalent Pharma Solutions

Formulation and Delivery

3:00 PM - 4:00 PM CT

Rapid Fires: Enabling Technologies and Materials for Formulation Innovation 2

Location: Stars at Night B2/B3

Rapid Fire Moderator: – University of Ferrara

Formulation and Delivery

3:15 PM - 3:30 PM CT

Considerations for Additional Strength Waivers of ANDA Oral Modified-Release Product

Location: Stars at Night B2/B3

Rapid Fire Speaker: – University of Maryland

Formulation and Delivery

3:30 PM - 3:45 PM CT

Drugs as Excipients: Colistin as Dual-Function Inhalable Excipient

Location: Stars at Night B2/B3

Rapid Fire Speaker: – University of Michigan

Formulation and Delivery

3:45 PM - 4:00 PM CT

Mitigating Alcohol Dose Dumping in Modified Release Drug Products

Location: Stars at Night B2/B3

Rapid Fire Speaker: – BASF

Formulation and Delivery

3:00 PM - 4:00 PM CT

Rapid Fires: Shaping Biologics: From Molecules to Manufacturing Excellence

Location: 301 ABC

Rapid Fire Moderator: – CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics

Manufacturing & Analytical Characterization

3:15 PM - 3:30 PM CT

ADA-SCID Manufacturing and Outcomes: Predictive Analytics Case Study

Location: 301 ABC

Rapid Fire Speaker: – CMC & Regulatory Strategy for CGT, Rare Diseases, and Biologics

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Strategy for Bridging Methods for an Accelerated Late-Stage mAb

Location: 301 ABC

Rapid Fire Speaker: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Molecular Modeling Assisted Critical Quality Attribute Assessment

Location: 301 ABC

Rapid Fire Speaker: – Amgen

Manufacturing & Analytical Characterization

3:00 PM - 4:00 PM CT

Rapid Fires: Smart Science for Complex Formulation: From Nano to Manufacturing

Location: 302 ABC

Rapid Fire Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

3:00 PM - 3:15 PM CT

TLR7-Adjuvanted Ionizable Lipid Nanoparticles for mRNA Vaccine Delivery

Location: 302 ABC

Rapid Fire Speaker: – West Virginia University

Manufacturing & Analytical Characterization

3:15 PM - 3:30 PM CT

From Milligrams to Manufacturing: Efficient Formulation Screening for Drug-Eluting Implants

Location: 302 ABC

Rapid Fire Speaker: – MeltPrep

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Recent Progress in High-Throughput Formulation of Nanocrystals at Laboratory Scale

Location: 302 ABC

Rapid Fire Speaker: – Queen's University Belfast

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Case Study: Viral Inactivation in Bioprocessing Using Hydroxypropyl Beta-Cyclodextrins

Location: 302 ABC

Rapid Fire Speaker: – Roquette Asia Pacific Pte Ltd

Manufacturing & Analytical Characterization

3:00 PM - 4:00 PM CT

Rapid Fires: Using Mass Spec to Support PD/PK

Location: 221 CD

Rapid Fire Moderator: – Amgen

Bioanalytics

3:00 PM - 3:15 PM CT

Linker-Cleavage Enzyme Comparison for Hybrid LC-MS Analysis of Antibody-Drug Conjugates

Location: 221 CD

Rapid Fire Speaker: – Johnson & Johnson Innovative Medicine

Bioanalytics

3:15 PM - 3:30 PM CT

A Streamlined, Rapid End-to-End Workflow for Discovery Bioanalysis Laboratories

Location: 221 CD

Rapid Fire Speaker: – Waters Corporation

Bioanalytics

3:30 PM - 3:45 PM CT

Mass Spectrometry-Imaging to Determine Drug Disposition Using Targeted Cell-Based Carriers

Location: 221 CD

Rapid Fire Speaker: – University of Washington

Bioanalytics

3:45 PM - 4:00 PM CT

LC-MS Quantification of an ASO Drug Candidate in Human Plasma

Location: 221 CD

Rapid Fire Speaker: – Novartis Biomedical Research

Bioanalytics

3:30 PM - 4:30 PM CT

Happy Hour Sponsored by 10x Genomics

Location: Booth #2836

Sponsored By

4:00 PM - 5:00 PM CT

Happy Hour Sponsored by Croda Pharma + Avanti Polar Lipids

Location: Booth #3442

Sponsored By

5:30 PM - 7:00 PM CT

Fellows Networking Reception (by invitation only)

Location: Lone Star A, Grand Hyatt San Antonio

Sponsored By Pfizer

5:30 PM - 7:00 PM CT

Sustaining Sponsor Reception (by invitation only)

Location: Bowie ABC, Grand Hyatt San Antonio

5:30 PM - 9:30 PM CT

American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting

Location: India Oven Restaurant: 1031 Patricia Dr. Suite 106 San Antonio, TX 78213

6:00 PM - 7:30 PM CT

NIPTE 20th Anniversary Reception

Location: Travis AB, Grand Hyatt San Antonio

6:00 PM - 8:00 PM CT

University of Mississippi Pharmaceutics and Drug Delivery

Location: Travis CD, Grand Hyatt San Antonio

6:00 PM - 9:00 PM CT

IPEC Foundation Awards Ceremony (Invited Guests Only)

Location: Lone Star B, Grand Hyatt San Antonio

6:00 PM - 9:00 PM CT

Simulations Plus After Hours Event (Invited Guests Only)

Location: Lone Star C, Grand Hyatt San Antonio

7:30 AM - 8:30 AM CT

Women in PharmSci Breakfast

Location: Lone Star ABC, Grand Hyatt San Antonio

Career Development

7:30 AM - 3:30 PM CT

Speaker Ready Room

Location: 305

8:00 AM - 2:30 PM CT

Registration Hours

Location: Lobby Registration

8:00 AM - 7:00 PM CT

Coat Check

Location: West Registration

8:30 AM - 12:30 PM CT

Free Professional Headshots

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 12:30 PM CT

LinkedIn Profile Critiques & Resume Reviews

Location: Careers 360, Exhibit Hall

Career Development

Sponsored By

8:30 AM - 12:30 PM CT

Mock Interviews

Location: Careers 360, Exhibit Hall

Career Development

8:30 AM - 1:30 PM CT

Solution Center Hours & Poster Presentations

Location: Exhibit Halls 2-4

9:00 AM - 10:00 AM CT

Pitching a Start-Up: Ask Me Anything

Location: Careers 360, Exhibit Hall

Moderator: – AAPS

Career Center Speaker: – Torque Bio

Career Center Speaker: – SARx Consulting

Career Development

9:00 AM - 11:00 AM CT

Symposium: Accelerating Drug Development Through Digital Innovation 1

Location: Stars at Night B1

Moderator: – Schrodinger, Inc. USA

Formulation and Delivery

9:00 AM - 9:30 AM CT

AI-Based Data-Efficient Approach for Formulation Screening and Dissolution Modeling

Location: Stars at Night B1

Speaker: – AbbVie

Formulation and Delivery

9:30 AM - 10:00 AM CT

Selecting Polymer Excipients Using Molecular Dynamics Simulation

Location: Stars at Night B1

Speaker: – Schrodinger, Inc

Formulation and Delivery

10:00 AM - 10:30 AM CT

Advances in Computational Analysis of Dissolution - ASD

Location: Stars at Night B1

Speaker: – AbbVie Inc.

Formulation and Delivery

10:30 AM - 11:00 AM CT

Advances in Computational Analysis of Dissolution - Orodispersible tablets

Location: Stars at Night B1

Speaker: – Jagiellonian University - Medical College

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Accelerating Drug Development Through Digital Innovation 2

Location: Stars at Night B2/B3

Moderator: – Schrodinger, Inc.

Formulation and Delivery

9:00 AM - 9:30 AM CT

Speed-Up and De-Risk Biologics Developability and Formulation Development in silico

Location: Stars at Night B2/B3

Speaker: – Coriolis Pharma Research GmbH

Formulation and Delivery

9:30 AM - 10:00 AM CT

Computational Modeling for Lipid Nanoparticle Formulation Development, Efficacy and Targeting

Location: Stars at Night B2/B3

Speaker: – Schrodinger, LLC

Formulation and Delivery

10:00 AM - 10:30 AM CT

Revolutionizing Excipients: How AI Advances Are Shaping Their Use

Location: Stars at Night B2/B3

Speaker: – University of Toronto

Formulation and Delivery

10:30 AM - 11:00 AM CT

Derisking Formulation Strategies Using PBBM: Mechanistic Case Studies on Evaluating Food Effects and Guiding Dissolution Specifications

Location: Stars at Night B2/B3

Speaker: – Simulations Plus, Inc.

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Advanced Basic Research as the Bedrock of Pharmaceutical Science

Location: 303 AB

Moderator: – University of Oklahoma Health Sciences Center

Discovery and Basic Research

9:00 AM - 9:30 AM CT

Targeting Glutamate Transporters in the Brain for Neurodegenerative Disease Treatment

Location: 303 AB

Speaker: – University of Arizona

Discovery and Basic Research

9:30 AM - 10:00 AM CT

Advanced Fluorescence Imaging for Novel mRNA-Lipid Nanoparticle Formulation Design

Location: 303 AB

Speaker: – University Of Texas At Austin

Discovery and Basic Research

10:00 AM - 10:30 AM CT

Enabling Oral and Parenteral Delivery of GLP-1 Peptide from Biophysical and Molecular Investigations

Location: 303 AB

Speaker: – Merck & Co., Inc.

Discovery and Basic Research

10:30 AM - 11:00 AM CT

Targeting Protein Kinase Signaling for Ovarian Cancer

Location: 303 AB

Speaker:

Discovery and Basic Research

9:00 AM - 11:00 AM CT

Symposium: Novel Instrumentations in Bioanalysis

Location: 221 CD

Moderator: – University of Texas at Austin

Bioanalytics

9:00 AM - 9:30 AM CT

Bioanalysis of Emerging Modality Therapeutics Using Novel Mass Spectrometry Approaches

Location: 221 CD

Speaker: – Genentech

Bioanalytics

9:30 AM - 10:00 AM CT

Ion Mobility Spectrometry (IMS) and its Integration with Mass Spectrometry

Location: 221 CD

Speaker: – University of Michigan

Bioanalytics

10:00 AM - 10:30 AM CT

Advancing High-Resolution Ion Mobility-Mass Spectrometry for Bioanalysis and Drug Applications

Location: 221 CD

Speaker: – Clemson University

Bioanalytics

10:30 AM - 11:00 AM CT

SampleStream Technology for Automated Analysis of Biotherapeutic Samples

Location: 221 CD

Speaker: – Integrated Protein Technologies, Inc.

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Oligo Bioanalysis, Platforms and Methods

Location: 221 AB

Moderator: – Biogen Inc.

Bioanalytics

9:00 AM - 9:30 AM CT

Comparison of Bioanalytical Assay Platforms for Oligonucleotide Quantitation

Location: 221 AB

Speaker: – Johnson & Johnson Innovative Medicine

Bioanalytics

9:30 AM - 10:00 AM CT

Comparison of Three LC-MS Platforms for Oligonucleotide Therapeutic Quantification

Location: 221 AB

Speaker: – Aliri Bioanalysis

Bioanalytics

10:00 AM - 10:30 AM CT

Comparison of Two Hybridization LBA Platforms for Oligonucleotide Therapeutic Quantification

Location: 221 AB

Speaker: – BioAgilytix

Bioanalytics

10:30 AM - 11:00 AM CT

Minimizing Immunogenicity Testing for Development of Oligonucleotide Therapeutics: Risk-Based Strategy

Location: 221 AB

Speaker: – Regeneron Pharmaceuticals

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Predictive Tools and Applications in Manufacturing and Product Quality 1

Location: 301 ABC

Moderator: – GSK

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Accelerating Long-Acting Injectable Development Using Novel In-Vitro & Preclinical Models

Location: 301 ABC

Speaker: – Gilead Sciences

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

Granulation Process Scaleup Using Growth Regime Mapping and Multivariate Modeling

Location: 301 ABC

Speaker: – Eli Lilly and Company

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

A Novel Combined Physics-Based and ML Virtual Cocrystal Screening Model

Location: 301 ABC

Speaker: – Porton USA/J-Star Research

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Phased & Focused: Regulatory Compliance Strategies for Advanced Therapies

Location: 301 ABC

Speaker: – Pharmatech Associates

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Predictive Tools and Applications in Manufacturing and Product Quality 2

Location: 302 ABC

Moderator: – Merck and Co Inc

Manufacturing & Analytical Characterization

9:00 AM - 9:30 AM CT

Extractables and Leachables: Ensuring Safety Through Science and Strategy

Location: 302 ABC

Speaker: – Veranova

Manufacturing & Analytical Characterization

9:30 AM - 10:00 AM CT

Ask FDA Guidance: AI-Assistant for Guidance Information Extraction and Insights Retrieval

Location: 302 ABC

Speaker: – US Food and Drug Administration

Manufacturing & Analytical Characterization

10:00 AM - 10:30 AM CT

Properties of Polymeric Materials in Solution Elucidated by Viscosity Measurements

Location: 302 ABC

Speaker: – Cannon Instrument Company

Manufacturing & Analytical Characterization

10:30 AM - 11:00 AM CT

Mechanistic Models of Compaction Property Prediction for APIs and Formulations

Location: 302 ABC

Speaker: – Boehringer Ingelheim Pharmaceuticals, Inc.

Manufacturing & Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Translational Development of Cell and Gene Therapies

Location: 225 CD

Moderator: – University of Florida

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Shedding Study in AAV-Gene Therapy Trials: What We Have Learned?

Location: 225 CD

Speaker: – Passage Bio

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Physiologically Based Pharmacokientics Modeling of RNA-LNP to Characterize Clinical Consequence

Location: 225 CD

Speaker: – Temple University

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

CAR-T Cell Therapy in Autoimmune Diseases: Clinical Pharmacology and Dosing Considerations

Location: 225 CD

Speaker: – Genentech, Inc.

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Quantitative Pharmacology of anti-CD19 Cell Therapies in Autoimmune conditions

Location: 225 CD

Speaker: – Johnson and Johnson Innovative Medicine

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Translational Development of Diverse Drug Formulations

Location: 225 AB

Moderator: – WuXi AppTec

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Harnessing In Vitro Models for NAMs-Based Inhalable Substance Safety Assessments

Location: 225 AB

Speaker: – RTI International

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Oral Peptide Drug Development: Addressing Preclinical Bioavailability and PK Challenges

Location: 225 AB

Speaker: – WuXi AppTec

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

State-of-the-Art In Vitro Tools for Better Subcutaneous Drug Development

Location: 225 AB

Speaker: – Merck & Co., Inc.

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Predicting Human Subcutaneous Bioavailability of Monoclonal Antibodies Using an Integrated In-Vitro/In-Silico Approach

Location: 225 AB

Speaker: – AstraZeneca

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Coffee Break in the Solution Center

Location: Exhibit Halls 2-4

10:30 AM - 11:30 AM CT

Business of Bioscience – Entrepreneurial Skill Development for Trainee Scientists

Location: Careers 360, Exhibit Hall

Career Center Moderator: – St. John's University

Career Center Speaker: – University of Iowa

Career Center Speaker: – City University of New York (CUNY)

Career Center Speaker: – Weill Cornell Medicine

Career Development

10:30 AM - 11:30 AM CT

Hot Topic: Exosomes and Extracellular Vesicles: An Emerging Multifaceted System

Location: 220

Hot Topic Moderator: – Creighton University

Discovery and Basic Research

10:30 AM - 10:45 AM CT

Bioengineering Exosomes for Tumor Targeting: How Many Can We Conquer?

Location: 220

Hot Topic Speaker: – Florida A & M University

Discovery and Basic Research

10:45 AM - 11:00 AM CT

Priming Immune-Evasive Tumors with T cell-derived Extracellular Vesicles

Location: 220

Hot Topic Speaker: – The Ohio State University College of Pharmacy

Discovery and Basic Research

11:00 AM - 11:15 AM CT

Engineering MSC-Derived Exosome Mimetics for Bone Regeneration

Location: 220

Hot Topic Speaker: – University of Maryland Eastern Shore

Discovery and Basic Research

11:15 AM - 11:30 AM CT

CRISPR-Cas9 Engineered Extracellular Vesicles for Treating Genetic Hearing Loss

Location: 220

Hot Topic Speaker: – University of Florida College of Pharmacy

Discovery and Basic Research

11:00 AM - 1:30 PM CT

Dedicated Solution Center Hours

Location: Exhibit Halls 2-4

12:00 PM - 1:00 PM CT

Science Meets Strategy: Building Business Development Careers from Research Roots

Location: Careers 360, Exhibit Hall

Career Center Moderator: – USP

Career Center Speaker: – COMMEX Consulting

Career Center Speaker: – BOYDS

Career Development

1:30 PM - 2:30 PM CT

Hot Topic: Identifying Gaps and Pushing Boundaries in Mechanistic Dissolution Modeling

Location: 220

Hot Topic Speaker: – Simulations Plus, Inc.

Hot Topic Speaker: – New Mexico State University

Hot Topic Speaker: – Johannes Gutenberg University Mainz and University of Michigan

Hot Topic Moderator: – Simulations Plus, Inc.

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Accelerating Drug Discovery and Development with Advanced Computational Modeling

Location: Stars at Night B1

Keynote Speaker: – Schrödinger

Moderator: – Schrodinger, Inc. USA

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Current Status and Future Perspective of Pre-Clinical in vivo Studies vs in vitro/in silico Predictive Biopharmaceutics Tools

Location: 225 CD

Moderator: – Merck & Co.

Keynote Speaker: – Eli Lilly and Company

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Development of Non-Invasive Wearable Physiological Sensors for Quantifying Treatment Outcomes

Location: 225 AB

Keynote Speaker: – Massachusetts General Hospital / Harvard Medical School

Moderator: – Pion Inc.

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Digital Twin Technologies to Accelerate Development, Reduce Wet Work and Optimize Process Performance

Location: 301 ABC

Keynote Speaker: – GSK

Moderator: – GlaxoSmithKline plc

Manufacturing & Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Glaucoma Therapy: An Unmet Need

Location: 303 AB

Keynote Speaker: – Creighton University

Moderator: – Creighton University

Discovery and Basic Research

1:30 PM - 2:30 PM CT

Keynote: Machine Learning for Small Molecule Drug Development and Delivery

Location: Stars at Night B2/B3

Keynote Speaker:

Moderator: – University of Toronto/Department of Pharmaceutical Sciences

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: New Frontiers in High Performance Mass Spectrometry for Bioanalysis of Therapeutics

Location: 221 CD

Keynote Speaker: – University of Texas at Austin

Moderator: – Bristol Myers Squibb Company

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: The Evolving Bioanalytical Strategies and Considerations for Advancing Gene and Cell Therapy Drug Development

Location: 221 AB

Keynote Speaker: – Sangamo Therapeutics

Moderator: – Merck

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Unsupervised AI-based Image Analysis of Cell Therapy Products: A New Non-Invasive Characterization Approach for QC

Location: 302 ABC

Keynote Speaker: – Ursa Analytics, Inc. & U. Colorado, Boulder

Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

1:30 PM - 8:00 PM CT

Exhibitor Move-Out

Location: Exhibit Halls 2-4

3:00 PM - 4:00 PM CT

Hot Topic: The Role of AI/ML in Accelerating Development of Nanomedicines

Location: 220

Hot Topic Moderator: – University of Witwatersrand

Formulation and Delivery

3:00 PM - 3:15 PM CT

Application of AI in Nanomedicine Discovery and Design

Location: 220

Hot Topic Speaker: – University of Florida

Formulation and Delivery

3:15 PM - 3:30 PM CT

Application of AI in Nanomedicine Delivery, PK/PD and Preclinical Development

Location: 220

Hot Topic Speaker: – University of Pittsburgh

Formulation and Delivery

3:30 PM - 3:45 PM CT

Application of AI in Nanomedicine Manufacturing, Characterization, and Quality Control

Location: 220

Hot Topic Speaker: – CONRAD / Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Formulation and Delivery

3:45 PM - 4:00 PM CT

Limitations of AI/ML, Regulatory Requirements and Future Perspective

Location: 220

Hot Topic Speaker: – HTD Biosystems Inc

Formulation and Delivery

3:00 PM - 4:00 PM CT

Rapid Fires: Accelerating Drug Development Through Digital Innovation

Location: Stars at Night B1

Rapid Fire Moderator: – J-Star Research Inc.

Formulation and Delivery

3:00 PM - 3:15 PM CT

Enabling Accelerated Drug Development Through Application of High Throughput Capabilities

Location: Stars at Night B1

Rapid Fire Speaker: – Process Development, Amgen

Formulation and Delivery

3:15 PM - 3:30 PM CT

A Framework for Drug Product Performance Modeling in Early-Stage Development

Location: Stars at Night B1

Rapid Fire Speaker: – AbbVie

Formulation and Delivery

3:30 PM - 3:45 PM CT

Drug Base Precipitation: A Model for Oral Absorption Predictions

Location: Stars at Night B1

Rapid Fire Speaker: – EMD Serono (Merck Healthcare KGaA)

Formulation and Delivery

3:45 PM - 4:00 PM CT

New Computational Approach for Rapid Screening of API–Polymer Mixtures

Location: Stars at Night B1

Rapid Fire Speaker: – BASF Corporation

Formulation and Delivery

3:00 PM - 4:00 PM CT

Rapid Fires: How can we Advance Basic Research as the Bedrock of Pharmaceutical Science?

Location: 303 AB

Rapid Fire Moderator: – Ohio State University

Discovery and Basic Research

3:00 PM - 3:15 PM CT

Ex-Vivo Model for Analyzing Drug Transport Phenomena at the Blood-Brain-Barrier

Location: 303 AB

Rapid Fire Speaker: – University of Bonn

Discovery and Basic Research

3:15 PM - 3:30 PM CT

Evaluating Glycosaminoglycan Composition at the Blood-Brain Barrier

Location: 303 AB

Rapid Fire Speaker: – Texas Tech University Health Sciences Center

Discovery and Basic Research

3:30 PM - 3:45 PM CT

Exofection via Trophoblast EVs Restores P-gp in Alzheimer’s

Location: 303 AB

Rapid Fire Speaker: – The University of Texas Medical Branch

Discovery and Basic Research

3:45 PM - 4:00 PM CT

Indacaterol Induces Metabolic Reprogramming in Obesity

Location: 303 AB

Rapid Fire Speaker: – Texas Tech UniversityHSC SOP

Discovery and Basic Research

3:00 PM - 4:00 PM CT

Rapid Fires: Novel Instrumentations in Bioanalysis/Oligo Bioanalysis, Platforms and Methods

Location: 221 AB

Rapid Fire Moderator: – BioAgilytix Labs, LLC.

Bioanalytics

3:00 PM - 3:15 PM CT

Capillary Assisted Vitrification: Stabilizing Critical Reagents and Biospecimens for Storage at Room Temperature

Location: 221 AB

Rapid Fire Speaker:

Bioanalytics

3:15 PM - 3:30 PM CT

Qualifying scRNA-seq Assay for Profiling Leukocytes from Human Blood Samples

Location: 221 AB

Rapid Fire Speaker: – Moderna Therapeutics

Bioanalytics

3:30 PM - 3:45 PM CT

The Tale of Two Methods: Charge Heterogeneity of Stressed Biotherapeutics

Location: 221 AB

Rapid Fire Speaker: – Merck

Bioanalytics

3:45 PM - 4:00 PM CT

Taming SEC columns: A Journey Through HMW Recovery

Location: 221 AB

Rapid Fire Speaker: – Amgen

Bioanalytics

3:00 PM - 4:00 PM CT

Rapid Fires: Predictive Power: Modeling, AI & Regulatory Design in Drug Development

Location: 301 ABC

Rapid Fire Moderator: – Merck & Co., Inc.

Manufacturing & Analytical Characterization

3:00 PM - 3:15 PM CT

Predicting Drug Release from Long-Acting Implants: Mechanisms, Modeling, and Simulation

Location: 301 ABC

Rapid Fire Speaker: – University of Texas At Austin

Manufacturing & Analytical Characterization

3:15 PM - 3:30 PM CT

Revealing Isotopic Patterns of Drug Products and Commonly Used Excipients

Location: 301 ABC

Rapid Fire Speaker: – Stanford University

Manufacturing & Analytical Characterization

3:30 PM - 3:45 PM CT

Regulatory-Driven CQA Specification Setting Using Innate Immunogenicity Assay for Peptide-Therapeutics

Location: 301 ABC

Rapid Fire Speaker: – EpiVax, Inc.

Manufacturing & Analytical Characterization

3:45 PM - 4:00 PM CT

Machine Learning-Driven Formulation and Process Design for Solid Dosage Forms

Location: 301 ABC

Rapid Fire Speaker: – PTI - Pharmaceutical Technologies International

Manufacturing & Analytical Characterization

3:00 PM - 4:00 PM CT

Rapid Fires: Translating Animal PK, Toxicology, and Biomarkers to Clinical Success

Location: 225 CD

Rapid Fire Moderator: – Takeda Development Center Americas, Inc.

Preclinical, Clinical, and Translational Sciences

3:00 PM - 3:15 PM CT

Next-Generation Incretin Therapies: Approaches to Carcinogenicity Safety Assessment

Location: 225 CD

Rapid Fire Speaker:

Preclinical, Clinical, and Translational Sciences

3:15 PM - 3:30 PM CT

Exposure Response Assessment of a Novel, Directly Acting Antiviral, BDGR-251

Location: 225 CD

Rapid Fire Speaker: – University of Tennessee Health Science Center

Preclinical, Clinical, and Translational Sciences

3:30 PM - 3:45 PM CT

Mechanistic Data to Support Iron-Carbohydrate Nanoparticle PBPK Models

Location: 225 CD

Rapid Fire Speaker: – CSL Vifor

Preclinical, Clinical, and Translational Sciences

3:45 PM - 4:00 PM CT

Pre-Clinical Model for Simultaneous PK-PD Studies of CNS Active Compounds

Location: 225 CD

Rapid Fire Speaker: – University of Florida

Preclinical, Clinical, and Translational Sciences

4:15 PM - 5:30 PM CT

Closing Plenary with Dr. Daniel G. Anderson

Location: Lila Cockrell Theatre

Plenary Speaker: – Koch Institute for Integrative Cancer Research, MIT

5:30 PM - 6:30 PM CT

Closing Reception

Location: The Grotto, River Level

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