Full Schedule

9:00 AM - 10:00 AM CT

Hot Topic: Enabling Peptides: From Crystallization to Formulation and In Silico Modeling

Hot Topic Speaker: – Eli Lilly and Company

Hot Topic Speaker: – Bioneer: FARMA

Hot Topic Speaker: – Eli Lilly and Company

Hot Topic Moderator: – Simulations Plus, Inc.

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Advancing Biologics Manufacturing Through Robust Process Design, Standards, and Lifecycle Management

Moderator: – USP

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

Can Next Generation Manufacturing Platforms Deliver mAbs at $10/ gm?

Speaker: – Indian Insitute of Technology Delhi

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Ensuring Robust Commercial Manufacturing: Impact of Formulation Process Selections

Speaker: – Product Development Science & Technology, AbbVie Inc

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

What Next in Public Standards to Foster Biologics Development?

Speaker: – USP

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

LNP

Speaker: – Moderna Therapeutics

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Bioanalysis at the Edge: NAM Bioanalysis and Complex Bioanalytical issues

Moderator: – Biotech

Bioanalytics

9:00 AM - 9:30 AM CT

Immunogenicity Risk Assessment of Novel Modalities Using NAMs

Speaker: – US Food and Drug Administration

Bioanalytics

9:30 AM - 10:00 AM CT

New Approach Methodologies in AAV Research Development: From MAPPs Assays to 3D Culture Systems

Speaker: – US Food and Drug Administration

Bioanalytics

10:00 AM - 10:30 AM CT

Supporting China Arm of Clinical Study

Speaker: – Alexion Pharmaceuticals, Inc.

Bioanalytics

10:30 AM - 11:00 AM CT

Case Study: Supporting China Arm of Clinical Study

Speaker: – Merck & Co., Inc.

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Biodistribution and Persistence as the New Exposure Science for Gene & Cell Therapies: From Vectors to Living Drugs

Moderator: – Bristol-Myers Squibb

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

From Guidance to Practice: Designing Regulatory‑Ready Biodistribution & Persistence Strategies Under ICH S12

Speaker: – Eli Lilly

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

AAV Biodistribution and Long‑Term Persistence: Linking Tissue Exposure, Durability, and Safety Risk Across Time

Speaker: – Novartis

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Quantifying the “Living Drug”: Integrating Biodistribution, Expansion, and Persistence into Actionable Cellular Kinetics

Speaker: – Genentech

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Beyond Hepatic Tropism: Mechanistic Drivers and Design Strategies for Tissue‑Targeted LNP Biodistribution

Speaker: – Bristol-Myers Squibb

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Building Regulatory Confidence in Molecular Assays

Moderator: – BioAgilytix

Bioanalytics

9:00 AM - 9:30 AM CT

White Papers to Practice: Building Regulatory Confidence in Molecular Assays

Speaker: – BioAgilytix

Bioanalytics

9:30 AM - 10:00 AM CT

RT-qPCR for LNP-mRNA PK: Case Study of Validation Strategy, In-Study Performance

Speaker: – Moderna

Bioanalytics

10:00 AM - 10:30 AM CT

Case Studies in Vector Shedding

Speaker: – Eurofins Viracor

Bioanalytics

10:30 AM - 11:00 AM CT

Unlocking Biomarkers: Lipidomics of Human Biofluids

Speaker: – Lipotype

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Engineering Complex Drug–Device Manufacturing Systems: From Process Understanding to Commercialization

Moderator: – St. John's University

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

Mechanistic Spray Drying Models for Pharmaceutical Product Development

Speaker: – Procegence

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Particle and Device Considerations for Inhaled Products

Speaker: – St. John's University

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

The Critical Interface: Managing Risks Where Drug Meets Device

Speaker: – Merck & Co., Inc.

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

From Control to Condition: Rethinking System Performance in Regulated Environments

Speaker: – Independent

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Integrating AI, Biomarkers, and Modeling to Advance Translational Drug Development

Moderator: – EpiVax Inc.

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Innovative AI-guided Preclinical and Translational Strategies to Support Drug Development

Speaker: – Auburn University

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Integrative Pan-Cancer Multi-Omics Profiling Identifies SERPINEs as Predictive Therapeutic Targets in Advanced Prostate Cancer

Speaker: – Harvard Medical School

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Mining PK and Immunogenicity Data to Build Predictive AI/ML NAM-Models

Speaker: – Bristol Myers Squibb

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Model-Informed Drug Development to Support Nemolizumab Dose Selection

Speaker: – Galderma

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Intentional and Unintentional Credibility Challenges, and First Steps to Solve Them

Moderator: – Center for Open Science

Innovator Curated Track

9:00 AM - 9:30 AM CT

The Entities Enabling Scientific Fraud at Scale Are Large, Resilient, and Growing Rapidly

Speaker:

Innovator Curated Track

9:30 AM - 10:00 AM CT

How Effective Are Publishers at Catching Problematic Manuscripts?

Speaker:

Innovator Curated Track

10:00 AM - 10:30 AM CT

Large-scale Replication of Preclinical Cancer Biology Experiments: Lessons, Surprises, and Opportunities

Speaker:

Innovator Curated Track

10:30 AM - 11:00 AM CT

Worth Repeating: Building an Ecosystem for Better Evidence, Better Decisions, and More Reliable Science

Speaker: – National Institutes of Health

Innovator Curated Track

9:00 AM - 11:00 AM CT

Symposium: Next-Gen Pharmaceutical Formulation: From Machine Learning to Mechanistic Modeling

Formulation and Delivery

9:00 AM - 9:30 AM CT

From Formulation to Inspection: AI‑Centric Pharmaceutical Development

Speaker: – PTI Inc

Formulation and Delivery

9:30 AM - 10:00 AM CT

Unmasking the Microphysics of Drug Release and the Spectral Grounding of IVIVC

Speaker: – Purdue University

Formulation and Delivery

10:00 AM - 10:30 AM CT

Formulation-Aware Machine-Learning for Prediction of Viscosity in High-Concentration Antibody Formulations

Speaker: – QATCH Technologies

Formulation and Delivery

10:30 AM - 11:00 AM CT

Mechanistic Modeling for Long-Acting Injectable Generic Development: Enabling Shorter Study Duration and Smaller Sample Size to Reduce Regulatory Burden

Speaker: – US Food and Drug Administration

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Rational Design of Small Molecule Formulations: From Modeling to Clinical Translation

Moderator: – Schrodinger, Inc. USA

Formulation and Delivery

9:00 AM - 9:30 AM CT

Mechanistic PBPK Modelling of Formulations (Salts/Acidulants) to Mitigate pH-mediated DDIs

Speaker: – Certara

Formulation and Delivery

9:30 AM - 10:00 AM CT

Predicting Flux Enhancement from Drug and Particle Properties

Speaker: – Pfizer Inc

Formulation and Delivery

10:00 AM - 10:30 AM CT

DDCS - A Classification System Guiding Development of Amorphous Products

Speaker: – Serán Bioscience, LLC

Formulation and Delivery

10:30 AM - 11:00 AM CT

A Translational Framework for Right‑First‑Time Amorphous Solid Dispersions Development

Speaker: – Hovione

Formulation and Delivery

10:00 AM - 11:00 AM CT

Hot Topic: Beyond Animal Models? Pros-Cons, and Regulatory Implications of NAM-Based Strategies

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

Hot Topic Speaker: – Flagship

Hot Topic Moderator: – Merck & Co, Inc - Rahway, NJ

Hot Topic Speaker:

Bioanalytics

10:00 AM - 10:15 AM CT

NAM Pros and Cons: Case Studies from Industry

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

Bioanalytics

10:15 AM - 10:30 AM CT

When Animal Data Is Still Essential: Lessons From the Clinic

Hot Topic Speaker:

Bioanalytics

10:30 AM - 11:00 AM CT

Panel Debate: Are We Moving Away from Animal Data Too Fast?

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

Hot Topic Speaker: – Flagship

Hot Topic Speaker:

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: 3D Printing: Driving Digital Transformation from Dosage Form Design to Product Development and Manufacturing

Keynote Speaker: – University of the Pacific

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Artificial Intelligence for Drug Delivery: Yesterday, Today and Tomorrow

Keynote Speaker: – University of Macau

Moderator: – Thermo Fisher Scientific

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Building Regulatory Confidence in Molecular Assays

Keynote Speaker: – Alexion

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: LNP and Delivery of RNA Products

Keynote Speaker:

Moderator: – US Food and Drug Administration

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Manufacturing Challenges in Inhalation Delivery :Concept to Commercial: The Inbrija® Journey from Invention and Development to Approval and Recent Scale-up

Keynote Speaker: – Catalent, Inc.

Moderator: – USP

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Navigating Change: PK/PD and Bioanalytical Strategies in NAM-Based Preclinical Development

Keynote Speaker: – Biotech

Moderator: – Beam Therapeutics

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Promoting Openness, Integrity, and Trustworthiness of Research Findings

Keynote Speaker: – Center for Open Science

Innovator Curated Track

1:30 PM - 2:30 PM CT

Keynote: Sandwich-Cultured Hepatocytes, Multicellular Hepatic Spheroids, and Liver-on-a-Chip Systems

Keynote Speaker: – UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill

Moderator: – University of Florida

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: The Present and Future of Quantitative Pharmacology in Clinical Drug Development - Pushing Scientific Boundaries for Patient Impact

Keynote Speaker: – Genentech, Inc.

Moderator: – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC

Preclinical, Clinical, and Translational Sciences

3:00 PM - 4:00 PM CT

Hot Topic: Promoting Open Science Policies to Accelerate Research Translation

Hot Topic Moderator: – Center for Open Science

Hot Topic Speaker:

Innovator Curated Track

3:30 PM - 4:30 PM CT

Hot Topic: Navigating CMC Strategy in the Current Landscape

Hot Topic Moderator: – Bristol Myers Squibb

Hot Topic Speaker: – Abbvie, Inc.

Hot Topic Speaker: – Pfizer

Hot Topic Speaker:

Manufacturing and Analytical Characterization