Full Schedule

5:00 PM - 6:30 PM CT

Opening Plenary with Dr. Julie Gerberding

Plenary Speaker: – Foundation for the National Institutes of Health (FNIH)

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

9:00 AM - 10:00 AM CT

Hot Topic: Immunogenicity Expectations: Are They Fact or Fear?

Hot Topic Speaker: – Former FDA OPQ

Hot Topic Speaker: – FDA OCP

Hot Topic Speaker: – Amgen

Bioanalytics

9:00 AM - 9:15 AM CT

Immunogenicity Expectations: Myth-Busting and Evidence Review

Hot Topic Speaker: – Former FDA OPQ

Bioanalytics

9:15 AM - 9:30 AM CT

FDA Perspective on Immunogenicity Risk Assessment and Tiered Assays

Hot Topic Speaker: – FDA OCP

Bioanalytics

9:30 AM - 10:00 AM CT

Panel Discussion: Industry Perspectives

Hot Topic Moderator: – BioData Solutions LLC

Hot Topic Speaker: – Former FDA OPQ

Hot Topic Speaker: – FDA OCP

Hot Topic Speaker:

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Advanced Structural and Biophysical Characterization of Lipid Nanoparticle Systems and Biosimilars

Moderator: – Sangamo Therapeutics

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

Structural Insights into mRNA/LNPs: Cryo-EM for Advanced Vaccine Platforms

Speaker: – Pfizer

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Thermodynamic Insights into Molecular Packing Governing mRNA Lipid Nanoparticles

Speaker: – Pfizer

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

Orthogonal SVP Analytics: Counts, Classification, and Decisions

Speaker: – Yokogawa Fluid Imaging Technologies

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

Next‑Generation Characterization of Targeted Lipid Nanoparticles for mRNA Delivery

Speaker: – AstraZeneca

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Enabling High Drug Load and High‑Viscosity Drug Products: From ASDs to Delivery Systems

Moderator: – Auburn University

Formulation and Delivery

9:00 AM - 9:30 AM CT

High‑Drug Load ASDs: Linking Microstructure to Dissolution

Speaker: – BASF Corporation

Formulation and Delivery

9:30 AM - 10:00 AM CT

Evaluating Kinetisol Technology as an alternative to spray drying to develop ASDs

Speaker: – Genentech, Inc.

Formulation and Delivery

10:00 AM - 10:30 AM CT

Impact of Polymeric Excipients on Physical Stability and Injectability of High-Concentration Protein Suspensions

Speaker: – Purdue University

Formulation and Delivery

10:30 AM - 11:00 AM CT

Drug–Device Co‑Design for High‑Viscosity and Large‑Volume Delivery

Speaker: – Pfizer Inc

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Innovating Cancer Therapy: Translational Approaches Across New Modalities

Moderator: – Novo Nordisk

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

In situ Immunization of Tumors

Speaker: – University of Iowa

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Translational PK/PD Modeling Framework for Tumor Growth Inhibition Across Modalities

Speaker: – GSK

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Targeting RNA-Binding Proteins as a Novel Therapeutic Modality in Cancer

Speaker: – Northwestern University Feinberg School of Medicine

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Strategic Preclinical and Clinical PK/PD Modeling of Novel Antibody-Based Constructs

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

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Measuring the Unmeasurable: Bioanalytical Innovation for Emerging Modalities

Moderator: – Beam Therapeutics

Bioanalytics

9:00 AM - 9:30 AM CT

Bioanalytical Strategies for Antibody Oligonucleotide Conjugates

Speaker: – Sanofi

Bioanalytics

9:30 AM - 10:00 AM CT

Data Integrity Through Orthogonal Confirmation: Strategies for Emerging Modalities

Speaker: – US Food and Drug Administration

Bioanalytics

10:00 AM - 10:30 AM CT

Unlocking Efficiency with In-Vitro Expression Multiplexing and Smart Automation

Speaker: – Pfizer Inc.

Bioanalytics

10:30 AM - 11:00 AM CT

Reagent Preparation and PK Method Development for Immuno-PCR Bioanalysis

Speaker: – GlaxoSmithKline

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Model-Informed Innovation: Integrating NAMs Across Translational Workflows

Moderator: – BioIVT

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Advancing NAMs with Quantitative Systems Toxicology and Microphysiological Systems

Speaker: – Simulations Plus Inc.

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Multi-Parametric Assessment of AAV Efficacy and Toxicity with Liver MPS

Speaker: – Javelin Biotech

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Integrating New Approach Methodologies to Advance Preclinical-Testing and Product Development

Speaker: – CONRAD, Macon & Joan Brock Virginia Health Sciences At Old Dominion University

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Whole Blood NAMs for Replacing Key Animal Immunotoxicology Studies

Speaker: – EpiVax, Inc.

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Modern Analytical Strategies for Impurity Characterization and Lifecycle Management

Moderator: – AbbVie, Inc.

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

Rapid Implementation of Spectroscopic Methods for Pharmaceutical Manufacturing

Speaker: – Duquesne University

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Rethinking Impurity and Trace-Level Analyses for Ultra‑Low-Dose Pharmaceuticals

Speaker: – AbbVie, Inc.

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

Impurity Characterization Across Drug Development: Phase-Appropriate Analytical and Regulatory Strategies

Speaker: – Veranova

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

Analytical Procedure Lifecycle Management

Speaker: – US Food and Drug Administration

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Oligonucleotide Bioanalysis: Ring Trial and Emerging Conjugate Modalities

Moderator: – Johnson & Johnson Innovative Medicine

Bioanalytics

9:00 AM - 9:30 AM CT

A One-Year Update from the Oligonucleotide Ring Trial

Speaker: – Aliri Bioanalysis

Bioanalytics

9:30 AM - 10:00 AM CT

Comparison of Three PCR Platforms for Oligonucleotide Therapeutic Quantification

Speaker: – Labcorp

Bioanalytics

10:00 AM - 10:30 AM CT

Bioanalytical Strategies for Antibody Oligonucleotide Conjugates: Preclinical PK Toolkit

Speaker: – LabCorp

Bioanalytics

10:30 AM - 11:00 AM CT

Fit-for-Purpose or Box-Checking? Metabolite Assessment Strategy for Oligonucleotides

Speaker: – Regeneron Pharmaceuticals

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Precision Delivery Frontiers: Redefining RNA and Advanced Therapeutics

Moderator: – AstraZeneca

Formulation and Delivery

9:00 AM - 9:30 AM CT

Future RNA Delivery Shaped by Next‑Generation LNP Mechanistic Insights 1

Speaker: – Northeastern University

Formulation and Delivery

9:30 AM - 10:00 AM CT

Design, Structure-Activity Relations, and Unique Applications of the Ionizable Lipids: From Infectious Disease Vaccines to Intravenous Muscle Restoration in DMD

Speaker:

Formulation and Delivery

10:00 AM - 10:30 AM CT

Next-Generation Ethanol-Free mRNA-Lipid Nanoparticle Formulation for Enhanced Transfection Efficiency

Speaker: – Sanofi

Formulation and Delivery

10:30 AM - 11:00 AM CT

Antibody‑Conjugated Targeted LNPs for Extrahepatic Nucleic Acid Delivery

Speaker: – AstraZeneca Pharmaceuticals LP

Formulation and Delivery

10:00 AM - 11:00 AM CT

Hot Topic: Hot Melt Extrusion 2.0-From Enabling Solubility to Smart Continuous Platforms

Hot Topic Moderator: – Queen's University Belfast

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: A Journey Navigating Drug-Drug Interaction in Discovery and Development

Keynote Speaker: – Food and Drug Administration

Moderator: – Boehringer Ingelheim

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Converging Platforms and Expanding Biological Insight

Keynote Speaker: – Johnson & Johnson Innovative Medicine

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Enabling Oral Delivery of Next-Generation Drugs: Expanding the Role of Amorphous Solid Dispersions

Keynote Speaker: – Purdue University

Moderator: – BASF Corporation

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: From Mechanism to Market: Transforming Biotherapeutic Delivery — Insights from Two Case Studies

Keynote Speaker: – AstraZeneca

Moderator: – Beam Tx

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Leveraging Advances in Analytical Technologies for Supporting Biosimilar Development/Characterization

Keynote Speaker: – U.S. Food & Drug Administration

Moderator: – US Food and Drug Administration

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Measuring the Unmeasurable

Keynote Speaker: – Bristol-Myers Squibb Company

Moderator: – Beam Therapeutics

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Nanomedicine in Translation: From Design to Therapeutic Outcome

Keynote Speaker: – AstraZeneca

Moderator: – Rutgers, the State University of New Jersey

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Seeing is Believing: Importance of Detailed Characterization in Understanding Complex Parenteral Drug Products

Keynote Speaker: – University of Connecticut

Moderator: – US Food and Drug Administration

Manufacturing and Analytical Characterization

2:30 PM - 3:30 PM CT

Hot Topic: GLP-1 Agonists and Drug Absorption: Gastric Emptying DDI Risks

Hot Topic Speaker: – Eli Lilly and Company

Hot Topic Moderator: – Eli Lilly and Company

Hot Topic Speaker: – Mayo Clinic

Preclinical, Clinical, and Translational Sciences

2:30 PM - 2:50 PM CT

Clinical Consequences of GLP-1-Induced Gastric Emptying Delay

Hot Topic Speaker: – Mayo Clinic

Preclinical, Clinical, and Translational Sciences

2:50 PM - 3:10 PM CT

GLP‑1–Induced Drug–Drug Interactions: Clinical Impact and Mechanistic Understanding

Hot Topic Speaker: – Eli Lilly and Company

Preclinical, Clinical, and Translational Sciences

3:10 PM - 3:30 PM CT

PBPK Modeling of GLP-1 Agonist DDIs: An Industry Approach

Hot Topic Speaker: – Eli Lilly and Company

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: Adaptive Dosage Modifications - MIDD Opportunities & Challenges

Moderator: – Gilead Sciences, Inc.

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Introduction to Adaptive Dosage Modifications - MIDD Opportunities & Challenges

Speaker: – Pharmetheus AB

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Dosage Modifications in Exposure-Response Analyses of Oncology Drug Development: The Brigimadlin Case Study

Speaker: – Boehringer Ingelheim Pharma GmbH & Co. KG

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Longitudinal Exposure-Response Modeling of Bounded Outcome Scores with Dose Modifications

Speaker: – Bristol Myers Squibb

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Model Evaluation in Adaptive Dosage Scenarios

Speaker: – InsightRX

Preclinical, Clinical, and Translational Sciences

9:00 AM - 11:00 AM CT

Symposium: AI-Enabled Predictive Manufacturing and Product Intelligence

Moderator: – AbbVie Inc.

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

nAI-Driven Dynamic Risk Prioritization Across Manufacturing Sites

Speaker: – Pharmalytik

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Material Property Database Multivariate Data Analysis Establishing Compression Scaling Parameters

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

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

Quantitative Morphological Analysis of Engineered Particles Using Machine Learning Techniques

Speaker: – US Food and Drug Administration

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

Ensuring Robust Commercial Manufacturing: Advanced Technologies and Modeling

Speaker: – Pfizer, Inc.

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Biomarker-to-Decision: Biomarker Contexts of Use and Fit-for-Purpose Strategies

Moderator: – BioAgilytix

Bioanalytics

9:00 AM - 9:30 AM CT

Dual Purpose Analytes: CLIA Results in Biomarker Contexts of Use?

Speaker: – BioData Solutions LLC

Bioanalytics

9:30 AM - 10:00 AM CT

Measurement of an Intracellular Biomarker in Liver Tissue

Speaker: – Regeneron Pharmacuticals

Bioanalytics

10:00 AM - 10:30 AM CT

Biomarker Assay Reference Materials: Why Current Practices Must Change

Speaker: – PBL Assay Science

Bioanalytics

10:30 AM - 11:00 AM CT

A Practical Path Forward

Speaker: – U.S. Pharmacopeia

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Digital Transformation Through Mechanistic Modeling, QbD, and Collaborative Innovation

Moderator: – Sangamo Therapeutics

Manufacturing and Analytical Characterization

9:00 AM - 9:30 AM CT

Biophysical Modeling of rAAV Chromatographic Purification

Speaker: – Procegence

Manufacturing and Analytical Characterization

9:30 AM - 10:00 AM CT

Machine Learning for Particle Characterization Workflows of Novel Medicines

Speaker: – Coriolis Pharma US Inc.

Manufacturing and Analytical Characterization

10:00 AM - 10:30 AM CT

QbD-Enabled Integrated Frameworks for OSD's Accelerated Scale-Up and Lifecycle Optimization

Speaker: – Forma

Manufacturing and Analytical Characterization

10:30 AM - 11:00 AM CT

Mechanistic Modeling of Solid Phase Peptide Synthesis Kinetics

Speaker: – Procegence

Manufacturing and Analytical Characterization

9:00 AM - 11:00 AM CT

Symposium: Emerging Strategies for Oral Macromolecular Delivery

Moderator: – AstraZeneca Pharmaceuticals

Formulation and Delivery

9:00 AM - 9:30 AM CT

Novel Drug Delivery Systems for GLP‑1s

Speaker: – Amgen Inc

Formulation and Delivery

9:30 AM - 10:00 AM CT

Overcoming Oral Absorption Challenges of Bro5 Molecules Using Permeation Enhancers and Enabling Technologies

Speaker: – Merck

Formulation and Delivery

10:00 AM - 10:30 AM CT

RIPTACs as a Novel Therapeutic Modality to Address Anti-Tumor Drug Resistance Mechanisms

Speaker:

Formulation and Delivery

10:30 AM - 11:00 AM CT

Patient-Centric Oral Peptide Delivery Using Softgel and Lyophilized ODT Technologies

Speaker: – Catalent

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: From Excipients to Outcomes: Optimizing Drug Performance Across Patient Populations

Moderator: – Eli Lilly and Company

Formulation and Delivery

9:00 AM - 9:30 AM CT

Role of Advanced Functional Excipients (AFEx) in Drug Repositioning

Speaker: – University of Alabama

Formulation and Delivery

9:30 AM - 10:00 AM CT

Patient-Centered Oral Drug Delivery Systems

Speaker:

Formulation and Delivery

10:00 AM - 10:30 AM CT

Geriatric Populations: How Age-Related Physiology Shapes Oral Drug Performance

Speaker: – National and Kapodistrian University of Athens

Formulation and Delivery

10:30 AM - 11:00 AM CT

Pediatric Populations: Biorelevant In Vitro Models and Recent Advances

Speaker: – University of Bath

Formulation and Delivery

9:00 AM - 11:00 AM CT

Symposium: Innovations in Clinical Sampling and BA Lab AI/Automation

Moderator: – Merck & Co., Inc.

Bioanalytics

9:00 AM - 9:30 AM CT

Digitized Bioanalysis: From Operational Readiness and Automation to AI

Speaker: – IQVIA Laboratories

Bioanalytics

9:30 AM - 10:00 AM CT

Seeing the Invisible: Isotope‑Labeling Strategies for Detecting Hidden DMPK Liabilities

Speaker: – Gilead Sciences

Bioanalytics

10:00 AM - 10:30 AM CT

From Volume to Value: Transforming Biomarker Sampling into a Patient-Centric Microsampling Ecosystem

Speaker: – Abbvie

Bioanalytics

10:30 AM - 11:00 AM CT

Unlocking Next-Gen Clinical Trials & the Promise of AI through Transformation of Specimen Management

Speaker:

Bioanalytics

9:00 AM - 11:00 AM CT

Symposium: Translational Pharmacology and Quantitative Strategies for Next-Generation Anti-Cancer Biologics

Moderator: – Genentech

Preclinical, Clinical, and Translational Sciences

9:00 AM - 9:30 AM CT

Challenges and Opportunities for Novel TCEs from a Translational PK/PD Perspective

Speaker: – Genentech, Inc

Preclinical, Clinical, and Translational Sciences

9:30 AM - 10:00 AM CT

Bridging the In Vitro to In Vivo Gap for T-Cell Engagers Using QSP Modeling

Speaker: – Certara

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:30 AM CT

Cracking the Dose Code: Modeling Strategies for Dose Selection for Multispecific Biologics

Speaker: – Genentech Inc.

Preclinical, Clinical, and Translational Sciences

10:30 AM - 11:00 AM CT

Application of Model-based Approaches to Integrate Pharmacology and Toxicology Data for Therapeutic Index Determination of an Fc Fusion Protein

Speaker:

Preclinical, Clinical, and Translational Sciences

10:00 AM - 11:00 AM CT

Hot Topic: Are Regulators on the Same Page for Pediatric Drug Data?

Hot Topic Speaker: – health canada

Hot Topic Moderator: – Merck & Co.

Hot Topic Speaker: – University College London/European Paediatric Formulation Initiative

Preclinical, Clinical, and Translational Sciences

10:00 AM - 10:20 AM CT

The Formulation Bottleneck: Where Pediatric Drug Development Still Falls Short

Hot Topic Speaker: – University College London/European Paediatric Formulation Initiative

Preclinical, Clinical, and Translational Sciences

10:20 AM - 10:40 AM CT

Health Canada’s Pediatric Drug Action Plan

Hot Topic Speaker: – health canada

Preclinical, Clinical, and Translational Sciences

10:40 AM - 11:00 AM CT

TBD

Hot Topic Speaker: – U.S. Food and Drug Administration

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Advancing Patient Focused Drug Product Design Through Intravitreal and Long Acting Delivery Innovation

Keynote Speaker: – Merck & Co., Inc.

Moderator: – Boehringer Ingelheim Pharmaceutical Inc

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Context Matters: Why Biomarker Strategy Starts with Purpose

Keynote Speaker: – BioAgilytix

Keynote Speaker: – Biotech

Bioanalytics

1:30 PM - 2:30 PM CT

Keynote: Developments in Lipid Formulations as Targeted and Personalized Approaches for Oral Delivery from Pediatrics to Geriatrics

Keynote Speaker: – Monash Institute of Pharmaceutical Sciences

Moderator: – Pfizer, Inc.

Formulation and Delivery

1:30 PM - 2:30 PM CT

Keynote: Navigating the Digital Event Horizon: Enabling Digital Transformation in Pharma with Standardization and Consistency through Cross-Collaborative Partnerships

Keynote Speaker:

Moderator: – US Food and Drug Administration

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: Potential Paradigm Shift in Basic Concepts of the Effects of Sunlight on Human Health and Its Regulatory Implications

Keynote Speaker: – University of Illinois at Chicago

Moderator: – Butler University

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Seeing Inside the Dose: Predictive Drug Development with Microstructure Intelligence

Keynote Speaker: – digiM Solution LLC.

Moderator: – USP

Manufacturing and Analytical Characterization

1:30 PM - 2:30 PM CT

Keynote: TBD

Keynote Speaker: – University of Florida

Moderator: – WuXi AppTec

Preclinical, Clinical, and Translational Sciences

1:30 PM - 2:30 PM CT

Keynote: Transforming the Regulated Lab of Today for the Digital World of Tomorrow

Moderator: – Merck & Co., Inc.

Keynote Speaker: – Merck

Bioanalytics

2:30 PM - 3:30 PM CT

Hot Topic: From Viscosity to Stability: Formulation Technologies for Concentrated Biologics

Hot Topic Speaker: – Novo Nordisk A/S

Hot Topic Speaker: – Harvard University

Hot Topic Speaker: – Halozyme Therapeutics

Hot Topic Speaker: – Stanford University

Hot Topic Moderator: – Novo Nordisk A/S

Formulation and Delivery

4:15 PM - 5:30 PM CT

Closing Plenary with Dr. David Berry

Plenary Speaker: