Full Schedule

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: