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Full Schedule

  • Saturday, October 24, 2026
  • 7:30 AM - 5:00 PM CT
    Registration Hours
  • 8:00 AM - 5:00 PM CT
    Exhibitor Move-In
  • Sunday, October 25, 2026
  • 7:30 AM - 7:00 PM CT
    Registration Hours
  • 8:00 AM - 5:00 PM CT
    Exhibitor Move-In
  • 11:30 AM - 4:30 PM CT
    GastroPlus® PBBM–PBPK Modeling: Oral Drug Product Workflows, Subpopulation Analysis, and API-Driven Automation (RSVP Required)
  • 12:00 PM - 4:00 PM CT
    Speaker Ready Room
  • 5:00 PM - 6:30 PM CT
    Opening Plenary with Dr. Julie Gerberding
    Plenary Speaker: Julie L. Gerberding – Foundation for the National Institutes of Health (FNIH)
  • 6:30 PM - 8:00 PM CT
    President's Welcome Reception
  • Monday, October 26, 2026
  • 7:30 AM - 9:00 AM CT
    Executive Track: What Actually Drives Development Speed? An Executive-Level Autopsy of Drug Development Delays
    Executive Education Speaker: Tanya Karakyriakou, MSc (she/her/hers) – UCL (University College London)
    Executive Track
  • 7:30 AM - 5:00 PM CT
    Registration Hours
  • 7:30 AM - 5:00 PM CT
    Speaker Ready Room
  • 8:30 AM - 5:00 PM CT
    Solution Center Hours & Poster Presentations
  • 9:00 AM - 10:00 AM CT
    Career Series 1: Unwritten Rules: What Women Should Know to Advance Their Careers
    Career Center Speaker: Stacey J. Tannenbaum, PhD – SJTPharm LLC
    Career Center Speaker: Carina Clingman, Ph.D. – Collaboratory Career Hub
    Career Development
  • 9:00 AM - 10:00 AM CT
    Hot Topic: Enabling Peptides: From Crystallization to Formulation and In Silico Modeling
    Hot Topic Speaker: Jing Teng, PhD – Eli Lilly and Company
    Hot Topic Speaker: Anette Müllertz, Ph.D. – Bioneer: FARMA
    Hot Topic Speaker: Stephen D. Stamatis, PhD – Eli Lilly and Company
    Hot Topic Moderator: Deanna M. Mudie, PhD (she/her/hers) – 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
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Bioanalysis At the Edge: NAM Bioanalysis and Complex Bioanalytical Issues
    Moderator: Mark Ma, PhD (he/him/his) – Biotech
    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: Steven W. Louie, M.S. (he/him/his) – Bristol-Myers Squibb
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: Building Regulatory Confidence in Molecular Assays
    Moderator: Amanda L. Hays, PhD – BioAgilytix
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Engineering Complex Drug–Device Manufacturing Systems: From Process Understanding to Commercialization
    Moderator: Vivek Gupta, PhD, FAAPS – St. John's University
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Integrating AI, Biomarkers, and Modeling to Advance Translational Drug Development
    Moderator: Narendra Chirmule, PhD (he/him/his) – Symphonytech
    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: Maryam Zaringhalam, PhD (she/her/hers) – Center for Open Science
    Innovator Curated Track
  • 9:00 AM - 11:00 AM CT
    Symposium: Next-Gen Pharmaceutical Formulation: From Machine Learning to Mechanistic Modeling
    Moderator: Pauric Bannigan, PhD (he/him/his) – Intrepid Labs
    Formulation and Delivery
  • 9:00 AM - 11:00 AM CT
    Symposium: Rational Design of Small Molecule Formulations: From Modeling to Clinical Translation
    Moderator: Naveen K. Thakral, PhD – Schrodinger, Inc. USA
    Formulation and Delivery
  • 9:30 AM - 10:00 AM CT
    Coffee Break in the Solution Center
  • 10:00 AM - 11:00 AM CT
    Hot Topic: Beyond Animal Models? Pros-Cons, and Regulatory Implications of NAM-Based Strategies
    Hot Topic Speaker: Jenny Valentine, PhD (she/her/hers) – Regeneron Pharmaceuticals Inc
    Hot Topic Speaker: Vibha Jawa, PhD, FAAPS (she/her/hers) – EpiVax Inc.
    Hot Topic Moderator: Vibha Jawa, PhD, FAAPS (she/her/hers) – EpiVax Inc.
    Hot Topic Speaker: Mita Mookherjee
    Bioanalytics
  • 10:30 AM - 11:30 AM CT
    Managing Difficult Stakeholders or Coworkers in a Workplace Environment
    Career Center Speaker: Kim Huynh-Ba, M.S., PMP, FAAPS (she/her/hers) – Pharmalytik
    Career Center Speaker: Allison Elizabeth Radwick, PhD (she/her/hers) – USP
    Career Development
  • 11:00 AM - 1:30 PM CT
    Dedicated Solution Center Hours
  • 12:00 PM - 1:00 PM CT
    From Passion to Practice: Global Health Opportunities for Pharmaceutical Scientists
  • 1:30 PM - 2:30 PM CT
    Keynote: 3D Printing: Driving Digital Transformation from Dosage Form Design to Product Development and Manufacturing
    Keynote Speaker: Xiaoling Li, PhD – University of the Pacific
    Moderator: Jie Shen, Ph.D. (she/her/hers) – Northeastern University
    Formulation and Delivery
  • 1:30 PM - 2:30 PM CT
    Keynote: Artificial Intelligence for Drug Delivery: Yesterday, Today and Tomorrow
    Keynote Speaker: Defang Ouyang, Ph.D. – University of Macau
    Moderator: Sanjay Konagurthu, PhD (he/him/his) – Thermo Fisher Scientific
    Formulation and Delivery
  • 1:30 PM - 2:30 PM CT
    Keynote: Building Regulatory Confidence in Molecular Assays
    Keynote Speaker: Russ S. Weiner, Ph.D., FAAPS – Alexion
    Bioanalytics
  • 1:30 PM - 2:30 PM CT
    Keynote: LNP and Delivery of RNA Products
    Keynote Speaker: Russel Johnson
    Moderator: Tian Li, Ph.D. – 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: Alan Watts, PhD – Catalent, Inc.
    Moderator: Ravi Kiran Kaja, PhD FRSC CChem (he/him/his) – 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: Mark Ma, PhD (he/him/his) – Biotech
    Moderator: Jennifer Grant, PhD – Beam Therapeutics
    Bioanalytics
  • 1:30 PM - 2:30 PM CT
    Keynote: Promoting Openness, Integrity, and Trustworthiness of Research Findings
    Keynote Speaker: Brian Nosek, Ph.D. – 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: Kim L.R Brouwer, PharmD, PhD – UNC Eshelman School of Pharmacy The University of North Carolina at Chapel Hill
    Moderator: Abhisheak Sharma, PhD – 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: Jin Y. Jin, PhD – Genentech, Inc.
    Moderator: Donald E. Mager, PharmD, PhD (he/him/his) – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
    Preclinical, Clinical, and Translational Sciences
  • 1:30 PM - 2:30 PM CT
    Strategic Career Mapping in a Dynamic Pharmaceutical Labor Market
  • 2:30 PM - 3:00 PM CT
    Coffee Break in the Solution Center
  • 3:00 PM - 4:00 PM CT
    Hot Topic: Promoting Open Science Policies to Accelerate Research Translation
    Hot Topic Moderator: Maryam Zaringhalam, PhD (she/her/hers) – Center for Open Science
    Hot Topic Speaker: Florian Montel
    Hot Topic Speaker: Fred Padilla
    Hot Topic Speaker: Robert Thibault
    Innovator Curated Track
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Accelerating Formulation Development via Predictive Modeling
    Rapid Fire Moderator: Yihong Qiu, Ph.D. – QPD Solutions
    Formulation and Delivery
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Advancing Bioanalysis for Next-Generation Therapeutics
    Rapid Fire Moderator: Xiaojiao Xue, PhD – Regeneron
    Bioanalytics
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Bioassay and Immunogenicity Decision Tools
    Rapid Fire Moderator: Pankajini Mallick
    Preclinical, Clinical, and Translational Sciences
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Continuous Manufacturing, Process Innovation & Biopharmaceutics
    Rapid Fire Moderator: Zhiqiang Guo – Merck and Co Inc
    Manufacturing and Analytical Characterization
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Emerging Manufacturing Technologies & Process Optimization
    Rapid Fire Moderator: Irena Tomaszewska, Ph.D. – Merck
    Manufacturing and Analytical Characterization
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Leveraging AI/ML in Formulation and Delivery Landscape
    Rapid Fire Moderator: Zhao Liu, PhD – Merck & Co., Inc.
    Formulation and Delivery
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Novel Modalities, Targeted Delivery and Disease Focused Translational Applications
    Rapid Fire Moderator: Susan Zondlo, PhD – QPS, LLC
    Preclinical, Clinical, and Translational Sciences
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Pushing the Boundaries of Hybrid LC-MS Bioanalysis
    Rapid Fire Moderator: Jim X. Shen, Ph.D. (he/him/his) – Bristol-Myers Squibb Company
    Bioanalytics
  • 3:30 PM - 4:30 PM CT
    Hot Topic: Navigating CMC Strategy in the Current Landscape
    Hot Topic Moderator: Swita Singh – Bristol Myers Squibb
    Hot Topic Speaker: Alfred Rumondor, PhD – Abbvie, Inc.
    Hot Topic Speaker: Ryan Soderquist
    Hot Topic Speaker: Parag Kolhe, PhD – Pfizer Inc.
    Hot Topic Speaker: Raj Hooli
    Manufacturing and Analytical Characterization
  • 5:30 PM - 7:30 PM CT
    University of Michigan Alumni & Friends Reception (by invitation only)
  • 5:30 PM - 7:30 PM CT
    UT Austin College of Pharmacy Alumni and Friends Reception
  • Tuesday, October 27, 2026
  • 7:00 AM - 8:30 AM CT
    Mentor Breakfast
  • 7:00 AM - 9:00 AM CT
    Quotient Sciences Breakfast Seminar: Integrated Formulation Development: Solubility Enhancement, Modified Release and AI-Informed Drug Development
  • 7:30 AM - 9:00 AM CT
    Dissolution Discussion Group Sponsored by Agilent
  • 7:30 AM - 5:00 PM CT
    Speaker Ready Room
  • 8:00 AM - 5:00 PM CT
    Registration Hours
  • 8:30 AM - 5:00 PM CT
    Solution Center Hours & Poster Presentations
  • 9:00 AM - 10:00 AM CT
    Hot Topic: Immunogenicity Expectations: Are They Fact or Fear?
    Hot Topic Speaker: Susan Kirshner – Former FDA OPQ
    Hot Topic Speaker: Yow-Ming C. Wang, PhD – FDA OCP
    Hot Topic Speaker: Mita Mookherjee
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Advanced Structural and Biophysical Characterization of Lipid Nanoparticle Systems and Biosimilars
    Moderator: Phillip Ramsey, M.S., M.B.A., R.A.C. (he/him/his) – Sangamo Therapeutics
    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: Jayachandra Ramapuram, Ph.D. – Auburn University
    Formulation and Delivery
  • 9:00 AM - 11:00 AM CT
    Symposium: Innovating Cancer Therapy: Translational Approaches Across New Modalities
    Moderator: Otilia M. Koo, PhD, FAAPS (she/her/hers) – Novo Nordisk
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: Measuring the Unmeasurable: Bioanalytical Innovation for Emerging Modalities
    Moderator: Jennifer Grant, PhD – Beam Therapeutics
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Model-Informed Innovation: Integrating NAMs Across Translational Workflows
    Moderator: Kent Grindstaff, PhD – BioIVT
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: Modern Analytical Strategies for Impurity Characterization and Lifecycle Management
    Moderator: Wenshan W. Zhuang, PhD – AbbVie, Inc.
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Oligonucleotide Bioanalysis: Ring Trial and Emerging Conjugate Modalities
    Moderator: Karan Agrawal, PhD (he/him/his) – Johnson & Johnson Innovative Medicine
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Precision Delivery Frontiers: Redefining RNA and Advanced Therapeutics
    Moderator: Annette Bak, PhD, MBA, FAAPS – AstraZeneca
    Formulation and Delivery
  • 9:00 AM - 11:30 AM CT
    Career Series 2: From Application to Offer: A Choose-Your-Own-Adventure Job Search
    Career Center Speaker: Stacey J. Tannenbaum, PhD – SJTPharm LLC
    Career Center Speaker: Carina Clingman, Ph.D. – Collaboratory Career Hub
    Career Development
  • 9:30 AM - 10:00 AM CT
    Coffee Break in the Solution Center
  • 10:00 AM - 11:00 AM CT
    Hot Topic: Hot Melt Extrusion 2.0-From Enabling Solubility to Smart Continuous Platforms
    Hot Topic Moderator: Gavin P. Andrews, PhD (he/him/his) – Queen's University Belfast
    Hot Topic Speaker: Chengzhe Gao
    Hot Topic Speaker: Dana E. Moseson-Tarrh, PhD (she/her/hers) – Eli Lilly and Company
    Hot Topic Speaker: Michael Repka, DDS PhD – University of Missippi
    Hot Topic Speaker: Thomas De Beer, PhD – Ghent University
    Manufacturing and Analytical Characterization
  • 11:00 AM - 1:30 PM CT
    Dedicated Solution Center Hours
  • 12:00 PM - 1:00 PM CT
    The A.R.T. of Connecting: A New Paradigm for Technical Presentations
    Career Center Speaker: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC
    Career Development
  • 1:30 PM - 2:30 PM CT
    Keynote: A Journey Navigating Drug-Drug Interaction in Discovery and Development
    Keynote Speaker: Xinning Yang, PhD (he/him/his) – Food and Drug Administration
    Moderator: Fenglei Huang, Ph.D. (he/him/his) – Boehringer Ingelheim
    Preclinical, Clinical, and Translational Sciences
  • 1:30 PM - 2:30 PM CT
    Keynote: Converging Platforms and Expanding Biological Insight
    Keynote Speaker: Karan Agrawal, PhD (he/him/his) – 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: Lynne S. Taylor, PhD – Purdue University
    Moderator: Sandip Tiwari, PhD (he/him/his) – 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: Mayank Patel, Ph.D. – AstraZeneca
    Moderator: Manmohan Singh, PhD – 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: Maria Guiterrez Lugo, PhD – U.S. Food & Drug Administration
    Moderator: Tian Li, Ph.D. – US Food and Drug Administration
    Manufacturing and Analytical Characterization
  • 1:30 PM - 2:30 PM CT
    Keynote: Measuring the Unmeasurable
    Keynote Speaker: Jim X. Shen, Ph.D. (he/him/his) – Bristol-Myers Squibb Company
    Moderator: Jennifer Grant, PhD – Beam Therapeutics
    Bioanalytics
  • 1:30 PM - 2:30 PM CT
    Keynote: Nanomedicine in Translation: From Design to Therapeutic Outcome
    Keynote Speaker: Annette Bak, PhD, MBA, FAAPS – AstraZeneca
    Moderator: Seeprarani Rath, PhD (she/her/hers) – 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: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
    Moderator: Tian Li, Ph.D. – US Food and Drug Administration
    Manufacturing and Analytical Characterization
  • 1:30 PM - 2:30 PM CT
    Owning Your Science — Intellectual Property, Contracts, and Career Leverage
    Career Center Moderator: Vivek Gupta, PhD, FAAPS – St. John's University
    Career Center Speaker: Aliasger Karimjee Salem, PhD – University of Iowa
    Career Center Speaker: Matyas Kolsofszki, RTTP, CPVA – St. John's University
    Career Center Speaker: Michelle Lavrichenko, PharmD, JD – Venable LLP
    Career Development
  • 2:30 PM - 3:00 PM CT
    Coffee Break in the Solution Center
  • 2:30 PM - 3:30 PM CT
    Hot Topic: GLP-1 Agonists and Drug Absorption: Gastric Emptying DDI Risks
    Hot Topic Speaker: Niloufar Salehi, PhD – Eli Lilly and Company
    Hot Topic Moderator: Niloufar Salehi, PhD – Eli Lilly and Company
    Hot Topic Speaker: Jessica Atieh, MD (she/her/hers) – Mayo Clinic
    Hot Topic Speaker: Jessica Rehmel, MS – Eli Lilly and Company
    Preclinical, Clinical, and Translational Sciences
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Advanced NAMs, Ex Vivo and Tissue Models
    Rapid Fire Moderator: Pankaj Dwivedi
    Preclinical, Clinical, and Translational Sciences
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Artificial Intelligence, Predictive Modeling & Digital Pharmaceutical Development
    Rapid Fire Moderator: Manish Baviskar, MS, DBM (he/him/his) – Hubot CDMO, South Bend, IN, USA
    Manufacturing and Analytical Characterization
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Breakthrough Technologies for Drug Product Development and Evaluation
    Rapid Fire Moderator: Li Li, PHD (she/her/hers) – Merck
    Formulation and Delivery
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Emerging Drug Product and Delivery Technologies
    Rapid Fire Moderator: Sharan Bobbala, PhD (he/him/his) – West Virginia University
    Formulation and Delivery
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Navigating Bioanalytical Complexity: Assay Performance, Biomarker Platforms, and Microsampling
    Bioanalytics
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Nitrosamine Risk Assessment & Advanced Analytical Characterization
    Rapid Fire Moderator: Heather Neu, PhD
    Manufacturing and Analytical Characterization
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Pre-Clinical and Clinical Models for Safety Assessment
    Rapid Fire Moderator: Sumanta Goswami
    Preclinical, Clinical, and Translational Sciences
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: When Biology Gets in the Way: Tackling Interference and Immunogenicity Challenges
    Bioanalytics
  • 5:30 PM - 7:00 PM CT
    Fellows Networking Reception (by invitation only)
  • 5:30 PM - 7:00 PM CT
    Sustaining Sponsor Reception (by invitation only)
  • 5:30 PM - 7:30 PM CT
    National Institute for Pharmaceutical Technology & Education (NIPTE)
  • 5:30 PM - 10:00 PM CT
    American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Dinner Meeting
  • 6:00 PM - 9:00 PM CT
    Simulations Plus After Hours Event "Rx to Rock" (by invitation only)
  • 6:00 PM - 10:00 PM CT
    IPEC Foundation Awards Ceremony (by invitation only)
  • Wednesday, October 28, 2026
  • 7:00 AM - 8:30 AM CT
    Women in PharmSci Breakfast
  • 7:30 AM - 3:30 PM CT
    Speaker Ready Room
  • 8:00 AM - 2:30 PM CT
    Registration Hours
  • 8:00 AM - 7:00 PM CT
    Coat Check
  • 8:30 AM - 1:30 PM CT
    Solution Center Hours & Poster Presentations
  • 9:00 AM - 10:00 AM CT
    Future-Ready Pharma Careers: AI Fluency, Cross-Disciplinary Skills, Market Awareness
  • 9:00 AM - 11:00 AM CT
    Symposium: Adaptive Dosage Modifications - MIDD Opportunities & Challenges
    Moderator: Ana Ruiz-Garcia, Pharm.D, PhD – Gilead Sciences, Inc.
    Preclinical, Clinical, and Translational Sciences
  • 9:00 AM - 11:00 AM CT
    Symposium: AI-Enabled Predictive Manufacturing and Product Intelligence
    Moderator: Yi Gao, Ph.D. – AbbVie 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: Amanda L. Hays, PhD – BioAgilytix
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Digital Transformation Through Mechanistic Modeling, QbD, and Collaborative Innovation
    Moderator: Phillip Ramsey, M.S., M.B.A., R.A.C. (he/him/his) – Sangamo Therapeutics
    Manufacturing and Analytical Characterization
  • 9:00 AM - 11:00 AM CT
    Symposium: Emerging Strategies for Oral Macromolecular Delivery
    Moderator: Wenzhan Yang, PhD – AstraZeneca Pharmaceuticals
    Formulation and Delivery
  • 9:00 AM - 11:00 AM CT
    Symposium: From Excipients to Outcomes: Optimizing Drug Performance Across Patient Populations
    Moderator: Niloufar Salehi, PhD – Eli Lilly and Company
    Formulation and Delivery
  • 9:00 AM - 11:00 AM CT
    Symposium: Innovations in Clinical Sampling and BA Lab AI/Automation
    Moderator: Maria Radu, MD PhD (she/her/hers) – Merck & Co., Inc.
    Bioanalytics
  • 9:00 AM - 11:00 AM CT
    Symposium: Translational Pharmacology and Quantitative Strategies for Next-Generation Anti-Cancer Biologics
    Moderator: Gautham Gampa, PhD – Genentech
    Preclinical, Clinical, and Translational Sciences
  • 9:30 AM - 10:00 AM CT
    Coffee Break in the Solution Center
  • 10:00 AM - 11:00 AM CT
    Hot Topic: Are Regulators on the Same Page for Pediatric Drug Data?
    Hot Topic Speaker: alysha Croker – health canada
    Hot Topic Moderator: Yasuhiro Tsume, PhD (he/him/his) – Merck & Co.
    Hot Topic Speaker: Smita Salunke, PhD (she/her/hers) – University College London/European Paediatric Formulation Initiative
    Hot Topic Speaker: John J. Alexander, MD, MPH (he/him/his) – U.S. Food and Drug Administration
    Preclinical, Clinical, and Translational Sciences
  • 10:30 AM - 11:30 AM CT
    Molecule to Market: Developing a Business Plan for Effective Fundraising
    Career Center Speaker: Karthik Raman, PhD (he/him/his) – Persist AI
    Career Center Speaker: Vivek Gupta, PhD, FAAPS – St. John's University
    Career Center Speaker: Vivek Mangalore Ghate, PhD – Yenepoya Technology Incubator and Shukra Laboratories
    Career Center Speaker: Seungik Cho
    Career Development
  • 11:00 AM - 1:30 PM CT
    Dedicated Solution Center Hours
  • 12:00 PM - 1:00 PM CT
    Building Artificial Intelligence Skills in Pharmaceutical Manufacturing and Validation
    Career Center Speaker: Manish Baviskar, MS, DBM (he/him/his) – Hubot CDMO, South Bend, IN, USA
    Career Development
  • 1:30 PM - 2:30 PM CT
    Keynote: Advancing Patient Focused Drug Product Design Through Intravitreal and Long Acting Delivery Innovation
    Keynote Speaker: Stephanie Barrett, Ph.D. – Merck & Co., Inc.
    Moderator: Seema Thakral, PhD – 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: Amanda L. Hays, PhD – BioAgilytix
    Moderator: Mark Ma, PhD (he/him/his) – 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: Ben Boyd, PhD (he/him/his) – Monash Institute of Pharmaceutical Sciences
    Moderator: Roger H. Pak, PhD – Pfizer, Inc.
    Formulation and Delivery
  • 1:30 PM - 2:30 PM CT
    Keynote: From Research to Impact: An Academic Perspective on Model-Informed Drug Discovery and Development (MID3)
    Keynote Speaker: Stephan Schmidt, PhD (he/him/his) – University of Florida
    Moderator: Shanghao Li, PhD – WuXi AppTec
    Preclinical, Clinical, and Translational Sciences
  • 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: Douglas Kiehl, MS – Purdue University
    Moderator: Tian Li, Ph.D. – 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: Win L. Chiou, PhD – University of Illinois at Chicago
    Moderator: Sudip K. Das, PhD (he/him/his) – 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: Shawn Zhang, Ph.D. (he/him/his) – digiM Solution LLC.
    Moderator: Ravi Kiran Kaja, PhD FRSC CChem (he/him/his) – USP
    Manufacturing and Analytical Characterization
  • 1:30 PM - 2:30 PM CT
    Keynote: Transforming the Regulated Lab of Today for the Digital World of Tomorrow
    Moderator: Maria Radu, MD PhD (she/her/hers) – Merck & Co., Inc.
    Keynote Speaker: Joe Rajarao, PhD, MBA (he/him/his) – Merck
    Bioanalytics
  • 1:30 PM - 8:00 PM CT
    Exhibitor Move-Out
  • 2:30 PM - 3:30 PM CT
    Hot Topic: From Viscosity to Stability: Formulation Technologies for Concentrated Biologics
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Advanced Modalities, Biologics & Next-Generation Characterization
    Rapid Fire Moderator: Heather Neu, PhD
    Manufacturing and Analytical Characterization
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Beyond Conventional Samples: Approaches in Tissue Bioanalysis and Biosensing
    Bioanalytics
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Product Development with Patient in Mind
    Rapid Fire Moderator: Thomas Durig, Ph.D. – Barentz
    Formulation and Delivery
  • 3:00 PM - 4:00 PM CT
    Rapid Fire: Quantitative Modeling and MIDD Approaches
    Rapid Fire Moderator: Abhisheak Sharma, PhD – University of Florida
    Preclinical, Clinical, and Translational Sciences
  • 4:15 PM - 5:30 PM CT
    Closing Plenary with Dr. David Berry
    Plenary Speaker: David Berry
  • 5:30 PM - 6:30 PM CT
    Closing Reception