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  • Prologue: "Grades" of Ancillary, Raw and Starting Materials and Excipients

    Prologue Speaker: Allison Elizabeth Radwick, Ph.D. – USP

  • Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous Biomarkers

    Prologue Speaker: Sibylle Neuhoff, PhD – Certara

  • Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine Innovations

    Prologue Speaker: Wei Xu, Ph.D. – Merck & Co., Inc.

  • Prologue: Alternative Methods to Animal Studies: Artificial Tissue to Artificial Intelligence

    Prologue Speaker: Ketan D. Patel, PhD – St. John's University

  • Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future Prospects

    Prologue Speaker: Kelly Fader

  • Prologue: Biomarker and Omics Approaches

    Prologue Speaker: Robert Dodge, PhD – Novartis

  • Prologue: Biomarker Assays Are Not PK Assays: Prologue on Biomarker Assays

    Prologue Speaker: Lauren Stevenson, PhD – Immunologix Laboratories

  • Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation Therapeutics

    Prologue Speaker: Ketan D. Patel, PhD – St. John's University

  • Prologue: Brevican-Targeting Peptide for Therapeutic Delivery to Glioblastoma: Tools for Drug Discovery

    Prologue Speaker: Choi-Fong Cho, PhD – Brigham and Women's Hospital, Harvard Medical School

  • Prologue: Current Status of Transporter-Mediated Drug Delivery

    Prologue Speaker: Elena Puris, PhD – Institute of Pharmacy and Molecular Biotechnology/Heidelberg University

  • Prologue: Current Trends and Research Opportunities for Collaboration in Pediatric Formulation Development

    Prologue Speaker: Stephen W. Hoag, Ph.D., FAAPS – University of Maryland, Baltimore

  • Prologue: Drug Delivery Alternatives to Injectables For Systemic Availability

    Prologue Speaker: Jaap Wieling, Ph.D. – PureIMS BV

  • Prologue: Embracing Innovation: Harnessing Emerging Technologies for Enhanced Pharmaceutical Quality
  • Prologue: Emerging Applications of Data Driven and Hybrid Modelling in Pharmaceutical Manufacturing
  • Prologue: Emerging Trends in Continuous Manufacturing of Pharmaceuticals
  • Prologue: Excipients: It's Complicated
  • Prologue: From Modality-Specific to Boundaryless Analytics – Delivering the Pipeline of Tomorrow
  • Prologue: Health Disparities Research: How Basic Science can Inform Clinical Practice
  • Prologue: Immunogenicity and Regulatory Considerations
  • Prologue: LC-MS Approaches and Advances
  • Prologue: Modelling and Predictive Design in Pharmaceutical Development
  • Prologue: Patient Centric Sampling: Tips and Tricks for Bioanalysis
  • Prologue: Preformulation and Biopharmaceutical Support for Drug Delivery
  • Prologue: Role of Biomarkers in Rare Disease Drug Development and Regulatory Approval
  • Prologue: The CGT Landscape
  • Prologue: Use of Artificial Intelligence and Machine Learning in Regulatory Submissions
  • Friday, October 20, 2023
  • 12:00 PM – 5:00 PM ET
    Registration Hours
  • 1:00 PM – 5:00 PM ET
    Exhibitor Move-In (Booths 300 SF or larger)
  • Saturday, October 21, 2023
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 8:00 AM – 5:00 PM ET
    Exhibitor Move-In
  • Sunday, October 22, 2023
  • 7:00 AM – 7:00 PM ET
    Registration Hours
  • 8:00 AM – 5:00 PM ET
    Exhibitor Move-In
  • 9:00 AM – 1:00 PM ET
    Business Development Advisory Board (by invitation only)
  • 12:00 PM – 4:00 PM ET
    Speaker Ready Room
  • 5:00 PM – 6:30 PM ET
    Opening Plenary with Dr. Thomas Hartung
    Plenary Speaker: Thomas Hartung, MD, PhD – Johns Hopkins University
  • 6:30 PM – 8:00 PM ET
    Welcome Reception
  • 8:00 PM – 9:30 PM ET
    American Society of Iranian Pharmaceutical Scientists
  • Monday, October 23, 2023
  • 7:00 AM – 9:00 AM ET
    The Integration of Clinical Trials and Clinical Care: A Revolution in the Participant and Sponsor Experience or an Implementation Nightmare? Or Both?
    Executive Education Speaker: Jeanne Hecht, MBA, PMP (she/her/hers) – JTH Consulting & Associates
    Executive Education Speaker: Gerald E. Finken, R.Ph., M.S. (he/him/his) – RxE2 Inc.
    Executive Track
  • 7:30 AM – 8:30 AM ET
    AAPS Joint Editorial Board Breakfast (by invitation only)
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 7:30 AM – 5:00 PM ET
    Speaker Ready Room
  • 8:00 AM – 9:00 AM ET
    Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)
  • 8:30 AM – 2:00 PM ET
    Guest Tour: Space Coast River Tour (additional fee required)
  • 8:30 AM – 4:30 PM ET
    Coffee Station
  • 8:30 AM – 4:30 PM ET
    Free Professional Headshots
  • 8:30 AM – 4:30 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 4:30 PM ET
    Mock Interviews
  • 8:30 AM – 5:00 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM ET
    Developing Critical Thinking Skills Needed for Your Job
    Career Center Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training
    Career Development
  • 9:00 AM – 10:00 AM ET
    Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century Modalities
    Hot Topic Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Hot Topic Speaker: Jenny Valentine, PhD (she/her/hers) – Regeneron Pharmaceuticals
    Hot Topic Speaker: Laura I. Salazar-Fontana, PhD (she/her/hers) – LAIZ Regulatory Science Consulting
    Hot Topic Moderator: Michael Partridge, PhD – Regeneron
    Hot Topic Speaker: Kyra J. Cowan, PhD – Merck KGaA
    Bioanalytics – Biomolecular
  • 9:00 AM – 10:00 AM ET
    Overcome Capping Challenges and Increase Tableting Speed in Direct Compression
    Partner Presentation Speaker: Talles Ernica, MD – Roquette America Inc.
    Formulation and Delivery
  • 9:00 AM – 10:30 AM ET
    Symposium: Advances in Predictive Biomarkers For Drug Development
    Moderator: Manthena V. Varma, PhD – Pfizer Inc
    Preclinical and Translational Sciences
  • 9:00 AM – 11:00 AM ET
    Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1
    Moderator: Jing Ling, PhD – Merck & Co., Inc.
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2
    Moderator: Na Li, Ph.D. (she/her/hers) – University of Connecticut
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1
    Moderator: Jason Rodriguez, PhD – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2
    Moderator: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug Delivery
    Moderator: Patrick Ronaldson, PhD – University of Arizona
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM ET
    Symposium: PD Biomarkers As Evidence in Rare Disease
    Moderator: Lakshmi Amaravadi, PhD – Kojin Therapeutics
    Preclinical and Translational Sciences
  • 9:00 AM – 11:00 AM ET
    Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 1
    Moderator: Shefali Patel, BSc., MLT – Janssen Research and Development, LLC
    Bioanalytics
  • 9:00 AM – 11:00 AM ET
    Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 2
    Moderator: Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc.
    Bioanalytics
  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    From Concept to Clinic: Navigating RNA-Lipid Nanoparticle Development
    Partner Presentation Speaker: Jagbir Singh, PhD – Precision NanoSystems
    Formulation and Delivery
  • 9:30 AM – 10:30 AM ET
    Lipidomic Applications to Support Pharmaceutical Early Discovery and Safety Assessment
    Partner Presentation Speaker: Andrea Coates, MRes PhD (she/her/hers) – Charles River
    Discovery and Basic Research
  • 9:30 AM – 10:30 AM ET
    Overcoming Formulation Challenges with Binder Jetting 3D Printing Platforms
    Chalk Talk Presenter: Michael Gosselin, PhD – Aprecia Pharmaceuticals
    Formulation and Delivery
  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Surveying the Landscape of Extracellular Vesicles as Drug Delivery Agents
    Moderator: Sudip Das, PhD (he/him/his) – Butler University
    Spotlight Speaker: Thomas Schmittgen, PhD (he/him/his) – University of Florida
    Discovery and Basic Research
  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: The Path to Peak Performance: PAT Solutions for Advanced Process Control in Continuous Pharmaceutical Manufacturing
    Spotlight Speaker: Thomas De Beer, PhD (he/him/his) – Ghent University
    Manufacturing & Analytical Characterization
  • 9:30 AM – 10:30 AM ET
    Special Poster Collection
  • 10:00 AM – 11:00 AM ET
    Career Conversations: Hosted by Merck
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Drug Delivery Technology: Quo Vadis?
    Hot Topic Speaker: Kinam Park, PhD (he/him/his) – Purdue University
    Hot Topic Speaker: Richard H. Guy, PhD, FAAPS – University of Bath
    Hot Topic Speaker: Robert Lionberger, PhD – U.S. Food & Drug Administration
    Hot Topic Moderator: Richard H. Guy, PhD, FAAPS – University of Bath
    Hot Topic Speaker: Randall Mrsny, Ph.D. (he/him/his) – University of Bath
    Formulation and Delivery – Chemical
  • 10:30 AM – 11:30 AM ET
    Catalyze Your Success: Developing Business Acumen and Leadership
    Career Center Moderator: Pankajini Mallick, PhD (she/her/hers) – Neurocrine
    Career Center Speaker: Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca
    Career Center Speaker: Venus Huang, PhD (she/her/hers) – TriLink Biotechnologies
    Career Development
  • 10:30 AM – 11:30 AM ET
    Precision Microspheres: Then and Now
    Partner Presentation Speaker: Nathan Dormer, PhD (he/him/his) – Adare Pharma Solutions
    Formulation and Delivery
  • 10:30 AM – 11:30 AM ET
    Special Poster Collection - Best Poster Award Winners
  • 11:00 AM – 12:00 PM ET
    Career Conversations: Hosted by GSK
  • 11:00 AM – 12:00 PM ET
    Inhalation Pharmacokinetics and Toxicity of CBD and other Cannabinoids
    Partner Presentation Speaker: Philip J. Kuehl, PhD – Lovelace Biomedical Research Institute
    Preclinical and Translational Sciences
  • 11:00 AM – 12:00 PM ET
    Unleash Small and Large Molecule Solutions for Biologics and Gene-Therapy
    Partner Presentation Speaker: Andre Mueller, PhD (he/him/his) – Unchained Labs
    Partner Presentation Speaker: Del Ray Jackson, PhD – Unchained Labs
    Partner Presentation Speaker: Ben Knappett, PhD – Unchained Labs
    Bioanalytics
  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM ET
    Accelerating Immunogenicity Analysis: From IgG- to AAV-based Therapies
    Chalk Talk Presenter: Eric Feeley, Ph.D. – Gyros Protein Technologies
    Preclinical and Translational Sciences
  • 11:15 AM – 12:00 PM ET
    Advances in Targeting Ion Channels with Biologics and Small Molecules
    Chalk Talk Presenter: Doug Krafte, PhD (he/him/his) – OmniAb, Inc.
    Discovery and Basic Research
  • 11:15 AM – 12:00 PM ET
    Microcrystalline cellulose with innovative and unique particle morphologies
    Chalk Talk Presenter: Raxit Mehta – Asahi Kasei America
    Formulation and Delivery
  • 11:30 AM – 12:30 PM ET
    Special Poster Collection
  • 12:00 PM – 1:00 PM ET
    AAPS Committee Chairs Discussion (by invitation only)
  • 12:00 PM – 1:00 PM ET
    How to Win a (Small Business) Grant
    Career Center Speaker: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.
    Career Development
  • 12:00 PM – 2:00 PM ET
    User Group Meeting: The Power of Phoenix Tools Analyzing PK Data
    Tech Spotlight Speaker: Ana Henry, M.S., Biomathematics – Certara
    Tech Spotlight Speaker: Chris Mehl, M.S – Certara
    Tech Spotlight Speaker: Fred Mahakian (he/him/his) – Certara
    Tech Spotlight Speaker: Michael Clifton, BS – Certara
    Preclinical and Translational Sciences
  • 12:30 PM – 1:15 PM ET
    Application of Accurate Mass Spectrometry for Nitrosamine Impurities in Metformin
    Chalk Talk Presenter: Dan Safarpour, PhD (he/him/his) – Symbiotic Research, LLC
    Bioanalytics
  • 12:30 PM – 1:15 PM ET
    Calcium Carbonate as Alternative to Titanium Dioxide in Coatings
    Chalk Talk Presenter: Giovanni Raspantini, PharmD (he/him/his) – MilliporeSigma a Business of Merck KGaA
    Formulation and Delivery
  • 12:30 PM – 1:15 PM ET
    Challenges and Opportunities for Bioanalytical Support of New Drug Modalities
    Chalk Talk Presenter: Daniel Sikkema, PhD – Labcorp
    Bioanalytics
  • 12:30 PM – 1:30 PM ET
    Leveraging Advanced Raman and UV-Vis Techniques in Pharmaceutical Manufacturing Processes
    Partner Presentation Speaker: Yanqia Wang, PhD – Agilent
    Manufacturing & Analytical Characterization
  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 12:30 PM – 1:30 PM ET
    The Viscosity Reduction Platform: Enabling High-concentration and Low-viscosity Protein Formulations
    Partner Presentation Speaker: Can Araman, PhD – MilliporeSigma
    Formulation and Delivery
  • 1:00 PM – 1:30 PM ET
    Sean Ekins, Author of “Winning Grants”, Book Signing and Meet and Greet
  • 1:00 PM – 2:00 PM ET
    Career Conversation: Hosted by AstraZeneca
  • 1:30 PM – 2:30 PM ET
    Employing Psychological Safety Approaches to Promote Inclusion and Innovation
    Career Center Moderator: Gayle A. Brazeau, PhD (she/her/hers) – Marshall University School of Pharmacy
    Career Center Speaker: Cynthia A. Jones, PhD (she/her/hers) – Marshall University School of Pharmacy
    Career Center Speaker: Evan T. Robinson, RPh, PhD – Creighton University School of Pharmacy and Health Professions
    Career Development
  • 1:30 PM – 2:30 PM ET
    Keynote: Apply Endogenous Biomarkers to Detect DDIs
    Keynote Speaker: Hiroyuki Kusuhara, PhD (he/him/his) – Graduate School of Pharmaceutical Sciences, the University of Tokyo
    Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and Unicorns
    Keynote Speaker: Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc
    Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Keynote: Crossing Modalities: Analytical Adventures at the Interface of Small and Large Molecules
    Keynote Speaker: Narayan Variankaval, PhD – Merck & Co
    Moderator: Jason Rodriguez, PhD – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Crystal and Particle Engineering Strategies in Pharmaceutical Product Development and Manufacturing
    Keynote Speaker: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen
    Moderator: Sushrut Marathe, PhD (he/him/his) – GSK
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Engineering and Characterizing Large Molecule Delivery to the Brain: Taking Antibodies, Enzymes, and Other Proteins to the Final Frontier
    Keynote Speaker: Robert G. Thorne, PhD (he/him/his) – Denali Therapeutics & University of Minnesota
    Moderator: Steven W. Louie, MS (he/him/his) – Moderna
    Discovery and Basic Research
  • 1:30 PM – 2:30 PM ET
    Keynote: Patient Centricity: One Blood Draw at a Time
    Keynote Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
    Moderator: Catherine L. Brockus, PhD (she/her/hers) – Eli Lilly and Company
    Bioanalytics
  • 1:30 PM – 2:30 PM ET
    Keynote: Predicting Formulation Performance: Learning from Generic Drugs
    Keynote Speaker: Robert Lionberger, PhD – U.S. Food & Drug Administration
    Moderator: Yan Wang, PhD (she/her/hers) – U.S. Food and Drug Administration
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: Shrinking Time to Market Through the Targeted Integration of Technology, Modeling, and Patient Centricity
    Keynote Speaker: Bikash Chatterjee (he/him/his) – Pharmatech Associates
    Moderator: Stephanie Gaulding, CPGP, CQA (she/her/hers) – Pharmatech Associates
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: The Bioanalytical Program: From Strategy to Implementation –Current State and Additional Considerations
    Keynote Speaker: Jad Zoghbi, MS – Biogen
    Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company
    Bioanalytics
  • 1:30 PM – 2:30 PM ET
    Special Poster Collection
  • 2:00 PM – 3:00 PM ET
    Leveraging Lipid-Based Formulations for Bioavailability, Compliance, and Scalability from Preclinical to Commercial
    Partner Presentation Speaker: Karunakar Sukuru, R.Ph., PhD, – Catalent
    Formulation and Delivery
  • 2:00 PM – 4:00 PM ET
    Challenges and Opportunities of Protein-long Active Injectables
    Partner Presentation Speaker: Karolina Dziemidowicz, PhD, MPharm (she/her/hers) – UCL School of Pharmacy
    Partner Presentation Speaker: Aiva Simaite, PhD – InnoCore Pharmaceuticals
    Partner Presentation Speaker: Puneet Tyagi, Ph.D. – Dosage Form Design and Development,
    Formulation and Delivery
  • 2:30 PM – 3:00 PM ET
    Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)
  • 2:30 PM – 3:00 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Hot Topic: Inhalable Aerosol Immune Engineering
    Hot Topic Speaker: Catherine A. Fromen, PhD (she/her/hers) – University of Delaware
    Hot Topic Moderator: Sumanta Goswami
    Discovery and Basic Research
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Advances in Predictive Biomarkers for DDIs
    Spotlight Speaker: Manthena V. Varma, PhD – Pfizer Inc
    Moderator: Fei Hua, PhD – Applied BioMath
    Preclinical and Translational Sciences
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Formulation & Delivery
    Spotlight Speaker: Steve Byrn, PhD – Purdue University
    Moderator: Vadim J. Gurvich, PhD – University of Minnesota
    Formulation and Delivery
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Single-Cell Multi-Omics for Cell and Gene Therapies
    Spotlight Speaker: Priya S. Chockalingam, PhD (she/her/hers) – Beam Therapeutics
    Moderator: Karen J. Quadrini, PhD – Passage Bio, Inc
    Bioanalytics
  • 2:30 PM – 3:30 PM ET
    Special Poster Collection
  • 3:00 PM – 4:00 PM ET
    Exploring Chromatography Methods for the Analysis of Oligonucleotide Therapeutics
    Partner Presentation Speaker: Sandeep kondaveeti, PhD (he/him/his) – Agilent
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by Porton
  • 3:00 PM – 4:00 PM ET
    Job Offers 101: What to Expect Across Different Career Stages
    Career Center Moderator: Maya Lipert, PhD – AbbVie Inc.
    Career Center Speaker: Anna Schwendeman, PhD (she/her/hers) – University of Michigan
    Career Center Speaker: Amy C. Doty, PhD (she/her/hers) – Sage Therapeutics
    Career Center Speaker: Elizabeth Joshi, PhD, MBA (she/her/hers) – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company
    Career Center Speaker: Jane Kenny, PhD (she/her/hers) – Genentech
    Career Development
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1
    Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2
    Rapid Fire Speaker: Tzichi Ju, Ph.D. – AbbVie Inc.
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1
    Rapid Fire Moderator: Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2
    Rapid Fire Moderator: Natalia Subelzu, Ph.D. (she/her/hers) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug Delivery
    Rapid Fire Moderator: Xiaoshu Pan, PhD – University of Florida College of Pharmacy
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Development 1
    Rapid Fire Moderator: Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Developments 2
    Rapid Fire Moderator: F. Yushra Thanzeel, PhD – Merck & Co., Inc.
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 1
    Rapid Fire Moderator: Linlin Luo, Ph.D. – Merck & Co., Inc.
    Bioanalytics
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 2
    Rapid Fire Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals
    Bioanalytics
  • 3:30 PM – 4:30 PM ET
    Customization of Functional Capsules: An Enteric Delivery Case Study
    Partner Presentation Speaker: Vincent Jannin, PhD (he/him/his) – Lonza
    Manufacturing & Analytical Characterization
  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by Alturas Analytics, Inc.
  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by GlobePharma, Inc.
  • 3:30 PM – 4:30 PM ET
    Hot Topic: Product and Process Design for Long Acting Injectable (LAI) Formulations
    Hot Topic Speaker: Sujatha Sonti, Dr – GSK
    Hot Topic Moderator: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
    Manufacturing & Analytical Characterization
  • 3:30 PM – 4:30 PM ET
    Special Poster Collection
  • 4:00 PM – 5:00 PM ET
    AAPS Biomarkers & Precision Medicine Community Membership Meeting
    Community Leader: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC
  • 4:00 PM – 5:00 PM ET
    AAPS Gene & Cell Therapy Products Community Membership Meeting
    Community Leader: Vittal Shivva, PhD – Genentech, Inc.
  • 4:00 PM – 5:00 PM ET
    AAPS Global Health Community Membership Meeting
    Community Leader: Sudip Das, PhD (he/him/his) – Butler University
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by Neopharm Labs
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by SENTRYSCIENCES, INC
  • 4:00 PM – 5:00 PM ET
    Start-Up Pavilion Happy Hour
  • 4:15 PM – 4:30 PM ET
    Rapid Fire: Nurturing Unity: Integrating New Graduates into the Pharmaceutical Industry Workspace
    Rapid Fire Speaker: Yoon Sik Jung (he/him/his) – University of Southern California
    Career Development
  • 5:00 PM – 6:00 PM ET
    AAPS Chemistry, Manufacturing, & Controls (CMC) Community Membership Meeting
    Community Leader: Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited
  • 5:00 PM – 6:00 PM ET
    AAPS Drug Transport Community Membership Meeting
    Community Leader: Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center
  • 5:00 PM – 6:00 PM ET
    AAPS In Vitro Release & Dissolution Testing Community Membership Meeting
    Community Leader: Jie Shen, PhD (she/her/hers) – Northeastern University
  • 5:00 PM – 6:00 PM ET
    AAPS Inhalation & Nasal Community Membership Meeting
    Community Leader: Vivek Gupta, PhD – St. John's University
  • 5:00 PM – 6:00 PM ET
    AAPS Ocular Drug Delivery & Disposition Community Membership Meeting
    Community Leader: Chun-Wan Yen, PhD (she/her/hers) – Genentech, Inc.
  • 5:00 PM – 6:00 PM ET
    AAPS Preformulation & Formulation Design/Development Community Membership Meeting
    Community Leader: Deepak Bahl, PhD – Bristol-Myers Squibb Company
  • 5:00 PM – 6:00 PM ET
    AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership Meeting
    Community Leader: Yuan Cheng, PhD (he/him/his) – Regeneron Pharmaceuticals
  • 5:00 PM – 6:00 PM ET
    AAPS Regulatory Sciences Community Membership Meeting
    Community Leader: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc
  • 5:00 PM – 6:00 PM ET
    AAPS Stability Community Membership Meeting
    Community Leader: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training
    Community Leader: Lori McCaig, PhD (she/her/hers) – Seagen Inc.
  • 5:00 PM – 6:00 PM ET
    AAPS Topical & Transdermal Community Membership Meeting
    Community Leader: Nisarg N. Modi, PhD (he/him/his) – Transdermal Research Pharm Laboratories LLC
  • 5:00 PM – 7:00 PM ET
    University of Kansas Department of Pharmaceutical Chemistry Alumni Reception (by invitation only)
  • 5:00 PM – 7:00 PM ET
    University of Michigan College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 6:30 PM ET
    Minnesota Alumni Reception
  • 5:30 PM – 7:30 PM ET
    University of Wisconsin-Madison School of Pharmacy Reception
  • 5:30 PM – 7:30 PM ET
    UT Austin College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 8:00 PM ET
    University at Buffalo Alumni & Friends Reception
  • 5:30 PM – 8:00 PM ET
    University of Utah - Department of Molecular Pharmaceutics Reception
  • 6:00 PM – 8:00 PM ET
    St. John's University Alumni & Friends Reception
  • 6:00 PM – 8:00 PM ET
    University of Florida College of Pharmacy Meet the Dean
  • 7:00 PM – 9:00 PM ET
    President's Reception (by invitation only)
  • 7:00 PM – 9:00 PM ET
    UConn School of Pharmacy Alumni Reception
  • Tuesday, October 24, 2023
  • 7:00 AM – 8:30 AM ET
    Mentor Breakfast
  • 7:00 AM – 9:00 AM ET
    Quotient Sciences Breakfast Seminar (by invitation only)
  • 7:30 AM – 5:00 PM ET
    Registration Hours
  • 7:30 AM – 5:00 PM ET
    Speaker Ready Room
  • 8:30 AM – 4:30 PM ET
    Coffee Station
  • 8:30 AM – 4:30 PM ET
    Free Professional Headshots
  • 8:30 AM – 4:30 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 4:30 PM ET
    Mock Interviews
  • 8:30 AM – 5:00 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 9:30 AM ET
    2023 AAPS High Impact Manuscript Award Rapid Fire Presentations
    Rapid Fire Moderator: Robert O. Williams, III, PhD (he/him/his) – University of Texas at Austin
  • 9:00 AM – 10:00 AM ET
    Recent Advances in Improving Patient Wellbeing Through Long-acting Injectable Formulations
    Partner Presentation Speaker: Purushottam Singnurkar, PhD (he/him/his) – Syngene International Ltd
    Formulation and Delivery
  • 9:00 AM – 10:00 AM ET
    The Science of Story Telling: Mastering Your Presentation
    Career Center Speaker: Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC
    Career Development
  • 9:00 AM – 11:00 AM ET
    Symposium: Addressing Health Disparities in Basic Science Research
    Moderator: Melanie Felmlee, Ph.D. (she/her/hers) – University of the Pacific
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM ET
    Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1
    Moderator: Sayantan Chattoraj, PhD – GSK
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2
    Moderator: Thomas De Beer, PhD (he/him/his) – Ghent University
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: Approaches for Emerging Modalities and Complex Studies 1
    Moderator: HsinPin Ho, Ph.D. – Bristol Myers Squibb Company
    Bioanalytics
  • 9:00 AM – 11:00 AM ET
    Symposium: Approaches for Emerging Modalities and Complex Studies 2
    Moderator: Troy Voelker, PhD – Aliri Bioanalysis
    Bioanalytics
  • 9:00 AM – 11:00 AM ET
    Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1
    Moderator: Anette Mullertz, PhD, FAAPS – University of Copenhagen
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2
    Moderator: Haichen Nie, PhD – Teva Pharmaceuticals
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Evolving Clinical Pharmacology and Translational PK/PD Approaches For New Modalities
    Moderator: Hardik Mody, PhD – Genetech
    Preclinical and Translational Sciences
  • 9:00 AM – 11:00 AM ET
    Symposium: Harnessing The Power of AI/ML in Drug Development
    Moderator: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc
    Preclinical and Translational Sciences
  • 9:00 AM – 4:00 PM ET
    Career Fair
  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    Challenges in Analytical Aerosol Methods for High Payload Inhalation Products
    Chalk Talk Presenter: Blaine Bueche, PhD – Kindeva Drug Delivery
    Formulation and Delivery
  • 9:30 AM – 10:30 AM ET
    Leverage Bioanalysis Outsourcing Partnerships to Support Complex Clinical Trials
    Partner Presentation Speaker: Joe Marino (he/him/his) – LabConnect
    Bioanalytics
  • 9:30 AM – 10:30 AM ET
    Next-Generation Bioprocessing Strategies to Improve Speed, Cost and Tech Transfer
    Partner Presentation Speaker: Shendi Lu – IDBS
    Manufacturing & Analytical Characterization
  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Evolving Clinical Pharmacology and Translational PK/PD Approaches for New Modalities
    Spotlight Speaker: Joshua F. Apgar, PhD (he/him/his) – Applied BioMath, LLC
    Moderator: Fei Hua, PhD – Applied BioMath
    Preclinical and Translational Sciences
  • 9:30 AM – 10:30 AM ET
    Speaker Spotlight: Targeted vs Untargeted Workflows to Quantify Oligonucleotide Therapeutics by High Resolution Mass Spectrometry
    Spotlight Speaker: Ryan Hill (he/him/his) – Drug Disposition/ADME/Eli Lilly and Company
    Moderator: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
    Bioanalytics
  • 9:30 AM – 10:30 AM ET
    Special Poster Collection
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Regulatory Challenges and Considerations for Orally Inhaled Drug Product
    Hot Topic Speaker: Adrian Goodey, PhD – Merck
    Hot Topic Speaker: Sue Holmes, MS – GSK
    Hot Topic Moderator: Parind Desai, PhD – GlaxoSmithKline
    Manufacturing & Analytical Characterization – Chemical
  • 10:00 AM – 12:00 PM ET
    Taste of Orlando Smoothie Station Sponsored by Eurofins
  • 10:30 AM – 11:30 AM ET
    New Generation of Digital Self-Serve Formulation Platform Boosts R&D Productivity
    Partner Presentation Speaker: Shahrzad Missaghi, PhD – Colorcon
    Partner Presentation Speaker: Jo Varshney, PhD – VeriSIM Life
    Formulation and Delivery
  • 10:30 AM – 11:30 AM ET
    Special Poster Collection
  • 10:30 AM – 11:30 AM ET
    Three Communication Skills You Must Build to Lead a Team
    Career Center Speaker: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC
    Career Development
  • 11:00 AM – 12:00 PM ET
    Improvements to PS80 Determination in Drug Product Formulations
    Partner Presentation Speaker: Joseph P. Campbell, PhD (he/him/his) – Prolytix - Essex Junction, VT
    Manufacturing & Analytical Characterization
  • 11:00 AM – 12:00 PM ET
    Safely Handling Potent APIs to Protect Workers/Product Protection at CMOs/CDMOs/CROs
    Partner Presentation Speaker: Robert G. Sussman, PhD, DABT (he/him/his) – SafeBridge Regulatory & Life Sciences Group
    Manufacturing & Analytical Characterization
  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM ET
    AI for Subvisible Particle Image Analysis Delivers Actionable Data
    Chalk Talk Presenter: Eric Gottlieb, BSc, MBA – SentrySciences, Inc.
    Manufacturing & Analytical Characterization
  • 11:15 AM – 12:00 PM ET
    Liposomal formulations in advanced-cancer therapies and challenges in early-stage development
    Chalk Talk Presenter: Naoki Yamada, MS – FUJIFILM Pharmaceutical U.S.A., Inc.
    Formulation and Delivery
  • 11:15 AM – 12:00 PM ET
    Revolutionize Critical Reagent Development with Rabbit Single B-Cell Technology
    Chalk Talk Presenter: Hao Cheng, PhD (he/him/his) – Yurogen Biosystems
    Bioanalytics
  • 11:30 AM – 12:00 PM ET
    David P. Otey, MA, MBA, Book Signing and Meet and Greet
  • 11:30 AM – 12:30 PM ET
    Special Poster Collection
  • 12:00 PM – 1:00 PM ET
    How Professionals Keep Work-Life Balance and What is Work-Culture?
    Career Center Speaker: Yasuhiro Tsume, PhD – Merck
    Career Center Speaker: Michael Callahan (he/him/his) – Charles River Laboratories
    Career Center Speaker: Catherine A. Fromen, PhD (she/her/hers) – University of Delaware
    Career Center Speaker: Corinne B. Jankovsky, PhD – Boehringer-Ingelheim
    Career Development
  • 12:00 PM – 1:00 PM ET
    Purification of Oligonucleotides Using Prep-LC MS/UV with Improved IP-RPLC Chromatography
    Partner Presentation Speaker: Olof Torsten Stålberg, Sr., PhD (he/him/his) – Agilent
    Discovery and Basic Research
  • 12:30 PM – 1:15 PM ET
    Considerations in the Development of Potency Assays for ATMPs
    Chalk Talk Presenter: Jeff Patrick, PhD (he/him/his) – BioAgilytix - Durham, NC
    Manufacturing & Analytical Characterization
  • 12:30 PM – 1:15 PM ET
    Designing Pharmaceutical Materials for Extrusion Enabled Continuous Manufacturing
    Chalk Talk Presenter: Thomas Dürig, PhD – Ashland
    Formulation and Delivery
  • 12:30 PM – 1:15 PM ET
    Hyaluronic Nanogel: Facile Fabrication for Solubilization, SR and Vaccine Applications
    Chalk Talk Presenter: Takero Kurosawa, M.S. – Asahi Kasei
    Formulation and Delivery
  • 12:30 PM – 1:30 PM ET
    Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?
    Partner Presentation Speaker: Jim Herman, PhD, DABT (1992-2022) – Certara
    Preclinical and Translational Sciences
  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 12:30 PM – 1:30 PM ET
    Subvisible Particle Analysis Using Flow Imaging Microscopy and Light Obscuration
    Partner Presentation Speaker: Austin Daniels, PhD (he/him/his) – Yokogawa Fluid Imaging Technologies
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Excipient Taxonomy for the 21st Century: A Grand Challenge for the Pharmaceutical Sciences Community
    Keynote Speaker: Bruno Hancock, PhD (he/him/his) – Pfizer Inc.
    Moderator: Haichen Nie, PhD – Teva Pharmaceuticals
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current Research
    Keynote Speaker: Michelle Lynn Hall, PhD (she/her/hers) – Eli Lilly
    Moderator: Yan G. Ni, PhD – Passage Bio
    Bioanalytics
  • 1:30 PM – 2:30 PM ET
    Keynote: Health Disparities in Basic Science: Implications for Pharmacological Research
    Keynote Speaker: Kathleen Giacomini, PhD (she/her/hers) – University of California, San Francisco
    Moderator: Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center
    Discovery and Basic Research
  • 1:30 PM – 2:30 PM ET
    Keynote: In Vitro In Vivo Correlation (IVIVC) for Long Acting Injectable (LAI) Formulations
    Keynote Speaker: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
    Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Navigating Project Optimus: Use of Modeling and Simulation to Inform Dosing Strategies in Oncology
    Moderator: Fei Hua, PhD – Applied BioMath
    Keynote Speaker: Dean Bottino, PhD (he/him/his) – Takeda Pharmaceuticals
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Keynote: New Era of Bioanalysis Post Covid-19 Pandemic
    Keynote Speaker: Qin Ji, PhD – AbbVie
    Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • 1:30 PM – 2:30 PM ET
    Keynote: Novel Nanotechnology-Based Approaches to Improving the Effectiveness of Anticancer Vaccines
    Keynote Speaker: Jayanth Panyam, PhD (he/him/his) – University of Washington
    Moderator: Anette Mullertz, PhD, FAAPS – University of Copenhagen
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbs
    Keynote Speaker: Marianthi Ierapetritou, PhD (she/her/hers) – University of Delaware
    Moderator: Ou Yang, PhD – GSK
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Towards Development of Translational PBPK Models for Biologics
    Keynote Speaker: Dhaval K. Shah, PhD (he/him/his) – University at Buffalo
    Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Special Poster Collection
  • 1:30 PM – 2:30 PM ET
    Strategies to Reduce Nitrosamine Contamination of Drug Products
    Partner Presentation Speaker: Andreas Sauer – Shin-Etsu
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Work-Life Harmony for Women: Strategies for Supporting Each Other
    Career Center Speaker: Meena Subramanyam, PhD (she/her/hers) – Takeda
    Career Center Moderator: Nivedita Shetty, PhD (she/her/hers) – Genentech
    Career Center Speaker: Priya Muralidharan, MS, PhD (she/her/hers) – AstraZeneca
    Career Center Speaker: Wendy O. Adamowicz, MS (she/her/hers) – PPD Clinical Research, Thermo Fisher Scientific
    Career Development
  • 2:00 PM – 3:00 PM ET
    A Paradigm Shift in Processing Amorphous Solid Dispersions (ASDs)
    Partner Presentation Speaker: Zafar Iqbal, PhD, RPh, MBA – Glatt Air Techniques, Inc. - Ramsey, NJ
    Formulation and Delivery
  • 2:00 PM – 3:00 PM ET
    Extractable Leachable Analysis from Sample Preparation to Compound Identification
    Partner Presentation Speaker: David A. Weil, PhD (he/him/his) – Agilent
    Manufacturing & Analytical Characterization
  • 2:30 PM – 3:00 PM ET
    Coffee Break in the Solution Center
  • 2:30 PM – 3:30 PM ET
    Hot Topic: Engineering Human Organoids and Organs-on-Chips for Disease Modeling, Drug Development and Personalized Medicine
    Hot Topic Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
    Hot Topic Speaker: Rodrigo Cristofoletti, Ph.D. (he/him/his) – University of Florida
    Preclinical and Translational Sciences
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Achieving Scientific Agility in a Rigid Matrix
    Spotlight Speaker: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs
    Moderator: Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc
    Manufacturing & Analytical Characterization
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: Analytical Testing Access and Capabilities Low-Income and Middle-Income Countries
    Moderator: Abhisheak Sharma, PhD – University of Florida
    Spotlight Speaker: Chaitanya Koduri, MTech (he/him/his) – US Pharmacopeia
    Discovery and Basic Research
  • 2:30 PM – 3:30 PM ET
    Speaker Spotlight: The Value of USP Standards for Excipients Used in Medicines: Current and Future State
    Spotlight Speaker: Catherine Sheehan, DRSc. MS. MS. – U.S. Pharmacopeia (USP)
    Moderator: Chris Moreton, PhD (he/him/his) – FinnBritt Consulting
    Formulation and Delivery
  • 2:30 PM – 3:30 PM ET
    Special Poster Collection
  • 3:00 PM – 4:00 PM ET
    Happy Hour Sponsored by ROQUETTE
  • 3:00 PM – 4:00 PM ET
    How to Thrive in the Workplace Without Sacrificing Mental Health
    Career Center Speaker: Adeola O. Coker, PhD (she/her/hers) – University of the Incarnate Word
    Career Center Moderator: Mustafa Bookwala, MS (he/him/his) – Duquesne University
    Career Development
  • 3:00 PM – 4:00 PM ET
    Microdosing– Powder in Capsule Technology Pathway from Development to Commercialization
    Partner Presentation Speaker: Mark Cappucci – Lonza
    Partner Presentation Speaker: Benito G. Graniela – Lonza
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Addressing Health Disparities in Basic Science Research
    Rapid Fire Moderator: Veeran Kadajji
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1
    Rapid Fire Moderator: MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2
    Rapid Fire Moderator: Diaa Shakleya, PhD – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advancing Innovation in In Silico Translational Approaches 1
    Rapid Fire Moderator: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Advancing Innovation in In Silico Translational Approaches 2
    Rapid Fire Moderator: Cheng Chang, PhD – Pfizer Inc.
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Approaches for Emerging Modalities and Complex Studies 1
    Rapid Fire Moderator: Heather A. Myler, PhD – Takeda
    Bioanalytics
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Approaches for Emerging Modalities and Complex Studies 2
    Rapid Fire Moderator: Sanjeev Bhardwaj, PhD – Janssen BioTherapeutics
    Bioanalytics
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1
    Rapid Fire Moderator: Tzichi Ju, Ph.D. – AbbVie Inc.
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2
    Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy
    Formulation and Delivery
  • 3:30 PM – 4:30 PM ET
    A Formulators Guide to Crossing the Valley of Death
    Partner Presentation Speaker: Darren Matthews, PhD – Charles River
    Partner Presentation Speaker: Dolly Jacob, PhD – Quotient Sciences
    Preclinical and Translational Sciences
  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by COREALIS Pharma Inc.
  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by IDBS
  • 3:30 PM – 4:30 PM ET
    Happy Hour Sponsored by Syngene International Limited
  • 3:30 PM – 4:30 PM ET
    Hot Topic: ICH M10 Bioanalytical Method Validation Guidance-1 year Later
    Hot Topic Speaker: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc
    Hot Topic Speaker: Faye Vazvaei-Smith, M.S. – Merck & Co.
    Hot Topic Speaker: Chongwoo Yu, Ph.D. – US Food and Drug Administration
    Hot Topic Speaker: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
    Hot Topic Moderator: Eric Joel Woolf, PhD, FAAPS (he/him/his) – Merck and Co Inc
    Bioanalytics
  • 3:30 PM – 4:30 PM ET
    Immunogenicity Assessment and Functional Testing of Candidate Therapeutics
    Partner Presentation Speaker: Chloe Ackaert, PhD (she/her/hers) – ImmunXperts, a Q2 Solutions Company
    Preclinical and Translational Sciences
  • 3:30 PM – 4:30 PM ET
    Special Poster Collection
  • 4:00 PM – 5:00 PM ET
    AAPS Excipients Community Membership Meeting
    Community Leader: Haichen Nie, PhD – Teva Pharmaceuticals
  • 4:00 PM – 5:00 PM ET
    AAPS Lipid-Based Drug Delivery Systems Community Membership Meeting
    Community Leader: Masumi Dave, PhD (she/her/hers) – Gattefosse USA
  • 4:00 PM – 5:00 PM ET
    AAPS Manufacturing Science & Engineering Community Membership Meeting
    Community Leader: Rajesh Dave, PhD (he/him/his) – NJIT
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by Infinity Laboratories
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by Agilent Technologies
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by Certara
  • 4:00 PM – 5:00 PM ET
    Happy Hour Sponsored by Prolytix
  • 4:15 PM – 5:00 PM ET
    AAPS Student Chapters Awards Ceremony
    Speaker: Dawn Klinefelter – American Association of Pharmaceutical Scientists (AAPS)
  • 5:00 PM – 6:00 PM ET
    AAPS Bioanalytical Community Membership Meeting
    Community Leader: Robert Dodge, PhD – Novartis
    Community Leader: Chad J. Briscoe, PhD – Celerion
  • 5:00 PM – 6:00 PM ET
    AAPS Bioequivalence and Bioavailability Science Community Membership Meeting
    Community Leader: Prasad N. Tata – Sandoz, Inc.
  • 5:00 PM – 6:00 PM ET
    AAPS Nanotechnology Community Membership Meeting
    Community Leader: Mandip Singh Sachdeva, PhD, FAAPS – Florida A & M University
    Community Leader: Ryan Pearson, PhD – University of Maryland Baltimore
  • 5:00 PM – 6:00 PM ET
    AAPS Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community Membership Meeting
    Community Leader: Abhisheak Sharma, PhD – University of Florida
  • 5:00 PM – 6:00 PM ET
    Handbook of Pharmaceutical Excipients: Grand challenges continued (Invited guests only)
  • 5:00 PM – 6:30 PM ET
    The University of Mississippi, School of Pharmacy Alumni & Friends Reception (by invitation only)
  • 5:00 PM – 7:00 PM ET
    The National Institute for Pharmaceutical Technology & Education (NIPTE)
  • 5:30 PM – 7:00 PM ET
    Fellows Networking Reception (by invitation only)
  • 5:30 PM – 7:00 PM ET
    Sustaining Sponsor Reception (by invitation only)
  • 5:30 PM – 8:30 PM ET
    Rutgers University Alumni & Friends Reception
  • 5:30 PM – 9:30 PM ET
    American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting
  • 6:00 PM – 8:00 PM ET
    Purdue University College of Pharmacy Reception
  • 6:00 PM – 10:00 PM ET
    IPEC Foundation 2023 Awards Ceremony (by invitation only)
  • 6:30 PM – 9:00 PM ET
    University of Iowa Alumni Dinner at AAPS PharmSci 360
  • Wednesday, October 25, 2023
  • 7:30 AM – 8:30 AM ET
    Women in PharmSci Breakfast
  • 7:30 AM – 2:30 PM ET
    Registration Hours
  • 7:30 AM – 4:00 PM ET
    Speaker Ready Room
  • 8:00 AM – 7:00 PM ET
    Coat Check
  • 8:30 AM – 12:30 PM ET
    Free Professional Headshots
  • 8:30 AM – 12:30 PM ET
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 12:30 PM ET
    Mock Interviews
  • 8:30 AM – 1:30 PM ET
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM ET
    Global Leadership: Inclusivity and Empathy for Multicultural Team
    Career Center Speaker: Binodh S. DeSilva, PhD – Bristol-Myers Squibb
    Career Center Speaker: Meena Subramanyam, PhD (she/her/hers) – Takeda
    Career Center Speaker: Tina S. Morris, PhD – AAPS
    Career Center Speaker: Cesar Compadre, Ph.D. – Department of Pharmaceutical Sciences, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, Tocol Pharmaceuticals, LLC, Little Rock, AR 77205, USA
    Career Center Moderator: Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca
    Career Development
  • 9:00 AM – 10:00 AM ET
    Overcoming the Unique Challenges in Today’s Early Stage Drug Development
    Partner Presentation Speaker: Nan Zhao, Ph.D – WuXi
    Partner Presentation Speaker: Santipharp Panmai, Ph.D. – WuXi STA, a subsidiary of WuXi AppTec
    Discovery and Basic Research
  • 9:00 AM – 10:30 AM ET
    Symposium: Alternative Approach to Animal Studies
    Moderator: Ketan D. Patel, PhD (he/him/his) – St. John's University
    Preclinical and Translational Sciences
  • 9:00 AM – 11:00 AM ET
    Symposium: Formulation and Delivery for Patient Centric Product Development 1
    Moderator: Jaap Wieling, PhD (he/him/his) – PureIMS BV
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Formulation and Delivery for Patient Centric Product Development 2
    Moderator: Stephen W. Hoag, PhD, FAAPS – University of Maryland, Baltimore
    Formulation and Delivery
  • 9:00 AM – 11:00 AM ET
    Symposium: Methodologies to Expedite Drug Development
    Moderator: Aniruddha S. Karve, PhD – University of Cincinnati
    Preclinical and Translational Sciences
  • 9:00 AM – 11:00 AM ET
    Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1
    Moderator: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2
    Moderator: Caitlin Wood, Ph.D. (she/her/hers) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM ET
    Symposium: State-of-the-Art Tools for Basic Research and Early-Stage Drug Discovery
    Moderator: Carsten Ehrhardt, Ph.D. – Trinity College Dublin
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM ET
    Symposium: The Bioanalytical Lab of the Future 1
    Moderator: Nanda Balasubramanian, MSc, PhD (he/him/his) – Bristol Myers Squibb
    Bioanalytics
  • 9:00 AM – 11:00 AM ET
    Symposium: The Bioanalytical Lab of the Future 2
    Moderator: Robert Dodge, PhD – Novartis
    Bioanalytics
  • 9:30 AM – 10:00 AM ET
    Coffee Break in the Solution Center
  • 9:30 AM – 10:30 AM ET
    Characterization of Polymer Molecules by Automated Viscosity Measurement
    Partner Presentation Speaker: David Trowbridge, PhD, MS – Cannon Instrument Company
    Manufacturing & Analytical Characterization
  • 10:00 AM – 11:00 AM ET
    Development of multiarticulate Formulations Using Innovative Excipients Through Algorithm-Based Tools
    Chalk Talk Presenter: Nitin K. Swarnakar, PhD (he/him/his) – BASF Corporation
    Chalk Talk Presenter: Ramesh Muttavarapu, M.S (Pharma), MBA – Patheon, by Thermo Fisher Scientific
    Formulation and Delivery
  • 10:00 AM – 11:00 AM ET
    Hot Topic: Challenges and Opportunities of in vitro Assays and Organ-On-A-Chip
    Hot Topic Speaker: Seyoum Ayehunie, PhD – Mattek
    Hot Topic Moderator: Twinkle R. Christian – Amgen
    Hot Topic Speaker: Lorna Ewart, PhD – Emulate
    Hot Topic Speaker: Annie Hamel, MSc (she/her/hers) – Charles River Laboratories
    Hot Topic Speaker: James R. Gosset (he/him/his) – Pfizer Inc
    Discovery and Basic Research
  • 10:00 AM – 11:00 AM ET
    Speaker Spotlight: Emerging Trends and Future Outlook for Advanced Manufacturing
    Spotlight Speaker: Fernando Muzzio, Ph.D. – Rutgers - The State University of New Jersey
    Moderator: Sushrut Marathe, PhD (he/him/his) – GSK
    Manufacturing & Analytical Characterization
  • 10:00 AM – 11:00 AM ET
    Speaker Spotlight: The Power of Hybrid LC-MS/MS: Case Studies from Simple to More Complex Biotherapeutic Modalities
    Moderator: James Huleatt, PhD (he/him/his) – Bill & Melinda Gates Medical Research Institute
    Spotlight Speaker: Dawn Dufield, PhD – KCAS
    Bioanalytics
  • 10:30 AM – 11:30 AM ET
    How to Mitigate Risks to Pharmaceutical Quality? Role of Reference Standards
    Partner Presentation Speaker: Yu Tang, PhD (she/her/hers) – United States Pharmacopeial Convention
    Manufacturing & Analytical Characterization
  • 10:30 AM – 11:30 AM ET
    Special Poster Collection
  • 10:30 AM – 11:30 AM ET
    Understanding a Multigenerational Workforce
    Career Center Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training
    Career Center Speaker: Yan Wu, PhD – Merck Sharp & Dohme
    Career Development
  • 11:00 AM – 12:00 PM ET
    Advancements in Oral Solid Dose Technologies for Potent Treatments
    Partner Presentation Speaker: Anshul Gupte, PhD – Catalent
    Manufacturing & Analytical Characterization
  • 11:00 AM – 12:00 PM ET
    U.S. Government Contracts & Grants: Non-Dilutive Funding for Life Sciences
    Partner Presentation Speaker: Laura Powell, PhD – EverGlade Consulting
    Partner Presentation Speaker: Steve Morris, PhD – EverGlade Consulting
    Preclinical and Translational Sciences
  • 11:00 AM – 1:30 PM ET
    Dedicated Solution Center Hours
  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: Innovative PK-PD is Helping Informed-Decision in Neuro-Oncology
    Moderator: Pankaj B. Desai, PhD (he/him/his) – University of Cincinnati
    Spotlight Speaker: Nader Sanai, MD (he/him/his) – Ivy Brain Tumor Center at Barrow Neurological Institute
    Preclinical and Translational Sciences
  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: Barriers and Disparities for Pediatric Drug Delivery
    Spotlight Speaker: Tulio Valdez, MD (he/him/his) – Stanford University
    Moderator: Xiuling Lu, PhD (she/her/hers) – University of Connecticut
    Formulation and Delivery
  • 11:30 AM – 12:30 PM ET
    Speaker Spotlight: ECCS Class 3A: Interaction of Gabapentin and its Analogues with Transporters: A Love-Hate Relationship
    Spotlight Speaker: Ayman El-Kattan, PhD (he/him/his) – IFM
    Moderator: Md Masud Parvez, PhD (he/him/his) – AbbVie Inc.
    Discovery and Basic Research
  • 12:00 PM – 1:00 PM ET
    New Considerations for LC-Based Characterization and Quantitation of Oligonucleotide Therapeutics
    Partner Presentation Speaker: Matthew Lauber, PhD – Waters Corporation
    Bioanalytics
  • 12:30 PM – 1:30 PM ET
    Co-processing: A Multifaceted Approach for Enhancing Density & Powder Flow
    Partner Presentation Speaker: San Kiang, PhD – Porton USA
    Formulation and Delivery
  • 12:30 PM – 1:30 PM ET
    Getting Your Research Right with Open Source Visual Programming
    Partner Presentation Speaker: Martyna Pawletta, MA – KNIME
    Partner Presentation Speaker: Corey Weisinger – KNIME
    Bioanalytics
  • 12:30 PM – 1:30 PM ET
    Special Poster Collection
  • 1:30 PM – 2:30 PM ET
    Keynote: High Resolution Analytical Tools to Enhance Regulatory Science
    Keynote Speaker: Jason Rodriguez, PhD – US Food and Drug Administration
    Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Impact of Animal Replacement Models on the Clinical Trials of the Future
    Keynote Speaker: Anthony Bahinski, MBA, PhD – Vivodyne, Inc.
    Moderator: Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC
    Bioanalytics
  • 1:30 PM – 2:30 PM ET
    Keynote: Novel NK and CAR-NK Expansion Platforms (Feeder Cells vs. No Feeder Cells)
    Keynote Speaker: Dongfang Liu, MD/PhD (he/him/his) – Rutgers University-New Jersey Medical School
    Moderator: Sayantan Chattoraj, PhD – GSK
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM ET
    Keynote: Novel Tools and Insights into Predicting Systemic and Tissue Drug Concentrations in Humans Including Special Populations
    Keynote Speaker: Jashvant D. Unadkat, PhD – University of Washington
    Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Keynote: Patient Centric Drug Formulation and Delivery: Lessons from FDA Approved and Pharmacy Compounded Products
    Keynote Speaker: Robert B. MacArthur, PharmD, MS, BCSCP (he/him/his) – Rockefeller University Hospital
    Moderator: Robin H. Bogner, PhD (she/her/hers) – University of Connecticut
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: Patient Centric Product Design-Not a Fad but an Imperative
    Keynote Speaker: Rao V. Mantri, PhD, MBA – Bristol Myers Squibb
    Moderator: Mary E. Krause, PhD – BMS
    Formulation and Delivery
  • 1:30 PM – 2:30 PM ET
    Keynote: Predictive Drug Discovery Platforms
    Keynote Speaker: James R. Gosset (he/him/his) – Pfizer Inc
    Moderator: Fei Hua, PhD – Applied BioMath
    Preclinical and Translational Sciences
  • 1:30 PM – 2:30 PM ET
    Keynote: State-of-The-Art Microfluidic Methodologies for Development of Micro- and Nanoparticles: Application to Drug Delivery Technologies
    Keynote Speaker: Helder Santos (he/him/his) – University Medical Center Groningen
    Moderator: Sudip Das, PhD (he/him/his) – Butler University
    Discovery and Basic Research
  • 1:30 PM – 2:30 PM ET
    Keynote: When Companion Diagnostics Met Bioanalysis: The Roles of Companion Diagnosis and Bioanalysis in Guiding Treatment Selection and Monitoring Drug Response
    Keynote Speaker: Mark Ma, MD (he/him/his) – Biotech
    Moderator: Catherine Vrentas, PhD – PPD, A ThermoFisher Company
    Bioanalytics
  • 1:30 PM – 8:00 PM ET
    Exhibitor Move-Out
  • 3:00 PM – 4:00 PM ET
    Hot Topic: Novel Excipients in Biopharma: Balancing Innovation, Risk, and Need
    Hot Topic Speaker: Joshua Katz, PhD – International Flavors and Fragrances Inc.
    Hot Topic Speaker: Mary E. Krause, PhD – BMS
    Hot Topic Moderator: Joshua Katz, PhD – International Flavors and Fragrances Inc.
    Hot Topic Speaker: Andrea Hawe, PhD (she/her/hers) – Coriolis Pharma
    Hot Topic Speaker: Can Araman, PhD – MilliporeSigma
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Hot Topic: Understanding Data Needs for AI/ML Approaches During Preclinical Development
    Hot Topic Speaker: Vibha Jawa, PhD, FAAPS – Bristol Myers Squibb
    Hot Topic Moderator: Fei Hua, PhD – Applied BioMath
    Hot Topic Speaker: Anant Madabhushi, PhD (he/him/his) – Emory University
    Hot Topic Speaker: Michelle Graham, PhD (she/her/hers) – AbbVie
    Hot Topic Speaker: Narendra Chirmule, Dr. (he/him/his) – SymphonyTech Biologucs
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Formulation and Delivery for Patient Centric Product Development 1
    Rapid Fire Moderator: Tzichi Ju, Ph.D. – AbbVie Inc.
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Formulation and Delivery for Patient Centric Product Development 2
    Rapid Fire Moderator: Michael Danquah, PhD – Chicago State University College of Pharmacy
    Formulation and Delivery
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1
    Rapid Fire Moderator: Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2
    Rapid Fire Moderator: Nahid S. Kamal, PhD (she/her/hers) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 1
    Rapid Fire Moderator: Claudio M. Marzo, PhD (he/him/his) – Evotec SE
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 2
    Rapid Fire Moderator: Bill R. Thelin, PhD (he/him/his) – Altis Biosystems
    Preclinical and Translational Sciences
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: State-of-the-Art Tools for Basic Research and Early-Stage Drug Discovery
    Rapid Fire Moderator: Somnath Singh, Ph.D. – Creighton University
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: The Bioanalytical Lab of the Future 1
    Rapid Fire Moderator: Robert Dodge, PhD – Novartis
    Bioanalytics
  • 3:00 PM – 4:00 PM ET
    Rapid Fires: The Bioanalytical Lab of the Future 2
    Rapid Fire Moderator: Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations
    Bioanalytics
  • 4:15 PM – 5:30 PM ET
    Closing Plenary with Dr. Julie DeMartino
    Plenary Speaker: Julie DeMartino, Ph.D. – AcheneRx LLC
  • 5:30 PM – 6:30 PM ET
    Closing Reception
  • Thursday, October 26, 2023
  • 8:00 AM – 12:00 PM ET
    Exhibitor Move-Out