Skip to main content

Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Full Schedule

Full Schedule

  • Cancelled
  • Prologue: "Grades" of Ancillary, Raw and Starting Materials and Excipients
  • Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous Biomarkers
  • Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine Innovations
  • Prologue: Alternative Methods to Animal Studies: Artificial Tissue to Artificial Intelligence
  • Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future Prospects
  • Prologue: Biomarker and Omics Approaches
  • Prologue: Biomarker Assays Are Not PK Assays: Prologue on Biomarker Assays
  • Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation Therapeutics
  • Prologue: Brevican-Targeting Peptide for Therapeutic Delivery to Glioblastoma: Tools for Drug Discovery
  • Prologue: Current Status of Transporter-Mediated Drug Delivery
  • Prologue: Current Trends and Research Opportunities for Collaboration in Pediatric Formulation Development
  • Prologue: Drug Delivery Alternatives to Injectables For Systemic Availability
  • 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

    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

    Discovery and Basic Research

  • 1:30 PM – 2:30 PM ET
    Keynote: Patient Centricity: One Blood Draw at a Time

    Bioanalytics

  • 1:30 PM – 2:30 PM ET
    Keynote: Predicting Formulation Performance: Learning from Generic Drugs

    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

    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

    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

    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

    Formulation and Delivery

  • 1:30 PM – 2:30 PM ET
    Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current Research

    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

    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

    Bioanalytics

  • 1:30 PM – 2:30 PM ET
    Keynote: Novel Nanotechnology-Based Approaches to Improving the Effectiveness of Anticancer Vaccines

    Formulation and Delivery

  • 1:30 PM – 2:30 PM ET
    Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbs

    Manufacturing & Analytical Characterization

  • 1:30 PM – 2:30 PM ET
    Keynote: Towards Development of Translational PBPK Models for Biologics

    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