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Full Schedule

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Full Schedule

  • 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