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Full Schedule

Full Schedule

  • On Demand
  • Prologue: Using Potency Readouts to Establish Critical Quality Attributes and Inform Vector Characterization Priorities
    Prologue Speaker: Hangtian Song, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • Prologue:  Applying Machine Learning to the Laboratory: How AI Can Help Us Innovate
    Prologue Speaker: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
    Bioanalytics
  • Prologue:  Challenges in Bioanalysis
    Prologue Speaker: Catherine Vrentas, PhD, MBA, MPH (she/her/hers) – Booz Allen Hamilton
    Bioanalytics
  • Prologue:  Regulatory Implications: From Immunogenicity to Diagnostics
    Prologue Speaker: Mohsen Rajabi, Ph.D. – US Food and Drug Administration
    Bioanalytics
  • Prologue:  Understanding HRMS in Regulated Bioanalysis, with Applications for ADCs
    Prologue Speaker: William R. Mylott, Jr., BS Chemistry – Thermo Fisher Scientific
    Bioanalytics
  • Prologue: Big Data Approaches to Understanding Particle Properties
    Prologue Speaker: Mike Tobyn, PhD (he/him/his) – Bristol Myers Squibb
    Manufacturing & Analytical Characterization
  • Prologue: Biomarker Strategies in Therapeutics Development for Rare Diseases
    Prologue Speaker: Yow-Ming Wang, PhD – US Food and Drug Administration
    Preclinical, Clinical and Translational Sciences
  • Prologue: Biomarkers as Linkers Between Preclinical, Clinical, and Patient Outcome
    Prologue Speaker: Matt D. Harwood, MSc, PhD – Certara UK (Simcyp Division)
    Preclinical, Clinical and Translational Sciences
  • Prologue: Can We Deliver Macro Peptides Orally?
    Prologue Speaker: Jenna Walker, PhD – Eli Lilly
    Formulation and Delivery
  • Prologue: Employing Machine Learning to Image, Quantify, and Predict Pharmacokinetics to Support Drug Development
    Prologue Speaker: Conor Evans, PhD – Massachusetts General Hospital / Harvard Medical School
    Preclinical, Clinical and Translational Sciences
  • Prologue: Flexible Manufacturing at Merck
    Prologue Speaker: Anna Jenks (she/her/hers) – Merck & Co., Inc. - Rahway NJ
    Manufacturing & Analytical Characterization
  • Prologue: High Dose Subcutaneous Delivery of Protein Therapeutics
    Prologue Speaker: Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC
    Formulation and Delivery
  • Prologue: Integrated in vitro-in silico Approach in Clinical Drug Development
    Prologue Speaker: Siddhi S. Hate, PhD – Eli Lilly and Company
    Formulation and Delivery
  • Prologue: LNP's: Formulations that Pushed Back COVID-19
    Prologue Speaker: Rajiv Nayar, PhD – HTD Biosystems Inc.
    Manufacturing & Analytical Characterization
  • Prologue: Mechanistic Models in Manufacturing
    Prologue Speaker: Indrajit Jagtap (he/him/his) – Intelimek LLC
    Manufacturing & Analytical Characterization
  • Prologue: Methods to Assess the Targeted Brain Drug Delivery in Preclinical Settings
    Prologue Speaker: Irena Loryan, MD, PhD (she/her/hers) – Uppsala University
    Discovery and Basic Research
  • Prologue: Prospects and Challenges of Cell Selective Liposome for the Treatment of Auto-Immune Diseases
    Prologue Speaker: Md Nurunnabi, PhD – University of Mississippi
    Discovery and Basic Research
  • Prologue: Regulatory Considerations for Continuous Manufacturing
    Prologue Speaker: Scott M. Krull, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • Prologue: Regulatory Implications: from Immunogenicity to Diagnostics
    Prologue Speaker: Weifeng Xu, PhD – Merck & Co.
    Bioanalytics
  • Prologue: The Effect of Excipients on the Colloidal Stability of Monoclonal Antibodies
    Prologue Speaker: Stephen W. Hoag, PhD – University of Maryland Baltimore
    Formulation and Delivery
  • Prologue: Transforming Drug Development: Advanced Modeling and Virtual Data for Enhanced Trials
    Prologue Speaker: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
    Preclinical, Clinical and Translational Sciences
  • 12:00 PM – 1:00 PM MT
    Prologue: How Artificial Intelligence will Redefine the Roles of Scientific and Medical Writers
    Prologue Speaker: David Hauss, PhD, RPh – Hauss Associates LLC
    Discovery and Basic Research
  • Friday, October 18, 2024
  • 12:30 PM – 5:00 PM MT
    Registration Hours
  • 1:00 PM – 5:00 PM MT
    Exhibitor Move-In (Booths 300 SF or larger)
  • Saturday, October 19, 2024
  • 7:30 AM – 5:00 PM MT
    Registration Hours
  • 8:00 AM – 5:00 PM MT
    Exhibitor Move-In
  • Sunday, October 20, 2024
  • 7:30 AM – 7:00 PM MT
    Registration Hours
  • 8:00 AM – 5:00 PM MT
    Exhibitor Move-In
  • 12:00 PM – 4:00 PM MT
    Speaker Ready Room
  • 5:00 PM – 6:30 PM MT
    Opening Plenary: Panel Discussion on Research Integrity
    Plenary Speaker: Ivan Oransky, MD (he/him/his) – Retraction Watch
    Plenary Speaker: Brian Nosek, Ph.D. – Center for Open Science
    Plenary Speaker: Colby Vorland, Ph.D. – Indiana University School of Public Health-Bloomington
    Moderator: Lynn Kamen, Ph.D. – BioAgilytix
  • 6:30 PM – 8:00 PM MT
    Welcome Reception
  • Monday, October 21, 2024
  • 7:30 AM – 8:30 AM MT
    AAPS Joint Editorial Board Breakfast (by invitation only)
  • 7:30 AM – 9:00 AM MT
    Executive Track: Trial, Study, and Program Success: Establishing Risk Tolerance and Evaluation Criteria for Cell & Gene Therapy Products
    Executive Education Speaker: Victoria Demby, PhD (she/her/hers) – Adlai Nortye USA Inc.
    Executive Education Speaker: Claudia Q. Lin, Ph.D (she/her/hers) – Pharmatech Associates
    Executive Education Speaker: Jason Bock, Ph.D. – CTMC
    Executive Education Speaker: Daniel A. Norris, Ph.D. – Ionis Pharmaceuticals
    Executive Track
  • 7:30 AM – 5:00 PM MT
    Registration Hours
  • 7:30 AM – 5:00 PM MT
    Speaker Ready Room
  • 8:30 AM – 2:00 PM MT
    Guest Tour (additional fee required)
  • 8:30 AM – 4:30 PM MT
    Coffee Station
  • 8:30 AM – 4:30 PM MT
    Free Professional Headshots
  • 8:30 AM – 4:30 PM MT
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 4:30 PM MT
    Mock Interviews
  • 8:30 AM – 5:00 PM MT
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM MT
    An Introduction to Business Decision-Making in Pharmaceutical Industry
    Career Center Speaker: Bo Tokarski, PhD, MBA – Charles River Laboratories Ashland LLC
    Career Development
  • 9:00 AM – 10:00 AM MT
    Hot Topic: Intelligent Nano-/Micro-Robots as a Drug-Carrier for Therapeutic Advancement
    Hot Topic Speaker: Joseph Wang, PhD (he/him/his) – Department of Nanoengineering University California San Diego (UCSD)
    Hot Topic Speaker: Minjun Kim, PhD – Southern Methodist University
    Hot Topic Moderator: Vibhuti Agrahari, PhD – University of Oklahoma Health Sciences Center
    Formulation and Delivery
  • 9:00 AM – 10:00 AM MT
    Stability and Palatability of Flavor Excipients--A Winning Combination for Veterinary Drug Formulation
    Partner Presentation Speaker: Darcy L. Forber, DVM, CVA, CVCH (she/her/hers) – Pet Flavors
    Manufacturing & Analytical Characterization
  • 9:00 AM – 10:00 AM MT
    You're hired! Selecting the Right Pre-IND Compound
    Partner Presentation Speaker: Darren Matthews, PhD – Charles River
    Partner Presentation Speaker: Eleanor Row – Quotient Sciences
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Bioanalytical Lab Innovations 1
    Moderator: Amy Lavelle, PhD (she/her/hers) – Thermo Fisher Scientific
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: Bioanalytical Lab Innovations 2
    Moderator: Lynn Kamen, Ph.D. – BioAgilytix
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: High Concentration Protein Bioprocess, Formulation, Processing, and Delivery Challenges
    Moderator: Mary E. Krause, PhD – BMS
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 1
    Moderator: Sai Chamarthy
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 2
    Moderator: Michael Lowinger, PhD (he/him/his) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Leveraging AI in the Processes of Drug Discovery, Lead Validation, Preclinical Development, and Regulatory Submissions
    Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM MT
    Symposium: Translating the Translational Sciences - Different Understanding, Common Aim 1
    Moderator: Xiaofei Wang, PhD – U.S. Food and Drug Administration
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Translating the Translational Sciences - Different Understanding, Common Aim 2
    Moderator: Sibylle Neuhoff, PhD (she/her/hers) – Certara Predictive Technologies
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Turbocharging the Efficient Delivery of Peptide Therapeutics Through Molecular Understanding
    Moderator: Tapan K. Das, PhD, FAAPS – Spyre Therapeutics
    Formulation and Delivery
  • 9:30 AM – 10:00 AM MT
    Coffee Break in the Solution Center
  • 9:30 AM – 10:15 AM MT
    Derisking Drug Development - Leveraging the Power of Key CMC activities and PBPK Modeling Approaches in Early Development Programs
    Chalk Talk Presenter: Deven S. Shah
    Chalk Talk Presenter: David B. Turner, Ph.D. – Certara UK Ltd.
    Preclinical, Clinical and Translational Sciences
  • 9:30 AM – 10:25 AM MT
    Special Poster Collection - Best Poster Award
  • 9:30 AM – 10:30 AM MT
    Continuous Improvement (CI) in Bioanalytical Laboratories: Challenges and Success Stories
    Partner Presentation Speaker: Jayaprakash Kotha, MBBS, Ph.D (he/him/his) – Worldwide Clinical Trials
    Bioanalytics
  • 9:30 AM – 10:30 AM MT
    Outsourcing Strategies to Simplify and Accelerate RNA-LNP Development
    Partner Presentation Speaker: Imran Vhora, M.Pharm, PhD (he/him/his) – Cytiva
    Formulation and Delivery
  • 9:30 AM – 10:30 AM MT
    Speaker Spotlight: Assessment of Permeability: Bridging Traditional and Novel Compounds in Discovery
    Spotlight Speaker: Mark Niosi – Pfizer Inc
    Moderator: Erica Schlesinger, Ph.D. (she/her/hers) – Serán Bioscience
    Discovery and Basic Research
  • 9:30 AM – 10:30 AM MT
    Speaker Spotlight: Managing Solid Form Transformation in Drug Product: Analytical & Biopharmaceutical Considerations
    Spotlight Speaker: Umesh Kestur, PhD – Bristol-Myers Squibb Company
    Moderator: Amit K. Tiwari, PhD (he/him/his) – University of Arkansas for Medical Sciences
    Manufacturing & Analytical Characterization
  • 10:00 AM – 11:00 AM MT
    Hot Topic: FDA Laboratory Developed Test Proposed Rule and Biomarker Testing
    Hot Topic Speaker: Steven P. Piccoli, PhD (he/him/his) – Sun Pharma Advanced Research
    Hot Topic Speaker: Patrice Hugo, PhD (he/him/his) – IQVIA Laboratories
    Hot Topic Moderator: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Hot Topic Speaker: Mark Ma, PhD (he/him/his) – Biotech
    Bioanalytics
  • 10:30 AM – 11:25 AM MT
    Special Poster Collection
  • 10:30 AM – 11:30 AM MT
    Non-Traditional Leadership Skills for Career Advancement of Young Pharmaceutical Professionals
    Career Center Speaker: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
    Career Center Speaker: Aliasger K. Salem, Ph.D. – University of Iowa
    Career Center Speaker: Donna M. Konicek, PhD – Insmed
    Career Center Moderator: Vivek Gupta, Ph.D. – St. John's University
    Career Development
  • 10:30 AM – 11:30 AM MT
    Optimization of Formulations - Screening with Less Drug Substance and Analysis
    Partner Presentation Speaker: Gabriele Kaiser, PhD (she/her/hers) – Netzsch Analyzing and Testing
    Partner Presentation Speaker: Dan Galvin – NETZSCH Premier Technologies, LLC
    Formulation and Delivery
  • 11:00 AM – 12:00 PM MT
    Integrated Bioanalysis and Biotransformation Strategies for Antibody-Drug Conjugates
    Partner Presentation Speaker: Li Qu, Ph.D – WuXi AppTec
    Partner Presentation Speaker: Peng Li, PhD (he/him/his) – WuXi AppTec
    Bioanalytics
  • 11:00 AM – 12:00 PM MT
    Oligo mapping of Large RNA Therapeutics by Novel Enzyme Specificities
    Partner Presentation Speaker: Bala Addepalli, PhD – Waters Corporation
    Manufacturing & Analytical Characterization
  • 11:00 AM – 1:30 PM MT
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM MT
    Beyond Classification: Combining AI and Particle Imaging to Analyze Shifts in Particle Morphology
    Chalk Talk Presenter: Eric Gottlieb – SentrySciences, Inc.
    Manufacturing & Analytical Characterization
  • 11:15 AM – 12:00 PM MT
    Bioanalytical Strategies, Innovations, and Future Considerations for ADCs
    Chalk Talk Presenter: Eric Thomas, PhD (he/him/his) – Labcorp
    Chalk Talk Presenter: Eric Bonner – Labcorp
    Bioanalytics
  • 11:15 AM – 12:00 PM MT
    Case study: Leveraging Hot Melt Extrusion to Improve Bioavailability, Reduce Pill Burden, and Increase Shelf Life
    Chalk Talk Presenter: Sebastien Branchu, PhD – AbbVie Inc.
    Manufacturing & Analytical Characterization
  • 11:30 AM – 12:25 PM MT
    Special Poster Collection - Sponsored by Merck
  • 12:00 PM – 1:00 PM MT
    Artificial Intelligence based Co-crystal Prediction Tool
    Partner Presentation Speaker: Mitali Bhagwat, MPharm, MBA – MilliporeSigma a Business of Merck KGaA
    Formulation and Delivery
  • 12:00 PM – 1:00 PM MT
    Business Acumen Skills for Landing and Excelling in Dream Job
    Career Center Speaker: Vivek Gupta, Ph.D. – St. John's University
    Career Center Speaker: Anuja Paprikar, PhD – Capstone Development Services Co, LLC
    Career Center Speaker: Heather J. Boyce, Ph.D. – US Food and Drug Administration
    Career Center Moderator: Adeola O. Coker, Ph.D. (she/her/hers) – University of the Incarnate Word
    Career Development
  • 12:00 PM – 1:00 PM MT
    Navigating Complexities: Overcoming Multi-Level Challenges in Modern Chromatography Labs
    Partner Presentation Speaker: William Long
    Manufacturing & Analytical Characterization
  • 12:30 PM – 1:15 PM MT
    Enhancing API Solubility and Bioavailability Using Novel Formulation Techniques
    Chalk Talk Presenter: Andrew Buis, MS – Altasciences
    Chalk Talk Presenter: Anthony James – Altasciences
    Formulation and Delivery
  • 12:30 PM – 1:25 PM MT
    Special Poster Collection
  • 12:30 PM – 1:30 PM MT
    Analytical Strategies for Complete Characterization and Purification of Synthetic Oligonucleotides
    Partner Presentation Speaker: Parul Angrish, PhD – Agilent
    Manufacturing & Analytical Characterization
  • 12:30 PM – 1:30 PM MT
    Optimizing Drug Delivery Strategies in Phase 1 Oral Development Through Developability Assessment
    Partner Presentation Speaker: Lisa Caralli, B.S. – Catalent
    Formulation and Delivery
  • 1:30 PM – 2:25 PM MT
    Special Poster Collection
  • 1:30 PM – 2:30 PM MT
    Age-Appropriate Patient-Centric Dosage Forms for Dysphagia and Special Patient Populations
    Partner Presentation Speaker: Srinivasan Shanmugam, PhD – Adare Pharma Solutions
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Innovating Together: How Diversity Drives Team Science Success
    Career Center Moderator: Allison Radwick, RPh, PhD (she/her/hers) – USP
    Career Development
  • 1:30 PM – 2:30 PM MT
    Keynote: Accelerating Formulation Development via Machine Learning and Automation
    Keynote Speaker: Christine Allen, PhD (she/her/hers) – University of Toronto
    Moderator: Sanjaykumar Patel (he/him/his) – Merck & Co., Inc.
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Keynote: Applying AI/ML Methodologies Within Regulated Bioanalysis
    Keynote Speaker: Mary Belfast (she/her/hers) – Teva Branded Pharmaceutical Products, Inc.
    Moderator: Joe Rajarao, PhD, MBA (he/him/his) – Accenture
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Bioanalytical Lab in the Era of AI and Revolutionary Technologies
    Keynote Speaker: Mark Ma, PhD (he/him/his) – Biotech
    Moderator: Honglue Shen, PhD – Merck & Co., Inc.
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Drug Discovery and Repurposing in the LLM (Large Language Model) Era
    Keynote Speaker: Tudor I. Oprea, MD, PhD – Expert Systems Inc
    Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Discovery and Basic Research
  • 1:30 PM – 2:30 PM MT
    Keynote: From Theory to Therapy: Charting the Course from the Lab to Global Health Outcomes in Translational Sciences
    Keynote Speaker: Brian Corrigan, PhD – Pfizer
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    Keynote: Takeaways from Translational Science Sharpshooters: Simple Strategies for Accuracy, Efficiency, and Impact
    Keynote Speaker: Sam Raney, PhD (he/him/his) – US Food and Drug Administration
    Moderator: Sebastian Polak, Professor – Certara UK / Simcyp
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    Keynote: Transitioning Novel Modalities from Exploratory to Patient Centered Medicinal Products: Development Approaches to Maximize Value
    Keynote Speaker: Sachin Mittal, PhD (he/him/his) – Merck & Co., Inc.
    Moderator: Andre Hermans, PhD (he/him/his) – Merck & Co., Inc.
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Keynote: Zero Waste Sustainable Pharmaceutical Manufacturing
    Keynote Speaker: Shweta Singh, PhD (she/her/hers) – Purdue University
    Moderator: Michael Lowinger, PhD (he/him/his) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines
    Partner Presentation Speaker: Moritz Perscheid, PhD, MBA (he/him/his) – LGC
    Manufacturing & Analytical Characterization
  • 2:00 PM – 3:00 PM MT
    Hydroxypropyl Beta-Cyclodextrin as a Safer Alternative for Viral Inactivation in Bioprocessing
    Partner Presentation Speaker: Shiqi Hong, PhD (she/her/hers) – Roquette
    Manufacturing & Analytical Characterization
  • 2:00 PM – 3:00 PM MT
    Sustainable Innovation for Manufacturing Amorphous Solid Dispersions
    Partner Presentation Speaker: Adi Kaushal, PhD (he/him/his) – Lonza
    Partner Presentation Speaker: Craig Sather – Lonza
    Manufacturing & Analytical Characterization
  • 2:30 PM – 3:00 PM MT
    Coffee Break in the Solution Center
  • 2:30 PM – 3:25 PM MT
    Special Poster Collection
  • 2:30 PM – 3:30 PM MT
    Hot Topic: APE1/Ref-1: One Target with Multiple Disease Indications Including Cancer, Ocular, and Inflammatory Bowel Disease
    Hot Topic Speaker: Mark R. Kelley, PhD (he/him/his) – Indiana University School of Medicine
    Hot Topic Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Discovery and Basic Research
  • 2:30 PM – 3:30 PM MT
    Meet-the-Editors
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: Automation in Regulated Bioanalysis
    Spotlight Speaker: Chad J. Briscoe, PhD (he/him/his) – Celerion
    Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals
    Bioanalytics
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: Human Radiolabeled Mass Balance Studies- A Turn of a Kaleidoscope
    Spotlight Speaker: Shriram M. Pathak, PhD – Eisai Ltd.
    Moderator: Philip J. Kuehl, PhD – Lovelace Biomedical
    Preclinical, Clinical and Translational Sciences
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: The Permeability Advantage of Non-Permeable Particles: Mechanistic Study and Modeling
    Spotlight Speaker: Na Li, PhD (she/her/hers) – University of Connecticut
    Moderator: Tze Ning Hiew, PhD (she/her/hers) – University of Iowa
    Formulation and Delivery
  • 3:00 PM – 3:45 PM MT
    Rapid Fires: Bioanalytical Lab Innovations 1
    Rapid Fire Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Affinity Capture-High Resolution Mass Spectrometry (AC-MS) for Bioanalysis of Pharmacodynamic Biomarkers and Therapeutics
    Partner Presentation Speaker: Hemanth Akkiraju – IQVIA Laboratories
    Partner Presentation Speaker: Prakash Bhosale, PhD – IQVIA Laboratories
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Happy Hour Sponsored by INTERPHEX
  • 3:00 PM – 4:00 PM MT
    Happy Hour Sponsored by Kindeva Drug Delivery
  • 3:00 PM – 4:00 PM MT
    Happy Hour Sponsored by Roquette
  • 3:00 PM – 4:00 PM MT
    High Functioning Global Teams: What’s the Secret Sauce?
    Career Center Speaker: Maya P. Lipert, PhD (she/her/hers) – AbbVie
    Career Center Speaker: Benjamin J. Ortiz Cardona, PhD – AbbVie
    Career Center Speaker: Lopa Bakrania, PhD, RAC (she/her/hers) – Biohaven Pharmaceuticals
    Career Center Speaker: Erika Walsh, PhD (she/her/hers) – Organon
    Career Center Moderator: Morgan B. Giles, Ph.D. (she/her/hers) – Merck & Co., Inc.
    Career Development
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Bioanalytical Lab Innovations 2
    Rapid Fire Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Formulation Approaches to Overcome Development Challenges Across Modalities 1
    Rapid Fire Moderator: Sharan Bobbala, PhD (he/him/his) – West Virginia University
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Formulation Approaches to Overcome Development Challenges Across Modalities 2
    Rapid Fire Moderator: Vibhuti Agrahari, PhD – University of Oklahoma Health Sciences Center
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 1
    Rapid Fire Moderator: Parind M. Desai, PhD – GSK
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 2
    Rapid Fire Moderator: Kevin Gurney, Ph.D. (he/him/his) – Merck & Co., Inc.
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Leveraging AI in the Processes of Drug Discovery, Lead Validation, Preclinical Development, and Regulatory Submissions
    Rapid Fire Moderator: Galina Bernstein, PhD (she/her/hers) – AzureDelta Consulting Inc
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Translating the Translational Sciences - Different Understanding, Common Aim 1
    Rapid Fire Moderator: Rodrigo Cristofoletti, Ph.D. – University of Florida
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Translating the Translational Sciences - Different Understanding, Common Aim 2
    Rapid Fire Moderator: Zhiyi Cui, PhD (she/her/hers) – GSK
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Targeting Sensory Receptors to Improve Drug Palatability
    Partner Presentation Speaker: Joseph Fotsing, Ph.D. – dsm-firmenich
    Discovery and Basic Research
  • 3:30 PM – 4:25 PM MT
    Special Poster Collection
  • 3:30 PM – 4:30 PM MT
    Happy Hour Sponsored by Agilent Technologies
  • 3:30 PM – 4:30 PM MT
    Hot Topic: Advancements and Challenges in Oral Peptide Delivery with Permeation Enhancers
    Hot Topic Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • 3:30 PM – 4:30 PM MT
    Softgels: The Missed Opportunity for Superior Bioavailability and Modulated Drug Release
    Partner Presentation Speaker: Karunakar (Karu) Sukuru, R.Ph., PhD – Catalent
    Formulation and Delivery
  • 4:00 PM – 5:00 PM MT
    AAPS Bioanalytical Community Membership Meeting
    Community Leader: Shoshana Oberstein (she/her/hers) – Takeda
  • 4:00 PM – 5:00 PM MT
    AAPS Global Health Community Membership Meeting
    Community Leader: Erica Schlesinger, Ph.D. (she/her/hers) – Serán Bioscience
  • 4:00 PM – 5:00 PM MT
    AAPS Lipid-Based Drug Delivery Systems Community Membership Meeting
    Community Leader: Shaukat Ali, PhD (he/him/his) – Ascendia Pharmaceuticals
    Community Leader: Dimple Modi, MS
  • 4:00 PM – 5:00 PM MT
    Happy Hour Sponsored by BioData Solutions
  • 5:00 PM – 6:00 PM MT
    AAPS Excipients Community Membership Meeting
    Community Leader: Jin Zhao, PhD – International Flavors and Fragrances
  • 5:00 PM – 6:00 PM MT
    AAPS Gene and Cell Therapy Products Community Membership Meeting
    Community Leader: Hardik R. Mody, PhD (he/him/his) – Genentech
  • 5:00 PM – 6:00 PM MT
    AAPS Inhalation and Nasal Community Membership Meeting
    Community Leader: Vivek Gupta, Ph.D. – St. John's University
    Community Leader: Alan B. Watts, PhD – Catalent
  • 5:00 PM – 6:00 PM MT
    AAPS Manufacturing Science and Engineering Community Membership Meeting
    Community Leader: Rajesh Dave, PhD (he/him/his) – New Jersey Institute of Technology
    Community Leader: Bhavishya Mittal, Ph.D.
  • 5:00 PM – 6:00 PM MT
    AAPS Nanotechnology Community Membership Meeting
    Community Leader: Ryan M. Pearson, PhD – University of Maryland Baltimore
    Community Leader: Mitra Mosharraf, M Pharm, PhD, MBA (she/her/hers) – HTD Biosystems
  • 5:00 PM – 6:00 PM MT
    AAPS Preformulation & Formulation Design/ Development Community Membership Meeting
    Community Leader: Ke Wu, Ph.D. – Abbvie Inc.
  • 5:00 PM – 6:00 PM MT
    AAPS Sterile Products Community Membership Meeting
    Community Leader: Hiten J. Gutka, PhD (he/him/his) – BMS
    Community Leader: Harsh Vardhan. Chauhan, PhD – Creighton University
  • 5:00 PM – 7:00 PM MT
    University of Kansas Department of Pharmaceutical Chemistry Alumni Reception
  • 5:00 PM – 7:30 PM MT
    Gordon Amidon 80th Birthday Celebration and U of M College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 6:30 PM MT
    Minnesota Alumni Reception
  • 5:30 PM – 7:30 PM MT
    OSU College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 7:30 PM MT
    University of Wisconsin-Madison School of Pharmacy Alumni & Friends Reception
  • 5:30 PM – 7:30 PM MT
    UT Austin College of Pharmacy Alumni and Friends Reception
  • 5:30 PM – 8:00 PM MT
    University of Utah Molecular Pharmaceutics Alumni & Friends Reception
  • 5:30 PM – 8:30 PM MT
    Rutgers University Alumni & Friends Reception
  • 6:00 PM – 7:00 PM MT
    NIPTE Reception
  • 6:00 PM – 7:30 PM MT
    St. John's University Alumni & Friends Reception
  • 6:00 PM – 8:00 PM MT
    University of Iowa College of Pharmacy Alumni and Friends Reception
  • 6:00 PM – 8:00 PM MT
    University of Nebraska College of Pharmacy Reception
  • 6:30 PM – 9:00 PM MT
    Mercer University Alumni Reception
  • 7:00 PM – 9:00 PM MT
    President's Reception (by invitation only)
  • Tuesday, October 22, 2024
  • 7:00 AM – 8:30 AM MT
    Mentor Breakfast
  • 7:30 AM – 5:00 PM MT
    Speaker Ready Room
  • 7:45 AM – 9:00 AM MT
    RapidFACT®: Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimization (pre-registration required)
  • 8:00 AM – 5:00 PM MT
    Registration Hours
  • 8:30 AM – 4:30 PM MT
    Coffee Station
  • 8:30 AM – 4:30 PM MT
    Free Professional Headshots
  • 8:30 AM – 4:30 PM MT
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 4:30 PM MT
    Mock Interviews
  • 8:30 AM – 5:00 PM MT
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM MT
    Characterization of Single Use System Components for Extractables & Leachables
    Partner Presentation Speaker: Eric Hill, MS MBA – BA Sciences
    Manufacturing & Analytical Characterization
  • 9:00 AM – 10:00 AM MT
    Hot Topic: Phase-Appropriate Strategies for Gene and Cell Therapy Regulatory Compliance
    Hot Topic Speaker: Allison Radwick, RPh, PhD (she/her/hers) – USP
    Hot Topic Moderator: Rajiv Nayar, PhD – HTD Biosystems Inc.
    Manufacturing & Analytical Characterization
  • 9:00 AM – 10:00 AM MT
    Improving Content Uniformity of Morphologically Challenging APIs by Excipient Choice
    Partner Presentation Speaker: Stephanie Stewart, PhD (she/her/hers) – JRS Pharma
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: An Accelerated Development of Poorly Soluble Drugs Using Predictive Tools
    Moderator: Niloufar Salehi, PhD – Eli Lilly and company
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Challenges and Opportunities Associated with Targeted Therapeutics
    Moderator: Patrick T. Ronaldson, PhD, FAAPS (he/him/his) – University of Arizona
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM MT
    Symposium: Current Challenges in Bioanalytical Labs
    Moderator: Jason Pennucci, MS (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 1
    Moderator: Indrajit Jagtap (he/him/his) – Intelimek LLC
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 2
    Moderator: Scott M. Krull, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: High Resolution Mass Spectrometry for Regulated Bioanalysis, Quo Vadis?
    Moderator: Sanjeev Bhardwaj, PhD (he/him/his) – Moderna Therapeutics
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: Impact of Excipients on Biologics Drug Product Development
    Moderator: Mary E. Krause, PhD – BMS
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Making Data Work for Us – Applying and Combining Empirical (AI/ML) and Mechanistic Modeling in the Preclinical, Clinical, and Post-Approval Realms 1
    Moderator: Sebastian Polak, Professor – Certara UK / Simcyp
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Making Data Work for Us – Applying and Combining Empirical (AI/ML) and Mechanistic Modeling in the Preclinical, Clinical, and Post-Approval Realms 2
    Moderator: Priyanka Ghosh, PhD – US Food and Drug Administration
    Preclinical, Clinical and Translational Sciences
  • 9:30 AM – 10:00 AM MT
    Coffee Break in the Solution Center
  • 9:30 AM – 10:15 AM MT
    Method Transfer and Validation: Lessons Learned and Recommendations for Success
    Chalk Talk Presenter: Lynn Kamen, Ph.D. – BioAgilytix
    Formulation and Delivery
  • 9:30 AM – 10:25 AM MT
    Special Poster Collection
  • 9:30 AM – 10:30 AM MT
    Risk in Pharmaceutical Quality: Role of the Documentary and Reference Standard. Case Studies.
    Partner Presentation Speaker: Naiffer Romero, MSc, MPH (he/him/his) – US Pharmacopeia
    Manufacturing & Analytical Characterization
  • 9:30 AM – 10:30 AM MT
    Role of Key Raw Materials in Improving Yield and Safety in Biomanufacturing
    Partner Presentation Speaker: Sreejit R. Menon, PhD – Croda Inc.
    Partner Presentation Speaker: Garima Sinha, PhD – Croda Pharma
    Manufacturing & Analytical Characterization
  • 9:30 AM – 10:30 AM MT
    Speaker Spotlight: Exosomes: Oral Delivery for Cancer Therapeutics: Is This possible?
    Spotlight Speaker: Mandip Singh sachdeva, PhD, FAAPS – Florida A & M University
    Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Discovery and Basic Research
  • 9:30 AM – 10:30 AM MT
    Speaker Spotlight: The Evolution of BioTech into TechBio
    Spotlight Speaker: Laura Schaevitz, PhD (she/her/hers) – Recursion Pharmaceuticals
    Moderator: Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals
    Preclinical, Clinical and Translational Sciences
  • 10:00 AM – 11:00 AM MT
    Hot Topic: Bioanalytics
    Hot Topic Moderator: Ines Santos, PhD (she/her/hers) – Bristol-Myers Squibb
    Bioanalytics
  • 10:30 AM – 11:25 AM MT
    Special Poster Collection
  • 10:30 AM – 11:30 AM MT
    Advancing Mass Spectrometry: Next-Generation Tools for Qualitative and Quantitative Workflows
    Partner Presentation Speaker: Ebru S. Selen, PhD (she/her/hers) – SCIEX
    Partner Presentation Speaker: Jacob McCabe, Ph.D. – SCIEX
    Discovery and Basic Research
  • 10:30 AM – 11:30 AM MT
    Artificial Intelligence Communication: The Do's and Don'ts for Using AI Language Tools in Your Technical Job at Every Level
    Career Center Speaker: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC
    Career Development
  • 10:30 AM – 11:30 AM MT
    Excipient Design and Selection for Sustainable Manufacturing of Pharmaceutical Products
    Partner Presentation Speaker: Thomas Durig, n/a – Ashland Life Sciences
    Formulation and Delivery
  • 11:00 AM – 12:00 PM MT
    Integrated Lifecycle Approach for Deterministic Container Closure Integrity in Biopharmaceuticals
    Partner Presentation Speaker: Michael R. Dominguez (he/him/his) – Kindeva Drug Delivery
    Manufacturing & Analytical Characterization
  • 11:00 AM – 12:00 PM MT
    Overcoming Global Analytical Challenges with Scientific Central Lab Expertise
    Partner Presentation Speaker: Stacy Kirn-Barker, MLS(ASCP) – LabConnect
    Bioanalytics
  • 11:00 AM – 1:30 PM MT
    Dedicated Solution Center Hours
  • 11:15 AM – 12:00 PM MT
    Accelerate your Drug Discovery with AI-Powered Serverless Supercomputing
    Chalk Talk Presenter: Fengbo Ren, PhD – Fovus
    Discovery and Basic Research
  • 11:15 AM – 12:00 PM MT
    Choosing Suitable Extraction Platforms for Bioanalytical qPCR
    Chalk Talk Presenter: Mark C. Wissel, MB(ASCP) – Eurofins Viracor BioPharma Services
    Bioanalytics
  • 11:15 AM – 12:00 PM MT
    Rediscovering Potentials of Liposome in Advanced Drug Discovery in Oncology
    Chalk Talk Presenter: Naoki Yamada, MS – FUJIFILM Pharmaceutical U.S.A., Inc.
    Formulation and Delivery
  • 11:30 AM – 12:25 PM MT
    Special Poster Collection - Sponsored by Merck
  • 12:00 PM – 1:00 PM MT
    Biosimulation at Scale: Industrializing Quantitative Systems Pharmacology (QSP) to Guide Drug-Development Decision Making
    Partner Presentation Speaker: Piet H. van der Graaf, Pharm.D., Ph.D. – Certara
    Partner Presentation Speaker: Fei Hua, PhD – Certara
    Preclinical, Clinical and Translational Sciences
  • 12:00 PM – 1:00 PM MT
    Extractable Leachable Analysis from Standardized Chromatography to Mass Spectral Databases
    Partner Presentation Speaker: David A. Weil, PhD (he/him/his) – Agilent
    Manufacturing & Analytical Characterization
  • 12:00 PM – 1:00 PM MT
    Will AI Eliminate or Enhance Your Job? Drafting of Regulatory Submissions as a Case Study
    Career Center Speaker: David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC
    Career Center Speaker: David Hauss, PhD, RPh – Hauss Associates LLC
    Career Development
  • 12:30 PM – 1:15 PM MT
    Ensuring Patient Safety by Chemical Assessment of the Container Closure Material and Drug Product - Container Interactions
    Chalk Talk Presenter: Frank de smedt, PhD (he/him/his) – Nelson Labs
    Bioanalytics
  • 12:30 PM – 1:15 PM MT
    Novel Pharma Excipient: Hyaluronic Acid Nanogel for Sustained Release and Solubility Enhancement
    Chalk Talk Presenter: Yoshiyuki Nakagawa, PhD (he/him/his) – Asahi Kasei Corporation
    Discovery and Basic Research
  • 12:30 PM – 1:25 PM MT
    Special Poster Collection
  • 12:30 PM – 1:30 PM MT
    Bioanalytical Methods/Platforms for PK and Immunogenicity of ADCs and Other Conjugated Therapeutics
    Partner Presentation Speaker: Dawn Dufield, PhD – KCAS Bio
    Partner Presentation Speaker: Dominic Warrino, PhD – KCAS Bio
    Bioanalytics
  • 12:30 PM – 1:30 PM MT
    Oral Delivery of Peptides and Proteins – Challenges & Opportunities
    Partner Presentation Speaker: Anil Kane, PhD – Thermo Fisher Scientific
    Formulation and Delivery
  • 12:30 PM – 1:30 PM MT
    Strategic Advantages of Hot Melt Extrusion for Challenging APIs in Oral Dosage Forms
    Chalk Talk Presenter: Hibreniguss Terefe, PhD – Catalent
    Formulation and Delivery
  • 1:00 PM – 1:30 PM MT
    David P. Otey, MA, MBA, Book Signing and Meet and Greet
  • 1:00 PM – 3:00 PM MT
    Frozen Beverage Station Sponsored by Eurofins Clinical Trial Solutions and Eurofins CDMO Alphora Inc.
  • 1:30 PM – 2:25 PM MT
    Special Poster Collection
  • 1:30 PM – 2:30 PM MT
    Faster, Leaner, Refined: Requirements for a Modern CRO
    Partner Presentation Speaker: Vimal Patel, MS – Charles River
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    How Can Non-Clinical Models Help in Intranasal Drug Development
    Partner Presentation Speaker: Philip J. Kuehl, PhD – Lovelace Biomedical
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    Keynote: Isoform-Selective Inhibition of Hsp90 Affords New Opportunities to Treat Cancer, Diseases of the CNS, and Glaucoma
    Keynote Speaker: Brian Blagg, PhD – University of Notre Dame
    Moderator: Patrick T. Ronaldson, PhD, FAAPS (he/him/his) – University of Arizona
    Discovery and Basic Research
  • 1:30 PM – 2:30 PM MT
    Keynote: ADC: Drug Development Challenges- What We are Measuring and What Does it Matter?
    Keynote Speaker: Malaz Abutarif, PhD – DSI
    Moderator: Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Digital Transformation: A Paradigm Shift in Pharmaceutical Manufacturing
    Keynote Speaker: Mohan Boggara, PhD – Sanofi
    Moderator: Indrajit Jagtap (he/him/his) – Intelimek LLC
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Enabling Digital Transformation From a Regulatory Perspective
    Keynote Speaker: Kevin Macias, Doctor of Philosophy – Eli Lilly
    Moderator: Sai Chamarthy
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Harnessing the Power of Synergy: How AI and Scientific Analytics Together Deliver Breakthrough Medicines
  • 1:30 PM – 2:30 PM MT
    Keynote: Purposeful Bioanalysis: Ask the Why and What Questions
    Keynote Speaker: Boris Gorovits, PhD – Regeneron
    Moderator: Jim X. Shen, PhD (he/him/his) – Bristol-Myers Squibb
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Recent Focus and Landscape Maneuvering of Excipients in Pharmaceutical Formulations
    Keynote Speaker: Mansoor A. Khan, PhD (he/him/his) – Texas A&M University
    Moderator: Haichen Nie, PhD – Teva Pharmaceuticals
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Keynote: The Importance of Excipient Quality and Development: New Frontiers for Use in Medicines
    Keynote Speaker: Catherine Sheehan, DRSc. MS. MS. – U.S. Pharmacopeia (USP)
    Moderator: Kenny Xie, PhD MBA (he/him/his) – US Pharmacopeia
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT
    Keynote: Using AI/ML What is Lacking to Make AI/ML Really Successful in the Drug Discovery/Development Processes
    Keynote Speaker: Aleksander Mendyk, MSc, PhD, DSc, Professor – Chair and Department of Pharmaceutical Technology and Biopharmacutics, Faculty of Pharmacy, Jagiellonian University - Medical College
    Moderator: Sebastian Polak, Professor – Certara UK / Simcyp
    Preclinical, Clinical and Translational Sciences
  • 1:30 PM – 2:30 PM MT
    The Future is Now: Understanding the Influence of AI and ML on Biotech Careers
    Career Center Moderator: Daniel Benavides (he/him/his) – Recursion Pharmaceuticals
    Career Center Speaker: Michaela Hatch (she/her/hers) – Recursion
    Career Center Speaker: Joze Carpenter, PhD – Recursion
    Career Center Speaker: Michael Cuccarese, PhD (he/him/his) – Recursion
    Career Development
  • 2:00 PM – 3:00 PM MT
    Co-processing technologies to Simplify Your Oral Solid Dosage (OSD) Formulation Process
    Partner Presentation Speaker: San Kiang, Ph.D. – Porton, J-Star
    Formulation and Delivery
  • 2:00 PM – 3:00 PM MT
    Tuning Antibody Drug Development Using Predictive Models Derived from Relevant Ex Vivo and In Vivo Data Sets
    Partner Presentation Speaker: Jake McDonald, PhD – Envol Biomedical
    Partner Presentation Speaker: C. Edwin Garner, II, PhD (he/him/his) – Envol Biomedical/ Mammoth Preclinical Consulting, LLC.
    Preclinical, Clinical and Translational Sciences
  • 2:30 PM – 3:00 PM MT
    Coffee Break in the Solution Center
  • 2:30 PM – 3:15 PM MT
    2024 AAPS High Impact Journal Article Rapid Fire Presentations
    Rapid Fire Moderator: Robert O. Williams, III, PhD (he/him/his) – The University of Texas at Austin
  • 2:30 PM – 3:25 PM MT
    Special Poster Collection
  • 2:30 PM – 3:30 PM MT
    Career Conversations: Hosted by Dr. Reddy's Laboratories Inc.
  • 2:30 PM – 3:30 PM MT
    Hot Topic: Emerging Translational Pharmacology and PK-PD Trends for Newer Cancer Therapeutics
    Hot Topic Moderator: Gautham Gampa, Ph.D. – Genentech
    Preclinical, Clinical and Translational Sciences
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: A Slice of the Immunerdy Pecan Pie- Regulatory Stakeholders in CDER’s Integrative Immunogenicity Review of Therapeutic Proteins and Peptides
    Spotlight Speaker: Joao Pedras-Vasconcelos, PhD (he/him/his) – U.S. Food and Drug Administration
    Moderator: Troy Voelker, PhD (he/him/his) – Aliri Bioanalysis
    Bioanalytics
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: Emerging Standards and Iterative Approaches to Novel Excipients
    Spotlight Speaker: Jenny Liu, PhD (she/her/hers) – USP
    Moderator: Jiaying Liu, PhD (she/her/hers) – Merck & Co., Inc.
    Formulation and Delivery
  • 2:30 PM – 3:30 PM MT
    Speaker Spotlight: Lifecycle Management Strategies for Liposomal Formulations
    Spotlight Speaker: Jayachandra Babu Ramapuram, PhD, FAAPS (he/him/his) – Auburn University
    Moderator: Amit K. Tiwari, PhD (he/him/his) – University of Arkansas for Medical Sciences
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Enhancing Communication with your CRO to Improve Scientific Collaboration
    Partner Presentation Speaker: Sara Underwood – Alturas Analytics, Inc.
    Partner Presentation Speaker: Jennifer Zimmer, PhD – Alturas Analytics, Inc.
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Happy Hour Sponsored by Corealis Pharma Inc.
  • 3:00 PM – 4:00 PM MT
    Happy Hour Sponsored by WuXi AppTec
  • 3:00 PM – 4:00 PM MT
    How Vegetal Soft Capsules Open New Opportunities for Administration of Lipid Based Formulations
    Partner Presentation Speaker: Catherine Cornille – NextPharma Ploermel
    Partner Presentation Speaker: Annabel Igonin – NextPharma Ploermel
    Partner Presentation Speaker: Carmen Popescu, Ph.D. – Roquette Pharmaceutical Innovation Center
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Practical Tips for Using GenAI in Biomedicine
    Career Center Speaker: Priyata Kalra, PhD (she/her/hers) – Simulations Plus, Inc.
    Career Center Moderator: Matthew J. Nethercott, PhD (he/him/his) – Kansas Analytical Services, LLC
    Career Development
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Challenges and Opportunities Associated with Targeted Therapeutics
    Rapid Fire Moderator: Fenglei Huang, Dr. (he/him/his) – Boehringer Ingelheim Pharmaceuticals, Inc.
    Discovery and Basic Research
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Current Challenges in Bioanalytical Labs 1
    Rapid Fire Moderator: Shoshana Oberstein (she/her/hers) – Takeda
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Current Challenges in Bioanalytical Labs 2
    Rapid Fire Moderator: Joanne Goodman (she/her/hers) – Celerion
    Bioanalytics
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 1
    Rapid Fire Moderator: Li Tian, PhD (she/her/hers) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 2
    Rapid Fire Moderator: Parind M. Desai, PhD – GSK
    Manufacturing & Analytical Characterization
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Making Data Work for Us – Applying and Combining Empirical (AI/ML) and Mechanistic Modeling in the Preclinical, Clinical, and Post-Approval Realms 1
    Rapid Fire Moderator: Rodrigo Cristofoletti, Ph.D. – University of Florida
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Making Data Work for Us – Applying and Combining Empirical (AI/ML) and Mechanistic Modeling in the Preclinical, Clinical, and Post-Approval Realms 2
    Rapid Fire Moderator: Punit Marathe, PhD – Agios Pharmaceuticals
    Preclinical, Clinical and Translational Sciences
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Turbocharging Drug Product Development: The Critical Role of Excipients 1
    Rapid Fire Moderator: Jasmin Monpara, PhD – Philadelphia College of Pharmacy
    Formulation and Delivery
  • 3:00 PM – 4:00 PM MT
    Rapid Fires: Turbocharging Drug Product Development: The Critical Role of Excipients 2
    Rapid Fire Moderator: Vivek Agrahari, PhD (he/him/his) – CONRAD
    Formulation and Delivery
  • 3:30 PM – 4:25 PM MT
    Special Poster Collection
  • 3:30 PM – 4:30 PM MT
    Nanoparticle Formation in Impinging Jet Turbulent Reactors with HPMCAS and Random Copolymer Stabilizers
    Partner Presentation Speaker: Robert K. Prudhomme, PhD – Princeton University, dept. Chemical and Biological Engineering
    Formulation and Delivery
  • 3:30 PM – 4:30 PM MT
    Nitrite Assessment & Tablet Compression Characterization of Low-Nitrite MCC According to USP
    Partner Presentation Speaker: Raxit Mehta – Asahi Kasei America
    Formulation and Delivery
  • 4:00 PM – 5:00 PM MT
    AAPS Oral Biopharmaceutics and Absorption Modeling Community Membership Meeting
    Community Leader: Siddhi S. Hate, PhD – Eli Lilly and Company
  • 4:00 PM – 5:00 PM MT
    AAPS Pharmaceutical Discovery and Preclinical Development Community Membership Meeting
    Community Leader: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
  • 4:00 PM – 5:00 PM MT
    AAPS Topical and Transdermal Community Membership Meeting
    Community Leader: Kevin S. Warner, PhD – Tarsus Pharmaceuticals
  • 4:00 PM – 5:00 PM MT
    Happy Hour Sponsored by Croda Pharm + Avanti Polar Lipids
  • 5:00 PM – 6:00 PM MT
    AAPS Biomarker & Precision Medicine Community Membership Meeting
    Community Leader: Amanda L. Hays, Ph.D. – BioAgilytix
  • 5:00 PM – 6:00 PM MT
    AAPS In Vitro Release and Dissolution Testing Community Membership Meeting
    Community Leader: Sanjaykumar Patel (he/him/his) – Merck & Co., Inc.
  • 5:00 PM – 6:00 PM MT
    AAPS Pharmaconkinetics, Pharmacodynamics, & Drug Metabolism Community Membership Meeting
    Community Leader: Chukwunonso Kingsley Nwabufo, M.S, M.B.A., PhD (c) – University of Toronto
  • 5:00 PM – 6:00 PM MT
    AAPS Stability Community Membership Meeting
    Community Leader: Kim Huynh-Ba, M.S., PMP, FAAPS – Pharmalytik
    Community Leader: Vinaya Kapoor
    Community Leader: Lori McCaig, PhD (she/her/hers) – Pfizer, Inc
  • 5:00 PM – 6:00 PM MT
    AAPS Therapeutic Product Immunogenicity Community Membership Meeting
    Community Leader: Kun Yang, PhD – Bristol Myers Squibb
  • 5:00 PM – 6:00 PM MT
    AAPS Women In Pharmaceutical Sciences Community Membership Meeting
    Community Leader: Vibha Jawa, PhD FAAPS (she/her/hers) – Bristol Myers Squibb
  • 5:15 PM – 7:00 PM MT
    UConn School of Pharmacy Alumni Reception
  • 5:30 PM – 7:00 PM MT
    Fellows Networking Reception (by invitation only)
  • 5:30 PM – 7:00 PM MT
    Sustaining Sponsor Reception (by invitation only)
  • 5:30 PM – 9:30 PM MT
    American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Banquet Meeting
  • 6:00 PM – 8:00 PM MT
    University of Mississippi School of Pharmacy (by invitation only)
  • 6:00 PM – 9:00 PM MT
    2024 IPEC Foundation Awards Ceremony (by invitation only)
  • 6:00 PM – 9:00 PM MT
    Simulations Plus User Forum and Networking (by invitation only)
  • Wednesday, October 23, 2024
  • 7:30 AM – 8:30 AM MT
    Women in PharmSci Breakfast
  • 7:30 AM – 3:30 PM MT
    Speaker Ready Room
  • 8:00 AM – 2:30 PM MT
    Registration Hours
  • 8:00 AM – 7:00 PM MT
    Coat Check
  • 8:30 AM – 12:30 PM MT
    Free Professional Headshots
  • 8:30 AM – 12:30 PM MT
    LinkedIn Profile Critiques & Resume Reviews
  • 8:30 AM – 12:30 PM MT
    Mock Interviews
  • 8:30 AM – 1:30 PM MT
    Solution Center Hours & Poster Presentations
  • 9:00 AM – 10:00 AM MT
    Symbiotic Approaches for Rapid and Cost-Effective Manufacturing of Multiparticulate Formulations
    Partner Presentation Speaker: Nitin K. Swarnakar, PhD (he/him/his) – BASF Corp
    Partner Presentation Speaker: Ramesh Muttavarapu, MS – Thermo Fisher Scientific
    Formulation and Delivery
  • 9:00 AM – 10:30 AM MT
    Symposium: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 1
    Moderator: Philip J. Kuehl, PhD – Lovelace Biomedical
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 10:30 AM MT
    Symposium: Advancing Vaccine Development: Utilizing the Power of Model-Based Approaches 2
    Moderator: Christopher Rowbottom, BS – Moderna TX
    Preclinical, Clinical and Translational Sciences
  • 9:00 AM – 11:00 AM MT
    Symposium: Advanced Drug Delivery Technologies for Targeted Therapeutics
    Moderator: Alejandro J. Paredes, Ph.D. – Queen's University Belfast
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 1
    Moderator: Thilak Mudalige, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 2
    Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovative Approaches for Inhaled Delivery
    Moderator: Nitesh K. Kunda, PhD – St. John's University
    Formulation and Delivery
  • 9:00 AM – 11:00 AM MT
    Symposium: Innovative Methodologies for Advancing Therapeutics from Bench to Bedside
    Moderator: Rosalinde Masereeuw, PhD (she/her/hers) – Utrecht Institute for Pharmaceutical Sciences
    Discovery and Basic Research
  • 9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 1
    Moderator: Manish Kumar, PhD (he/him/his) – Daiichi Sankyo
    Bioanalytics
  • 9:00 AM – 11:00 AM MT
    Symposium: Regulatory Implications for Bioanalysis 2
    Moderator: Darshana Jani, Ph.D. – Moderna Therapeutics
    Bioanalytics
  • 9:30 AM – 10:00 AM MT
    Coffee Break in the Solution Center
  • 9:30 AM – 10:25 AM MT
    Special Poster Collection
  • 9:30 AM – 10:30 AM MT
    Mitigating Nitrosamine Risks: An In-Silico Approach to Identifying NDSRIs and Evaluating API-Excipient Interactions
    Partner Presentation Speaker: Rainer Dobrawa, PhD (he/him/his) – BASF Pharma Solutions
    Partner Presentation Speaker: Sandip Tiwari, PhD (he/him/his) – BASF Corporation
    Formulation and Delivery
  • 9:30 AM – 10:30 AM MT
    Speed to Market: The Power of Controlled Release Formulated Systems
    Partner Presentation Speaker: Lawrence Martin, BS – Colorcon
    Partner Presentation Speaker: Ali Rajabi-Siahboomi – Colorcon
    Formulation and Delivery
  • 10:00 AM – 10:45 AM MT
    Advancements in Oral Drug Delivery via Drug Pelleting
    Chalk Talk Presenter: Lauren G. Petraglia, BS – LCI Corporation
    Formulation and Delivery
  • 10:00 AM – 11:00 AM MT
    Hot Topic: Beyond the Hype: The Realities of AI in Drug Discovery
    Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC
    Hot Topic Moderator: Md Masud Parvez, PhD (he/him/his) – AbbVie Inc.
    Discovery and Basic Research
  • 10:00 AM – 11:00 AM MT
    Speaker Spotlight: Optimizing CAR T Cell Trials: Guidance on Developing and Validating Flow Cytometry Assays for Pharmacokinetics in Clinical Trials
    Spotlight Speaker: Kevin Lang, PhD (he/him/his) – PPD, part of Thermo Fisher Scientific
    Moderator: Long Yuan, PhD – Biogen Inc.
    Bioanalytics
  • 10:00 AM – 11:00 AM MT
    Speaker Spotlight: Overcoming Challenges in Manufacturing and Scale-up of CGT (Cell and Gene Therapy)
    Spotlight Speaker: Raghu Malapaka, PhD – AGC Biologics
    Moderator: Sai Chamarthy
    Manufacturing & Analytical Characterization
  • 10:30 AM – 11:30 AM MT
    Analytical Method Advances in Measuring Nitrites in Pharmaceutical Excipients
    Partner Presentation Speaker: Koudi Zhu, MS – IFF Pharma Solutions
    Manufacturing & Analytical Characterization
  • 10:30 AM – 11:30 AM MT
    Evaluation of Solid Self-Emulsifying Drug Delivery System by Fluid-Bed Technology
    Partner Presentation Speaker: Tasneem Gandhi, n/a – Glatt Group - Pharmaceutical Services CDMO Unlimited
    Formulation and Delivery
  • 10:30 AM – 11:30 AM MT
    How to Negotiate Contracts Like a Pro
    Career Center Speaker: Prabu Nambiar, PhD MBA FRAPS (he/him/his) – Syner-G Biopharma Group
    Career Center Speaker: Ashok Dang, PhD – Perkin Elmer
    Career Center Speaker: Kim Huynh-Ba, M.S., PMP, FAAPS – Pharmalytik
    Career Development
  • 11:00 AM – 1:30 PM MT
    Dedicated Solution Center Hours
  • 11:30 AM – 12:25 PM MT
    Special Poster Collection
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Omics-Driven Drug Delivery: Pioneering Precision Medicine
    Spotlight Speaker: Robert Arnold, PhD (he/him/his) – Auburn University
    Moderator: Sibylle Neuhoff, PhD (she/her/hers) – Certara Predictive Technologies
    Preclinical, Clinical and Translational Sciences
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Patient-Focused Drug Development: CMC Considerations
    Spotlight Speaker: Hong Cai, PhD (she/her/hers) – U.S. Food and Drug Administration
    Moderator: Josephine Aimiuwu, PhD – U.S. Food and Drug Administration
    Formulation and Delivery
  • 11:30 AM – 12:30 PM MT
    Speaker Spotlight: Synthesis and Characterization of Dual-Payload Antibody-Drug Conjugates
    Spotlight Speaker: Shawn Owen, PhD (he/him/his) – University of Utah
    Moderator: Abhisheak Sharma, Ph.D. – University of Florida
    Discovery and Basic Research
  • 12:00 PM – 1:00 PM MT
    Empowering Success:Developing Transferable Skills for Graduate Students and Postdoctoral Fellows
    Career Center Speaker: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Career Center Speaker: Bo Tokarski, PhD, MBA – Charles River Laboratories Ashland LLC
    Career Center Moderator: Sudip K. Das, PhD (he/him/his) – Butler University, College of Pharmacy & Health Sciences
    Career Development
  • 12:30 PM – 1:25 PM MT
    Special Poster Collection
  • 1:30 PM – 2:30 PM MT
    Keynote: Impact of Immunogenicity on Gene Therapy Development – Science, Regulatory and Patients
    Keynote Speaker: Jim McNally, PhD – BioAgilytix
    Moderator: Maria Jadhav, PhD – Novartis Institutes for BioMedical Research, Inc.
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Challenges with New Modalities: Hitting the Stride from Day 1
    Keynote Speaker: Jennifer Chadwick, PhD – Jennifer Chadwick
    Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry
    Keynote Speaker: Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories
    Moderator: Chad J. Briscoe, PhD (he/him/his) – Celerion
    Bioanalytics
  • 1:30 PM – 2:30 PM MT
    Keynote: Innovation Through Advanced Manufacturing: What We Can Learn From the Future
    Keynote Speaker: Xiaoming Xu, PhD (he/him/his) – US Food and Drug Administration
    Moderator: Thilak Mudalige, PhD (he/him/his) – US Food and Drug Administration
    Manufacturing & Analytical Characterization
  • 1:30 PM – 2:30 PM MT
    Keynote: Materials and Protein Engineering to Counter Inflammation and Autoimmunity
    Keynote Speaker: Jeffrey A. Hubbell, PhD (he/him/his) – University of Chicago
    Moderator: Shijie Cao
    Formulation and Delivery
  • 1:30 PM – 2:30 PM MT