- 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: – JTH Consulting & Associates
Executive Education Speaker: – RxE2 Inc.
Executive Track
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?Location:308 AB WestExecutive Education Speaker: – JTH Consulting & Associates
Executive Education Speaker: – RxE2 Inc.
Executive Track
Jeanne Hecht, MBA, PMP (she/her/hers) – JTH Consulting & Associates ### 2144164###Executive Education Speaker###Founder and CEO###JTH Consulting & Associates###Executive Education Speaker: – JTH Consulting & Associates
### she/her/hers @@@ Gerald E. Finken, R.Ph., M.S. (he/him/his) – RxE2 Inc. ### 2144166###Executive Education Speaker###CEO###RxE2 Inc.###Executive Education Speaker: – RxE2 Inc.
### he/him/his7:30 AM – 8:30 AM ET
AAPS Joint Editorial Board Breakfast (by invitation only)
7:30 AM – 8:30 AM ET
AAPS Joint Editorial Board Breakfast (by invitation only)Location:Florida A, Hyatt Regency Orlando
7:30 AM – 5:00 PM ET
Registration Hours
7:30 AM – 5:00 PM ET
Registration Hours
Location:Concourse A4-B3 West
7:30 AM – 5:00 PM ET
Speaker Ready Room
7:30 AM – 5:00 PM ET
Speaker Ready Room
Location:307 AB West
8:00 AM – 9:00 AM ET
Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)
8:00 AM – 9:00 AM ET
Coffee and Conversation With the Fellows Communications Task Force (Fellows Only)Location:312 A WestCommittee Chair: – University of Iowa
Dale Eric Wurster, Ph.D., FAAPS – University of Iowa ### 846619###Committee Chair###Professor Emeritus###University of Iowa###Committee Chair: – University of Iowa
### 8:30 AM – 2:00 PM ET
Guest Tour: Space Coast River Tour (additional fee required)
8:30 AM – 2:00 PM ET
Guest Tour: Space Coast River Tour (additional fee required)Location:Meet at the Hyatt Regency Orlando at 8:30 am
8:30 AM – 4:30 PM ET
Coffee Station
8:30 AM – 4:30 PM ET
Coffee StationLocation:Booth #2335, Exhibit Hall West A4-B3
8:30 AM – 4:30 PM ET
Free Professional Headshots
8:30 AM – 4:30 PM ET
Free Professional HeadshotsLocation:Careers 360, Exhibit Hall West A4-B3Career Development
8:30 AM – 4:30 PM ET
LinkedIn Profile Critiques & Resume Reviews
8:30 AM – 4:30 PM ET
LinkedIn Profile Critiques & Resume ReviewsLocation:Careers 360, Exhibit Hall West A4-B3Career Development
8:30 AM – 4:30 PM ET
Mock Interviews
8:30 AM – 4:30 PM ET
Mock Interviews Location:Careers 360, Exhibit Hall West A4-B3Career Development
8:30 AM – 5:00 PM ET
Solution Center Hours & Poster Presentations
8:30 AM – 5:00 PM ET
Solution Center Hours & Poster PresentationsLocation:Exhibit Hall West A4-B3
9:00 AM – 10:00 AM ET
Developing Critical Thinking Skills Needed for Your JobCareer Center Speaker: – Pharmalytik Consulting & Training
Career Development
9:00 AM – 10:00 AM ET
Developing Critical Thinking Skills Needed for Your JobLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Pharmalytik Consulting & Training
Career Development
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training ### 636579###Career Center Speaker###Managing Director###Pharmalytik Consulting & Training###Career Center Speaker: – Pharmalytik Consulting & Training
### 9:00 AM – 10:00 AM ET
Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century ModalitiesHot Topic Speaker: – Immunologix Laboratories
Hot Topic Speaker: – Regeneron Pharmaceuticals
Hot Topic Speaker: – LAIZ Regulatory Science Consulting
Hot Topic Moderator: – Regeneron
Hot Topic Speaker: – Merck KGaA
Bioanalytics – Biomolecular
9:00 AM – 10:00 AM ET
Hot Topic: Rethinking the Immunogenicity Testing Paradigm for 21st Century ModalitiesLocation:308 CD WestHot Topic Speaker: – Immunologix Laboratories
Hot Topic Speaker: – Regeneron Pharmaceuticals
Hot Topic Speaker: – LAIZ Regulatory Science Consulting
Hot Topic Moderator: – Regeneron
Hot Topic Speaker: – Merck KGaA
Bioanalytics – Biomolecular
Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories ### 802379###Hot Topic Speaker###Chief Scientific Officer###Immunologix Laboratories###Hot Topic Speaker: – Immunologix Laboratories
### she/her/hers @@@ Jenny Valentine, PhD (she/her/hers) – Regeneron Pharmaceuticals ### 1820680###Hot Topic Speaker###Principal Scientist###Regeneron Pharmaceuticals###Hot Topic Speaker: – Regeneron Pharmaceuticals
### she/her/hers @@@ Laura I. Salazar-Fontana, PhD (she/her/hers) – LAIZ Regulatory Science Consulting ### 1976698###Hot Topic Speaker###Principal###LAIZ Regulatory Science Consulting###Hot Topic Speaker: – LAIZ Regulatory Science Consulting
### she/her/hers @@@ Michael Partridge, PhD – Regeneron ### 846562###Hot Topic Moderator###Director###Regeneron###Hot Topic Moderator: – Regeneron
### @@@ Kyra J. Cowan, PhD – Merck KGaA ### 1055950###Hot Topic Speaker###Senior Director, Global Head of NBE DMPK ###Merck KGaA###Hot Topic Speaker: – Merck KGaA
### 9:00 AM – 10:00 AM ET
Overcome Capping Challenges and Increase Tableting Speed in Direct CompressionPartner Presentation Speaker: – Roquette America Inc.
Formulation and Delivery
9:00 AM – 10:00 AM ET
Overcome Capping Challenges and Increase Tableting Speed in Direct CompressionLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Roquette America Inc.
Formulation and Delivery
Talles Ernica, MD – Roquette America Inc. ### 1743099###Partner Presentation Speaker###Global Technical Developer###Roquette America Inc.###Partner Presentation Speaker: – Roquette America Inc.
### 9:00 AM – 10:30 AM ET
Symposium: Advances in Predictive Biomarkers For Drug DevelopmentPreclinical and Translational Sciences
9:00 AM – 10:30 AM ET
Symposium: Advances in Predictive Biomarkers For Drug Development Location:311 CD WestPreclinical and Translational Sciences
Manthena V. Varma, PhD – Pfizer Inc ### 567481###Moderator###Research Fellow###Pfizer Inc###Moderator: – Pfizer Inc
### 9:00 AM – 9:30 AM ET
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and ApprovalLocation:311 CD WestPreclinical and Translational Sciences
Lakshmi Manasa S. Chekka, PharmD, PhD – U.S. FDA ### 2135665###Speaker###Visiting Associate###U.S. FDA###Speaker: – U.S. FDA
### 9:30 AM – 10:00 AM ET
Leveraging Biomarkers in Establishing PK/PD ModelsLocation:311 CD WestSpeaker: – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
Preclinical and Translational Sciences
Donald E. Mager, PharmD, PhD – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC ### 576352###Speaker###Professor and Chair of Pharmaceutical Sciences/President and CEO###University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC###Speaker: – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
### 10:00 AM – 10:30 AM ET
Metabolomics: a Powerful and Efficient Tool for Drug Discovery and DevelopmentLocation:311 CD WestPreclinical and Translational Sciences
Thomas P. Roddy, PhD (he/him/his) – Atavistik Bio ### 1976704###Speaker###Senior Vice President of Platform###Atavistik Bio###Speaker: – Atavistik Bio
### he/him/his9:00 AM – 11:00 AM ET
Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1Moderator: – Merck & Co., Inc.
Formulation and Delivery
9:00 AM – 11:00 AM ET
Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1 Location:208 AB WestModerator: – Merck & Co., Inc.
Formulation and Delivery
Jing Ling, PhD – Merck & Co., Inc. ### 1650352###Moderator###Associate Principal Scientist###Merck & Co., Inc.###Moderator: – Merck & Co., Inc.
### 9:00 AM – 9:30 AM ET
Regulatory Considerations for Demonstrating Pharmaceutical Equivalence and Bioequivalence of Complex PLGA Based LAI ProductsLocation:208 AB WestSpeaker: – U.S. Food and Drug Administration
Formulation and Delivery
Yan Wang, PhD (she/her/hers) – U.S. Food and Drug Administration ### 848517###Speaker###Lead Pharmacologist ###U.S. Food and Drug Administration###Speaker: – U.S. Food and Drug Administration
### she/her/hers9:30 AM – 10:00 AM ET
Long-Acting Injectables: Advances in In Vitro Equivalence TestingLocation:208 AB WestFormulation and Delivery
Bin Qin, PhD – U.S. FDA ### 605647###Speaker###Senior Staff Fellow###U.S. FDA###Speaker: – U.S. FDA
### 10:00 AM – 10:30 AM ET
Novel Analytical Imaging and Dissolution ModelingLocation:208 AB WestSpeaker: – DigiM Solution LLC
Formulation and Delivery
Shawn Zhang, PhD – DigiM Solution LLC ### 466053###Speaker###founder and managing director of DigiM###DigiM Solution LLC###Speaker: – DigiM Solution LLC
### 10:30 AM – 11:00 AM ET
Advancing Delivery of mAbs and RNA Through Drug-Eluting ImplantsLocation:208 AB WestFormulation and Delivery
Harsh Patel, PhD (he/him/his) – Celanese ### 1446419###Speaker###Senior Scientist - Team Lead###Celanese###Speaker: – Celanese
### he/him/his9:00 AM – 11:00 AM ET
Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2Moderator: – University of Connecticut
Formulation and Delivery
9:00 AM – 11:00 AM ET
Symposium: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2Location:209 AB WestModerator: – University of Connecticut
Formulation and Delivery
Na Li, Ph.D. (she/her/hers) – University of Connecticut ### 1377855###Moderator###Assistant Professor###University of Connecticut###Moderator: – University of Connecticut
### she/her/hers9:00 AM – 9:30 AM ET
Advancing Nanoparticle-Based Delivery Systems with Novel Assessment ApproachesLocation:209 AB WestFormulation and Delivery
Xiaoming Xu, PhD (he/him/his) – FDA ### 603915###Speaker###Division Director###FDA###Speaker: – FDA
### he/him/his9:30 AM – 10:00 AM ET
NanoLipoSome Technology: a Toolbox for the Oral Delivery of PeptidesLocation:209 AB WestFormulation and Delivery
Ansgar Bögershausen, PhD (he/him/his) – Losan Pharma ### 1976727###Speaker###Head of Research & Development###Losan Pharma###Speaker: – Losan Pharma
### he/him/his10:00 AM – 10:30 AM ET
Particle Engineering for High Concentration Protein SuspensionsLocation:209 AB WestSpeaker: – Seran Biosciences, LLC
Formulation and Delivery
Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC ### 847532###Speaker###VP, Technical Development###Seran Biosciences, LLC###Speaker: – Seran Biosciences, LLC
### she/her/hers10:30 AM – 11:00 AM ET
Post-Production Processes for Cell Therapy ProductsLocation:209 AB WestSpeaker: – Children's National Hospital
Formulation and Delivery
Patrick Hanley, PhD – Children's National Hospital ### 2038594###Speaker###Chief & Director, Cellular Therapy Program###Children's National Hospital###Speaker: – Children's National Hospital
### 9:00 AM – 11:00 AM ET
Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1Moderator: – 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 1Location:205 AB WestModerator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
Jason Rodriguez, PhD – US Food and Drug Administration ### 1378515###Moderator###Director DCDA###US Food and Drug Administration###Moderator: – US Food and Drug Administration
### 9:00 AM – 9:30 AM ET
API Co-Processing for Enhanced Solid Oral DosagesLocation:205 AB WestManufacturing & Analytical Characterization
Rajesh Dave, PhD (he/him/his) – NJIT ### 604958###Speaker###Distinguished Professor###NJIT###Speaker: – NJIT
### he/him/his9:30 AM – 10:00 AM ET
Mixing Systems for Floating and Settling Particles for Sterile Drug ProductsLocation:205 AB WestSpeaker: – GlaxoSmithKline
Manufacturing & Analytical Characterization
Parind Desai, PhD – GlaxoSmithKline ### 1650328###Speaker###Team Leader, GSK Fellow###GlaxoSmithKline###Speaker: – GlaxoSmithKline
### 10:00 AM – 10:30 AM ET
Novel 3D Printing Techniques to Assess Adhesion Testing for PatchesLocation:205 AB WestSpeaker: – Florida A & M University
Manufacturing & Analytical Characterization
Mandip Singh Sachdeva, PhD, FAAPS – Florida A & M University ### 848734###Speaker###Professor###Florida A & M University###Speaker: – Florida A & M University
### 10:30 AM – 11:00 AM ET
Development and Scale-Up of HDAd Process Using iCELLis® Bioreactor PlatformLocation:205 AB WestManufacturing & Analytical Characterization
Jyoti Amatya, MS (she/her/hers) – Cytiva ### 2081034###Speaker###Senior Scientist###Cytiva###Speaker: – Cytiva
### she/her/hers9:00 AM – 11:00 AM ET
Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2Moderator: – University of Copenhagen
Manufacturing & Analytical Characterization
9:00 AM – 11:00 AM ET
Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2Location:206 AB WestModerator: – University of Copenhagen
Manufacturing & Analytical Characterization
Jukka Rantanen, PhD (he/him/his) – University of Copenhagen ### 844122###Moderator###Professor###University of Copenhagen###Moderator: – University of Copenhagen
### he/him/his9:00 AM – 9:30 AM ET
Impact of Raw Materials Variation On Continuous Feeders PerformanceLocation:206 AB WestManufacturing & Analytical Characterization
Sara Fathollahi, PhD – DFE Pharma ### 1976725###Speaker###Product Application Specialist###DFE Pharma###Speaker: – DFE Pharma
### 9:30 AM – 10:00 AM ET
Troubleshooting Difficult Formulations For Continuous Twin-Screw Wet GranulationLocation:206 AB WestSpeaker: – McMaster University
Manufacturing & Analytical Characterization
Michael R. Thompson, PhD (he/him/his) – McMaster University ### 1446192###Speaker###Professor###McMaster University###Speaker: – McMaster University
### he/him/his10:00 AM – 10:30 AM ET
Development and Control Strategy for a Semi-Continuous Granulation ProcessLocation:206 AB WestManufacturing & Analytical Characterization
Yasmin Suessenbach, PhD (she/her/hers) – Bayer AG ### 1976700###Speaker###Laboratory Head###Bayer AG###Speaker: – Bayer AG
### she/her/hers10:30 AM – 11:00 AM ET
Optimization of Design Space for Continuous Manufacturing of Extended-Release TabletsLocation:206 AB WestSpeaker: – US Food and Drug Administration
Manufacturing & Analytical Characterization
Ahmed S. Zidan, Ph.D – US Food and Drug Administration ### 603509###Speaker###Senior Staff Pharmacologist###US Food and Drug Administration###Speaker: – US Food and Drug Administration
### 9:00 AM – 11:00 AM ET
Symposium: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug DeliveryModerator: – University of Arizona
Discovery and Basic Research
9:00 AM – 11:00 AM ET
Symposium: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug DeliveryLocation:309 AB WestModerator: – University of Arizona
Discovery and Basic Research
Patrick Ronaldson, PhD – University of Arizona ### 1378339###Moderator###Professor###University of Arizona###Moderator: – University of Arizona
### 9:00 AM – 9:30 AM ET
The Shift From Passive To Active Targeting Drug DeliveryLocation:309 AB WestDiscovery and Basic Research
Silvia Sonzini, Ph.D. (she/her/hers) – AstraZeneca ### 1976706###Speaker###Associate Principal Scientist###AstraZeneca###Speaker: – AstraZeneca
### she/her/hers9:30 AM – 10:00 AM ET
Regulatory Pathways of Folate Delivery To The BrainLocation:309 AB WestSpeaker: – University of Toronto
Discovery and Basic Research
Reina Bendayan, PharmD, FAAPS, FCSPS, FCAHS – University of Toronto ### 567625###Speaker###Professor###University of Toronto###Speaker: – University of Toronto
### 10:00 AM – 10:30 AM ET
Recent Advances in the In Vitro and In Vivo Methods to Assess Impact of P-gp and BCRP in Drug Intestinal Absorption and Brain PenetrationLocation:309 AB WestSpeaker: – Bristol Myers Squibb Company
Discovery and Basic Research
Hong Shen, PhD – Bristol Myers Squibb Company ### 465951###Speaker###Scientific Director###Bristol Myers Squibb Company###Speaker: – Bristol Myers Squibb Company
### 10:30 AM – 11:00 AM ET
Bioanalytical Strategies for the Determination of Peptide-Conjugated Phosphorodiamidate Morpholino OligonucleotidesLocation:309 AB WestDiscovery and Basic Research
Pallavi Lonkar, Post Graduate – PepGen ### 1976702###Speaker###VP-Bioanalytical, Biomarkers, DMPK###PepGen###Speaker: – PepGen
### 9:00 AM – 11:00 AM ET
Symposium: PD Biomarkers As Evidence in Rare DiseaseModerator: – Kojin Therapeutics
Preclinical and Translational Sciences
9:00 AM – 11:00 AM ET
Symposium: PD Biomarkers As Evidence in Rare DiseaseLocation:311 AB WestModerator: – Kojin Therapeutics
Preclinical and Translational Sciences
Lakshmi Amaravadi, PhD – Kojin Therapeutics ### 567500###Moderator###SVP, Head of Preclinical and Translational Development###Kojin Therapeutics###Moderator: – Kojin Therapeutics
### 9:00 AM – 9:30 AM ET
Supporting Rare Disease Drug Development and Use of Biomarkers: Ravulizumab Case StudyLocation:311 AB WestPreclinical and Translational Sciences
Mark Ma, MD (he/him/his) – Biotech ### 1792079###Speaker###VP, Head of Translational Clinical Sciences###Biotech###Speaker: – Biotech
### he/him/his9:30 AM – 10:00 AM ET
Critical Path for Rare Neurodegenerative Diseases Initiative for Drug DevelopmentLocation:311 AB WestSpeaker: – C-Path Institute
Preclinical and Translational Sciences
Colin Hovinga – C-Path Institute ### 1976726###Speaker###Vice President, Rare and Orphan Diseases; Rare Neurodegenerative Disease (CP-RND)###C-Path Institute###Speaker: – C-Path Institute
### 10:00 AM – 10:30 AM ET
Neurodegenerative Rare Diseases: Biomarkers in Drug Development and Regulatory DecisionsLocation:311 AB WestPreclinical and Translational Sciences
Bilal AbuAsal, PhD – US FDA ### 1976722###Speaker###Team Leader###US FDA###Speaker: – US FDA
### 10:30 AM – 11:00 AM ET
Pharmacodynamic Biomarkers as Confirmatory Evidence in Rare Disease Drug DevelopmentLocation:311 AB WestPreclinical and Translational Sciences
Nayeem Hossain, PhD – US FDA ### 1976720###Speaker###Clinical Pharmacology Reviewer###US FDA###Speaker: – US FDA
### 9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 1Bioanalytics
9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of BioanalysisLocation:311 EF WestBioanalytics
Shefali Patel, BSc., MLT – Janssen Research and Development, LLC ### 627102###Moderator###Senior Scientist###Janssen Research and Development, LLC###Moderator: – Janssen Research and Development, LLC
### 9:00 AM – 9:30 AM ET
Low Volume Sampling Technologies Versus Venipuncture in a Clinical StudyLocation:311 EF WestBioanalytics
Saloumeh K. Fischer, PhD – Genentech Inc ### 1976710###Speaker###Sr. Fellow / Sr.Director###Genentech Inc###Speaker: – Genentech Inc
### 9:30 AM – 10:00 AM ET
Multi-Omics Microsampling for Dynamic Health Monitoring and Biomarker DiscoveryLocation:311 EF WestSpeaker: – Stanford University
Bioanalytics
Michael Snyder – Stanford University ### 1976708###Speaker###Professor and Chair of the Department of Genetics, Director of the Center for Genomics and###Stanford University###Speaker: – Stanford University
### 10:00 AM – 10:30 AM ET
Advance Clinical Studies with Patient Centric Sampling: Opportunities and ChallengesLocation:311 EF WestBioanalytics
Zhuo Chen, PhD (he/him/his) – GSK ### 1976678###Speaker###Associate Fellow, Principal Scientist###GSK###Speaker: – GSK
### he/him/his10:30 AM – 11:00 AM ET
Investigation of Patient Centric Sampling Solutions for Routine Clinical MeasurementsLocation:311 EF WestBioanalytics
Bradley Collier, PhD – Labcorp ### 2029619###Speaker###Scientist III###Labcorp###Speaker: – Labcorp
### 9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 2Moderator: – Olaris, Inc.
Bioanalytics
9:00 AM – 11:00 AM ET
Symposium: Setting up for Success: Considerations for Study Design in the Context of Bioanalysis 2Location:311 GH WestModerator: – Olaris, Inc.
Bioanalytics
Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc. ### 1690207###Moderator###VP of Mass Spectrometry Technology & Biomarkers###Olaris, Inc.###Moderator: – Olaris, Inc.
### he/him/his9:00 AM – 9:30 AM ET
Metabolomics in Drug Discovery & Precision Diagnostics, and the Importance of Context-of-UseLocation:311 GH WestBioanalytics
Jurre J. Kamphorst, PhD (he/him/his) – Olaris, Inc. ### 1690207###Speaker###VP of Mass Spectrometry Technology & Biomarkers###Olaris, Inc.###Speaker: – Olaris, Inc.
### he/him/his9:30 AM – 10:00 AM ET
Mitigation Strategies for Batch-Effects in Biomarker Data in Long-Term StudiesLocation:311 GH WestBioanalytics
Jihee Sohn, PhD (she/her/hers) – Biogen ### 1976683###Speaker###Sr. Scientist###Biogen###Speaker: – Biogen
### she/her/hers10:00 AM – 10:30 AM ET
A Novel Method to Overcome ADA Interference in PK AssayLocation:311 GH WestSpeaker: – Takeda Pharmaceuticals
Bioanalytics
Saleem Shaik, PhD – Takeda Pharmaceuticals ### 1976734###Speaker###Scientific Associate Director###Takeda Pharmaceuticals###Speaker: – Takeda Pharmaceuticals
### 10:30 AM – 11:00 AM ET
Stability and Method Performance Considerations for Bioanalytical Enzymatic Activity AssaysLocation:311 GH WestSpeaker: – PPD, part of Thermo Fisher Scientific
Bioanalytics
Christian Duke, MBA (he/him/his) – PPD, part of Thermo Fisher Scientific ### 1976690###Speaker###Manager###PPD, part of Thermo Fisher Scientific###Speaker: – PPD, part of Thermo Fisher Scientific
### he/him/his9:30 AM – 10:00 AM ET
Coffee Break in the Solution Center
9:30 AM – 10:00 AM ET
Coffee Break in the Solution CenterLocation:Exhibit Hall West A4-B3
9:30 AM – 10:30 AM ET
From Concept to Clinic: Navigating RNA-Lipid Nanoparticle DevelopmentPartner Presentation Speaker: – Precision NanoSystems
Formulation and Delivery
9:30 AM – 10:30 AM ET
From Concept to Clinic: Navigating RNA-Lipid Nanoparticle DevelopmentLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Precision NanoSystems
Formulation and Delivery
Jagbir Singh, PhD – Precision NanoSystems ### 604910###Partner Presentation Speaker###Director of Pre-Clinical Services###Precision NanoSystems###Partner Presentation Speaker: – Precision NanoSystems
### 9:30 AM – 10:30 AM ET
Lipidomic Applications to Support Pharmaceutical Early Discovery and Safety AssessmentPartner Presentation Speaker: – Charles River
Discovery and Basic Research
9:30 AM – 10:30 AM ET
Lipidomic Applications to Support Pharmaceutical Early Discovery and Safety AssessmentLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Charles River
Discovery and Basic Research
Andrea Coates, MRes PhD (she/her/hers) – Charles River ### 2129020###Partner Presentation Speaker###Research Scientist###Charles River###Partner Presentation Speaker: – Charles River
### she/her/hers9:30 AM – 10:30 AM ET
Overcoming Formulation Challenges with Binder Jetting 3D Printing PlatformsChalk Talk Presenter: – Aprecia Pharmaceuticals
Formulation and Delivery
9:30 AM – 10:30 AM ET
Overcoming Formulation Challenges with Binder Jetting 3D Printing PlatformsLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – Aprecia Pharmaceuticals
Formulation and Delivery
Michael Gosselin, PhD – Aprecia Pharmaceuticals ### 1743108###Chalk Talk Presenter###VP, Innovation & Development###Aprecia Pharmaceuticals###Chalk Talk Presenter: – Aprecia Pharmaceuticals
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: Surveying the Landscape of Extracellular Vesicles as Drug Delivery AgentsModerator: – Butler University
Spotlight Speaker: – University of Florida
Discovery and Basic Research
9:30 AM – 10:30 AM ET
Speaker Spotlight: Surveying the Landscape of Extracellular Vesicles as Drug Delivery AgentsLocation:Spotlight Stage A Exhibit Hall West A4-B3Moderator: – Butler University
Spotlight Speaker: – University of Florida
Discovery and Basic Research
Sudip Das, PhD (he/him/his) – Butler University ### 606117###Moderator###Professor of pharmaceutics & drug delivery ###Butler University###Moderator: – Butler University
### he/him/his @@@ Thomas Schmittgen, PhD (he/him/his) – University of Florida ### 604706###Spotlight Speaker###College of Pharmacy###University of Florida###Spotlight Speaker: – University of Florida
### he/him/his9:30 AM – 10:30 AM ET
Speaker Spotlight: The Path to Peak Performance: PAT Solutions for Advanced Process Control in Continuous Pharmaceutical ManufacturingSpotlight Speaker: – Ghent University
Manufacturing & Analytical Characterization
9:30 AM – 10:30 AM ET
Speaker Spotlight: The Path to Peak Performance: PAT Solutions for Advanced Process Control in Continuous Pharmaceutical ManufacturingLocation:Spotlight Stage B Exhibit Hall West A4-B3Spotlight Speaker: – Ghent University
Manufacturing & Analytical Characterization
Thomas De Beer, PhD (he/him/his) – Ghent University ### 849132###Spotlight Speaker###Professor###Ghent University###Spotlight Speaker: – Ghent University
### he/him/his9:30 AM – 10:30 AM ET
Special Poster Collection
9:30 AM – 10:30 AM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Rutgers University
Patrick J. Sinko, Ph.D. – Rutgers University ### 602328###Poster Collection Host###Distinguished Professor###Rutgers University###Poster Collection Host: – Rutgers University
### 10:00 AM – 11:00 AM ET
Career Conversations: Hosted by Merck
10:00 AM – 11:00 AM ET
Career Conversations: Hosted by MerckLocation:Careers 360, Exhibit Hall West A4-B3Career Development
10:00 AM – 11:00 AM ET
Hot Topic: Drug Delivery Technology: Quo Vadis?Hot Topic Speaker: – Purdue University
Hot Topic Speaker: – University of Bath
Hot Topic Speaker: – U.S. Food & Drug Administration
Hot Topic Moderator: – University of Bath
Hot Topic Speaker: – University of Bath
Formulation and Delivery – Chemical
10:00 AM – 11:00 AM ET
Hot Topic: Drug Delivery Technology: Quo Vadis?Location:308 AB WestHot Topic Speaker: – Purdue University
Hot Topic Speaker: – University of Bath
Hot Topic Speaker: – U.S. Food & Drug Administration
Hot Topic Moderator: – University of Bath
Hot Topic Speaker: – University of Bath
Formulation and Delivery – Chemical
Kinam Park, PhD (he/him/his) – Purdue University ### 856608###Hot Topic Speaker###Showalter Distinguished Professor of Biomedical Engineering###Purdue University###Hot Topic Speaker: – Purdue University
### he/him/his @@@ Richard H. Guy, PhD, FAAPS – University of Bath ### 466149###Hot Topic Speaker###Professor###University of Bath###Hot Topic Speaker: – University of Bath
### @@@ Robert Lionberger, PhD – U.S. Food & Drug Administration ### 576394###Hot Topic Speaker###Director, Office of Research Standards, Office of Generic Drugs###U.S. Food & Drug Administration###Hot Topic Speaker: – U.S. Food & Drug Administration
### @@@ Richard H. Guy, PhD, FAAPS – University of Bath ### 466149###Hot Topic Moderator###Professor###University of Bath###Hot Topic Moderator: – University of Bath
### @@@ Randall Mrsny, Ph.D. (he/him/his) – University of Bath ### 1602134###Hot Topic Speaker###Professor###University of Bath###Hot Topic Speaker: – University of Bath
### he/him/his10:30 AM – 11:30 AM ET
Catalyze Your Success: Developing Business Acumen and LeadershipCareer Center Moderator: – Neurocrine
Career Center Speaker: – Astra Zeneca
Career Center Speaker: – TriLink Biotechnologies
Career Development
10:30 AM – 11:30 AM ET
Catalyze Your Success: Developing Business Acumen and LeadershipLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Moderator: – Neurocrine
Career Center Speaker: – Astra Zeneca
Career Center Speaker: – TriLink Biotechnologies
Career Development
Pankajini Mallick, PhD (she/her/hers) – Neurocrine ### 1329420###Career Center Moderator###Principal Scientist###Neurocrine###Career Center Moderator: – Neurocrine
### she/her/hers @@@ Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca ### 466184###Career Center Speaker###Head of Advanced Drug Delivery###Astra Zeneca###Career Center Speaker: – Astra Zeneca
### she/her/hers @@@ Venus Huang, PhD (she/her/hers) – TriLink Biotechnologies ### 2135217###Career Center Speaker###Business Development Manager###TriLink Biotechnologies###Career Center Speaker: – TriLink Biotechnologies
### she/her/hers10:30 AM – 11:30 AM ET
Precision Microspheres: Then and NowPartner Presentation Speaker: – Adare Pharma Solutions
Formulation and Delivery
10:30 AM – 11:30 AM ET
Precision Microspheres: Then and NowLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Adare Pharma Solutions
Formulation and Delivery
Nathan Dormer, PhD (he/him/his) – Adare Pharma Solutions ### 2159191###Partner Presentation Speaker###Director, Drug Product Development and Site Leader###Adare Pharma Solutions###Partner Presentation Speaker: – Adare Pharma Solutions
### he/him/his10:30 AM – 11:30 AM ET
Special Poster Collection - Best Poster Award Winners
10:30 AM – 11:30 AM ET
Special Poster Collection - Best Poster Award WinnersLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Trinity College Dublin
Carsten Ehrhardt, Ph.D. – Trinity College Dublin ### 1536972###Poster Collection Host###Professor in Pharmaceutics and Biopharmaceutics###Trinity College Dublin###Poster Collection Host: – Trinity College Dublin
### 11:00 AM – 12:00 PM ET
Career Conversations: Hosted by GSK
11:00 AM – 12:00 PM ET
Career Conversations: Hosted by GSKLocation:Careers 360, Exhibit Hall West A4-B3Career Development
11:00 AM – 12:00 PM ET
Inhalation Pharmacokinetics and Toxicity of CBD and other CannabinoidsPartner Presentation Speaker: – Lovelace Biomedical Research Institute
Preclinical and Translational Sciences
11:00 AM – 12:00 PM ET
Inhalation Pharmacokinetics and Toxicity of CBD and other CannabinoidsLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Lovelace Biomedical Research Institute
Preclinical and Translational Sciences
Philip J. Kuehl, PhD – Lovelace Biomedical Research Institute ### 603512###Partner Presentation Speaker###Senior Scientist###Lovelace Biomedical Research Institute###Partner Presentation Speaker: – Lovelace Biomedical Research Institute
### 11:00 AM – 12:00 PM ET
Unleash Small and Large Molecule Solutions for Biologics and Gene-TherapyPartner Presentation Speaker: – Unchained Labs
Partner Presentation Speaker: – Unchained Labs
Partner Presentation Speaker: – Unchained Labs
Bioanalytics
11:00 AM – 12:00 PM ET
Unleash Small and Large Molecule Solutions for Biologics and Gene-TherapyLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Unchained Labs
Partner Presentation Speaker: – Unchained Labs
Partner Presentation Speaker: – Unchained Labs
Bioanalytics
Andre Mueller, PhD (he/him/his) – Unchained Labs ### 2159185###Partner Presentation Speaker###Marketing Manager, Biologics Solutions###Unchained Labs###Partner Presentation Speaker: – Unchained Labs
### he/him/his @@@ Del Ray Jackson, PhD – Unchained Labs ### 2159186###Partner Presentation Speaker###Marketing Manager, Workflows###Unchained Labs###Partner Presentation Speaker: – Unchained Labs
### @@@ Ben Knappett, PhD – Unchained Labs ### 2159187###Partner Presentation Speaker###Product Manager, LNP Solutions###Unchained Labs###Partner Presentation Speaker: – Unchained Labs
### 11:00 AM – 1:30 PM ET
Dedicated Solution Center Hours
11:00 AM – 1:30 PM ET
Dedicated Solution Center HoursLocation:Exhibit Hall West A4-B3
11:15 AM – 12:00 PM ET
Accelerating Immunogenicity Analysis: From IgG- to AAV-based TherapiesChalk Talk Presenter: – Gyros Protein Technologies
Preclinical and Translational Sciences
11:15 AM – 12:00 PM ET
Accelerating Immunogenicity Analysis: From IgG- to AAV-based TherapiesLocation:Spotlight Stage B Exhibit Hall West A4-B3Chalk Talk Presenter: – Gyros Protein Technologies
Preclinical and Translational Sciences
Eric Feeley, Ph.D. – Gyros Protein Technologies ### 2030932###Chalk Talk Presenter###Senior Field Applications Scientist###Gyros Protein Technologies###Chalk Talk Presenter: – Gyros Protein Technologies
### 11:15 AM – 12:00 PM ET
Advances in Targeting Ion Channels with Biologics and Small MoleculesChalk Talk Presenter: – OmniAb, Inc.
Discovery and Basic Research
11:15 AM – 12:00 PM ET
Advances in Targeting Ion Channels with Biologics and Small MoleculesLocation:Spotlight Stage A Exhibit Hall West A4-B3Chalk Talk Presenter: – OmniAb, Inc.
Discovery and Basic Research
Doug Krafte, PhD (he/him/his) – OmniAb, Inc. ### 2159184###Chalk Talk Presenter###Sr. Vice President, Ion Channels/Transporters###OmniAb, Inc.###Chalk Talk Presenter: – OmniAb, Inc.
### he/him/his11:15 AM – 12:00 PM ET
Microcrystalline cellulose with innovative and unique particle morphologiesChalk Talk Presenter: – Asahi Kasei America
Formulation and Delivery
11:15 AM – 12:00 PM ET
Microcrystalline cellulose with innovative and unique particle morphologiesLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – Asahi Kasei America
Formulation and Delivery
Raxit Mehta – Asahi Kasei America ### 2144067###Chalk Talk Presenter###Technical Sales Manager###Asahi Kasei America###Chalk Talk Presenter: – Asahi Kasei America
### 11:30 AM – 12:30 PM ET
Special Poster Collection
11:30 AM – 12:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – University of Iowa
Aliasger K. Salem – University of Iowa ### 567411###Poster Collection Host###Professor, College of Pharmacy###University of Iowa###Poster Collection Host: – University of Iowa
### 12:00 PM – 1:00 PM ET
AAPS Committee Chairs Discussion (by invitation only)
12:00 PM – 1:00 PM ET
AAPS Committee Chairs Discussion (by invitation only)
Location:Florida C, Hyatt Regency Orlando
12:00 PM – 1:00 PM ET
How to Win a (Small Business) GrantCareer Center Speaker: – Collaborations Pharmaceuticals, Inc.
Career Development
12:00 PM – 1:00 PM ET
How to Win a (Small Business) GrantLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Collaborations Pharmaceuticals, Inc.
Career Development
Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc. ### 1650348###Career Center Speaker###CEO###Collaborations Pharmaceuticals, Inc.###Career Center Speaker: – Collaborations Pharmaceuticals, Inc.
### 12:00 PM – 2:00 PM ET
User Group Meeting: The Power of Phoenix Tools Analyzing PK DataTech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Preclinical and Translational Sciences
12:00 PM – 2:00 PM ET
User Group Meeting: The Power of Phoenix Tools Analyzing PK DataLocation:360 Stage #1 Exhibit Hall West A4-B3Tech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Tech Spotlight Speaker: – Certara
Preclinical and Translational Sciences
Ana Henry, M.S., Biomathematics – Certara ### 583858###Tech Spotlight Speaker###Executive Director of Training###Certara###Tech Spotlight Speaker: – Certara
### @@@ Chris Mehl, M.S – Certara ### 606463###Tech Spotlight Speaker###Product Manager###Certara###Tech Spotlight Speaker: – Certara
### @@@ Fred Mahakian (he/him/his) – Certara ### 2166348###Tech Spotlight Speaker###Director of Product###Certara###Tech Spotlight Speaker: – Certara
### he/him/his @@@ Michael Clifton, BS – Certara ### 1795014###Tech Spotlight Speaker###Product Owner###Certara###Tech Spotlight Speaker: – Certara
### 12:30 PM – 1:15 PM ET
Application of Accurate Mass Spectrometry for Nitrosamine Impurities in MetforminChalk Talk Presenter: – Symbiotic Research, LLC
Bioanalytics
12:30 PM – 1:15 PM ET
Application of Accurate Mass Spectrometry for Nitrosamine Impurities in MetforminLocation:Spotlight Stage B Exhibit Hall West A4-B3Chalk Talk Presenter: – Symbiotic Research, LLC
Bioanalytics
Dan Safarpour, PhD (he/him/his) – Symbiotic Research, LLC ### 2144062###Chalk Talk Presenter###CEO###Symbiotic Research, LLC###Chalk Talk Presenter: – Symbiotic Research, LLC
### he/him/his12:30 PM – 1:15 PM ET
Calcium Carbonate as Alternative to Titanium Dioxide in CoatingsChalk Talk Presenter: – MilliporeSigma a Business of Merck KGaA
Formulation and Delivery
12:30 PM – 1:15 PM ET
Calcium Carbonate as Alternative to Titanium Dioxide in CoatingsLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – MilliporeSigma a Business of Merck KGaA
Formulation and Delivery
Giovanni Raspantini, PharmD (he/him/his) – MilliporeSigma a Business of Merck KGaA ### 2102882###Chalk Talk Presenter###Application Specialist###MilliporeSigma a Business of Merck KGaA###Chalk Talk Presenter: – MilliporeSigma a Business of Merck KGaA
### he/him/his12:30 PM – 1:15 PM ET
Challenges and Opportunities for Bioanalytical Support of New Drug ModalitiesChalk Talk Presenter: – Labcorp
Bioanalytics
12:30 PM – 1:15 PM ET
Challenges and Opportunities for Bioanalytical Support of New Drug ModalitiesLocation:Spotlight Stage A Exhibit Hall West A4-B3Chalk Talk Presenter: – Labcorp
Bioanalytics
Daniel Sikkema, PhD – Labcorp ### 2144064###Chalk Talk Presenter###Executive Dir Global iChem • Mgmt, Science & Support###Labcorp###Chalk Talk Presenter: – Labcorp
### 12:30 PM – 1:30 PM ET
Leveraging Advanced Raman and UV-Vis Techniques in Pharmaceutical Manufacturing ProcessesPartner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
12:30 PM – 1:30 PM ET
Leveraging Advanced Raman and UV-Vis Techniques in Pharmaceutical Manufacturing ProcessesLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
Yanqia Wang, PhD – Agilent ### 2129017###Partner Presentation Speaker###Molecular Spectroscopy Application Scientist###Agilent###Partner Presentation Speaker: – Agilent
### 12:30 PM – 1:30 PM ET
Special Poster Collection
12:30 PM – 1:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Insmed
David Cipolla – Insmed ### 1075511###Poster Collection Host######Insmed###Poster Collection Host: – Insmed
### 12:30 PM – 1:30 PM ET
The Viscosity Reduction Platform: Enabling High-concentration and Low-viscosity Protein FormulationsPartner Presentation Speaker: – MilliporeSigma
Formulation and Delivery
12:30 PM – 1:30 PM ET
The Viscosity Reduction Platform: Enabling High-concentration and Low-viscosity Protein FormulationsLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – MilliporeSigma
Formulation and Delivery
Can Araman, PhD – MilliporeSigma ### 2032495###Partner Presentation Speaker###Senior Manager, Laboratory Head Protein Formulations R&D###MilliporeSigma###Partner Presentation Speaker: – MilliporeSigma
### 1:00 PM – 1:30 PM ET
Sean Ekins, Author of “Winning Grants”, Book Signing and Meet and Greet
1:00 PM – 1:30 PM ET
Sean Ekins, Ph.D, Ds, Author of “Winning Grants”, Book Signing and Meet and GreetLocation:Careers 360, Exhibit Hall West A4-B3Author: – Collaborations Pharmaceuticals, Inc.
Career Development
Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc. ### 1650348###Author###CEO###Collaborations Pharmaceuticals, Inc.###Author: – Collaborations Pharmaceuticals, Inc.
### 1:00 PM – 2:00 PM ET
Career Conversation: Hosted by AstraZeneca
1:00 PM – 2:00 PM ET
Career Conversation: Hosted by AstraZenecaLocation:Careers 360, Exhibit Hall West A4-B3Career Development
1:30 PM – 2:30 PM ET
Employing Psychological Safety Approaches to Promote Inclusion and InnovationCareer Center Moderator: – Marshall University School of Pharmacy
Career Center Speaker: – Marshall University School of Pharmacy
Career Center Speaker: – Creighton University School of Pharmacy and Health Professions
Career Development
1:30 PM – 2:30 PM ET
Employing Psychological Safety Approaches to Promote Inclusion and InnovationLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Moderator: – Marshall University School of Pharmacy
Career Center Speaker: – Marshall University School of Pharmacy
Career Center Speaker: – Creighton University School of Pharmacy and Health Professions
Career Development
Gayle A. Brazeau, PhD (she/her/hers) – Marshall University School of Pharmacy ### 1976685###Career Center Moderator###Professor Pharmaceutical Sciences###Marshall University School of Pharmacy###Career Center Moderator: – Marshall University School of Pharmacy
### she/her/hers @@@ Cynthia A. Jones, PhD (she/her/hers) – Marshall University School of Pharmacy ### 1976686###Career Center Speaker###Associate Professor###Marshall University School of Pharmacy###Career Center Speaker: – Marshall University School of Pharmacy
### she/her/hers @@@ Evan T. Robinson, RPh, PhD – Creighton University School of Pharmacy and Health Professions ### 1976687###Career Center Speaker###Professor###Creighton University School of Pharmacy and Health Professions###Career Center Speaker: – Creighton University School of Pharmacy and Health Professions
### 1:30 PM – 2:30 PM ET
Keynote: Apply Endogenous Biomarkers to Detect DDIsKeynote Speaker: – Graduate School of Pharmaceutical Sciences, the University of Tokyo
Moderator: – Gilead Sciences, Inc.
Preclinical and Translational Sciences
1:30 PM – 2:30 PM ET
Keynote: Apply Endogenous Biomarkers to Detect DDIsLocation:311 AB WestKeynote Speaker: – Graduate School of Pharmaceutical Sciences, the University of Tokyo
Moderator: – Gilead Sciences, Inc.
Preclinical and Translational Sciences
Hiroyuki Kusuhara, PhD (he/him/his) – Graduate School of Pharmaceutical Sciences, the University of Tokyo ### 1929784###Keynote Speaker###Professor###Graduate School of Pharmaceutical Sciences, the University of Tokyo###Keynote Speaker: – Graduate School of Pharmaceutical Sciences, the University of Tokyo
### he/him/his @@@ Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc. ### 1767660###Moderator###Executive Director###Gilead Sciences, Inc.###Moderator: – Gilead Sciences, Inc.
### he/him/his1:30 PM – 2:30 PM ET
Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and UnicornsKeynote Speaker: – Pfizer Inc
Moderator: – 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: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and UnicornsLocation:311 CD WestKeynote Speaker: – Pfizer Inc
Moderator: – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
Preclinical and Translational Sciences
Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc ### 1044025###Keynote Speaker###Senior Director###Pfizer Inc###Keynote Speaker: – Pfizer Inc
### he/him/his @@@ Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration ### 1011705###Moderator###Associate Director for Therapeutic Review###Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration###Moderator: – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
### 1:30 PM – 2:30 PM ET
Keynote: Crossing Modalities: Analytical Adventures at the Interface of Small and Large MoleculesKeynote Speaker: – Merck & Co
Moderator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
1:30 PM – 2:30 PM ET
Keynote: Crossing Modalities: Analytical Adventures at the Interface of Small and Large MoleculesLocation:206 AB WestKeynote Speaker: – Merck & Co
Moderator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
Narayan Variankaval, PhD – Merck & Co ### 847136###Keynote Speaker###Executive Director, Analytical R&D###Merck & Co###Keynote Speaker: – Merck & Co
### @@@ Jason Rodriguez, PhD – US Food and Drug Administration ### 1378515###Moderator###Director DCDA###US Food and Drug Administration###Moderator: – US Food and Drug Administration
### 1:30 PM – 2:30 PM ET
Keynote: Crystal and Particle Engineering Strategies in Pharmaceutical Product Development and ManufacturingKeynote Speaker: – University of Copenhagen
Moderator: – GSK
Manufacturing & Analytical Characterization
1:30 PM – 2:30 PM ET
Keynote: Crystal and Particle Engineering Strategies in Pharmaceutical Product Development and ManufacturingLocation:205 AB WestKeynote Speaker: – University of Copenhagen
Moderator: – GSK
Manufacturing & Analytical Characterization
Jukka Rantanen, PhD (he/him/his) – University of Copenhagen ### 844122###Keynote Speaker###Professor###University of Copenhagen###Keynote Speaker: – University of Copenhagen
### he/him/his @@@ Sushrut Marathe, PhD (he/him/his) – GSK ### 624987###Moderator###Investigator - Modelling and Simulation###GSK###Moderator: – GSK
### he/him/his1:30 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: Engineering and Characterizing Large Molecule Delivery to the Brain: Taking Antibodies, Enzymes, and Other Proteins to the Final FrontierLocation:309 AB WestDiscovery and Basic Research
Robert G. Thorne, PhD (he/him/his) – Denali Therapeutics & University of Minnesota ### 653428###Keynote Speaker###Denali Fellow & Adjunct Associate Professor###Denali Therapeutics & University of Minnesota###Keynote Speaker: – Denali Therapeutics & University of Minnesota
### he/him/his @@@ Steven W. Louie, MS (he/him/his) – Moderna ### 1328552###Moderator###Associate Director###Moderna###Moderator: – Moderna
### he/him/his1:30 PM – 2:30 PM ET
Keynote: Patient Centricity: One Blood Draw at a Time
Bioanalytics
1:30 PM – 2:30 PM ET
Keynote: Patient Centricity: One Blood Draw at a TimeLocation:311 EF WestBioanalytics
Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute ### 627103###Keynote Speaker###Bioassay Development Lead###Bill and Melinda Gates Medical Research Institute###Keynote Speaker: – Bill and Melinda Gates Medical Research Institute
### he/him/his @@@ Catherine L. Brockus, PhD (she/her/hers) – Eli Lilly and Company ### 2043313###Moderator###Director, ADME Drug Disposition###Eli Lilly and Company###Moderator: – Eli Lilly and Company
### she/her/hers1:30 PM – 2:30 PM ET
Keynote: Predicting Formulation Performance: Learning from Generic Drugs
Formulation and Delivery
1:30 PM – 2:30 PM ET
Keynote: Predicting Formulation Performance: Learning from Generic DrugsLocation:208 AB WestFormulation and Delivery
Robert Lionberger, PhD – U.S. Food & Drug Administration ### 576394###Keynote Speaker###Director, Office of Research Standards, Office of Generic Drugs###U.S. Food & Drug Administration###Keynote Speaker: – U.S. Food & Drug Administration
### @@@ Yan Wang, PhD (she/her/hers) – U.S. Food and Drug Administration ### 848517###Moderator###Lead Pharmacologist ###U.S. Food and Drug Administration###Moderator: – U.S. Food and Drug Administration
### she/her/hers1:30 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: Shrinking Time to Market Through the Targeted Integration of Technology, Modeling, and Patient CentricityLocation:209 AB WestFormulation and Delivery
Bikash Chatterjee (he/him/his) – Pharmatech Associates ### 1921888###Keynote Speaker###President and Chief Science Officer###Pharmatech Associates###Keynote Speaker: – Pharmatech Associates
### he/him/his @@@ Stephanie Gaulding, CPGP, CQA (she/her/hers) – Pharmatech Associates ### 2029651###Moderator###Managing Director###Pharmatech Associates###Moderator: – Pharmatech Associates
### she/her/hers1:30 PM – 2:30 PM ET
Keynote: The Bioanalytical Program: From Strategy to Implementation –Current State and Additional ConsiderationsKeynote Speaker: – Biogen
Moderator: – PPD, A ThermoFisher Company
Bioanalytics
1:30 PM – 2:30 PM ET
Keynote: The Bioanalytical Program: From Strategy to Implementation –Current State and Additional ConsiderationsLocation:311 GH WestKeynote Speaker: – Biogen
Moderator: – PPD, A ThermoFisher Company
Bioanalytics
Jad Zoghbi, MS – Biogen ### 584187###Keynote Speaker###Scientific Director###Biogen###Keynote Speaker: – Biogen
### @@@ Catherine Vrentas, PhD – PPD, A ThermoFisher Company ### 1650329###Moderator###Principal Scientist###PPD, A ThermoFisher Company###Moderator: – PPD, A ThermoFisher Company
### 1:30 PM – 2:30 PM ET
Special Poster Collection
1:30 PM – 2:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Astellas Pharma
Amit Desai, Ph.D. – Astellas Pharma ### 596861###Poster Collection Host###Director, Pharmacokinetics, Modeling and Simulation###Astellas Pharma###Poster Collection Host: – Astellas Pharma
### 2:00 PM – 3:00 PM ET
Leveraging Lipid-Based Formulations for Bioavailability, Compliance, and Scalability from Preclinical to CommercialPartner Presentation Speaker: – Catalent
Formulation and Delivery
2:00 PM – 3:00 PM ET
Leveraging Lipid-Based Formulations for Bioavailability, Compliance, and Scalability from Preclinical to CommercialLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Catalent
Formulation and Delivery
Karunakar Sukuru, R.Ph., PhD, – Catalent ### 1690085###Partner Presentation Speaker###Global Vice President Rx Product Development -Pharma & CH###Catalent###Partner Presentation Speaker: – Catalent
### 2:00 PM – 4:00 PM ET
Challenges and Opportunities of Protein-long Active InjectablesPartner Presentation Speaker: – UCL School of Pharmacy
Partner Presentation Speaker: – InnoCore Pharmaceuticals
Partner Presentation Speaker: – Dosage Form Design and Development,
Formulation and Delivery
2:00 PM – 4:00 PM ET
Challenges and Opportunities of Protein-long Active InjectablesLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – UCL School of Pharmacy
Partner Presentation Speaker: – InnoCore Pharmaceuticals
Partner Presentation Speaker: – Dosage Form Design and Development,
Formulation and Delivery
Karolina Dziemidowicz, PhD, MPharm (she/her/hers) – UCL School of Pharmacy ### 2144072###Partner Presentation Speaker###Lecturer in Pharmaceutics###UCL School of Pharmacy###Partner Presentation Speaker: – UCL School of Pharmacy
### she/her/hers @@@ Aiva Simaite, PhD – InnoCore Pharmaceuticals ### 2144073###Partner Presentation Speaker###Project Manager###InnoCore Pharmaceuticals###Partner Presentation Speaker: – InnoCore Pharmaceuticals
### @@@ Puneet Tyagi, Ph.D. – Dosage Form Design and Development, ### 1329785###Partner Presentation Speaker###Senior Scientist, Drug Delivery,###Dosage Form Design and Development,###Partner Presentation Speaker: – Dosage Form Design and Development,
### 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 and Conversation With the Fellows Communications Task Force (Fellows Only)Location:312 A WestCommittee Chair: – University of Iowa
Dale Eric Wurster, Ph.D., FAAPS – University of Iowa ### 846619###Committee Chair###Professor Emeritus###University of Iowa###Committee Chair: – University of Iowa
### 2:30 PM – 3:00 PM ET
Coffee Break in the Solution Center
2:30 PM – 3:00 PM ET
Coffee Break in the Solution CenterLocation:Exhibit Hall West A4-B3
2:30 PM – 3:30 PM ET
Hot Topic: Inhalable Aerosol Immune EngineeringHot Topic Speaker: – University of Delaware
Hot Topic Moderator:
Discovery and Basic Research
2:30 PM – 3:30 PM ET
Hot Topic: Inhalable Aerosol Immune EngineeringLocation:308 CD WestHot Topic Speaker: – University of Delaware
Hot Topic Moderator:
Discovery and Basic Research
Catherine A. Fromen, PhD (she/her/hers) – University of Delaware ### 1328428###Hot Topic Speaker###Associate Professor###University of Delaware###Hot Topic Speaker: – University of Delaware
### she/her/hers @@@ Sumanta Goswami ### 2032971###Hot Topic Moderator#########Hot Topic Moderator:
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Advances in Predictive Biomarkers for DDIsSpotlight Speaker: – Pfizer Inc
Moderator: – Applied BioMath
Preclinical and Translational Sciences
2:30 PM – 3:30 PM ET
Speaker Spotlight: Advances in Predictive Biomarkers for DDIsLocation:Spotlight Stage B Exhibit Hall West A4-B3Spotlight Speaker: – Pfizer Inc
Moderator: – Applied BioMath
Preclinical and Translational Sciences
Manthena V. Varma, PhD – Pfizer Inc ### 567481###Spotlight Speaker###Research Fellow###Pfizer Inc###Spotlight Speaker: – Pfizer Inc
### @@@ Fei Hua, PhD – Applied BioMath ### 844132###Moderator###VP of Modeling and Simulation Services###Applied BioMath###Moderator: – Applied BioMath
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Formulation & DeliveryFormulation and Delivery
2:30 PM – 3:30 PM ET
Speaker Spotlight: Accelerating Drug Development: Past, Present and FutureLocation:Spotlight Stage C Exhibit Hall West A4-B3Formulation and Delivery
Steve Byrn, PhD – Purdue University ### 1045099###Spotlight Speaker###Professor###Purdue University###Spotlight Speaker: – Purdue University
### @@@ Vadim J. Gurvich, PhD – University of Minnesota ### 2032571###Moderator###Executive Director###University of Minnesota###Moderator: – University of Minnesota
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Single-Cell Multi-Omics for Cell and Gene TherapiesSpotlight Speaker: – Beam Therapeutics
Moderator: – Passage Bio, Inc
Bioanalytics
2:30 PM – 3:30 PM ET
Speaker Spotlight: Single-Cell Multi-Omics for Cell and Gene TherapiesLocation:Spotlight Stage A Exhibit Hall West A4-B3Spotlight Speaker: – Beam Therapeutics
Moderator: – Passage Bio, Inc
Bioanalytics
Priya S. Chockalingam, PhD (she/her/hers) – Beam Therapeutics ### 1820694###Spotlight Speaker###VP, Head of Clinical BioAnalytics & Translational Sciences###Beam Therapeutics###Spotlight Speaker: – Beam Therapeutics
### she/her/hers @@@ Karen J. Quadrini, PhD – Passage Bio, Inc ### 604596###Moderator###Director, Biomarkers and Precision Medicine###Passage Bio, Inc###Moderator: – Passage Bio, Inc
### 2:30 PM – 3:30 PM ET
Special Poster Collection
2:30 PM – 3:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Ionis Pharmaceuticals
Daniel A. Norris, Ph.D. – Ionis Pharmaceuticals ### 828884###Poster Collection Host###Executive Director, Pharmacokinetics and Clinical Pharmacology###Ionis Pharmaceuticals###Poster Collection Host: – Ionis Pharmaceuticals
### 3:00 PM – 4:00 PM ET
Exploring Chromatography Methods for the Analysis of Oligonucleotide TherapeuticsPartner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Exploring Chromatography Methods for the Analysis of Oligonucleotide TherapeuticsLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
Sandeep kondaveeti, PhD (he/him/his) – Agilent ### 2129019###Partner Presentation Speaker###Account Manager###Agilent###Partner Presentation Speaker: – Agilent
### he/him/his3:00 PM – 4:00 PM ET
Happy Hour Sponsored by Porton
3:00 PM – 4:00 PM ET
Happy Hour Sponsored by PortonLocation:Booth #2942, Exhibit Hall West A4-B3
3:00 PM – 4:00 PM ET
Job Offers 101: What to Expect Across Different Career StagesCareer Center Moderator: – AbbVie Inc.
Career Center Speaker: – University of Michigan
Career Center Speaker: – Sage Therapeutics
Career Center Speaker: – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company
Career Center Speaker: – Genentech
Career Development
3:00 PM – 4:00 PM ET
Job Offers 101: What to Expect Across Different Career StagesLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Moderator: – AbbVie Inc.
Career Center Speaker: – University of Michigan
Career Center Speaker: – Sage Therapeutics
Career Center Speaker: – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company
Career Center Speaker: – Genentech
Career Development
Maya Lipert, PhD – AbbVie Inc. ### 1611945###Career Center Moderator###Principal Research Scientist###AbbVie Inc.###Career Center Moderator: – AbbVie Inc.
### @@@ Anna Schwendeman, PhD (she/her/hers) – University of Michigan ### 1767738###Career Center Speaker###Hans W. Vahlteich Professor of Pharmacy###University of Michigan###Career Center Speaker: – University of Michigan
### she/her/hers @@@ Amy C. Doty, PhD (she/her/hers) – Sage Therapeutics ### 1690284###Career Center Speaker###Principal Scientist, Formulation Development###Sage Therapeutics###Career Center Speaker: – Sage Therapeutics
### she/her/hers @@@ Elizabeth Joshi, PhD, MBA (she/her/hers) – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company ### 2118625###Career Center Speaker###Associate Vice President###Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company###Career Center Speaker: – Investigative ADME/Toxicology & Bioanalytical Research/Eli Lilly & Company
### she/her/hers @@@ Jane Kenny, PhD (she/her/hers) – Genentech ### 624849###Career Center Speaker###Senior Director/Distinguished Scientist###Genentech###Career Center Speaker: – Genentech
### she/her/hers3:00 PM – 4:00 PM ET
Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 1Rapid Fire Moderator: – 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 1Location:208 AB WestRapid Fire Moderator: – Chicago State University College of Pharmacy
Formulation and Delivery
Michael Danquah, PhD – Chicago State University College of Pharmacy ### 2102929###Rapid Fire Moderator###Professor and Chair###Chicago State University College of Pharmacy###Rapid Fire Moderator: – Chicago State University College of Pharmacy
### 3:00 PM – 3:15 PM ET
The Potential for a Ban on TiO2 (E171) Use in Pharmaceuticals and the Impact on Patients and the IndustryLocation:208 AB WestRapid Fire Speaker: – Black Diamond Regulatory Consulting/IPEC-Americas
Formulation and Delivery
David R. Schoneker, M.S. (he/him/his) – Black Diamond Regulatory Consulting/IPEC-Americas ### 1011741###Rapid Fire Speaker###President/Owner/Consultant & Chair of IPEC-Americas QbD Committee###Black Diamond Regulatory Consulting/IPEC-Americas###Rapid Fire Speaker: – Black Diamond Regulatory Consulting/IPEC-Americas
### he/him/his3:15 PM – 3:30 PM ET
Machine-Learning Prediction of Antibody Aggregation and Viscosity in Formulation DevelopmentLocation:208 AB WestRapid Fire Speaker: – AstraZeneca
Formulation and Delivery
Neil Mody – AstraZeneca ### 2086975###Rapid Fire Speaker###Associate Director, Early-Stage Formulation Sciences, Biopharmaceutical Development###AstraZeneca###Rapid Fire Speaker: – AstraZeneca
### 3:30 PM – 3:45 PM ET
Cisplatin/Hyaluronan film for Loco-Regional Chemotherapy: Technology and Preclinical Evidence of Activity Location:208 AB WestRapid Fire Speaker: – University of Ferrara
Formulation and Delivery
Sabrina Banella – University of Ferrara ### 1045692###Rapid Fire Speaker###Post Doc###University of Ferrara###Rapid Fire Speaker: – University of Ferrara
### 3:45 PM – 4:00 PM ET
High Concentration Protein Suspensions: Optimizing the Suspension VehicleLocation:208 AB WestRapid Fire Speaker: – Serán Bioscience, LLC
Formulation and Delivery
Cindy Chung, PhD (she/her/hers) – Serán Bioscience, LLC ### 2086996###Rapid Fire Speaker###Principal Engineer###Serán Bioscience, LLC###Rapid Fire Speaker: – Serán Bioscience, LLC
### she/her/hers3:00 PM – 4:00 PM ET
Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2Rapid Fire Speaker: – AbbVie Inc.
Formulation and Delivery
3:00 PM – 4:00 PM ET
Rapid Fires: Accelerating the Drug Development Process through Formulation and Delivery Strategies 2Location:209 AB WestRapid Fire Speaker: – AbbVie Inc.
Formulation and Delivery
Tzichi Ju, Ph.D. – AbbVie Inc. ### 1767250###Rapid Fire Speaker######AbbVie Inc.###Rapid Fire Speaker: – AbbVie Inc.
### 3:00 PM – 3:15 PM ET
FDA in vitro Studies on Sunscreen Formulations to Support SafetyLocation:209 AB WestRapid Fire Speaker: – US Food and Drug Administration
Formulation and Delivery
Yang Yang, PhD – US Food and Drug Administration ### 603102###Rapid Fire Speaker###PhD###US Food and Drug Administration###Rapid Fire Speaker: – US Food and Drug Administration
### 3:15 PM – 3:30 PM ET
Leveraging Microgravity to Achieve Elusive Drug Solid-State ObjectivesLocation:209 AB WestRapid Fire Speaker: – Varda Space Industries
Formulation and Delivery
Dom Hebrault, PhD Organic Chemistry – Varda Space Industries ### 2086973###Rapid Fire Speaker###Life Science Market Developement Lead###Varda Space Industries###Rapid Fire Speaker: – Varda Space Industries
### 3:30 PM – 3:45 PM ET
Experiment Design Considerations in the Development of Dermal Absorption ModelsLocation:209 AB WestRapid Fire Speaker: – University of Waterloo
Formulation and Delivery
Abdullah Hamadeh, PhD – University of Waterloo ### 2087009###Rapid Fire Speaker###Research Associate ###University of Waterloo###Rapid Fire Speaker: – University of Waterloo
### 3:45 PM – 4:00 PM ET
Using DyGIST to Predict PK Performance of Immediate Release ProductsLocation:209 AB WestFormulation and Delivery
Anette Mullertz ### 2168408###Rapid Fire Speaker#########Rapid Fire Speaker:
### 3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1Rapid Fire Moderator: – Merck & Co, Inc
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1Location:205 AB WestRapid Fire Moderator: – Merck & Co, Inc
Manufacturing & Analytical Characterization
Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc ### 2086981###Rapid Fire Moderator###Principal Scientist###Merck & Co, Inc###Rapid Fire Moderator: – Merck & Co, Inc
### she/her/hers3:00 PM – 3:15 PM ET
Atmospheric Freeze Drying – Towards a More Sustainable Lyophilization ProcessLocation:205 AB WestRapid Fire Speaker: – University of Bonn
Manufacturing & Analytical Characterization
Alf Lamprecht – University of Bonn ### 846862###Rapid Fire Speaker###Professor###University of Bonn###Rapid Fire Speaker: – University of Bonn
### 3:15 PM – 3:30 PM ET
Ambient Temperature Preservation of Biomolecules Using Capillary-Mediated Vitrification ProcessLocation:205 AB WestRapid Fire Speaker: – Upkara, Inc
Manufacturing & Analytical Characterization
Sankar Renu, PhD (he/him/his) – Upkara, Inc ### 2030895###Rapid Fire Speaker###Senior Scientist###Upkara, Inc###Rapid Fire Speaker: – Upkara, Inc
### he/him/his3:30 PM – 3:45 PM ET
Layered Microneedles for Protein Delivery from CoacervateLocation:205 AB WestRapid Fire Speaker: – Cornell University
Manufacturing & Analytical Characterization
Nathaniel S. Wright, M.S. – Cornell University ### 2086982###Rapid Fire Speaker###Graduate Research Assistant###Cornell University###Rapid Fire Speaker: – Cornell University
### 3:45 PM – 4:00 PM ET
Novel Strategies for Process-Related Impurity Clearance during Biologics ManufacturingLocation:205 AB WestRapid Fire Speaker: – Merck Research Laboratories
Manufacturing & Analytical Characterization
Aba Acquaah, BS (she/her/hers) – Merck Research Laboratories ### 2030285###Rapid Fire Speaker###Associate Scientist###Merck Research Laboratories###Rapid Fire Speaker: – Merck Research Laboratories
### she/her/hers3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2Rapid Fire Moderator: – Merck & Co., Inc.
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2Location:206 AB WestRapid Fire Moderator: – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Natalia Subelzu, Ph.D. (she/her/hers) – Merck & Co., Inc. ### 2102874###Rapid Fire Moderator###Senior Scientist###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### she/her/hers3:00 PM – 3:15 PM ET
The Risks Triggering FDA’s Pre-Approval Inspection for a Manufacturing FacilityLocation:206 AB WestRapid Fire Speaker: – US Food and Drug Administration
Manufacturing & Analytical Characterization
MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration ### 2086987###Rapid Fire Speaker###Pharmaceutical Scientist###US Food and Drug Administration###Rapid Fire Speaker: – US Food and Drug Administration
### he/him/his3:15 PM – 3:30 PM ET
How Twin-Screw Wet Granulation Factors Impact Granules and Tablets AttributesLocation:206 AB WestRapid Fire Speaker: – Aptuit (an Evotec Company)
Manufacturing & Analytical Characterization
Piero Piccinni, MSc (he/him/his) – Aptuit (an Evotec Company) ### 2030345###Rapid Fire Speaker###Sr. Supervisor Formulation and Process Development###Aptuit (an Evotec Company)###Rapid Fire Speaker: – Aptuit (an Evotec Company)
### he/him/his3:30 PM – 3:45 PM ET
Personalized Pediatric Dosing Enabled by 3D Printing- A Case StudyLocation:206 AB WestRapid Fire Speaker: – TNO
Manufacturing & Analytical Characterization
Jayeeta Sengupta, PhD (she/her/hers) – TNO ### 2087003###Rapid Fire Speaker###Program Manager - Senior Consultant###TNO###Rapid Fire Speaker: – TNO
### she/her/hers3:45 PM – 4:00 PM ET
Pharma 4.0: Digital Manufacturing of Advanced Continuous Pharmaceutical Tablet ManufacturingLocation:206 AB WestRapid Fire Speaker: – Rutgers University
Manufacturing & Analytical Characterization
Ravendra Singh (he/him/his) – Rutgers University ### 1976697###Rapid Fire Speaker###Faculty###Rutgers University###Rapid Fire Speaker: – Rutgers University
### he/him/his3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug DeliveryRapid Fire Moderator: – University of Florida College of Pharmacy
Discovery and Basic Research
3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Therapeutic Discovery and Development: Mechanistic Considerations for Drug DeliveryLocation:309 AB WestRapid Fire Moderator: – University of Florida College of Pharmacy
Discovery and Basic Research
Xiaoshu Pan, PhD – University of Florida College of Pharmacy ### 1328564###Rapid Fire Moderator###Postdoctoral Associate###University of Florida College of Pharmacy###Rapid Fire Moderator: – University of Florida College of Pharmacy
### 3:00 PM – 3:15 PM ET
New Approach for Extracellular Vesicle Cargo Loading and Drug DeliveryLocation:309 AB WestRapid Fire Speaker: – University of Florida College of Pharmacy
Discovery and Basic Research
Zuo Ding, PhD – University of Florida College of Pharmacy ### 2086968###Rapid Fire Speaker###Postdoc Associate###University of Florida College of Pharmacy###Rapid Fire Speaker: – University of Florida College of Pharmacy
### 3:15 PM – 3:30 PM ET
The Combination of miRNA-Loaded Nanobubbles and Ultrasound for Cancer TherapyLocation:309 AB WestRapid Fire Speaker: – Tokyo University of Pharmacy and Life Sciences
Discovery and Basic Research
Taiki Yamaguchi – Tokyo University of Pharmacy and Life Sciences ### 2086986###Rapid Fire Speaker###Doctoral Course Student###Tokyo University of Pharmacy and Life Sciences###Rapid Fire Speaker: – Tokyo University of Pharmacy and Life Sciences
### 3:25 PM – 3:45 PM ET
Microglia-Derived Exosomes As A Drug Delivery Tool In Alzheimer's DiseaseLocation:309 AB WestRapid Fire Speaker: – St John's University
Discovery and Basic Research
Terjahna Richards, PhD – St John's University ### 2086979###Rapid Fire Speaker###PhD Graduate###St John's University###Rapid Fire Speaker: – St John's University
### 3:45 PM – 4:00 PM ET
Therapeutic Delivery of Proteolysis Targeting Chimeras Loaded Extracellular VesiclesLocation:309 AB WestRapid Fire Speaker: – University of Florida
Discovery and Basic Research
Nina Erwin (she/her/hers) – University of Florida ### 1755669###Rapid Fire Speaker###Doctoral Student###University of Florida###Rapid Fire Speaker: – University of Florida
### she/her/hers3:00 PM – 4:00 PM ET
Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Development 1Rapid Fire Moderator: – 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 Development 1Location:311 AB WestRapid Fire Moderator: – Texas Tech University Health Sciences Center
Preclinical and Translational Sciences
Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center ### 2030611###Rapid Fire Moderator###Assistant Professor###Texas Tech University Health Sciences Center###Rapid Fire Moderator: – Texas Tech University Health Sciences Center
### he/him/his3:00 PM – 3:15 PM ET
Deciphering Molecular Insights of Meis1 and Hoxb13 for Cardiac RegenerationLocation:311 AB WestRapid Fire Speaker: – Texas Tech University Health Sciences Center
Preclinical and Translational Science - Chemical
Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center ### 2030611###Rapid Fire Speaker###Assistant Professor###Texas Tech University Health Sciences Center###Rapid Fire Speaker: – Texas Tech University Health Sciences Center
### he/him/his3:15 PM – 3:30 PM ET
FAP Inhibitor Enabled Inhalable Nano-Theranostics for Treating Pulmonary Fibrotic ComplicationsLocation:311 AB WestRapid Fire Speaker: – St. John's University
Preclinical and Translational Science - Biomolecular
Mukti Vats, PhD (she/her/hers) – St. John's University ### 2031010###Rapid Fire Speaker###Postdoctoral Research Associate###St. John's University###Rapid Fire Speaker: – St. John's University
### she/her/hers3:30 PM – 3:45 PM ET
PD-L1/PD-1 Targeting in Immunotherapy with NK-EVs in Resistant Lung CancerLocation:311 AB WestRapid Fire Speaker: – Florida A&M University
Preclinical and Translational Science - Biomolecular
Aakash Nathani, MS (he/him/his) – Florida A&M University ### 1755703###Rapid Fire Speaker###PhD Student###Florida A&M University###Rapid Fire Speaker: – Florida A&M University
### he/him/his3:45 PM – 4:00 PM ET
Development of Immunoactive Polymeric Nanocomplex to Activate Innate Immune Response for Cancer ImmunotherapyLocation:311 AB WestRapid Fire Speaker: – University of Mass-Lowell
Preclinical and Translational Sciences
Fanfei Meng, PhD (he/him/his) – University of Mass-Lowell ### 1446801###Rapid Fire Speaker###Assistant Professor###University of Mass-Lowell###Rapid Fire Speaker: – University of Mass-Lowell
### he/him/his3:00 PM – 4:00 PM ET
Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Developments 2Rapid Fire Moderator: – Merck & Co., Inc.
Preclinical and Translational Sciences
3:00 PM – 4:00 PM ET
Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Developments 2Location:311 CD WestRapid Fire Moderator: – Merck & Co., Inc.
Preclinical and Translational Sciences
F. Yushra Thanzeel, PhD – Merck & Co., Inc. ### 2086998###Rapid Fire Moderator###Senior Scientist###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### 3:00 PM – 3:15 PM ET
Spatial Biomarker to Inform Biological Context Drug ResponseLocation:311 CD WestRapid Fire Speaker: – Aliri
Preclinical and Translational Sciences
Corinne Ramos (she/her/hers) – Aliri ### 2030440###Rapid Fire Speaker###Director R&D###Aliri###Rapid Fire Speaker: – Aliri
### she/her/hers3:15 PM – 3:30 PM ET
Stability & Compatibility of Peptides for Oral Drug DeliveryLocation:311 CD WestRapid Fire Speaker: – Merck & Co., Inc.
Preclinical and Translational Sciences
F. Yushra Thanzeel, PhD – Merck & Co., Inc. ### 2086998###Rapid Fire Speaker###Senior Scientist###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### 3:30 PM – 3:45 PM ET
Comprehensive LC-MS/MS Analysis of VSV-GP LipidomeLocation:311 CD WestRapid Fire Speaker: – Boehringer Ingelheim
Preclinical and Translational Sciences
Yuecheng Xi, PhD (she/her/hers) – Boehringer Ingelheim ### 2030841###Rapid Fire Speaker###Postdoc fellow###Boehringer Ingelheim###Rapid Fire Speaker: – Boehringer Ingelheim
### she/her/hers3:45 PM – 4:00 PM ET
Strategy for Assessing Stability in Multiplexed Cytokine PanelsLocation:311 CD WestRapid Fire Speaker: – BioAgilytix
Preclinical and Translational Sciences
Christian Braithwaite, M.S. – BioAgilytix ### 607032###Rapid Fire Speaker###Associate Director###BioAgilytix###Rapid Fire Speaker: – BioAgilytix
### 3:00 PM – 4:00 PM ET
Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 1Rapid Fire Moderator: – 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 1Location:311 EF WestRapid Fire Moderator: – Merck & Co., Inc.
Bioanalytics
Linlin Luo, Ph.D. – Merck & Co., Inc. ### 1075483###Rapid Fire Moderator###Director###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### 3:00 PM – 3:15 PM ET
ADA and NAb Assays with Distinct Formats Determined by BiologicsLocation:311 EF WestRapid Fire Speaker: – Frontage Laboratories, Inc.
Bioanalytics
Yongzhong Zhao, PhD – Frontage Laboratories, Inc. ### 2087006###Rapid Fire Speaker###Principal Scientist###Frontage Laboratories, Inc.###Rapid Fire Speaker: – Frontage Laboratories, Inc.
### 3:15 PM – 3:30 PM ET
Bead-Based NAb Assay with High Drug Tolerance for A BispecificLocation:311 EF WestRapid Fire Speaker: – Janssen
Bioanalytics
Megan Schnarr, MS – Janssen ### 2086992###Rapid Fire Speaker###Scientist###Janssen###Rapid Fire Speaker: – Janssen
### 3:30 PM – 3:45 PM ET
Utilization of Quality-by-Design/Design-of-Experiment(s) for Optimization of Flow Cytometric Wet-Lab MethodsLocation:311 EF WestRapid Fire Speaker: – Miltenyi Biotec B.V. & Co. KG
Bioanalytics
Stefanie Biedermann, MS (she/her/hers) – Miltenyi Biotec B.V. & Co. KG ### 1690892###Rapid Fire Speaker###Translational Research Scientist###Miltenyi Biotec B.V. & Co. KG###Rapid Fire Speaker: – Miltenyi Biotec B.V. & Co. KG
### she/her/hers3:45 PM – 4:00 PM ET
Quantification of mRNA from mRNA-LNP Therapeutics by RT-qPCRLocation:311 EF WestRapid Fire Speaker: – Moderna Therapeutics
Bioanalytics
Suresh Peddigari, PhD (he/him/his) – Moderna Therapeutics ### 2086999###Rapid Fire Speaker###Senior Scientist###Moderna Therapeutics###Rapid Fire Speaker: – Moderna Therapeutics
### he/him/his3:00 PM – 4:00 PM ET
Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 2Rapid Fire Moderator: – Recursion Pharmaceuticals
Bioanalytics
3:00 PM – 4:00 PM ET
Rapid Fires: Setting up for Success -- Considerations for Study Design in the Context of Bioanalysis 2Location:311 GH WestRapid Fire Moderator: – Recursion Pharmaceuticals
Bioanalytics
Jennifer A. Vance, PhD (she/her/hers) – Recursion Pharmaceuticals ### 604530###Rapid Fire Moderator###Director, Bioanalytical and Biomarker Development###Recursion Pharmaceuticals###Rapid Fire Moderator: – Recursion Pharmaceuticals
### she/her/hers3:00 PM – 3:15 PM ET
Investigation of Compound-A Rat Exposure Bias Observed in Toxicological StudiesLocation:311 GH WestRapid Fire Speaker: – Merck and Co Inc
Bioanalytics
Rajesh B. Desai, M.S. – Merck and Co Inc ### 602775###Rapid Fire Speaker###Principal Scientist###Merck and Co Inc###Rapid Fire Speaker: – Merck and Co Inc
### 3:15 PM – 3:30 PM ET
Use of AI to Guide Immunoassay DevelopmentLocation:311 GH WestRapid Fire Speaker: – Biotech
Bioanalytics
Mark Ma, MD (he/him/his) – Biotech ### 1792079###Rapid Fire Speaker###VP, Head of Translational Clinical Sciences###Biotech###Rapid Fire Speaker: – Biotech
### he/him/his3:30 PM – 3:45 PM ET
Novel Approaches and Troubleshooting for Developing High-Throughput Oligonucleotide LC-MS MethodLocation:311 GH WestRapid Fire Speaker: – Merck & Co.
Bioanalytics
Changhong Yun, PhD – Merck & Co. ### 857290###Rapid Fire Speaker###Senior Scientist###Merck & Co.###Rapid Fire Speaker: – Merck & Co.
### 3:45 PM – 4:00 PM ET
Platform Methods: Universal Immunoaffinity-LCMS Bioanalytical Methods for Drug Development PlatformsLocation:311 GH WestRapid Fire Speaker: – BioAgilytix
Bioanalytics
Ben Nie, PhD (he/him/his) – BioAgilytix ### 2016524###Rapid Fire Speaker###Scientist III###BioAgilytix###Rapid Fire Speaker: – BioAgilytix
### he/him/his3:30 PM – 4:30 PM ET
Customization of Functional Capsules: An Enteric Delivery Case StudyPartner Presentation Speaker: – Lonza
Manufacturing & Analytical Characterization
3:30 PM – 4:30 PM ET
Customization of Functional Capsules: An Enteric Delivery Case StudyLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Lonza
Manufacturing & Analytical Characterization
Vincent Jannin, PhD (he/him/his) – Lonza ### 846358###Partner Presentation Speaker###Director, R&D and Head of the Capsules Application Lab Services###Lonza###Partner Presentation Speaker: – Lonza
### he/him/his3:30 PM – 4:30 PM ET
Happy Hour Sponsored by Alturas Analytics, Inc.
3:30 PM – 4:30 PM ET
Happy Hour Sponsored by Alturas Analytics, Inc.Location:Booth #2522, Exhibit Hall West A4-B3
3:30 PM – 4:30 PM ET
Happy Hour Sponsored by GlobePharma, Inc.
3:30 PM – 4:30 PM ET
Happy Hour Sponsored by GlobePharma, Inc.Location:Booth #3215, Exhibit Hall West A4-B3
3:30 PM – 4:30 PM ET
Hot Topic: Product and Process Design for Long Acting Injectable (LAI) FormulationsHot Topic Speaker: – GSK
Hot Topic Moderator: – University of Connecticut
Manufacturing & Analytical Characterization
3:30 PM – 4:30 PM ET
Hot Topic: Product and Process Design for Long Acting Injectable (LAI) FormulationsLocation:308 AB WestHot Topic Speaker: – GSK
Hot Topic Moderator: – University of Connecticut
Manufacturing & Analytical Characterization
Sujatha Sonti, Dr – GSK ### 1743104###Hot Topic Speaker###VP, Drug Product Development###GSK###Hot Topic Speaker: – GSK
### @@@ Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut ### 1377156###Hot Topic Moderator###Distinguished Professor###University of Connecticut###Hot Topic Moderator: – University of Connecticut
### she/her/hers3:30 PM – 4:30 PM ET
Special Poster Collection
3:30 PM – 4:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Takeda
Russ S. Weiner, Ph.D., FAAPS – Takeda ### 1650369###Poster Collection Host######Takeda###Poster Collection Host: – Takeda
### 4:00 PM – 5:00 PM ET
AAPS Biomarkers & Precision Medicine Community Membership MeetingCommunity Leader: – BioAgilytix Labs, LLC
4:00 PM – 5:00 PM ET
AAPS Biomarkers & Precision Medicine Community Membership MeetingLocation:Spotlight Stage C Exhibit Hall West A4-B3Community Leader: – BioAgilytix Labs, LLC
Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC ### 1529523###Community Leader###Scientific Officer###BioAgilytix Labs, LLC###Community Leader: – BioAgilytix Labs, LLC
### 4:00 PM – 5:00 PM ET
AAPS Gene & Cell Therapy Products Community Membership MeetingCommunity Leader: – Genentech, Inc.
4:00 PM – 5:00 PM ET
AAPS Gene & Cell Therapy Products Community Membership MeetingLocation:Spotlight Stage A Exhibit Hall West A4-B3Community Leader: – Genentech, Inc.
Vittal Shivva, PhD – Genentech, Inc. ### 1010870###Community Leader###Senior Principal Scientist###Genentech, Inc.###Community Leader: – Genentech, Inc.
### 4:00 PM – 5:00 PM ET
AAPS Global Health Community Membership MeetingCommunity Leader: – Butler University
4:00 PM – 5:00 PM ET
AAPS Global Health Community Membership MeetingLocation:Spotlight Stage B Exhibit Hall West A4-B3Community Leader: – Butler University
Sudip Das, PhD (he/him/his) – Butler University ### 606117###Community Leader###Professor of pharmaceutics & drug delivery ###Butler University###Community Leader: – Butler University
### he/him/his4:00 PM – 5:00 PM ET
Happy Hour Sponsored by Neopharm Labs
4:00 PM – 5:00 PM ET
Happy Hour Sponsored by Neopharm LabsLocation:Booth#2356, Exhibit Hall A4-B3Sponsored By Neopharm Labs
4:00 PM – 5:00 PM ET
Happy Hour Sponsored by SENTRYSCIENCES, INC
4:00 PM – 5:00 PM ET
Happy Hour Sponsored by SENTRYSCIENCES, INCLocation:Booth #2347, Exhibit Hall West A4-B3
4:00 PM – 5:00 PM ET
Start-Up Pavilion Happy Hour
4:00 PM – 5:00 PM ET
Start-Up Pavilion Happy HourLocation:Start-Up Pavilion (Aisle 2000), Exhibit Hall West A4-B3
4:15 PM – 4:30 PM ET
Rapid Fire: Nurturing Unity: Integrating New Graduates into the Pharmaceutical Industry WorkspaceRapid Fire Speaker: – University of Southern California
Career Development
4:15 PM – 4:30 PM ET
Rapid Fire: Nurturing Unity: Integrating New Graduates into the Pharmaceutical Industry WorkspaceLocation:360 Stage #3 Exhibit Hall West A4-B3Rapid Fire Speaker: – University of Southern California
Career Development
Yoon Sik Jung (he/him/his) – University of Southern California ### 2087007###Rapid Fire Speaker###Pharmaceutical Researcher###University of Southern California###Rapid Fire Speaker: – University of Southern California
### he/him/his5:00 PM – 6:00 PM ET
AAPS Chemistry, Manufacturing, & Controls (CMC) Community Membership MeetingCommunity Leader: – Takeda Pharmaceutical Company Limited
5:00 PM – 6:00 PM ET
AAPS Chemistry, Manufacturing, & Controls (CMC) Community Membership MeetingLocation:205 AB WestCommunity Leader: – Takeda Pharmaceutical Company Limited
Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited ### 720714###Community Leader###Global Head, CMC Business Process Excellence & Devices###Takeda Pharmaceutical Company Limited###Community Leader: – Takeda Pharmaceutical Company Limited
### 5:00 PM – 6:00 PM ET
AAPS Drug Transport Community Membership MeetingCommunity Leader: – University of Oklahoma Health Sciences Center
5:00 PM – 6:00 PM ET
AAPS Drug Transport Community Membership MeetingLocation:311 AB WestCommunity Leader: – University of Oklahoma Health Sciences Center
Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center ### 605584###Community Leader###Associate Professor###University of Oklahoma Health Sciences Center###Community Leader: – University of Oklahoma Health Sciences Center
### she/her/hers5:00 PM – 6:00 PM ET
AAPS In Vitro Release & Dissolution Testing Community Membership MeetingCommunity Leader: – Northeastern University
5:00 PM – 6:00 PM ET
AAPS In Vitro Release & Dissolution Testing Community Membership MeetingLocation:311 EF WestCommunity Leader: – Northeastern University
Jie Shen, PhD (she/her/hers) – Northeastern University ### 605040###Community Leader###Associate Professor###Northeastern University###Community Leader: – Northeastern University
### she/her/hers5:00 PM – 6:00 PM ET
AAPS Inhalation & Nasal Community Membership MeetingCommunity Leader: – St. John's University
5:00 PM – 6:00 PM ET
AAPS Inhalation & Nasal Community Membership MeetingLocation:206 AB WestCommunity Leader: – St. John's University
Vivek Gupta, PhD – St. John's University ### 604838###Community Leader###Associate Professor###St. John's University###Community Leader: – St. John's University
### 5:00 PM – 6:00 PM ET
AAPS Ocular Drug Delivery & Disposition Community Membership MeetingCommunity Leader: – Genentech, Inc.
5:00 PM – 6:00 PM ET
AAPS Ocular Drug Delivery & Disposition Community Membership MeetingLocation:308 CD WestCommunity Leader: – Genentech, Inc.
Chun-Wan Yen, PhD (she/her/hers) – Genentech, Inc. ### 1768341###Community Leader###Sr. Principal Scientist###Genentech, Inc.###Community Leader: – Genentech, Inc.
### she/her/hers5:00 PM – 6:00 PM ET
AAPS Preformulation & Formulation Design/Development Community Membership MeetingCommunity Leader: – Bristol-Myers Squibb Company
5:00 PM – 6:00 PM ET
AAPS Preformulation & Formulation Design/Development Community Membership MeetingLocation:311 GH WestCommunity Leader: – Bristol-Myers Squibb Company
Deepak Bahl, PhD – Bristol-Myers Squibb Company ### 1767744###Community Leader###Associate Scientific Director###Bristol-Myers Squibb Company###Community Leader: – Bristol-Myers Squibb Company
### 5:00 PM – 6:00 PM ET
AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership MeetingCommunity Leader: – Regeneron Pharmaceuticals
5:00 PM – 6:00 PM ET
AAPS Protein Purification, Storage, Transportation, and Drug-Device Combination Community Membership MeetingLocation:208 AB WestCommunity Leader: – Regeneron Pharmaceuticals
Yuan Cheng, PhD (he/him/his) – Regeneron Pharmaceuticals ### 2159752###Community Leader###Senior Principal Scientist###Regeneron Pharmaceuticals###Community Leader: – Regeneron Pharmaceuticals
### he/him/his5:00 PM – 6:00 PM ET
AAPS Regulatory Sciences Community Membership MeetingCommunity Leader: – Tolmar Inc
5:00 PM – 6:00 PM ET
AAPS Regulatory Sciences Community Membership MeetingLocation:309 AB WestCommunity Leader: – Tolmar Inc
Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc ### 567542###Community Leader###Sr. Director, Clinical Development###Tolmar Inc###Community Leader: – Tolmar Inc
### he/him/his5:00 PM – 6:00 PM ET
AAPS Stability Community Membership MeetingCommunity Leader: – Pharmalytik Consulting & Training
Community Leader: – Seagen Inc.
5:00 PM – 6:00 PM ET
AAPS Stability Community Membership MeetingLocation:308 AB WestCommunity Leader: – Pharmalytik Consulting & Training
Community Leader: – Seagen Inc.
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training ### 636579###Community Leader###Managing Director###Pharmalytik Consulting & Training###Community Leader: – Pharmalytik Consulting & Training
### @@@ Lori McCaig, PhD (she/her/hers) – Seagen Inc. ### 1207457###Community Leader###Director, Global Stability Program Management###Seagen Inc.###Community Leader: – Seagen Inc.
### she/her/hers5:00 PM – 6:00 PM ET
AAPS Topical & Transdermal Community Membership MeetingCommunity Leader: – Transdermal Research Pharm Laboratories LLC
5:00 PM – 6:00 PM ET
AAPS Topical & Transdermal Community Membership MeetingLocation:311 CD WestCommunity Leader: – Transdermal Research Pharm Laboratories LLC
Nisarg N. Modi, PhD (he/him/his) – Transdermal Research Pharm Laboratories LLC ### 624933###Community Leader###Director of R&D###Transdermal Research Pharm Laboratories LLC###Community Leader: – Transdermal Research Pharm Laboratories LLC
### he/him/his5:00 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 Kansas Department of Pharmaceutical Chemistry Alumni Reception (by invitation only)Location:Challenger 38-39, Hyatt Regency Orlando
5:00 PM – 7:00 PM ET
University of Michigan College of Pharmacy Alumni and Friends Reception
5:00 PM – 7:00 PM ET
University of Michigan College of Pharmacy Alumni and Friends ReceptionLocation:Orlando L, Hyatt Regency Orlando
5:30 PM – 6:30 PM ET
Minnesota Alumni Reception
5:30 PM – 6:30 PM ET
Minnesota Alumni ReceptionLocation:Discovery 48, Hyatt Regency Orlando
5:30 PM – 7:30 PM ET
University of Wisconsin-Madison School of Pharmacy Reception
5:30 PM – 7:30 PM ET
University of Wisconsin-Madison School of Pharmacy ReceptionLocation:Challenger 41-42, Hyatt Regency Orlando
5:30 PM – 7:30 PM ET
UT Austin College of Pharmacy Alumni and Friends Reception
5:30 PM – 7:30 PM ET
UT Austin College of Pharmacy Alumni and Friends ReceptionLocation:Plaza K Ballroom, Hyatt Regency Orlando
5:30 PM – 8:00 PM ET
University at Buffalo Alumni & Friends Reception
5:30 PM – 6:30 PM ET
University at Buffalo Alumni & Friends ReceptionLocation:Plaza I Ballroom, Hyatt Regency Orlando
5:30 PM – 8:00 PM ET
University of Utah - Department of Molecular Pharmaceutics Reception
5:30 PM – 8:00 PM ET
University of Utah - Department of Molecular Pharmaceutics ReceptionLocation:Plaza F Ballroom, Hyatt Regency Orlando
6:00 PM – 8:00 PM ET
St. John's University Alumni & Friends Reception
6:00 PM – 8:00 PM ET
St. John's University Alumni & Friends ReceptionLocation:Plaza D Ballroom, Hyatt Regency Orlando
6:00 PM – 8:00 PM ET
University of Florida College of Pharmacy Meet the Dean
6:00 PM – 8:00 PM ET
University of Florida College of Pharmacy Meet the DeanLocation:Cafe Tu Tu Tango
7:00 PM – 9:00 PM ET
President's Reception (by invitation only)
7:00 PM – 9:00 PM ET
President's Reception (by invitation only)Location:Discovery Cove
7:00 PM – 9:00 PM ET
UConn School of Pharmacy Alumni Reception
7:00 PM – 9:00 PM ET
UConn School of Pharmacy Alumni ReceptionLocation:The Pub - Orlando