- Cancelled
Prologue: "Grades" of Ancillary, Raw and Starting Materials and Excipients
Prologue: "Grades" of Ancillary, Raw and Starting Materials and ExcipientsLocation:On DemandFormulation and Delivery – Chemical
Allison Elizabeth Radwick, PhD (she/her/hers) – USP ### 1976694###Prologue Speaker###Sr Regulatory & Policy Comms Mgr###USP###Prologue Speaker: – USP
### she/her/hers
Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous Biomarkers
Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous BiomarkersLocation:On DemandPrologue Speaker: – Certara UK Limited, Simcyp Division
Preclinical and Translational Sciences
Sibylle Neuhoff, PhD – Certara UK Limited, Simcyp Division ### 567517###Prologue Speaker###Senior Principal Scientist###Certara UK Limited, Simcyp Division###Prologue Speaker: – Certara UK Limited, Simcyp Division
###
Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine Innovations
Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine InnovationsLocation:On DemandPrologue Speaker: – Merck
Manufacturing & Analytical Characterization
Wei Xu, PhD (she/her/hers) – Merck ### 567494###Prologue Speaker###Distinguished Scienst###Merck###Prologue Speaker: – Merck
### she/her/hers
Prologue: Alternative Methods to Animal Studies: Artificial Tissue to Artificial Intelligence
Prologue: Alternative Methods to Animal Studies: Artificial Tissue to Artificial IntelligenceLocation:On DemandPrologue Speaker: – St. John's University
Preclinical and Translational Science - Biomolecular
Ketan D. Patel, PhD (he/him/his) – St. John's University ### 604511###Prologue Speaker###Associate Professor###St. John's University###Prologue Speaker: – St. John's University
### he/him/his
Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future Prospects
Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future ProspectsLocation:On DemandPrologue Speaker: – Pfizer Inc.
Preclinical and Translational Sciences
Kelly A. Fader, PhD (she/her/hers) – Pfizer Inc. ### 2032691###Prologue Speaker###Translational Medicine Lead, Precision Medicine, Early Clinical Development###Pfizer Inc.###Prologue Speaker: – Pfizer Inc.
### she/her/hers
Prologue: Biomarker and Omics Approaches
Prologue: Biomarker and Omics ApproachesLocation:On DemandPrologue Speaker: – Novartis
Bioanalytics
Robert Dodge, PhD – Novartis ### 466130###Prologue Speaker###Director###Novartis###Prologue Speaker: – Novartis
###
Prologue: Biomarker Assays Are Not PK Assays: Prologue on Biomarker Assays
Prologue: Biomarker Assays Are Not PK Assays: Prologue on Biomarker AssaysLocation:On DemandPrologue Speaker: – Immunologix Laboratories
Bioanalytics – Biomolecular
Lauren Stevenson, PhD (she/her/hers) – Immunologix Laboratories ### 802379###Prologue Speaker###Chief Scientific Officer###Immunologix Laboratories###Prologue Speaker: – Immunologix Laboratories
### she/her/hers
Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation Therapeutics
Prologue: Breaking Barriers for bRo5 Molecules: Formulation Strategies for Next-Generation TherapeuticsLocation:On DemandPrologue Speaker: – St. John's University
Formulation and Delivery – Chemical
Ketan D. Patel, PhD (he/him/his) – St. John's University ### 604511###Prologue Speaker###Associate Professor###St. John's University###Prologue Speaker: – St. John's University
### he/him/his
Prologue: Brevican-Targeting Peptide for Therapeutic Delivery to Glioblastoma: Tools for Drug Discovery
Prologue: Brevican-Targeting Peptide for Therapeutic Delivery to Glioblastoma: Tools for Drug DiscoveryLocation:On DemandPrologue Speaker: – Brigham and Women's Hospital, Harvard Medical School
Discovery and Basic Research
Choi-Fong Cho, PhD – Brigham and Women's Hospital, Harvard Medical School ### 653557###Prologue Speaker###Assistant Professor###Brigham and Women's Hospital, Harvard Medical School###Prologue Speaker: – Brigham and Women's Hospital, Harvard Medical School
###
Prologue: Current Status of Transporter-Mediated Drug Delivery
Prologue: Current Status of Transporter-Mediated Drug DeliveryLocation:On DemandPrologue Speaker: – Institute of Pharmacy and Molecular Biotechnology/Heidelberg University
Discovery and Basic Research
Elena Puris, PhD (she/her/hers) – Institute of Pharmacy and Molecular Biotechnology/Heidelberg University ### 2032743###Prologue Speaker###Postdoctoral Researcher###Institute of Pharmacy and Molecular Biotechnology/Heidelberg University###Prologue Speaker: – Institute of Pharmacy and Molecular Biotechnology/Heidelberg University
### she/her/hers
Prologue: Current Trends and Research Opportunities for Collaboration in Pediatric Formulation Development
Prologue: Current Trends and Research Opportunities for Collaboration in Pediatric Formulation DevelopmentLocation:On DemandPrologue Speaker: – University of Maryland, Baltimore
Formulation and Delivery – Biomolecular
Stephen W. Hoag, PhD, FAAPS – University of Maryland, Baltimore ### 604903###Prologue Speaker###Professor###University of Maryland, Baltimore###Prologue Speaker: – University of Maryland, Baltimore
###
Prologue: Drug Delivery Alternatives to Injectables For Systemic Availability
Prologue: Drug Delivery Alternatives to Injectables For Systemic AvailabilityLocation:On DemandPrologue Speaker: – PureIMS BV
Formulation and Delivery – Chemical
Jaap Wieling, PhD (he/him/his) – PureIMS BV ### 803550###Prologue Speaker###CEO###PureIMS BV###Prologue Speaker: – PureIMS BV
### he/him/his
Prologue: Embracing Innovation: Harnessing Emerging Technologies for Enhanced Pharmaceutical Quality
Prologue: Embracing Innovation: Harnessing Emerging Technologies for Enhanced Pharmaceutical QualityLocation:On DemandPrologue Speaker: – US FDA
Manufacturing & Analytical Characterization
Geng Tian, PhD (he/him/his) – US FDA ### 2031554###Prologue Speaker###Lab Chief###US FDA###Prologue Speaker: – US FDA
### he/him/his
Prologue: Emerging Applications of Data Driven and Hybrid Modelling in Pharmaceutical Manufacturing
Prologue: Emerging Applications of Data Driven and Hybrid Modelling in Pharmaceutical ManufacturingLocation:On DemandManufacturing & Analytical Characterization
Gabriele Bano, PhD (he/him/his) – GSK ### 2031693###Prologue Speaker###Team Leader, Process Analytics###GSK###Prologue Speaker: – GSK
### he/him/his
Prologue: Emerging Trends in Continuous Manufacturing of Pharmaceuticals
Prologue: Emerging Trends in Continuous Manufacturing of PharmaceuticalsLocation:On DemandPrologue Speaker: – Pharmatech Associates Inc.
Manufacturing & Analytical Characterization
Lawrence De Belder, MSc (he/him/his) – Pharmatech Associates Inc. ### 2031564###Prologue Speaker###Continuous Manufacturing Practice Lead###Pharmatech Associates Inc.###Prologue Speaker: – Pharmatech Associates Inc.
### he/him/his
Prologue: Excipients: It's Complicated
Prologue: Excipients: It's ComplicatedLocation:On DemandPrologue Speaker: – FinnBritt Consulting
Formulation and Delivery
Chris Moreton, PhD (he/him/his) – FinnBritt Consulting ### 466122###Prologue Speaker###Partner###FinnBritt Consulting###Prologue Speaker: – FinnBritt Consulting
### he/him/his
Prologue: From Modality-Specific to Boundaryless Analytics – Delivering the Pipeline of Tomorrow
Prologue: From Modality-Specific to Boundaryless Analytics – Delivering the Pipeline of TomorrowLocation:On DemandPrologue Speaker: – Merck
Manufacturing & Analytical Characterization
Jason Cheung, PhD – Merck ### 1980608###Prologue Speaker###Distinguished Scientist###Merck###Prologue Speaker: – Merck
###
Prologue: Health Disparities Research: How Basic Science can Inform Clinical Practice
Prologue: Health Disparities Research: How Basic Science can Inform Clinical PracticeLocation:On DemandPrologue Speaker: – The University of Arizona
Discovery and Basic Research
Julie Armin, PhD (she/her/hers) – The University of Arizona ### 2029616###Prologue Speaker###Assistant Professor###The University of Arizona###Prologue Speaker: – The University of Arizona
### she/her/hers
Prologue: Immunogenicity and Regulatory Considerations
Prologue: Immunogenicity and Regulatory ConsiderationsLocation:On DemandPrologue Speaker: – Merck & Co.
Bioanalytics – Biomolecular
Karen Liao, MD (she/her/hers) – Merck & Co. ### 1976723###Prologue Speaker###Principal Scientist, Regulated Bioanalytics###Merck & Co.###Prologue Speaker: – Merck & Co.
### she/her/hers
Prologue: LC-MS Approaches and Advances
Prologue: LC-MS Approaches and AdvancesLocation:On DemandPrologue Speaker: – LabCorp Drug Development - Bioanalytical Services
Bioanalytics – Biomolecular
Brendan Powers, PhD (he/him/his) – LabCorp Drug Development - Bioanalytical Services ### 1976733###Prologue Speaker###Senior Manager###LabCorp Drug Development - Bioanalytical Services###Prologue Speaker: – LabCorp Drug Development - Bioanalytical Services
### he/him/his
Prologue: Modelling and Predictive Design in Pharmaceutical Development
Prologue: Modelling and Predictive Design in Pharmaceutical DevelopmentLocation:On DemandManufacturing & Analytical Characterization
Simeone Zomer, DR – GSK ### 1977833###Prologue Speaker###Scientific Director###GSK###Prologue Speaker: – GSK
###
Prologue: Patient Centric Sampling: Tips and Tricks for Bioanalysis
Prologue: Patient Centric Sampling: Tips and Tricks for BioanalysisLocation:On DemandPrologue Speaker: – Veloxity Labs, LLC
Bioanalytics – Chemical
Shane Needham, PhD – Veloxity Labs, LLC ### 1611936###Prologue Speaker###CEO###Veloxity Labs, LLC###Prologue Speaker: – Veloxity Labs, LLC
###
Prologue: Preformulation and Biopharmaceutical Support for Drug Delivery
Prologue: Preformulation and Biopharmaceutical Support for Drug DeliveryLocation:On DemandPrologue Speaker: – Clearview Pharma Solutions LLC
Formulation and Delivery – Chemical
Andrei Blasko, PhD, FRSC – Clearview Pharma Solutions LLC ### 1976682###Prologue Speaker###President and CEO###Clearview Pharma Solutions LLC###Prologue Speaker: – Clearview Pharma Solutions LLC
###
Prologue: Role of Biomarkers in Rare Disease Drug Development and Regulatory Approval
Prologue: Role of Biomarkers in Rare Disease Drug Development and Regulatory ApprovalLocation:On DemandPrologue Speaker: – Kojin Therapeutics
Preclinical and Translational Sciences
Lakshmi Amaravadi, PhD – Kojin Therapeutics ### 567500###Prologue Speaker###SVP, Head of Preclinical and Translational Development###Kojin Therapeutics###Prologue Speaker: – Kojin Therapeutics
###
Prologue: The CGT Landscape
Prologue: The CGT LandscapeLocation:On DemandPrologue Speaker: – PPD, A ThermoFisher Company
Bioanalytics – Biomolecular
Catherine Vrentas, PhD – PPD, A ThermoFisher Company ### 1650329###Prologue Speaker###Principal Scientist###PPD, A ThermoFisher Company###Prologue Speaker: – PPD, A ThermoFisher Company
###
Prologue: Use of Artificial Intelligence and Machine Learning in Regulatory Submissions
Prologue: Use of Artificial Intelligence and Machine Learning in Regulatory SubmissionsLocation:On DemandPrologue Speaker: – Tolmar Inc
Preclinical and Translational Science - Chemical
Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc ### 567542###Prologue Speaker###Sr. Director, Clinical Development###Tolmar Inc###Prologue Speaker: – Tolmar Inc
### he/him/his
- Friday, October 20, 2023
12:00 PM – 5:00 PM ET
Registration Hours
12:00 PM – 5:00 PM ET
Registration Hours
Location:Concourse A4-B3 West
1:00 PM – 5:00 PM ET
Exhibitor Move-In (Booths 300 SF or larger)
1:00 PM – 5:00 PM ET
Exhibitor Move-In (Booths 300 SF or larger)
Location:Exhibit Hall West A4-B3
- Saturday, October 21, 2023
7:30 AM – 5:00 PM ET
Registration Hours
7:30 AM – 5:00 PM ET
Registration Hours
Location:Concourse A4-B3 West
8:00 AM – 5:00 PM ET
Exhibitor Move-In
8:00 AM – 5:00 PM ET
Exhibitor Move-In
Location:Exhibit Hall West A4-B3
- Sunday, October 22, 2023
7:00 AM – 7:00 PM ET
Registration Hours
7:00 AM – 7:00 PM ET
Registration Hours
Location:Concourse A4-B3 West
8:00 AM – 5:00 PM ET
Exhibitor Move-In
8:00 AM – 5:00 PM ET
Exhibitor Move-In
Location:Exhibit Hall West A4-B3
9:00 AM – 1:00 PM ET
Business Development Advisory Board (by invitation only)
9:00 AM – 1:00 PM ET
Business Development Advisory Board (by invitation only)
Location:Manatee Spring, Hyatt Regency Orlando
12:00 PM – 4:00 PM ET
Speaker Ready Room
12:00 PM – 4:00 PM ET
Speaker Ready Room
Location:307 AB West
5:00 PM – 6:30 PM ET
Opening Plenary with Dr. Thomas Hartung Plenary Speaker: – Johns Hopkins University
5:00 PM – 6:30 PM ET
Opening Plenary with Dr. Thomas Hartung Location:Chapin TheaterPlenary Speaker: – Johns Hopkins University
Thomas Hartung, MD, PhD – Johns Hopkins University ### 802308###Plenary Speaker###Professor & Chair###Johns Hopkins University###Plenary Speaker: – Johns Hopkins University
### 6:30 PM – 8:00 PM ET
Welcome Reception
6:30 PM – 8:00 PM ET
Welcome ReceptionLocation:Plaza Ballroom, Hyatt Regency OrlandoSponsored By Merck & Co Inc., Regeneron Pharmaceuticals
8:00 PM – 9:30 PM ET
American Society of Iranian Pharmaceutical Scientists
8:00 PM – 9:30 PM ET
American Society of Iranian Pharmaceutical ScientistsLocation:Challenger 41-42, Hyatt Regency Orlando
- 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
- Tuesday, October 24, 2023
7:00 AM – 8:30 AM ET
Mentor Breakfast
7:00 AM – 8:30 AM ET
Mentor BreakfastLocation:Florida AB, Hyatt Regency OrlandoCareer Development
7:00 AM – 9:00 AM ET
Quotient Sciences Breakfast Seminar (by invitation only)
7:00 AM – 9:00 AM ET
Quotient Sciences Breakfast Seminar - How To Accelerate Drug Product Optimization: Integrated Program Delivery Using Translational Pharmaceutics® (by invitation only, pre-registration required))Location:Plaza K Ballroom, 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
8:30 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 InterviewsLocation: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 – 9:30 AM ET
2023 AAPS High Impact Manuscript Award Rapid Fire PresentationsRapid Fire Moderator: – University of Texas at Austin
9:00 AM – 9:30 AM ET
2023 AAPS High Impact Manuscript Award Rapid Fire PresentationsLocation:308 CD WestRapid Fire Moderator: – University of Texas at Austin
Robert O. Williams, III, PhD (he/him/his) – University of Texas at Austin ### 466197###Rapid Fire Moderator###Division Head###University of Texas at Austin###Rapid Fire Moderator: – University of Texas at Austin
### he/him/his9:00 AM – 9:15 AM ET
Integrating Biomarkers in PD-1/PD-L1 Antibody Therapy for Personalized Cancer TreatmentLocation:308 CD WestRapid Fire Speaker: – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Baolin Zhang, PhD (he/him/his) – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) ### 1650365###Rapid Fire Speaker###SBRBPAS Expert###Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)###Rapid Fire Speaker: – Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
### he/him/his9:15 AM – 9:30 AM ET
Polyvinyl Alcohol/Chitosan Single-Layered and Polyvinyl Alcohol/Chitosan/Eudragit RL100 Multi-layered Electrospun Nanofibers as an Ocular Matrix for the Controlled Release of Ofloxacin: an In Vitro and In Vivo EvaluationLocation:308 CD WestRapid Fire Speaker: – University of Sussex
Ali Nokhodchi, PhD (he/him/his) – University of Sussex ### 1046023###Rapid Fire Speaker###Professor of Pharmaceutics and Drug Delivery###University of Sussex###Rapid Fire Speaker: – University of Sussex
### he/him/his9:00 AM – 10:00 AM ET
Recent Advances in Improving Patient Wellbeing Through Long-acting Injectable FormulationsPartner Presentation Speaker: – Syngene International Ltd
Formulation and Delivery
9:00 AM – 10:00 AM ET
Recent Advances in Improving Patient Wellbeing Through Long-acting Injectable FormulationsLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Syngene International Ltd
Formulation and Delivery
Purushottam Singnurkar, PhD (he/him/his) – Syngene International Ltd ### 635968###Partner Presentation Speaker###Vice President and Head, Formulation Development###Syngene International Ltd###Partner Presentation Speaker: – Syngene International Ltd
### he/him/his9:00 AM – 10:00 AM ET
The Science of Story Telling: Mastering Your PresentationCareer Center Speaker: – Seran Biosciences, LLC
Career Development
9:00 AM – 10:00 AM ET
The Science of Story Telling: Mastering Your PresentationLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Seran Biosciences, LLC
Career Development
Erica Schlesinger, PhD (she/her/hers) – Seran Biosciences, LLC ### 847532###Career Center Speaker###VP, Technical Development###Seran Biosciences, LLC###Career Center Speaker: – Seran Biosciences, LLC
### she/her/hers9:00 AM – 11:00 AM ET
Symposium: Addressing Health Disparities in Basic Science ResearchModerator: – University of the Pacific
Discovery and Basic Research
9:00 AM – 11:00 AM ET
Symposium: Addressing Health Disparities in Basic Science ResearchLocation:311 AB WestModerator: – University of the Pacific
Discovery and Basic Research
Melanie Felmlee, Ph.D. (she/her/hers) – University of the Pacific ### 1689851###Moderator###Associate Professor###University of the Pacific###Moderator: – University of the Pacific
### she/her/hers9:00 AM – 9:30 AM ET
Harnessing Machine Learning and Protein Structure to Characterize SLC Structure and FunctionLocation:311 AB WestDiscovery and Basic Research
Avner Schlessinger ### 2037281###Speaker#########Speaker:
### 9:30 AM – 10:00 AM ET
Deciphering Genetic Causes for Sex Differences in Human Health Through Drug Metabolism and Transporter GenesLocation:311 AB WestSpeaker: – University of Minnesota
Discovery and Basic Research
R. Stephanie Huang, PhD (she/her/hers) – University of Minnesota ### 2029618###Speaker###Professor###University of Minnesota###Speaker: – University of Minnesota
### she/her/hers10:00 AM – 10:30 AM ET
Leveraging Power of Quantitative Omics Tools and Biorepositories to Address Health Disparity in Basic and Translational ResearchLocation:311 AB WestSpeaker: – Washington State University
Discovery and Basic Research
Bhagwat Prasad, Ph.D – Washington State University ### 1536982###Speaker###Associate Professor###Washington State University###Speaker: – Washington State University
### 10:30 AM – 11:00 AM ET
Understanding the Impact of Ancestral and Demographic Diversity On -Omics Data is Essential For Biomedical Research: Case StudiesLocation:311 AB WestSpeaker: – Bristol Myers Squibb
Discovery and Basic Research
Joseph Daniel Szustakowski, PhD – Bristol Myers Squibb ### 2037832###Speaker###Vice President, Translational Bioinformatics###Bristol Myers Squibb###Speaker: – Bristol Myers Squibb
### 9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1Manufacturing & Analytical Characterization
9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1Location:205 AB WestManufacturing & Analytical Characterization
Sayantan Chattoraj, PhD – GSK ### 828674###Moderator###Team Director - Process Analytics, Drug Product Development###GSK###Moderator: – GSK
### 9:00 AM – 9:30 AM ET
Small Molecule Drug In Silico Crystal Structure and Property PredictionsLocation:205 AB WestSpeaker: – Schrodinger, LLC
Manufacturing & Analytical Characterization
John C. Shelley, PhD – Schrodinger, LLC ### 1976681###Speaker###Fellow###Schrodinger, LLC###Speaker: – Schrodinger, LLC
### 9:30 AM – 10:00 AM ET
Computational Approaches to Salt Screening: Case of Aripiprazole Salts CrystallizationLocation:205 AB WestSpeaker: – J-Star Research | Porton
Manufacturing & Analytical Characterization
Yuriy Abramov, PhD – J-Star Research | Porton ### 1778370###Speaker###Executive Director of Computational Chemistry and Data Science###J-Star Research | Porton###Speaker: – J-Star Research | Porton
### 10:00 AM – 10:30 AM ET
Next Generation Lab-Scale Transport Validation: Fluid Behavior and Quality ImpactsLocation:205 AB WestSpeaker: – F. Hoffman - La Roche Ltd.
Manufacturing & Analytical Characterization
Florian Rosenthal, MSc ETH (he/him/his) – F. Hoffman - La Roche Ltd. ### 1976696###Speaker###Senior Scientist###F. Hoffman - La Roche Ltd.###Speaker: – F. Hoffman - La Roche Ltd.
### he/him/his10:30 AM – 11:00 AM ET
A Novel Digital Twin of End-to-End Continuous Manufacturing of InjectableLocation:205 AB WestSpeaker: – Rutgers University
Manufacturing & Analytical Characterization
Ravendra Singh (he/him/his) – Rutgers University ### 1976697###Speaker###Faculty###Rutgers University###Speaker: – Rutgers University
### he/him/his9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2Moderator: – Ghent University
Manufacturing & Analytical Characterization
9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2Location:206 AB WestModerator: – Ghent University
Manufacturing & Analytical Characterization
Thomas De Beer, PhD (he/him/his) – Ghent University ### 849132###Moderator###Professor###Ghent University###Moderator: – Ghent University
### he/him/his9:00 AM – 9:30 AM ET
Recent Advances in Machine Learning for Characterizing Subvisible ParticlesLocation:206 AB WestSpeaker: – Ursa Analytics
Manufacturing & Analytical Characterization
Chris P. Calderon, PhD – Ursa Analytics ### 1011746###Speaker###Founder###Ursa Analytics###Speaker: – Ursa Analytics
### 9:30 AM – 10:00 AM ET
Deep Learning Models to Reduce False Rejects in Pharmaceutical manufacturingLocation:206 AB WestSpeaker: – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Vijay Yadav – Merck & Co., Inc. ### 1328485###Speaker###Director, Data Science - Advanced Analytics###Merck & Co., Inc.###Speaker: – Merck & Co., Inc.
### 10:00 AM – 10:30 AM ET
Continuous Manufacturing: Optimizing Quality and Efficiency Improvement Using AILocation:206 AB WestSpeaker: – Vertex Pharmaceuticals
Manufacturing & Analytical Characterization
Rupesh Malhotra, MS – Vertex Pharmaceuticals ### 2031695###Speaker###Associate Director###Vertex Pharmaceuticals###Speaker: – Vertex Pharmaceuticals
### 10:30 AM – 11:00 AM ET
Scale-Down Modeling of Bioreactor Operations for Monoclonal Antibody ProductionLocation:206 AB WestManufacturing & Analytical Characterization
Ou Yang, PhD – GSK ### 2031696###Speaker###Investigator###GSK###Speaker: – GSK
### 9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 1Moderator: – Bristol Myers Squibb Company
Bioanalytics
9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 1Location:311 EF WestModerator: – Bristol Myers Squibb Company
Bioanalytics
HsinPin Ho, Ph.D. – Bristol Myers Squibb Company ### 1466231###Moderator###Principal Scientist###Bristol Myers Squibb Company###Moderator: – Bristol Myers Squibb Company
### 9:00 AM – 9:30 AM ET
Advances in Regulated Bioanalytical Strategies Supporting Quantitation of Protein DegradersLocation:311 EF WestSpeaker: – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations
Bioanalytics
Jim Shen, PhD (he/him/his) – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations ### 754507###Speaker###Executive Director###Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations###Speaker: – Bristol Myers Squibb/Head of Regulated Bioanalysis & Operations
### he/him/his9:30 AM – 10:00 AM ET
Quantitation of Oligonucleotides – LC-HRMS or LC-MS/MS, Which is Better?Location:311 EF WestBioanalytics
Zamas Lam, PhD (he/him/his) – QPS ### 2029620###Speaker###SVP & Global Head Bioanalytical (Mass Spec)###QPS###Speaker: – QPS
### he/him/his10:00 AM – 10:30 AM ET
Hybridization LC-MS/MS Bioanalysis of Oligonucleotides to Support PET Imaging StudyLocation:311 EF WestBioanalytics
Di Jiang, PhD (she/her/hers) – Biogen Inc. ### 1767347###Speaker###Scientist###Biogen Inc.###Speaker: – Biogen Inc.
### she/her/hers10:30 AM – 11:00 AM ET
Developing a Semi-Quantitative LBA LC-MS Assay for Anti-Drug Antibody IsotypesLocation:311 EF WestSpeaker: – Labcorp Drug Development
Bioanalytics
Paige A. Malec, PhD (she/her/hers) – Labcorp Drug Development ### 1010815###Speaker###Staff Scientist III###Labcorp Drug Development###Speaker: – Labcorp Drug Development
### she/her/hers9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 2Moderator: – Aliri Bioanalysis
Bioanalytics
9:00 AM – 11:00 AM ET
Symposium: Approaches for Emerging Modalities and Complex Studies 2Location:311 GH WestModerator: – Aliri Bioanalysis
Bioanalytics
Troy Voelker, PhD – Aliri Bioanalysis ### 1447215###Moderator###Director of Laboratory Operations###Aliri Bioanalysis###Moderator: – Aliri Bioanalysis
### 9:00 AM – 9:30 AM ET
A Hybridization Approach to Oligonucleotide Sample Extraction and LC/MS AnalysisLocation:311 GH WestSpeaker: – Aliri Bioanalysis
Bioanalytics
Troy Voelker, PhD – Aliri Bioanalysis ### 1447215###Speaker###Director of Laboratory Operations###Aliri Bioanalysis###Speaker: – Aliri Bioanalysis
### 9:30 AM – 10:00 AM ET
Amplicon-Based Next-Generation Sequencing Nonclinical Assay ValidationLocation:311 GH WestSpeaker: – Beam Therapeutics
Bioanalytics
Kelly S. Colletti, PhD, MBA (she/her/hers) – Beam Therapeutics ### 1940581###Speaker###Director, Preclinical Bioanalytics###Beam Therapeutics###Speaker: – Beam Therapeutics
### she/her/hers10:00 AM – 10:30 AM ET
High Content Biomarkers: Application of High Parameter Flow Cytometry for Single-Cell Analysis in Clinical TrialsLocation:311 GH WestBioanalytics
Michelle Graham, PhD (she/her/hers) – AbbVie ### 2032818###Speaker###Principal Research Scientist ###AbbVie###Speaker: – AbbVie
### she/her/hers10:30 AM – 11:00 AM ET
Scientific Challenges Developing Bioanalytical Assays for Novel Modalities: Car-TLocation:311 GH WestSpeaker: – Navigate Biopharma
Bioanalytics
Mark Blimline, MS (he/him/his) – Navigate Biopharma ### 1976699###Speaker###Principal Scientist###Navigate Biopharma###Speaker: – Navigate Biopharma
### he/him/his9:00 AM – 11:00 AM ET
Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1Moderator: – University of Copenhagen
Formulation and Delivery
9:00 AM – 11:00 AM ET
Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 1Location:208 AB WestModerator: – University of Copenhagen
Formulation and Delivery
Anette Mullertz, PhD, FAAPS – University of Copenhagen ### 466033###Moderator###Professor###University of Copenhagen###Moderator: – University of Copenhagen
### 9:00 AM – 9:30 AM ET
Enabling Oral Absorption of Peptides By Self-Nanoemulsifying Drug Delivery SystemsLocation:208 AB WestSpeaker: – University of Copenhagen
Formulation and Delivery
Anette Mullertz, PhD, FAAPS – University of Copenhagen ### 466033###Speaker###Professor###University of Copenhagen###Speaker: – University of Copenhagen
### 9:30 AM – 10:00 AM ET
Environmentally-Responsive Hydrogel Excipient Broadly Enhances Oral Bioavailability of Insoluble DrugsLocation:208 AB WestFormulation and Delivery
Doug Godfrin, PhD – VeraMorph ### 1976680###Speaker###Founder & CEO###VeraMorph###Speaker: – VeraMorph
### 10:00 AM – 10:30 AM ET
High-Throughput Screening Workflow for Amorphous Solubility and Excipient PerformanceLocation:208 AB WestSpeaker: – Genentech Inc.
Formulation and Delivery
Yuchen Fan, PhD – Genentech Inc. ### 1976679###Speaker###Principal Scientist###Genentech Inc.###Speaker: – Genentech Inc.
### 10:30 AM – 11:00 AM ET
Understanding Surfactant-Protein Interactions in Mitigating Interface-Induced Protein Particle Formation in Biotherapeutic Solutions Subjected to Interfacial StressesLocation:208 AB WestSpeaker: – The University of Kansas
Formulation and Delivery
Prajnaparamita Dhar, PhD (she/her/hers) – The University of Kansas ### 2029660###Speaker###Professor###The University of Kansas ###Speaker: – The University of Kansas
### she/her/hers9:00 AM – 11:00 AM ET
Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2Moderator: – Teva Pharmaceuticals
Formulation and Delivery
9:00 AM – 11:00 AM ET
Symposium: Enabling Excipients and Approaches for Advancing Formulation and Delivery 2Location:209 AB WestModerator: – Teva Pharmaceuticals
Formulation and Delivery
Haichen Nie, PhD – Teva Pharmaceuticals ### 1976730###Moderator###Associate Director###Teva Pharmaceuticals###Moderator: – Teva Pharmaceuticals
### 9:00 AM – 9:30 AM ET
Strategic Overview of Complex Excipients in US Pharmacopeia With a Focus on Polysorbates and LG PolymerLocation:209 AB WestSpeaker: – Bristol Myers Squibb
Formulation and Delivery
Otilia M. Koo, Ph.D., FAAPS (she/her/hers) – Bristol Myers Squibb ### 575911###Speaker###Executive Director###Bristol Myers Squibb###Speaker: – Bristol Myers Squibb
### she/her/hers9:30 AM – 10:00 AM ET
Mechanistic Insights on Fogging in Lyophilized FormulationsLocation:209 AB WestFormulation and Delivery
Navpreet Kaur, PhD (she/her/hers) – Sanofi ### 1976689###Speaker###Scientist, Biologics drug product development###Sanofi###Speaker: – Sanofi
### she/her/hers10:00 AM – 10:30 AM ET
Revisiting the Crucial Role of Amino Acids as Excipients in Protein-Based Drug Product DevelopmentLocation:209 AB WestSpeaker: – Teva Pharmaceuticals
Formulation and Delivery
Haichen Nie, PhD – Teva Pharmaceuticals ### 1976730###Speaker###Associate Director###Teva Pharmaceuticals###Speaker: – Teva Pharmaceuticals
### 10:30 AM – 11:00 AM ET
Role of Excipients in Frozen and Freeze-Dried Protein FormulationsLocation:209 AB WestSpeaker: – College of Pharmacy/University of Minnesota
Formulation and Delivery
Raj Suryanarayanan, PhD, MPharm, MSc – College of Pharmacy/University of Minnesota ### 466096###Speaker###Professor and William and Mildred Peters Endowed Chair###College of Pharmacy/University of Minnesota###Speaker: – College of Pharmacy/University of Minnesota
### 9:00 AM – 11:00 AM ET
Symposium: Evolving Clinical Pharmacology and Translational PK/PD Approaches For New ModalitiesPreclinical and Translational Sciences
9:00 AM – 11:00 AM ET
Symposium: Evolving Clinical Pharmacology and Translational PK/PD Approaches For New ModalitiesLocation:309 AB WestPreclinical and Translational Sciences
Hardik Mody, PhD – Genetech ### 1010836###Moderator###Principal Scientist###Genetech###Moderator: – Genetech
### 9:00 AM – 9:30 AM ET
Application of Mechanistic Physiologically Based Pharmacokinetic Models to OligonucleotidesLocation:309 AB WestSpeaker: – Certara UK Limited
Preclinical and Translational Sciences
Felix Stader, PhD (he/him/his) – Certara UK Limited ### 1976735###Speaker###Senior Research Scientist###Certara UK Limited###Speaker: – Certara UK Limited
### he/him/his9:30 AM – 10:00 AM ET
PK/PD Modeling of Bispecific T Cell Engagers for Clinical TranslationLocation:309 AB WestSpeaker: – University of North Carolina at Chapel Hill
Preclinical and Translational Sciences
Yanguang (Carter) Cao, PH.D – University of North Carolina at Chapel Hill ### 1976741###Speaker###Associate Professor###University of North Carolina at Chapel Hill###Speaker: – University of North Carolina at Chapel Hill
### 10:00 AM – 10:30 AM ET
Clinical Pharmacology Considerations for Allogeneic Cell TherapiesLocation:309 AB WestPreclinical and Translational Sciences
Dhruvitkumar Sutaria, PhD (he/him/his) – Genentech ### 1976731###Speaker###Principal Scientist###Genentech###Speaker: – Genentech
### he/him/his10:30 AM – 11:00 AM ET
A Quantitative Systems Pharmacology Model to Characterize the PKPD Relationship Following Treatment with IL-15R AgonistsLocation:309 AB WestPreclinical and Translational Sciences
Louis Joslyn, PhD – Genentech ### 1976729###Speaker###Principal Scientist###Genentech###Speaker: – Genentech
### 9:00 AM – 11:00 AM ET
Symposium: Harnessing The Power of AI/ML in Drug DevelopmentPreclinical and Translational Sciences
9:00 AM – 11:00 AM ET
Symposium: Harnessing The Power of AI/ML in Drug DevelopmentLocation:311 CD WestPreclinical and Translational Sciences
Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc ### 567542###Moderator###Sr. Director, Clinical Development###Tolmar Inc###Moderator: – Tolmar Inc
### he/him/his9:00 AM – 9:30 AM ET
Understand the Regulatory Environment for AI and Machine LearningLocation:311 CD WestSpeaker: – Pharmalytik Consulting & Training
Preclinical and Translational Sciences
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training ### 636579###Speaker###Managing Director###Pharmalytik Consulting & Training###Speaker: – Pharmalytik Consulting & Training
### 9:30 AM – 10:00 AM ET
The Use of Machine Learning in the Development of Scoring Rule for the Identification of Adult Patients Under the Emergency Use Authorization for Anakinra for Treatment of COVID-19 in the United StatesLocation:311 CD WestSpeaker: – U.S. Food and Drug Administration
Preclinical and Translational Sciences
Ruihao Huang, PhD (he/him/his) – U.S. Food and Drug Administration ### 2031549###Speaker###AI/ML reviewer###U.S. Food and Drug Administration###Speaker: – U.S. Food and Drug Administration
### he/him/his10:00 AM – 10:30 AM ET
Integrating Machine Learning and Systems Pharmacology to Predict Clinical Outcomes to CAR-T TherapiesLocation:311 CD WestSpeaker: – Notch Therapeutics
Preclinical and Translational Sciences
Avisek Deyati, PhD (he/him/his) – Notch Therapeutics ### 2031551###Speaker###Senior Scientist###Notch Therapeutics###Speaker: – Notch Therapeutics
### he/him/his10:30 AM – 11:00 AM ET
When Modeling & Simulation Meets GPTLocation:311 CD WestSpeaker: – US Food and Drug Administration
Preclinical and Translational Sciences
Liang Zhao, PhD – US Food and Drug Administration ### 1377529###Speaker###Division Director###US Food and Drug Administration###Speaker: – US Food and Drug Administration
### 9:00 AM – 4:00 PM ET
Career Fair
9:00 AM – 4:00 PM ET
Career FairLocation:Careers 360, Exhibit Hall West A4-B3Career Development
9:30 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
Challenges in Analytical Aerosol Methods for High Payload Inhalation ProductsChalk Talk Presenter: – Kindeva Drug Delivery
Formulation and Delivery
9:30 AM – 10:30 AM ET
Challenges in Analytical Aerosol Methods for High Payload Inhalation ProductsLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – Kindeva Drug Delivery
Formulation and Delivery
Blaine Bueche, PhD – Kindeva Drug Delivery ### 2159188###Chalk Talk Presenter###R&D Principal Scientist###Kindeva Drug Delivery###Chalk Talk Presenter: – Kindeva Drug Delivery
### 9:30 AM – 10:30 AM ET
Leverage Bioanalysis Outsourcing Partnerships to Support Complex Clinical TrialsPartner Presentation Speaker: – LabConnect
Bioanalytics
9:30 AM – 10:30 AM ET
Leverage Bioanalysis Outsourcing Partnerships to Support Complex Clinical TrialsLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – LabConnect
Bioanalytics
Joe Marino (he/him/his) – LabConnect ### 2144065###Partner Presentation Speaker###Senior Director, FSP Solutions###LabConnect###Partner Presentation Speaker: – LabConnect
### he/him/his9:30 AM – 10:30 AM ET
Next-Generation Bioprocessing Strategies to Improve Speed, Cost and Tech TransferPartner Presentation Speaker: – IDBS
Manufacturing & Analytical Characterization
9:30 AM – 10:30 AM ET
Next-Generation Bioprocessing Strategies to Improve Speed, Cost and Tech TransferLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – IDBS
Manufacturing & Analytical Characterization
Shendi Lu – IDBS ### 2144069###Partner Presentation Speaker###Lead Solutions Consultant###IDBS###Partner Presentation Speaker: – IDBS
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: Evolving Clinical Pharmacology and Translational PK/PD Approaches for New ModalitiesSpotlight Speaker: – Applied BioMath, LLC
Moderator: – Applied BioMath
Preclinical and Translational Sciences
9:30 AM – 10:30 AM ET
Speaker Spotlight: Evolving Clinical Pharmacology and Translational PK/PD Approaches for New ModalitiesLocation:Spotlight Stage B Exhibit Hall West A4-B3Spotlight Speaker: – Applied BioMath, LLC
Moderator: – Applied BioMath
Preclinical and Translational Sciences
Joshua F. Apgar, PhD (he/him/his) – Applied BioMath, LLC ### 1689611###Spotlight Speaker###CSO Co Founder###Applied BioMath, LLC###Spotlight Speaker: – Applied BioMath, LLC
### he/him/his @@@ Fei Hua, PhD – Applied BioMath ### 844132###Moderator###VP of Modeling and Simulation Services###Applied BioMath###Moderator: – Applied BioMath
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: Targeted vs Untargeted Workflows to Quantify Oligonucleotide Therapeutics by High Resolution Mass SpectrometrySpotlight Speaker: – Drug Disposition/ADME/Eli Lilly and Company
Moderator: – Bill and Melinda Gates Medical Research Institute
Bioanalytics
9:30 AM – 10:30 AM ET
Speaker Spotlight: Targeted vs Untargeted Workflows to Quantify Oligonucleotide Therapeutics by High Resolution Mass SpectrometryLocation:Spotlight Stage A Exhibit Hall West A4-B3Spotlight Speaker: – Drug Disposition/ADME/Eli Lilly and Company
Moderator: – Bill and Melinda Gates Medical Research Institute
Bioanalytics
Ryan Hill (he/him/his) – Drug Disposition/ADME/Eli Lilly and Company ### 2032577###Spotlight Speaker###Senior Principal Scientist###Drug Disposition/ADME/Eli Lilly and Company###Spotlight Speaker: – Drug Disposition/ADME/Eli Lilly and Company
### he/him/his @@@ Enaksha Wickremsinhe, PhD (he/him/his) – Bill and Melinda Gates Medical Research Institute ### 627103###Moderator###Bioassay Development Lead###Bill and Melinda Gates Medical Research Institute###Moderator: – Bill and Melinda Gates Medical Research Institute
### 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: – Larimartx
Gopi Shankar, Ph.D., M.B.A., FAAPS – Larimartx ### 572031###Poster Collection Host######Larimartx###Poster Collection Host: – Larimartx
### 10:00 AM – 11:00 AM ET
Hot Topic: Regulatory Challenges and Considerations for Orally Inhaled Drug ProductHot Topic Speaker: – Merck
Hot Topic Speaker: – GSK
Hot Topic Moderator: – GlaxoSmithKline
Manufacturing & Analytical Characterization – Chemical
10:00 AM – 11:00 AM ET
Hot Topic: Regulatory Challenges and Considerations for Orally Inhaled Drug ProductLocation:308 AB WestHot Topic Speaker: – Merck
Hot Topic Speaker: – GSK
Hot Topic Moderator: – GlaxoSmithKline
Manufacturing & Analytical Characterization – Chemical
Adrian Goodey, PhD – Merck ### 1663734###Hot Topic Speaker###Senior Principal Scientist###Merck###Hot Topic Speaker: – Merck
### @@@ Sue Holmes, MS – GSK ### 1976691###Hot Topic Speaker###CMC Consultant###GSK###Hot Topic Speaker: – GSK
### @@@ Parind Desai, PhD – GlaxoSmithKline ### 1650328###Hot Topic Moderator###Team Leader, GSK Fellow###GlaxoSmithKline###Hot Topic Moderator: – GlaxoSmithKline
### 10:00 AM – 12:00 PM ET
Taste of Orlando Smoothie Station Sponsored by Eurofins
10:00 AM – 12:00 PM ET
Taste of Orlando Smoothie Station Sponsored by EurofinsLocation:Booth #2234/2236
10:30 AM – 11:30 AM ET
New Generation of Digital Self-Serve Formulation Platform Boosts R&D ProductivityFormulation and Delivery
10:30 AM – 11:30 AM ET
New Generation of Digital Self-Serve Platforms Boost R&D ProductivityLocation:360 Stage #1 Exhibit Hall West A4-B3Formulation and Delivery
Shahrzad Missaghi, PhD – Colorcon ### 1045556###Partner Presentation Speaker###Senior Manager Product Development###Colorcon###Partner Presentation Speaker: – Colorcon
### @@@ Jo Varshney, PhD – VeriSIM Life ### 2144188###Partner Presentation Speaker###Chief Executive Officer (CEO)###VeriSIM Life###Partner Presentation Speaker: – VeriSIM Life
### 10:30 AM – 11:30 AM ET
Special Poster Collection
10:30 AM – 11:30 AM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – BioAgilytix Labs, LLC
Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC ### 1529523###Poster Collection Host###Scientific Officer###BioAgilytix Labs, LLC###Poster Collection Host: – BioAgilytix Labs, LLC
### 10:30 AM – 11:30 AM ET
Three Communication Skills You Must Build to Lead a TeamCareer Center Speaker: – Speaking of Solutions, LLC
Career Development
10:30 AM – 11:30 AM ET
Three Communication Skills You Must Build to Lead a TeamLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Speaking of Solutions, LLC
Career Development
David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC ### 466187###Career Center Speaker###Principal Speaking Coach###Speaking of Solutions, LLC###Career Center Speaker: – Speaking of Solutions, LLC
### he/him/his11:00 AM – 12:00 PM ET
Improvements to PS80 Determination in Drug Product FormulationsPartner Presentation Speaker: – Prolytix - Essex Junction, VT
Manufacturing & Analytical Characterization
11:00 AM – 12:00 PM ET
Improvements to PS80 Determination in Drug Product FormulationsLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Prolytix - Essex Junction, VT
Manufacturing & Analytical Characterization
Joseph P. Campbell, PhD (he/him/his) – Prolytix - Essex Junction, VT ### 2127112###Partner Presentation Speaker###Senior Scientist###Prolytix - Essex Junction, VT###Partner Presentation Speaker: – Prolytix - Essex Junction, VT
### he/him/his11:00 AM – 12:00 PM ET
Safely Handling Potent APIs to Protect Workers/Product Protection at CMOs/CDMOs/CROsPartner Presentation Speaker: – SafeBridge Regulatory & Life Sciences Group
Manufacturing & Analytical Characterization
11:00 AM – 12:00 PM ET
Safely Handling Potent APIs to Protect Workers/Product Protection at CMOs/CDMOs/CROsLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – SafeBridge Regulatory & Life Sciences Group
Manufacturing & Analytical Characterization
Robert G. Sussman, PhD, DABT (he/him/his) – SafeBridge Regulatory & Life Sciences Group ### 2144074###Partner Presentation Speaker###Managing Director###SafeBridge Regulatory & Life Sciences Group###Partner Presentation Speaker: – SafeBridge Regulatory & Life Sciences Group
### he/him/his11:00 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
AI for Subvisible Particle Image Analysis Delivers Actionable DataChalk Talk Presenter: – SentrySciences, Inc.
Manufacturing & Analytical Characterization
11:15 AM – 12:00 PM ET
AI for Subvisible Particle Image Analysis Delivers Actionable DataLocation:Spotlight Stage A Exhibit Hall West A4-B3Chalk Talk Presenter: – SentrySciences, Inc.
Manufacturing & Analytical Characterization
Eric Gottlieb, BSc, MBA – SentrySciences, Inc. ### 2144061###Chalk Talk Presenter###ParticleSentryAI Business Development Manager###SentrySciences, Inc.###Chalk Talk Presenter: – SentrySciences, Inc.
### 11:15 AM – 12:00 PM ET
Liposomal formulations in advanced-cancer therapies and challenges in early-stage developmentChalk Talk Presenter: – FUJIFILM Pharmaceutical U.S.A., Inc.
Formulation and Delivery
11:15 AM – 12:00 PM ET
Liposomal formulations in advanced-cancer therapies and challenges in early-stage developmentLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – FUJIFILM Pharmaceutical U.S.A., Inc.
Formulation and Delivery
Naoki Yamada, MS – FUJIFILM Pharmaceutical U.S.A., Inc. ### 1377184###Chalk Talk Presenter###Director of Strategy & Operation###FUJIFILM Pharmaceutical U.S.A., Inc.###Chalk Talk Presenter: – FUJIFILM Pharmaceutical U.S.A., Inc.
### 11:15 AM – 12:00 PM ET
Revolutionize Critical Reagent Development with Rabbit Single B-Cell TechnologyChalk Talk Presenter: – Yurogen Biosystems
Bioanalytics
11:15 AM – 12:00 PM ET
Revolutionize Critical Reagent Development with Rabbit Single B-Cell TechnologyLocation:Spotlight Stage B Exhibit Hall West A4-B3Chalk Talk Presenter: – Yurogen Biosystems
Bioanalytics
Hao Cheng, PhD (he/him/his) – Yurogen Biosystems ### 2159192###Chalk Talk Presenter###Chief Scientific Officer###Yurogen Biosystems###Chalk Talk Presenter: – Yurogen Biosystems
### he/him/his11:30 AM – 12:00 PM ET
David P. Otey, MA, MBA, Book Signing and Meet and Greet
11:30 AM – 12:00 PM ET
David P. Otey, MA, MBA, Book Signing and Meet and GreetLocation:Careers 360, Exhibit Hall West A4-B3 Author: – Speaking of Solutions, LLC
Career Development
David P. Otey, MA, MBA (he/him/his) – Speaking of Solutions, LLC ### 466187### Author###Principal Speaking Coach###Speaking of Solutions, LLC### Author: – Speaking of Solutions, LLC
### he/him/his11:30 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: – BioAgilytix
Lynn Kamen, Ph.D. – BioAgilytix ### 1718506###Poster Collection Host###Scientific Officer, Executive Director###BioAgilytix###Poster Collection Host: – BioAgilytix
### 12:00 PM – 1:00 PM ET
How Professionals Keep Work-Life Balance and What is Work-Culture?Career Center Speaker: – Merck
Career Center Speaker: – Charles River Laboratories
Career Center Speaker: – University of Delaware
Career Center Speaker: – Boehringer-Ingelheim
Career Development
12:00 PM – 1:00 PM ET
How Professionals Keep Work-Life Balance and What is Work-Culture?Location:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Merck
Career Center Speaker: – Charles River Laboratories
Career Center Speaker: – University of Delaware
Career Center Speaker: – Boehringer-Ingelheim
Career Development
Yasuhiro Tsume, PhD – Merck ### 583852###Career Center Speaker###Scientist###Merck###Career Center Speaker: – Merck
### @@@ Michael Callahan (he/him/his) – Charles River Laboratories ### 2037900###Career Center Speaker###Principal Scientist III###Charles River Laboratories###Career Center Speaker: – Charles River Laboratories
### he/him/his @@@ Catherine A. Fromen, PhD (she/her/hers) – University of Delaware ### 1328428###Career Center Speaker###Associate Professor###University of Delaware###Career Center Speaker: – University of Delaware
### she/her/hers @@@ Corinne B. Jankovsky, PhD – Boehringer-Ingelheim ### 604585###Career Center Speaker###Senior Scientist###Boehringer-Ingelheim###Career Center Speaker: – Boehringer-Ingelheim
### 12:00 PM – 1:00 PM ET
Purification of Oligonucleotides Using Prep-LC MS/UV with Improved IP-RPLC ChromatographyPartner Presentation Speaker: – Agilent
Discovery and Basic Research
12:00 PM – 1:00 PM ET
Purification of Oligonucleotides Using Prep-LC MS/UV with Improved IP-RPLC ChromatographyLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Agilent
Discovery and Basic Research
Olof Torsten Stålberg, Sr., PhD (he/him/his) – Agilent ### 2129018###Partner Presentation Speaker###Senior Development Engineer###Agilent###Partner Presentation Speaker: – Agilent
### he/him/his12:30 PM – 1:15 PM ET
Considerations in the Development of Potency Assays for ATMPsChalk Talk Presenter: – BioAgilytix - Durham, NC
Manufacturing & Analytical Characterization
12:30 PM – 1:15 PM ET
Considerations in the Development of Potency Assays for ATMPsLocation:Spotlight Stage B Exhibit Hall West A4-B3Chalk Talk Presenter: – BioAgilytix - Durham, NC
Manufacturing & Analytical Characterization
Jeff Patrick, PhD (he/him/his) – BioAgilytix - Durham, NC ### 2127344###Chalk Talk Presenter###Senior Director of GMP Operations###BioAgilytix - Durham, NC###Chalk Talk Presenter: – BioAgilytix - Durham, NC
### he/him/his12:30 PM – 1:15 PM ET
Designing Pharmaceutical Materials for Extrusion Enabled Continuous ManufacturingChalk Talk Presenter: – Ashland
Formulation and Delivery
12:30 PM – 1:15 PM ET
Designing Pharmaceutical Materials for Extrusion Enabled Continuous ManufacturingLocation:Spotlight Stage A Exhibit Hall West A4-B3Chalk Talk Presenter: – Ashland
Formulation and Delivery
Thomas Dürig, PhD – Ashland ### 603503###Chalk Talk Presenter###Sr. R&D Director###Ashland###Chalk Talk Presenter: – Ashland
### 12:30 PM – 1:15 PM ET
Hyaluronic Nanogel: Facile Fabrication for Solubilization, SR and Vaccine ApplicationsChalk Talk Presenter: – Asahi Kasei
Formulation and Delivery
12:30 PM – 1:15 PM ET
Hyaluronic Nanogel: Facile Fabrication for Solubilization, SR and Vaccine ApplicationsLocation:Spotlight Stage C Exhibit Hall West A4-B3Chalk Talk Presenter: – Asahi Kasei
Formulation and Delivery
Takero Kurosawa, M.S. – Asahi Kasei ### 2126770###Chalk Talk Presenter###Business development###Asahi Kasei###Chalk Talk Presenter: – Asahi Kasei
### 12:30 PM – 1:30 PM ET
Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?Partner Presentation Speaker: – Certara
Preclinical and Translational Sciences
12:30 PM – 1:30 PM ET
Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?Location:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Certara
Preclinical and Translational Sciences
Jim Herman, PhD, DABT (1992-2022) – Certara ### 2144066###Partner Presentation Speaker###Vice President###Certara###Partner Presentation Speaker: – Certara
### 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: – OnKure Therapeutics
Kevin Litwiler, Ph.D. (he/him/his) – OnKure Therapeutics ### 803611###Poster Collection Host###Senior Vice President###OnKure Therapeutics###Poster Collection Host: – OnKure Therapeutics
### he/him/his12:30 PM – 1:30 PM ET
Subvisible Particle Analysis Using Flow Imaging Microscopy and Light ObscurationPartner Presentation Speaker: – Yokogawa Fluid Imaging Technologies
Manufacturing & Analytical Characterization
12:30 PM – 1:30 PM ET
Subvisible Particle Analysis Using Flow Imaging Microscopy and Light ObscurationLocation:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Yokogawa Fluid Imaging Technologies
Manufacturing & Analytical Characterization
Austin Daniels, PhD (he/him/his) – Yokogawa Fluid Imaging Technologies ### 2029743###Partner Presentation Speaker###Application Scientist###Yokogawa Fluid Imaging Technologies###Partner Presentation Speaker: – Yokogawa Fluid Imaging Technologies
### he/him/his1:30 PM – 2:30 PM ET
Keynote: Excipient Taxonomy for the 21st Century: A Grand Challenge for the Pharmaceutical Sciences Community
Formulation and Delivery
1:30 PM – 2:30 PM ET
Keynote: Excipient Taxonomy for the 21st Century: A Grand Challenge for the Pharmaceutical Sciences CommunityLocation:209 AB WestFormulation and Delivery
Bruno Hancock, PhD (he/him/his) – Pfizer Inc. ### 1921890###Keynote Speaker###Senior Advisor###Pfizer Inc.###Keynote Speaker: – Pfizer Inc.
### he/him/his @@@ Haichen Nie, PhD – Teva Pharmaceuticals ### 1976730###Moderator###Associate Director###Teva Pharmaceuticals###Moderator: – Teva Pharmaceuticals
### 1:30 PM – 2:30 PM ET
Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current Research
Bioanalytics
1:30 PM – 2:30 PM ET
Keynote: Genetic (Nano) Medicine: State of the Art, Frontiers and Current ResearchLocation:311 GH WestBioanalytics
Michelle Lynn Hall, PhD (she/her/hers) – Eli Lilly ### 1922307###Keynote Speaker###Associate Vice President, Genetic Nanomedicine###Eli Lilly###Keynote Speaker: – Eli Lilly
### she/her/hers @@@ Yan G. Ni, PhD – Passage Bio ### 803355###Moderator###Executive Director###Passage Bio###Moderator: – Passage Bio
### 1:30 PM – 2:30 PM ET
Keynote: Health Disparities in Basic Science: Implications for Pharmacological ResearchKeynote Speaker: – University of California, San Francisco
Moderator: – University of Oklahoma Health Sciences Center
Discovery and Basic Research
1:30 PM – 2:30 PM ET
Keynote: Health Disparities in Basic Science: Implications for Pharmacological ResearchLocation:311 AB WestKeynote Speaker: – University of California, San Francisco
Moderator: – University of Oklahoma Health Sciences Center
Discovery and Basic Research
Kathleen Giacomini, PhD (she/her/hers) – University of California, San Francisco ### 465952###Keynote Speaker###Dean- School of Pharmacy###University of California, San Francisco###Keynote Speaker: – University of California, San Francisco
### she/her/hers @@@ Wei Yue, PhD (she/her/hers) – University of Oklahoma Health Sciences Center ### 605584###Moderator###Associate Professor###University of Oklahoma Health Sciences Center###Moderator: – University of Oklahoma Health Sciences Center
### she/her/hers1:30 PM – 2:30 PM ET
Keynote: In Vitro In Vivo Correlation (IVIVC) for Long Acting Injectable (LAI) Formulations
Manufacturing & Analytical Characterization
1:30 PM – 2:30 PM ET
Keynote: In Vitro In Vivo Correlation (IVIVC) for Long Acting Injectable (LAI) FormulationsLocation:205 AB WestManufacturing & Analytical Characterization
Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut ### 1377156###Keynote Speaker###Distinguished Professor###University of Connecticut###Keynote Speaker: – University of Connecticut
### she/her/hers @@@ Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration ### 1980657###Moderator###Research Chemist###US Food and Drug Administration###Moderator: – US Food and Drug Administration
### he/him/his1:30 PM – 2:30 PM ET
Keynote: Navigating Project Optimus: Use of Modeling and Simulation to Inform Dosing Strategies in OncologyModerator: – Applied BioMath
Keynote Speaker: – Takeda Pharmaceuticals
Preclinical and Translational Sciences
1:30 PM – 2:30 PM ET
Keynote: Navigating Project Optimus: Use of Modeling and Simulation to Inform Dosing Strategies in OncologyLocation:311 CD WestModerator: – Applied BioMath
Keynote Speaker: – Takeda Pharmaceuticals
Preclinical and Translational Sciences
Fei Hua, PhD – Applied BioMath ### 844132###Moderator###VP of Modeling and Simulation Services###Applied BioMath###Moderator: – Applied BioMath
### @@@ Dean Bottino, PhD (he/him/his) – Takeda Pharmaceuticals ### 2149182###Keynote Speaker###Senior Scientific Director###Takeda Pharmaceuticals###Keynote Speaker: – Takeda Pharmaceuticals
### he/him/his1:30 PM – 2:30 PM ET
Keynote: New Era of Bioanalysis Post Covid-19 Pandemic
Bioanalytics
1:30 PM – 2:30 PM ET
Keynote: New Era of Bioanalysis Post Covid-19 Pandemic Location:311 EF WestBioanalytics
Qin Ji, PhD – AbbVie ### 1311048###Keynote Speaker###Director###AbbVie###Keynote Speaker: – AbbVie
### @@@ Long Yuan, PhD – Biogen Inc. ### 1767348###Moderator###Scientific Director###Biogen Inc.###Moderator: – Biogen Inc.
### 1:30 PM – 2:30 PM ET
Keynote: Novel Nanotechnology-Based Approaches to Improving the Effectiveness of Anticancer Vaccines
Formulation and Delivery
1:30 PM – 2:30 PM ET
Keynote: Novel Nanotechnology-Based Approaches to Improving the Effectiveness of Anticancer VaccinesLocation:208 AB WestFormulation and Delivery
Jayanth Panyam, PhD (he/him/his) – University of Washington ### 1092593###Keynote Speaker###Dean and Professor###University of Washington###Keynote Speaker: – University of Washington
### he/him/his @@@ Anette Mullertz, PhD, FAAPS – University of Copenhagen ### 466033###Moderator###Professor###University of Copenhagen###Moderator: – University of Copenhagen
### 1:30 PM – 2:30 PM ET
Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbs
Manufacturing & Analytical Characterization
1:30 PM – 2:30 PM ET
Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbsLocation:206 AB WestManufacturing & Analytical Characterization
Marianthi Ierapetritou, PhD (she/her/hers) – University of Delaware ### 985269###Keynote Speaker###Bob and Jane Gore Centennial Chair###University of Delaware###Keynote Speaker: – University of Delaware
### she/her/hers @@@ Ou Yang, PhD – GSK ### 2031696###Moderator###Investigator###GSK###Moderator: – GSK
### 1:30 PM – 2:30 PM ET
Keynote: Towards Development of Translational PBPK Models for Biologics
Preclinical and Translational Sciences
1:30 PM – 2:30 PM ET
Keynote: Towards Development of Translational PBPK Models for BiologicsLocation:309 AB WestPreclinical and Translational Sciences
Dhaval K. Shah, PhD (he/him/his) – University at Buffalo ### 567505###Keynote Speaker###Associate Professor###University at Buffalo###Keynote Speaker: – University at Buffalo
### 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
Special Poster Collection
1:30 PM – 2:30 PM ET
Special Poster CollectionLocation:Poster Forum #7; Exhibit Hall West A4-B3Poster Collection Host: – Astra Zeneca
Poster Collection Host: – AstraZeneca
Annette Bak, Ph.D, M.B.A., FAAPS (she/her/hers) – Astra Zeneca ### 466184###Poster Collection Host###Head of Advanced Drug Delivery###Astra Zeneca###Poster Collection Host: – Astra Zeneca
### she/her/hers @@@ Silvia Sonzini, Ph.D. (she/her/hers) – AstraZeneca ### 1976706###Poster Collection Host###Associate Principal Scientist###AstraZeneca###Poster Collection Host: – AstraZeneca
### she/her/hers1:30 PM – 2:30 PM ET
Strategies to Reduce Nitrosamine Contamination of Drug ProductsPartner Presentation Speaker: – Shin-Etsu
Formulation and Delivery
1:30 PM – 2:30 PM ET
Strategies to Reduce Nitrosamine Contamination of Drug ProductsLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Shin-Etsu
Formulation and Delivery
Andreas Sauer – Shin-Etsu ### 1045003###Partner Presentation Speaker###Technical Sales Director###Shin-Etsu###Partner Presentation Speaker: – Shin-Etsu
### 1:30 PM – 2:30 PM ET
Work-Life Harmony for Women: Strategies for Supporting Each OtherCareer Center Speaker: – Takeda
Career Center Moderator: – Genentech
Career Center Speaker: – AstraZeneca
Career Center Speaker: – PPD Clinical Research, Thermo Fisher Scientific
Career Development
1:30 PM – 2:30 PM ET
Work-Life Harmony for Women: Strategies for Supporting Each OtherLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – Takeda
Career Center Moderator: – Genentech
Career Center Speaker: – AstraZeneca
Career Center Speaker: – PPD Clinical Research, Thermo Fisher Scientific
Career Development
Meena Subramanyam, PhD (she/her/hers) – Takeda ### 1140744###Career Center Speaker###Vice President, Global Program & Portfolio Lead, Immune Enhancers & Cell Engagers###Takeda###Career Center Speaker: – Takeda
### she/her/hers @@@ Nivedita Shetty, PhD (she/her/hers) – Genentech ### 862021###Career Center Moderator###Principal Scientist###Genentech###Career Center Moderator: – Genentech
### she/her/hers @@@ Priya Muralidharan, MS, PhD (she/her/hers) – AstraZeneca ### 2037858###Career Center Speaker###Associate Principal Engineer###AstraZeneca ###Career Center Speaker: – AstraZeneca
### she/her/hers @@@ Wendy O. Adamowicz, MS (she/her/hers) – PPD Clinical Research, Thermo Fisher Scientific ### 1976712###Career Center Speaker###Principal Scientist###PPD Clinical Research, Thermo Fisher Scientific###Career Center Speaker: – PPD Clinical Research, Thermo Fisher Scientific
### she/her/hers2:00 PM – 3:00 PM ET
A Paradigm Shift in Processing Amorphous Solid Dispersions (ASDs)Partner Presentation Speaker: – Glatt Air Techniques, Inc. - Ramsey, NJ
Formulation and Delivery
2:00 PM – 3:00 PM ET
A Paradigm Shift in Processing Amorphous Solid Dispersions (ASDs)Location:360 Stage #4 Exhibit Hall West A4-B3Partner Presentation Speaker: – Glatt Air Techniques, Inc. - Ramsey, NJ
Formulation and Delivery
Zafar Iqbal, PhD, RPh, MBA – Glatt Air Techniques, Inc. - Ramsey, NJ ### 623893###Partner Presentation Speaker###V.P. /Head of Pharmaceutical Development###Glatt Air Techniques, Inc. - Ramsey, NJ###Partner Presentation Speaker: – Glatt Air Techniques, Inc. - Ramsey, NJ
### 2:00 PM – 3:00 PM ET
Extractable Leachable Analysis from Sample Preparation to Compound IdentificationPartner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
2:00 PM – 3:00 PM ET
Extractable Leachable Analysis from Sample Preparation to Compound IdentificationLocation:360 Stage #2 Exhibit Hall West A4-B3Partner Presentation Speaker: – Agilent
Manufacturing & Analytical Characterization
David A. Weil, PhD (he/him/his) – Agilent ### 2031175###Partner Presentation Speaker###Master Applications Scientist###Agilent###Partner Presentation Speaker: – Agilent
### he/him/his2:30 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: Engineering Human Organoids and Organs-on-Chips for Disease Modeling, Drug Development and Personalized MedicineHot Topic Moderator: – Gilead Sciences, Inc.
Hot Topic Speaker: – University of Florida
Preclinical and Translational Sciences
2:30 PM – 3:30 PM ET
Hot Topic: Engineering Human Organoids and Organs-on-Chips for Disease Modeling, Drug Development and Personalized MedicineLocation:308 AB WestHot Topic Moderator: – Gilead Sciences, Inc.
Hot Topic Speaker: – University of Florida
Preclinical and Translational Sciences
Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc. ### 1767660###Hot Topic Moderator###Executive Director###Gilead Sciences, Inc.###Hot Topic Moderator: – Gilead Sciences, Inc.
### he/him/his @@@ Rodrigo Cristofoletti, Ph.D. (he/him/his) – University of Florida ### 2030835###Hot Topic Speaker######University of Florida###Hot Topic Speaker: – University of Florida
### he/him/his2:30 PM – 3:30 PM ET
Speaker Spotlight: Achieving Scientific Agility in a Rigid MatrixSpotlight Speaker: – FDA/Office of Regulatory Affairs
Moderator: – Merck and Co Inc
Manufacturing & Analytical Characterization
2:30 PM – 3:30 PM ET
Speaker Spotlight: Achieving Scientific Agility in a Rigid MatrixLocation:Spotlight Stage B Exhibit Hall West A4-B3Spotlight Speaker: – FDA/Office of Regulatory Affairs
Moderator: – Merck and Co Inc
Manufacturing & Analytical Characterization
Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs ### 2031697###Spotlight Speaker###Associate Director for Research###FDA/Office of Regulatory Affairs###Spotlight Speaker: – FDA/Office of Regulatory Affairs
### she/her/hers @@@ Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc ### 844114###Moderator###Principal Scientist###Merck and Co Inc###Moderator: – Merck and Co Inc
### he/him/his2:30 PM – 3:30 PM ET
Speaker Spotlight: Analytical Testing Access and Capabilities Low-Income and Middle-Income CountriesModerator: – University of Florida
Spotlight Speaker: – US Pharmacopeia
Discovery and Basic Research
2:30 PM – 3:30 PM ET
Speaker Spotlight: Analytical Testing Access and Capabilities Low-Income and Middle-Income CountriesLocation:Spotlight Stage A Exhibit Hall West A4-B3Moderator: – University of Florida
Spotlight Speaker: – US Pharmacopeia
Discovery and Basic Research
Abhisheak Sharma, PhD – University of Florida ### 604109###Moderator###Assistant Professor and Assistant Director###University of Florida###Moderator: – University of Florida
### @@@ Chaitanya Koduri, MTech (he/him/his) – US Pharmacopeia ### 2144237###Spotlight Speaker###Director###US Pharmacopeia###Spotlight Speaker: – US Pharmacopeia
### he/him/his2:30 PM – 3:30 PM ET
Speaker Spotlight: The Value of USP Standards for Excipients Used in Medicines: Current and Future StateSpotlight Speaker: – U.S. Pharmacopeia (USP)
Moderator: – FinnBritt Consulting
Formulation and Delivery
2:30 PM – 3:30 PM ET
Speaker Spotlight: The Value of USP Standards for Excipients Used in Medicines: Current and Future StateLocation:Spotlight Stage C Exhibit Hall West A4-B3Spotlight Speaker: – U.S. Pharmacopeia (USP)
Moderator: – FinnBritt Consulting
Formulation and Delivery
Catherine Sheehan, DRSc. MS. MS. – U.S. Pharmacopeia (USP) ### 465966###Spotlight Speaker###Senior Director, Excipients and Foods###U.S. Pharmacopeia (USP)###Spotlight Speaker: – U.S. Pharmacopeia (USP)
### @@@ Chris Moreton, PhD (he/him/his) – FinnBritt Consulting ### 466122###Moderator###Partner###FinnBritt Consulting###Moderator: – FinnBritt Consulting
### he/him/his2:30 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: – Bristol-Myers Squibb Company
Carl Allenspach – Bristol-Myers Squibb Company ### 597483###Poster Collection Host###Director###Bristol-Myers Squibb Company###Poster Collection Host: – Bristol-Myers Squibb Company
### 3:00 PM – 4:00 PM ET
Happy Hour Sponsored by ROQUETTE
3:00 PM – 4:00 PM ET
Happy Hour Sponsored by ROQUETTELocation:Booth #2542, Exhibit Hall West A4-B3
3:00 PM – 4:00 PM ET
How to Thrive in the Workplace Without Sacrificing Mental HealthCareer Center Speaker: – University of the Incarnate Word
Career Center Moderator: – Duquesne University
Career Development
3:00 PM – 4:00 PM ET
How to Thrive in the Workplace Without Sacrificing Mental HealthLocation:360 Stage #3 Exhibit Hall West A4-B3Career Center Speaker: – University of the Incarnate Word
Career Center Moderator: – Duquesne University
Career Development
Adeola O. Coker, PhD (she/her/hers) – University of the Incarnate Word ### 857368###Career Center Speaker###Professor###University of the Incarnate Word###Career Center Speaker: – University of the Incarnate Word
### she/her/hers @@@ Mustafa Bookwala, MS (he/him/his) – Duquesne University ### 1377263###Career Center Moderator###Ph.D. Candidate###Duquesne University###Career Center Moderator: – Duquesne University
### he/him/his3:00 PM – 4:00 PM ET
Microdosing– Powder in Capsule Technology Pathway from Development to CommercializationPartner Presentation Speaker: – Lonza
Partner Presentation Speaker: – Lonza
Formulation and Delivery
3:00 PM – 4:00 PM ET
Microdosing– Powder in Capsule Technology Pathway from Development to CommercializationLocation:360 Stage #1 Exhibit Hall West A4-B3Partner Presentation Speaker: – Lonza
Partner Presentation Speaker: – Lonza
Formulation and Delivery
Mark Cappucci – Lonza ### 603851###Partner Presentation Speaker###Preformulation Team Lead###Lonza###Partner Presentation Speaker: – Lonza
### @@@ Benito G. Graniela – Lonza ### 2144071###Partner Presentation Speaker###MSAT Engineer II###Lonza###Partner Presentation Speaker: – Lonza
### 3:00 PM – 4:00 PM ET
Rapid Fires: Addressing Health Disparities in Basic Science ResearchDiscovery and Basic Research
3:00 PM – 4:00 PM ET
Rapid Fires: Addressing Health Disparities in Basic Science ResearchLocation:311 AB WestDiscovery and Basic Research
Veeran Kadajji ### 2167582###Rapid Fire Moderator#########Rapid Fire Moderator:
### 3:00 PM – 3:15 PM ET
SARS-CoV-2 Infection Affects Drug Metabolizing Enzymes and Membrane TransportersLocation:311 AB WestRapid Fire Speaker: – University of Toronto
Discovery and Basic Research
Chukwunonso Kingsley Nwabufo, MSc, MBA – University of Toronto ### 1767485###Rapid Fire Speaker###PhD Candidate###University of Toronto###Rapid Fire Speaker: – University of Toronto
### 3:15 PM – 3:30 PM ET
Sex Differences in Steady-State Pharmacokinetic Studies of MitragynineLocation:311 AB WestRapid Fire Speaker: – University of Florida
Discovery and Basic Research
Yi-Hua Chiang, MS (she/her/hers) – University of Florida ### 1767965###Rapid Fire Speaker###Ph.D. Student###University of Florida###Rapid Fire Speaker: – University of Florida
### she/her/hers3:30 PM – 3:45 PM ET
Expanding the Extracellular Vesicle Pancreatic Cancer Biomarker Space With Peptide-Based Capture-and-ReleaseLocation:311 AB WestRapid Fire Speaker: – University of Florida
Discovery and Basic Research
Zachary Greenberg, MS (he/him/his) – University of Florida ### 1328730###Rapid Fire Speaker###Doctoral Candidate###University of Florida###Rapid Fire Speaker: – University of Florida
### he/him/his3:45 PM – 4:00 PM ET
Extracellular Vesicles for Developing Targeted Therapeutics to the Inner EarLocation:311 AB WestRapid Fire Speaker: – University of Florida College of Pharmacy
Discovery and Basic Research
Xiaoshu Pan, PhD – University of Florida College of Pharmacy ### 1328564###Rapid Fire Speaker###Postdoctoral Associate###University of Florida College of Pharmacy###Rapid Fire Speaker: – University of Florida College of Pharmacy
### 3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1Rapid Fire Moderator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1Location:205 AB WestRapid Fire Moderator: – 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 Moderator###Pharmaceutical Scientist###US Food and Drug Administration###Rapid Fire Moderator: – US Food and Drug Administration
### he/him/his3:00 PM – 3:15 PM ET
PAT to Support Continuous Manufacturing: from Development to CommercializationLocation:205 AB WestRapid Fire Speaker: – Merck & Co, Inc
Manufacturing & Analytical Characterization
Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc ### 2086981###Rapid Fire Speaker###Principal Scientist###Merck & Co, Inc###Rapid Fire Speaker: – Merck & Co, Inc
### she/her/hers3:15 PM – 3:30 PM ET
Simulation and Troubleshooting of Mixing Systems for Secondary Biopharm ManufactureLocation:205 AB WestRapid Fire Speaker: – GSK
Manufacturing & Analytical Characterization
Elaheh Ardalani, PhD (she/her/hers) – GSK ### 2086990###Rapid Fire Speaker###Investigator-Modeling & Simulation###GSK###Rapid Fire Speaker: – GSK
### she/her/hers3:30 PM – 3:45 PM ET
In-Depth Characterization of Polysorbate 80 Degradation in Biologics Drug ProductsLocation:205 AB WestRapid Fire Speaker: – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Rong-Sheng Yang, M.S. (he/him/his) – Merck & Co., Inc. ### 2086993###Rapid Fire Speaker###Senior Scientist###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### he/him/his3:45 PM – 4:00 PM ET
Strategic Modular Approaches to Continuous ManufacturingLocation:205 AB WestRapid Fire Speaker: – GEA Pharma Systems
Manufacturing & Analytical Characterization
Andrew Birkmire – GEA Pharma Systems ### 604780###Rapid Fire Speaker###Senior Process Scientist###GEA Pharma Systems###Rapid Fire Speaker: – GEA Pharma Systems
### 3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2Rapid Fire Moderator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2Location:206 AB WestRapid Fire Moderator: – US Food and Drug Administration
Manufacturing & Analytical Characterization
Diaa Shakleya, PhD – US Food and Drug Administration ### 603286###Rapid Fire Moderator###Senior Research Scientist (Pharmacologist)###US Food and Drug Administration###Rapid Fire Moderator: – US Food and Drug Administration
### 3:00 PM – 3:15 PM ET
Amorphous Solid Dispersion Physical Stability: Historical Examples and Shelf-Life AssessmentLocation:206 AB WestRapid Fire Speaker: – AbbVie
Manufacturing & Analytical Characterization
Anura Indulkar, PhD – AbbVie ### 602466###Rapid Fire Speaker###Principal Research Scientist###AbbVie###Rapid Fire Speaker: – AbbVie
### 3:15 PM – 3:30 PM ET
Using Surface Dissolution Imaging to Understand Weakly Basic Drug DissolutionLocation:206 AB WestRapid Fire Speaker: – Merck & Co., Inc
Manufacturing & Analytical Characterization
Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc ### 1767219###Rapid Fire Speaker###Senior Scientist###Merck & Co., Inc###Rapid Fire Speaker: – Merck & Co., Inc
### she/her/hers3:30 PM – 3:45 PM ET
Nitrosamines Mitigation Strategies in Drug ProductLocation:206 AB WestRapid Fire Speaker: – US Food and Drug Administration
Manufacturing & Analytical Characterization
Diaa Shakleya, PhD – US Food and Drug Administration ### 603286###Rapid Fire Speaker###Senior Research Scientist (Pharmacologist)###US Food and Drug Administration###Rapid Fire Speaker: – US Food and Drug Administration
### 3:45 PM – 4:00 PM ET
Ultra-High-Resolution Optical Coherence Tomography for Investigating Very Thin Pharmaceutical Coatings Location:206 AB WestRapid Fire Speaker: – RCPE GmbH
Manufacturing & Analytical Characterization
Moaaz Abdelhamid, M.Sc. – RCPE GmbH ### 2086977###Rapid Fire Speaker###Scientist###RCPE GmbH###Rapid Fire Speaker: – RCPE GmbH
### 3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 1Rapid Fire Moderator: – Collaborations Pharmaceuticals, Inc.
Preclinical and Translational Sciences
3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 1Location:309 AB WestRapid Fire Moderator: – Collaborations Pharmaceuticals, Inc.
Preclinical and Translational Sciences
Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc. ### 1650348###Rapid Fire Moderator###CEO###Collaborations Pharmaceuticals, Inc.###Rapid Fire Moderator: – Collaborations Pharmaceuticals, Inc.
### 3:00 PM – 3:15 PM ET
Large Language Models for Predicting ADME/ToxLocation:309 AB WestRapid Fire Speaker: – Collaborations Pharmaceuticals, Inc.
Preclinical and Translational Science - Chemical
Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc. ### 1650348###Rapid Fire Speaker###CEO###Collaborations Pharmaceuticals, Inc.###Rapid Fire Speaker: – Collaborations Pharmaceuticals, Inc.
### 3:15 PM – 3:30 PM ET
Mechanistic Modelling of pH-Dependent Drug-Drug InteractionsLocation:309 AB WestRapid Fire Speaker: – Certara UK / Simcyp
Preclinical and Translational Science - Chemical
Sebastian Polak, PhD – Certara UK / Simcyp ### 1377746###Rapid Fire Speaker###Senior Scientific Advisor###Certara UK / Simcyp###Rapid Fire Speaker: – Certara UK / Simcyp
### 3:30 PM – 3:45 PM ET
Physiologically Based Pharmacokinetic Modeling for Nanomedicines: Resolving Parameter GapsLocation:309 AB WestRapid Fire Speaker: – CSL Vifor
Preclinical and Translational Science - Biomolecular
Amy Alston, PharmD, MS – CSL Vifor ### 2086989###Rapid Fire Speaker###Medical Associate Director, Nanomedicine###CSL Vifor###Rapid Fire Speaker: – CSL Vifor
### 3:45 PM – 4:00 PM ET
AI-Based Discovery and IND-Enabling of BMX Inhibitors for Cancer-Therapeutics DevelopmentLocation:309 AB WestRapid Fire Speaker: – Long Island University
Preclinical and Translational Science - Chemical
Ahmed Abu Fayyad, PhD, R.Ph. – Long Island University ### 2087000###Rapid Fire Speaker###Associate Professor of Pharmaceutics###Long Island University###Rapid Fire Speaker: – Long Island University
### 3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 2Rapid Fire Moderator: – Pfizer Inc.
Preclinical and Translational Sciences
3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 2Location:311 CD WestRapid Fire Moderator: – Pfizer Inc.
Preclinical and Translational Sciences
Cheng Chang, PhD – Pfizer Inc. ### 2086974###Rapid Fire Moderator###Clinical Pharmacologist/Director###Pfizer Inc.###Rapid Fire Moderator: – Pfizer Inc.
### 3:00 PM – 3:15 PM ET
The Estimates for Absorption Rate Constant in Pharmacokinetics/Pharmacometrics Are Wrong (Focus On Finite Absorption Time)Location:311 CD WestRapid Fire Speaker: – University of Athens
Preclinical and Translational Science - Biomolecular
Panos Macheras, Ph.D., FAAPS – University of Athens ### 603825###Rapid Fire Speaker###Emeritus Professor###University of Athens###Rapid Fire Speaker: – University of Athens
### 3:15 PM – 3:30 PM ET
A Translational Minimal Physiologically Based Pharmacokinetic Model (mPBPK) for CRISPR-Cas Gene TherapyLocation:311 CD WestRapid Fire Speaker: – University of Florida
Preclinical and Translational Science - Chemical
Devam A. Desai, MS – University of Florida ### 2165261###Rapid Fire Speaker###PhD Student###University of Florida###Rapid Fire Speaker: – University of Florida
### 3:30 PM – 3:45 PM ET
Concentrations and Causal Confounding: Choosing Exposure Measures with CareLocation:311 CD WestRapid Fire Speaker: – Metrum Research Group
Preclinical and Translational Science - Biomolecular
Rena Byrne, PhD – Metrum Research Group ### 2030996###Rapid Fire Speaker###Senior Scientist II###Metrum Research Group###Rapid Fire Speaker: – Metrum Research Group
### 3:45 PM – 4:00 PM ET
Translational Analysis Across Formulations/Populations to Support a Pediatric Formulation ApprovalLocation:311 CD WestRapid Fire Speaker: – Pfizer Inc.
Preclinical and Translational Science - Chemical
Cheng Chang, PhD – Pfizer Inc. ### 2086974###Rapid Fire Speaker###Clinical Pharmacologist/Director###Pfizer Inc.###Rapid Fire Speaker: – Pfizer Inc.
### 3:00 PM – 4:00 PM ET
Rapid Fires: Approaches for Emerging Modalities and Complex Studies 1Rapid Fire Moderator: – Takeda
Bioanalytics
3:00 PM – 4:00 PM ET
Rapid Fires: Approaches for Emerging Modalities and Complex Studies 1Location:311 EF WestRapid Fire Moderator: – Takeda
Bioanalytics
Heather A. Myler, PhD – Takeda ### 571991###Rapid Fire Moderator###Senior Director, Bioanalytical and Biomarker Science and Technologies###Takeda###Rapid Fire Moderator: – Takeda
### 3:00 PM – 3:15 PM ET
Measuring and Understanding the Relevance of Cellular-Immune Responses to CAR-T-CellsLocation:311 EF WestRapid Fire Speaker: – Bristol Myers Squibb
Bioanalytics
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)