- On Demand
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
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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
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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
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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
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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
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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
