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A
Abdeen, Sanofar
B2S Life Sciences
Utilizing Octet Platform for Characterizing Critical Reagents in Support of Drug Development for Contemporary Biotherapeutics
Sanofar Abdeen
Favorite
Achour, Brahim
University of Manchester
Precision Dosing: 'Liquid Biopsy' Reflects Hepatic Enzyme and Transporter Expression
Brahim Achour
Favorite
Ackermann, Brad
Eli Lilly and Company
Quantitative Analysis of Protein Biomarkers in the Tumor Microenvironment Using High Resolution LC/MS/MS
Brad Ackermann
Favorite
Agarwal, Sagar
Alnylam Pharmaceuticals
The Clinical Pharmacology of siRNA Therapy: Is DDI a Concern - A Case Study of Givosiran
Sagar Agarwal
Favorite
Ainslie, Kristy
University of North Carolina At Chapel Hill
Acetalated Dextran Enhances Vaccine Delivery
Kristy Ainslie
Favorite
Ajjarapu, Sankar Srinivas
University of Mississippi
Impact of Fractional Solubility on Drug Permeation from Topical Formulations
Sankar Srinivas Ajjarapu
Favorite
Akhtar, Nadim
AstraZeneca
Terminal Sterilization of Oligonucleotide Drug Products – Challenge, Considerations and Opportunities
Nadim Akhtar
Favorite
Akpinar Singh, Fulya
Bristol-Myers Squibb Company
A Mechanistic PKPD Model to Guide siRNA Therapy Design
Fulya Akpinar Singh
Favorite
Alavattam, Sreedhara
Genentech, Inc.
Prologue: Can You Handle It? Post Production Handling and Administration of Biologics
Sreedhara Alavattam
Favorite
Symposium: Drug Delivery and Device Development
Sreedhara Alavattam
Favorite
Allinson, John
Immunologix Laboratories
How Do We Get from a Biomarker Assay Request to an Analytical Method Which Is Validated to Meet COU?
John Allinson
Favorite
Almaya, Ahmad
Eli Lilly and Company
Continuous Manufacturing to Enable Speed of Development and Commercialization
Ahmad Almaya
Favorite
Alphonse Ignatius, Arun
Pfizer Inc.
Advances and Challenges in Gene Therapy Formulation Development
Arun Alphonse Ignatius
Favorite
Bridging Product Quality Attributes and Higher Order Structure of Biologics
Arun Alphonse Ignatius
Favorite
Altman, Russ
Stanford University
Artificial Intelligence/Machine Learning : An Emerging Bioanalytical Solution
Russ Altman
Favorite
Amidon, Gregory
University of Michigan College of Pharmacy
Excipient Variability and Application of USP : How General Chapter Can Assist You in Selecting of Excipients for Pharmaceutical Use
Gregory Amidon
Favorite
ANDERSONDEVRIES, Shelby
AIT Bioscience
What's the Context of Use for Generic Biomarker Panels?
Shelby ANDERSONDEVRIES
Favorite
Anderson, Wesley
AxoSim
Development and Qualification of a Novel In Vitro Assay of Oligodendrocyte Myelination and Demyelination using a Human Brain Spheroid Model
Wesley Anderson
Favorite
Andruski, Stephen
U.S. Pharmacopeia (USP)
USP VERIFICATION PROGRAM: How Excipient Verification, GMP Related Chapters, and Up-to-date Monographs Are Important in Qualifying Excipients for Intended Use
Stephen Andruski
Favorite
Annaji, Manjusha
Auburn University
Meloxicam Coated 3D-printed Stainless Steel Implants to Prevent Implant Rejections
Manjusha Annaji
Favorite
Anselmo, Aaron
Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
Delivery Strategies for Microbe Therapeutics
Aaron Anselmo
Favorite
Anspach, Jason
Phenomenex
Miniaturized Separations and Increased Sensitivity with Micro/Nano Scale HPLC
Jason Anspach
Favorite
Apiyo, David
ForteBio, A Sartorius Brand
Facilitating Process Economy in GMP Applications with the Octet Platform
David Apiyo
Favorite
Araojo, Richardae
U.S. Food and Drug Administration
An FDA Perspective: Advancing Racial and Ethnic Minority Participation in Clinical Trials
Richardae Araojo
Favorite
Armstrong, Luke
BioAgilytix
Validated Assay for Neutralizing Antibodies Against AAV9 in Human Serum
Luke Armstrong
Favorite
Arnold, Mark
Covance Inc.
Keynote: Samples That Convey Both Identity and Drug Use: Rapid and Non-invasive Sampling from Single Fingerprints
Mark Arnold
Favorite
LIVE Special Poster Collection — Pushing the Envelope – With Dr. Mark Arnold
Mark Arnold
Favorite
Arora, Sumit
Certara UK (Simcyp Division)
Integrating Topical Drug Product Quality Attributes Within Physiologically-based Pharmacokinetic Models
Sumit Arora
Favorite
Atassi, Faraj
AstraZeneca
Applications of Controlled Release Formulations and Technologies in Drug Discovery
Faraj Atassi
Favorite
Ayon, Navid
University of Missouri Kansas City
Multidimensional Chemical Library Screening for Novel Antibacterial Activities
Navid Ayon
Favorite
B
Badawy, Sherif
Bristol-Myers Squibb Company
Prologue: Next Generation Manufacturing Enabling Speed to Patient
Sherif Badawy
Favorite
Baertschi, Steve
Baertschi Consulting, LLC
Strategic Approaches to Develop Phase-Appropriate Organic Impurity Control Strategies (Part 1) (Ticketed Event)
Steve Baertschi
Favorite
Baertschi, Steven
Baertschi Consulting, LLC
Strategic Approaches to Develop Phase-Appropriate Organic Impurity Control Strategies (Part 2) (Ticketed Event)
Steven Baertschi
Favorite
Bailey, Melanie
University of Surrey
Keynote: Samples That Convey Both Identity and Drug Use: Rapid and Non-invasive Sampling from Single Fingerprints
Melanie Bailey
Favorite
Bak, Annette
AstraZeneca
LIVE Special Poster Collection — Gene Therapy Drug Delivery – With Dr. Annette Bak
Annette Bak
Favorite
Bandari, Suresh
University of Mississippi
Addressing Challenges in Oral Solid Dosage Form Development & Manufacturing Pt. 2
Suresh Bandari
Favorite
Bandukwala, Abbas
U.S. Food and Drug Administration
Perspective from the Biomarker Qualification Program - How COU Influences Analytical Validation
Abbas Bandukwala
Favorite
Banks, William
University of Washington
Keynote: The Permeability of the Blood-Brain Barrier to Peptides, Regulatory Proteins, and Antisense: Physiological Foundations and Pharmacological Implications
William Banks
Favorite
Banu Mohsin, Sheher
Agilent Technologies
Accurate Nitrosamines Evaluation in ARB and Ranitidine-Based Drugs Topic
Sheher Banu Mohsin
Favorite
Barash, Eyal
Barash Law, LLC
Protecting APIs with Solid Form Patents- Drug Development and/or Repositioning
Eyal Barash
Favorite
Barnaby, Omar
Amgen
Intact LC-HRMS: An Enabling Technology for the Quantification of Intact Protein Therapeutics
Omar Barnaby
Favorite
Barrett, Jeff
Critical Path Institute
Dose Selection Strategies for Rare Pediatric Diseases
Jeff Barrett
Favorite
Bartlett, Derek
Pfizer Inc.
Leveraging Mechanistic Modeling to Guide Translational PK-PD of Protein Degraders
Derek Bartlett
Favorite
Bateman, Kevin
Merck & Co., Inc.
Is Your Bioanalytical Lab Ready for a Pandemic?
Kevin Bateman
Favorite
Bauer, Bjoern
University of Kentucky
Drug Transporters 2020: Old Challenges and New Opportunities : Predicting Human Clearance For Molecules With Transporter-Mediated Clearance (Ticketed Event)
Bjoern Bauer
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Humanized Transporter Animal Models (Ticketed Event)
Bjoern Bauer
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Transporters as Drug Targets (Ticketed Event)
Bjoern Bauer
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Transporters Introduction & Regulatory Guidelines (Ticketed Event)
Bjoern Bauer
Favorite
Prologue: Targeting the Blood-brain Barrier: Exploiting Biology to Optimize Neuropharmacology
Bjoern Bauer
Favorite
Bendayan, Reina
University of Toronto
Rapid Fire: Taming the Blood-Brain-Barrier and Innovations in Pharmaceutical Bioengineering
Reina Bendayan
Favorite
Symposium: Novel Roles of Emerging Transporters
Reina Bendayan
Favorite
Benet, Leslie
UCSF School of Pharmacy
Predicting Human Clearance for Molecules with Transporter-Mediated Clearance
Leslie Benet
Favorite
Revisiting Mean Residence Time Concepts to Characterize Drug Metabolite Pharmacokinetics
Leslie Benet
Favorite
Bennett, Patrick
PPD Development, LP
Is Your Bioanalytical Lab Ready for a Pandemic?
Patrick Bennett
Favorite
Benque, Benedict
Graz University of Technology
Dispersion Estimation in Capsule-based Dpis Using Dynamic Inhalation Profile Simulations
Benedict Benque
Favorite
Bertolotti-Ciarlet, Andrea
Takeda
The Ins and Outs of Analytical Characterization of Vaccines
Andrea Bertolotti-Ciarlet
Favorite
Besheer, Ahmed
Lonza Group AG
Strategies in Formulation Development of Novel Biologics Modalities
Ahmed Besheer
Favorite
Betts, Alison
Applied BioMath, LLC
Prologue: Translational and Functional Considerations for Bi-specifics
Alison Betts
Favorite
Bhambhani, Akhilesh
Merck & Co., Inc.
Rapid Fire: Next Generation Manufacturing Enabling Speed to Patient
Akhilesh Bhambhani
Favorite
Biba, Edmond
U.S. Pharmacopeia (USP)
Pharmaceutical Continuous Manufacturing (PCM): The Role of Compendial Standards to Ensure the Quality of Manufacturing and Of the Product
Edmond Biba
Favorite
Birkmire, Andrew
GEA Pharma Systems
Roundtable Discussion: The Amorphous Solid Dispersion Ecosystem: Current Challenges and Future Opportunities
Andrew Birkmire
Favorite
Blaha, Josephine
Holmdel High School
Promoting STEM in Schools; Women in Science Initiative
Josephine Blaha
Favorite
Boerrigter, Stephan
AMRI Global
Roundtable Discussion: Solid Form Development
Stephan Boerrigter
Favorite
Bolla, Pradeep Kumar
U.S. Food and Drug Administration (FDA)
Effect of Formulation Parameters on Permeation From Ibuprofen Topical Formulations
Pradeep Kumar Bolla
Favorite
Targeted Delivery of Lutein Using Biotinylated PLGA-PEG Nanoparticles for AMD
Pradeep Kumar Bolla
Favorite
Bonacquisti, Emily
University of North Carolina at Chapel Hill
Keynote: Single Cell Profiling of Coding & Noncoding RNA as Predictive Inflammatory Biomarkers
Emily Bonacquisti
Favorite
Symposium: Preclinical Biomarker Studies: Connecting Discovery and Clinical Development
Emily Bonacquisti
Favorite
Bonate, Peter
Astellas
Keynote: Will Clinical Pharmacology Follow the Dinosaurs?
Peter Bonate
Favorite
Borbás, Enikő
Pion Inc
The Absorption Driven Drug Formulation Concept
Enikő Borbás
Favorite
Borges, Olga
University of Coimbra
Shedding Light on Chitosan-based Nanoparticles as Intranasal Vaccine Adjuvant
Olga Borges
Favorite
Bowsher, Ronald
B2S Life Sciences
Utilizing Octet Platform for Characterizing Critical Reagents in Support of Drug Development for Contemporary Biotherapeutics
Ronald Bowsher
Favorite
Boyce, Heather
US Food and Drug Administration
Establishing Bioequivalence for “Additional Strengths” of Oral Modified-Release Drug Products
Heather Boyce
Favorite
Braatz, Richard
Massachusetts Institute of Technology
Keynote: Advances in Process Control, Modeling, and Analytics for Biomanufacturing
Richard Braatz
Favorite
Brandl, Ferdinand
BASF
Addressing Challenges in Oral Solid Dosage Form Development & Manufacturing Pt. 1
Ferdinand Brandl
Favorite
Roundtable Discussion: Leveraging Digitalization to Solve Coating Formulation Challenges with ZoomLab™ 2.0
Ferdinand Brandl
Favorite
Brinson, Robert
NIST
Higher Order Structure Assessment of Emerging Biotherapeutic Modalities
Robert Brinson
Favorite
Brinz, Thomas
Syntegon
Doe with Process Automation: New Approach to Quality by Design
Thomas Brinz
Favorite
Briscoe, Chad
BioAgilytix Labs
Keynote: Is Your Protein Biomarker Mass Spectrometry Lab Ready For The Next Horizon?
Chad Briscoe
Favorite
Brito, Luis
Moderna Therapeutics
Formulation Optimization of mRNA Vaccines
Luis Brito
Favorite
Brown, Andrew
Quartz Imaging Corporation
Fast and Easy CFR 21 Part 11 Compliance for Microscopes
Andrew Brown
Favorite
Brynczka, Christopher
Merck & Co., Inc.
Beagle Dog As a Viable Model For Safety Assessment Of a Small Molecule Immunotherapy
Christopher Brynczka
Favorite
Rapid Fire: Advances in Preclinical Development of Immuno-Therapeutics
Christopher Brynczka
Favorite
Buckley, Stephen
Novo Nordisk A/S
Oral Delivery of Biologics: Challenges and Opportunities
Stephen Buckley
Favorite
C
Calderon, Christopher
Ursa Analytics, Inc.
Artificial Intelligence/Machine Learning : An Emerging Bioanalytical Solution
Christopher Calderon
Favorite
Machine Learning & Statistical Analyses for Formulation Design, Manufacturing, and Quality Control
Christopher Calderon
Favorite
Cao, Liching
Sangamo Therapeutics
Strategies to Monitor an Anti-AAV NAb Assay Supporting Clinical Trials
Liching Cao
Favorite
Cao, Shijie
University of Chicago
Glyco-Polymerization of Dietary Allergens to Prevent Food Allergy
Shijie Cao
Favorite
Cape, Jonathan
Lonza Pharma and Biotech
Modeling Phase Separation Risk During Spray Drying from Mixed Solvents
Jonathan Cape
Favorite
Caralli, Lisa
Catalent, Inc.
Data-Driven Strategies to Accelerate Your Molecule’s Development Path
Lisa Caralli
Favorite
Carlin, Brian
Latest Developments in Excipients That Are Relevant To Formulation, Analytical and Manufacturing: Drug Product Quality and Performance (Ticketed Event)
Brian Carlin
Favorite
Carlson, Natasha
AcuImmune
Association of HLA with Immunogenicity Risk in Clinic
Natasha Carlson
Favorite
Carlson, Paul
CBER, FDA
Regulatory Considerations for Microbiome Based Therapeutics
Paul Carlson
Favorite
Carter, Percy
FibroGen, Inc.
Keynote: The Continued Evolution of ‘Synthetics’ as Therapeutics
Percy Carter
Favorite
Carter, William
Evonik
Panel Discussion on Supplier Qualification: A Quality Risk-Based Approach on How to Select, Assess, Approve, and Monitor Suppliers of Materials, Components, and Services
William Carter
Favorite
Cech, Thorsten
BASF SE
Addressing Challenges in Oral Solid Dosage Form Development & Manufacturing Pt. 1
Thorsten Cech
Favorite
Roundtable Discussion: Leveraging Digitalization to Solve Coating Formulation Challenges with ZoomLab™ 2.0
Thorsten Cech
Favorite
Cha, Kenny
U.S. Food and Drug Administration
Artificial Intelligence/Machine Learning : An Emerging Bioanalytical Solution
Kenny Cha
Favorite
Chang, Hsueh-Yuan
University at Buffalo
Development of PBPK Model for Brain Disposition of Monoclonal Antibodies
Hsueh-Yuan Chang
Favorite
Chang, Jae
ORIC Pharmaceuticals
New Kids on the Block: genetically Altered Animal Models and Their Utility in Investigating Drug Distribution, Clearance and Induction
Jae Chang
Favorite
Chappell, John
Gyros Protein Technologies
Overcoming Drug Interference and Shrinking Sample Volumes in ADA Immunoassays
John Chappell
Favorite
Chavez-Eng, Cynthia
Merck & Co., Inc.
Strategy to Replace Quantitation of Nucleoside Phosphates in Pbmcs by Indirect Quantitation in Human Dried Blood Using Volumetric Absorptive Microsampling
Cynthia Chavez-Eng
Favorite
Cheeti, Sravanthi
Genentech, Inc.
Pediatric Dosing Considerations Based on Two Case Studies
Sravanthi Cheeti
Favorite
Chemuturi, Nagendra
Takeda
Biodistribution and Shedding of Viral Gene Therapies
Nagendra Chemuturi
Favorite
Gene Therapy: Inserting Old Genes into a New Modality! : Clinical Perspectives for Gene Therapy (Part 2) (Ticketed Event)
Nagendra Chemuturi
Favorite
Gene Therapy: Inserting Old Genes into a New Modality! : Manufacturing and Regulatory Perspectives on Gene Therapy (Part 3) (Ticketed Event)
Nagendra Chemuturi
Favorite
Gene Therapy: Inserting Old Genes into a New Modality! : Non-Clinical ADME-Tox and Bioanalytical Strategies Addressing Gene Therapy (Part 1) (Ticketed Event)
Nagendra Chemuturi
Favorite
Modeling and Simulation of Viral Gene Therapies: Applicability and Feasibility
Nagendra Chemuturi
Favorite
Role of DMPK in Discovery and Development of Viral Gene Therapies
Nagendra Chemuturi
Favorite
Session Introduction
Nagendra Chemuturi
Favorite
Session Introduction
Nagendra Chemuturi
Favorite
Cheng, Limei
Bristol-Myers Squibb
Quantitative Systems Pharmacology Modeling for Heart Failure
Limei Cheng
Favorite
Chen, Jingxian
Merck & Co, Inc
Body Size and Maturation in Monoclonal Antibody PK in Infants
Jingxian Chen
Favorite
Rapid Fire: Clinical Pharmacology Driving Innovative Trial Design
Jingxian Chen
Favorite
Chen, Mong-Jen
AbbVie, Inc.
Role of Modeling and Simulation in Biopharmaceutics
Mong-Jen Chen
Favorite
Chen, Xiaodong
Bristol Myers Squibb
Rapid Fire: Manufacturing and Analytical Challenges of Emerging Therapeutic Modalities and Novel Delivery Systems
Xiaodong Chen
Favorite
Chen, Yinshan
Genentech, Inc.
Counterions Facilitate High Drug Loading in Amorphous Solid Dispersion
Yinshan Chen
Favorite
Chesterman, Julian
U.S. Pharmacopeia (USP)
USP's Development of PLGA Monographs: Challenges with Characterization and Development of Appropriate Compendial Specifications
Julian Chesterman
Favorite
Chin, William
Catalent, Inc.
Patient-Focused Drug Design: A Structured Approach to Dose Form Design
William Chin
Favorite
Chirmule, Narendra
AcuImmune /SymphonyTech
Failure-Mode and Effect Risk-Analysis Developability of Cell and Gene Therapies
Narendra Chirmule
Favorite
Chowdhury, Ekram Ahmed
State University of New York at Buffalo
The Impact of Bulk Flow on Non-Compartmental Brain Uptake Measurements
Ekram Ahmed Chowdhury
Favorite
Chuong, Monica
Massachusetts College of Pharmacy and Health Sciences University
Rapid Fire: Advances in Process Control , Modeling, and Analytics
Monica Chuong
Favorite
Chu, Xiaoyan
Merck & Co., Inc.
OATP-Humanized Rats And Their Use In Drug Discovery
Xiaoyan Chu
Favorite
Ciccolini, Joseph
University Hospital of Marseille
PK/PD Relationships and Pharmacometric with Immunotherapy for Combinatorial Strategies
Joseph Ciccolini
Favorite
Clark, Annie
BioMarin Pharmaceutical Inc.
Considerations in Design and Development of Gene Therapy Products: A Translational PKPD Perspective
Annie Clark
Favorite
Coker, Adeola
University of The Incarnate Word
How To Build A Diverse Organization Where You Work: Advice for Scientists
Adeola Coker
Favorite
Corredor, Claudia
Bristol-Myers Squibb Company
Real Time Monitoring of Cell Health, Apoptosis and Aggregation in Biopharmaceutical Development
Claudia Corredor
Favorite
Coutant, Michael
Pfizer Inc.
Control Strategies in Early Development: Organic Non-mutagenic Impurities
Michael Coutant
Favorite
Coutant, Michael
Pfizer Inc.
Strategic Approaches to Develop Phase-Appropriate Organic Impurity Control Strategies (Part 1) (Ticketed Event)
Michael Coutant
Favorite
Strategic Approaches to Develop Phase-Appropriate Organic Impurity Control Strategies (Part 3) (Ticketed Event)
Michael Coutant
Favorite
Cowan, Kyra
Merck KGaA
EBF Perspective: Updates of the EBF Recommendations for Biomarker Assay Validation: Overcoming the Hurdles of Bringing COU into Practice
Kyra Cowan
Favorite
Cowan, Paul
USP
Roundtable Discussion: Pharmaceutical Industry’s Role in USP Monograph Development
Paul Cowan
Favorite
Crawford, Lindsey
Pfizer Inc.
A Multi-Faceted Approach to Characterizing the Silicone Oil Particle Load
Lindsey Crawford
Favorite
Creekmore, Richard
Creekmore Pharma Consulting
How To Establish Definitions, Identification and Detection For Excipient Organic Impurities in Pharmaceutical Development and Manufacturing
Richard Creekmore
Favorite
Croughan, Matt
Matthew S. Croughan Consulting Services
Keynote: Increasing Speed to Clinic - Whether for COVID-19 or Not
Matt Croughan
Favorite
Croyle, Maria
University of Texas at Austin
Technology for Rapid Deployment of Vaccines During Global Pandemic Emergencies
Maria Croyle
Favorite
Cui, Zhengrong
The University of Texas at Austin
Prologue: Opportunities and Challenges of Intranasal Vaccine Delivery
Zhengrong Cui
Favorite
Symposium: Making the Immune System Behave: Vaccines, Immunotherapies and Other Treatments
Zhengrong Cui
Favorite
D
Dasgupta, Arindam
US Food and Drug Administration
Common BA/BE Inspection Observations and Their Scientific Evaluations
Arindam Dasgupta
Favorite
Dave, Sambhav
WuXi AppTec
Emerging Therapeutic Modalities: Challenges and Considerations in Developing Successful Programs
Sambhav Dave
Favorite
Davies, Claire
Sanofi
CQAs for CGT Versus Biologics, Opportunities and Challenges for Complex ATMPs
Claire Davies
Favorite
Dellatore, Shara
Merck & Co., Inc.
Introduction to Vaccine Clinical Development (Part 1) (Ticketed Event)
Shara Dellatore
Favorite
Introduction to Vaccine Clinical Development (Part 2) (Ticketed Event)
Shara Dellatore
Favorite
Introduction to Vaccine Clinical Development (Part 3) (Ticketed Event)
Shara Dellatore
Favorite
Introduction to Vaccine Clinical Development (Part 4) (Ticketed Event)
Shara Dellatore
Favorite
Introduction to Workshop
Shara Dellatore
Favorite
Dennis, Emily
University of Kentucky
Promoting STEM in Schools; Women in Science Initiative
Emily Dennis
Favorite
Desai, Amit
Astellas Pharma
Career Development in Pharmaceutical Industry and Role of AAPS
Amit Desai
Favorite
Keynote: The Next Decade in Clinical Pharmacology: Do We Re-invent Ourselves?
Amit Desai
Favorite
Keynote: Will Clinical Pharmacology Follow the Dinosaurs?
Amit Desai
Favorite
Role of Modeling and Simulation in Biopharmaceutics
Amit Desai
Favorite
Desai, Rajesh
Merck & Co., Inc.
Optimization of an LC-MS/MS Generic Human Igg Assay Using Heat Stable Trypsin to Reduce Sample Analysis Time in Preclinical Samples
Rajesh Desai
Favorite
Deshmukh, Smeet
Merck Co. Inc
Keynote: Increasing Speed to Clinic - Whether for COVID-19 or Not
Smeet Deshmukh
Favorite
Symposium: Manufacturing and Analytical Challenges of Emerging Therapeutic Modalities and Novel Delivery Systems
Smeet Deshmukh
Favorite
Symposium: Next Generation Manufacturing Enabling Speed to Patient
Smeet Deshmukh
Favorite
Devanarayan, Viswanath
GlaxoSmithKline
Statistical Perspective - Establishing Fit-for-purpose Requirements on Precision of a Biomarker Assay
Viswanath Devanarayan
Favorite
Devine, Jennifer
United States Pharmacopeia
Evolution of Standards and the Pharmacopeia Advancing Drug Product Quality
Jennifer Devine
Favorite
Doktorovova, Slavomira
Hovione
Material Sparing Approaches for Right First-time Fast Track Tablet Development
Slavomira Doktorovova
Favorite
Doudna, Jennifer
U.C. Berkeley
Opening Plenary with Dr. Jennifer Doudna
Jennifer Doudna
Favorite
Draganov, Dragomir
Roundtable Discussion: Best Practices for Overcoming CDISC Roadblocks
Dragomir Draganov
Favorite
Dressman, Jennifer
Goethe Universitat
In Vivo Predictive in Vitro Dissolution Methodologies (Current and Newer Methods)
Jennifer Dressman
Favorite
Dubey, Sheri
Merck & Co., Inc.
Bioanalytical Case Study: Bridging Immune Responses Between Non-human Primates and Humans
Sheri Dubey
Favorite
Dutta, Sandeep
Amgen
Clinical Pharmacology Considerations For Targeted Covalent Inhibitors
Sandeep Dutta
Favorite
Du, Zhimei
Merck & Co., Inc.
Manufacturing Control in Cell Gene Therapy
Zhimei Du
Favorite
Dykstra, Kevin
Rapid Fire: Clinical Pharmacology Driving Innovative Trial Design
Kevin Dykstra
Favorite
E
Estevam, Jose
Takeda
Prologue: Novel Non-invasive Methods for Early Disease Detection
Jose Estevam
Favorite
F
Fabre, Kristin
Translation Research Institute for Space Health
Space Exploration Challenges to Drive Pharmaceutical Innovations
Kristin Fabre
Favorite
Fandy, Tamer
Department of Pharmaceutical & Administrative Sciences University of Charleston
Clinical Implications of SIRT6 Enzyme Activation by DNA Hypomethylating Agents
Tamer Fandy
Favorite
Keynote: Development of Microneedle Technology for Simplified Vaccination, Long-Acting Contraception and Wearable Diagnostics
Tamer Fandy
Favorite
Symposium: Innovations in Pharmaceutical Bioengineering
Tamer Fandy
Favorite
Felmlee, Melanie
University of the Pacific
Drug Transporters 2020: Old Challenges and New Opportunities : Predicting Human Clearance For Molecules With Transporter-Mediated Clearance (Ticketed Event)
Melanie Felmlee
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Humanized Transporter Animal Models (Ticketed Event)
Melanie Felmlee
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Transporters as Drug Targets (Ticketed Event)
Melanie Felmlee
Favorite
Drug Transporters 2020: Old Challenges and New Opportunities: Transporters Introduction & Regulatory Guidelines (Ticketed Event)
Melanie Felmlee
Favorite
Fernandez-Metzler, Carmen
Pharma Cadence Analytical Services, LLC
Prologue: Applying Context of Use in Chemical and LC/MS/MS Assays
Carmen Fernandez-Metzler
Favorite
Symposium: Will the Context of Use for Each Assay Please Stand Up?
Carmen Fernandez-Metzler
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Fielder, Paul
Genentech, Inc.
How To Build A Diverse Organization Where You Work: Advice for Scientists
Paul Fielder
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Prologue: Novel Approaches Informing Understudied Populations
Paul Fielder
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Symposium: Novel Approaches Informing Understudied Populations
Paul Fielder
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Fletcher, Jamie
Children's Cancer Institute
Novel Roles of Multidrug-Resistance Proteins in Cancer
Jamie Fletcher
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Florian, Jeffry
US Food and Drug Administration
Roundtable Discussion: Best Practices for Overcoming CDISC Roadblocks
Jeffry Florian
Favorite
Fotaki, Nikoletta
University of Bath
Predicting Performance in Paediatrics with PBPK Modelling and Biorelevant Data
Nikoletta Fotaki
Favorite
French, Donna
AstraZeneca
Keynote: Advances in Dosage Form Design for Biologics
Donna French
Favorite
Fretland, Jennifer
Sanofi
Model-based Approach to Design Bi-specific Modalities in Early Discovery
Jennifer Fretland
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G
Gadkar, Kapil
Denali
Mathematical Model to Elucidate the Bio-distribution of T-cell-dependent Bispecific Molecules
Kapil Gadkar
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Garr, Eric
Keynote: Advances in Process Control, Modeling, and Analytics for Biomanufacturing
Eric Garr
Favorite
Symposium: Advances in Process Control, Modeling, and Analytics
Eric Garr
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Garshick, Rebecca
PPD Laboratories
Neutralizing Antibody Assay Testing and Reporting Harmonization
Rebecca Garshick
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Garvin, Debi
Pacific Rim GLP Consulting
Is Your Bioanalytical Lab Ready for a Pandemic?
Debi Garvin
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Gassensmith, Jeremiah
University of Texas at Dallas
Coordination Polymers for Controlled Vaccine Delivery and Enhanced Antigen Presentation
Jeremiah Gassensmith
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Gelb, Michael
University of Washington
Development of Technology for Expanded Newborn Screening of Inborn Errors of Metabolism: Lysosomal Enzymes, Biomarkers and Beyond
Michael Gelb
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Ghimire, Manish
Colorcon, Inc.
Flow Properties, Morphology and Compression Characteristics of StarTab in Continuous-Processing
Manish Ghimire
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Givand, Jeffrey
Merck & Co., Inc.
A Holistic Approach to Achieving Drug-Device Combination Product Quality Attributes: Injection Force Case Study
Jeffrey Givand
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Gobburu, Jogarao
University of Maryland
Trials Affected by COVID-19: How to Still Interpret Them?
Jogarao Gobburu
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Gollen, Rakesh
Synteract
Career Development in Pharmaceutical Industry and Role of AAPS
Rakesh Gollen
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Rapid Fire: Formulation Development Strategies for Novel Modalities
Rakesh Gollen
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Gonda, Igor
Respidex
Inhaled Anti-infectives: Opportunity for Self-administered Interventions in Respiratory Infection Pandemics?
Igor Gonda
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Gonzales, Melissa
Genentech, Inc.
Increasing Diversity in Clinical Research
Melissa Gonzales
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Goodman, Joanne
AstraZeneca
EBF Perspective: Updates of the EBF Recommendations for Biomarker Assay Validation: Overcoming the Hurdles of Bringing COU into Practice
Joanne Goodman
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Gorovits, Boris
Pfizer Inc.
Prologue: A Look into the Future of the Biomolecular Bioanalytical Laboratory
Boris Gorovits
Favorite
Symposium: Are You Ready for the Laboratory of the Future?
Boris Gorovits
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Gould, Stephen
Genentech, Inc.
Keynote: Preclinical Validation of T Cell Bispecific Antibodies
Stephen Gould
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Grant, Joshuaine
Applied BioMath, LLC
Quantitative Systems Pharmacology Approaches in Drug Discovery and Clinical Translation
Joshuaine Grant
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Guedj, Jeremie
French National Institute of Health and Medical Research (INSERM)
MIDD to Inform Drug Repurposing for Global Pandemics
Jeremie Guedj
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Guenday-Tuereli, Nazende
MyBiotech GmbH
Nanoparticle Manufacturing All-in-one
Nazende Guenday-Tuereli
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Gu, Huidong
Bristol-Myers Squibb Company
Cell Surface, Intracellular, Extracellular PD-1 Determination Using Cell Surface Labeling
Huidong Gu
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Gu, Jianghong
FDA
Application of Mass Spectrometry in Dexamethasone Intravitreal Implant Analysis
Jianghong Gu
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Gunsior, Michele
VielaBio
Leadership and Communication Styles to Achieve Results in the Workplace
Michele Gunsior
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Gupta, Neeraj
Takeda Pharmaceuticals
Brigatinib PBPK Model-informed Dosing Recommendations in Lieu of Clinical Trial
Neeraj Gupta
Favorite
Rapid Fire: Approaches Informing Understudied Populations
Neeraj Gupta
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Gu, Zhen
University of California, Los Angeles
Bioresponsive Drug Delivery
Zhen Gu
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H
Hageman, Michael
University of Kansas
Keynote: As Drug Modalities Evolve so Must Our Development Strategies
Michael Hageman
Favorite
Harrer, Stefan
IBM Research
Artificial Intelligence for Clinical Trial Design
Stefan Harrer
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Harrill, Alison
NIEHS
Journey of Biomarker from Discovery to Qualification (Renal Biomarker)
Alison Harrill
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Hassanein, Mohamed
Pfizer
Bioanalytical Challenges in Oncology Patients with Prior Exposure to Biotherapeutics
Mohamed Hassanein
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Hathcock, James
Pall Biotech
Roundtable Discussion: Analytical Advances in Detecting, Quantifying and Monitoring Extractables / Leachables From Single-use Systems
James Hathcock
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Hays, Amanda
PRA
Extending Flow Cytometry Sample Stability for Regulatory T Cells
Amanda Hays
Favorite
Rapid Fire: Will the Context of Use for Each Assay Please Stand Up?
Amanda Hays
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Hazlehurst, Lori
West Virginia University
Keynote: Novel Treatment Strategies for Treatment of Hematopoietic Malignancies in the Context of the Bone Marrow Microenvironment
Lori Hazlehurst
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Heffron, Timothy
Genentech
Brain Penetrant PI3Ka Inhibitors
Timothy Heffron
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Helmy, Roy
Merck & Co., Inc.
Keynote: Taking Vaccine Bioanalytical Assays into A New Frontier- Boldly Going Where No One Has Gone Before
Roy Helmy
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He, Mei
University of Florida
Extracellular Vesicles and Exosomes as the Emerging Nano-delivery Platform
Mei He
Favorite
Keynote: Blocking Bacterial Lipopolysaccharide to Relieve Immune Suppression in Colorectal Cancer
Mei He
Favorite
Keynote: Biodegradable Polymeric Particles as Adjuvant and Vaccine Delivery Systems
Mei He
Favorite
Symposium: Bugs, Drugs, and the Microbiome: What’s the Hype, What’s the Promise?
Mei He
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Hepworth, David
Pfizer Inc.
SLCs As Drug Targets: Challenges And Opportunities
David Hepworth
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Hettini, Khaled
Sangamo Therapeutics, Inc.
Anti-Transgene Antibody Assays Development to Support Fabry Gene Therapy Studies
Khaled Hettini
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Hickman, James
Hesperos, Inc
Human-on-a-chip Systems for Use in Therapeutic Index Determination and Systemic Toxicity in Pre-clinical Drug Discovery Application
James Hickman
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Hilgenfeld, Rolf
University of Lübeck, Germany
Presentation with Dr. Rolf Hilgenfeld
Rolf Hilgenfeld
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Holloway, Galina
U.S. Pharmacopeia (USP)
Review The Elemental Impurities (EI) Joint Subcommittee’s (JSC) Roadmap To Remove Element Specific Chapters and Standalone EI Tests From Excipient Monographs
Galina Holloway
Favorite
Holter, Joshua
Sangamo Therapeutics
An Enzymatic Neutralizing Antibody Assay for Gene Therapy Clinical Enrollment
Joshua Holter
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Hong, Seungpyo
University of Wisconsin-Madison
Nanoengineered Surfaces For Effective Capture and Analysis of Tumor-Derived Exosomes and Circulating Tumor Cells
Seungpyo Hong
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Hoogendoorn, Karin
Lonza Pharma & Biotech
Drug Delivery in Cell Therapy: Dealing with a Living Active Drug Substance
Karin Hoogendoorn
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Hornby, Pamela
Janssen Research and Development, LLC
Oral Delivery of Monoclonal Antibodies
Pamela Hornby
Favorite
Howard, Kit
Roundtable Discussion: Best Practices for Overcoming CDISC Roadblocks
Kit Howard
Favorite
Huang, Leaf
University of North Carolina at Chapel Hill
Keynote: Blocking Bacterial Lipopolysaccharide to Relieve Immune Suppression in Colorectal Cancer
Leaf Huang
Favorite
Hubel, Allison
University of Minnesota
Formulation Development of Cell Therapy Products
Allison Hubel
Favorite
Huck, Bayard
EMD Serono
Keynote: Use of Small Molecules to Make Giant Leaps in Immuno-oncology
Bayard Huck
Favorite
Hu, Jing
Sangamo Therapeutics
Anti-Aav6 Antibody Assay for Detecting Gene Therapy Treatment-Induced Antibody Response
Jing Hu
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Hunsberger, Kay
Merck & Co., Inc.
Addressing a Public Health Concern – ERVEBO
Kay Hunsberger
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Hunt, Desmond
U.S. Pharmacopeia (USP)
Panel Discussion on Supplier Qualification: A Quality Risk-Based Approach on How to Select, Assess, Approve, and Monitor Suppliers of Materials, Components, and Services
Desmond Hunt
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Huynh-Ba, Kim
Pharmalytik
Leadership and Communication Styles to Achieve Results in the Workplace
Kim Huynh-Ba
Favorite
Post Approval Phase Strategies for Non- mutagenic Impurities, Including Generics and OTC
Kim Huynh-Ba
Favorite
I
Ierapetritou, Marianthi
University of Delaware
Keynote: Towards a Digital Twin: Advances in Process Modeling and Integration of Pharmaceutical Manufacturing
Marianthi Ierapetritou
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Indulkar, Anura
AbbVie, Inc.
Strategies to Formulate High Drug-load Amorphous Dispersions to Reduce Pill-burden
Anura Indulkar
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Izmailova, Elena
Konekesa Health
Wearables and Outpatient Sampling in the Time of COVID
Elena Izmailova
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J
Jahn, Michael
Lonza Group Ltd
Polysorbate in Biologics – Understanding Degradation by Applying Proper Analytics
Michael Jahn
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Jalodia, Richa
University of Miami
Opioid Use/Abuse and Human Health: Role of Changing Gut Microbiome
Richa Jalodia
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Jawa, Rayan
Holmdel High School
Designing Effective T-Cell Epitope Vaccine From Non-Structural COVID Derived Proteins
Rayan Jawa
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Jawa, Vibha
Bristol Myers Squibb
Implementation of Risk Assessment Outputs to Drive Clinical Immunogenicity Strategy and Meet Regulatory Expectations
Vibha Jawa
Favorite
Prologue: Bold Advances in Biomolecular Bioanalysis
Vibha Jawa
Favorite
Promoting STEM in Schools; Women in Science Initiative
Vibha Jawa
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Symposium: Bioanalytics – Biomolecular: To Boldly Go Where No Assay Has Gone Before!
Vibha Jawa
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Johnson, Lindsay
BASF
Roundtable Discussion: The Amorphous Solid Dispersion Ecosystem: Current Challenges and Future Opportunities
Lindsay Johnson
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Johnson, Trevor
Certara UK Limited
Roundtable Discussion: Using Quantitative Approaches to Support Pediatric Drug Formulation Development Strategies
Trevor Johnson
Favorite
Jordan, Gregor
Roche Diagnostics GmbH
Clinical Study Support - Bioanalytical Monitoring of Transient Drug-target-drug Complexes
Gregor Jordan
Favorite
Joyce, Joseph
Merck & Co., Inc.
Vaccine Process Development: Bridging Discovery to Commercialization
Joseph Joyce
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Jusko, William
University at Buffalo
Population PK/PD Modeling of IM and Oral Dexamethasone and Betamethasone Effects on Six Biomarkers in Indian Women
William Jusko
Favorite
K
Kamen, Lynn
Genentech, Inc.
Universal Sample Pretreatment Method: Dream to Reality?
Lynn Kamen
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Kane, Anil
Thermo Fisher Scientific
Addressing Technical Challenges in Development Drug Products: a CDMO Perspective
Anil Kane
Favorite
Kang, Lijuan
Janssen Research & Development, LLC
Rapid Fire:To Boldly Go Where No Assay Has Gone Before!
Lijuan Kang
Favorite
Kaplan, David L.
Tufts University
New Stabilization Matrices for Medications During Space Travel
David L. Kaplan
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Kapoor, Mamta
US FDA
Rapid Fire: Advances and Innovation in Formulation Development
Mamta Kapoor
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Karry, Krizia
BASF Corporation
Addressing Challenges in Oral Solid Dosage Form Development & Manufacturing Pt. 2
Krizia Karry
Favorite
Roundtable Discussion: Taste Masking as an Alternative to Improve Patient Convenience and Compliance
Krizia Karry
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Kar, Sambit
Bristol-Myers Squibb Company
Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle
Sambit Kar
Favorite
Kar, Sumit
Celerion
Leveraging Pathophysiology and Context-of-Use to Identify NASH Clinical Trial Biomarkers
Sumit Kar
Favorite
Rapid SARS-CoV-2 Assay Development Technologies: Recombinant Antibodies, In-Vitro Assays, Biomarkers
Sumit Kar
Favorite
Katz, Joshua
DuPont Nutrition and Biosciences
Surfactant Hydrophobe Variation Significantly Impacts Fundamental Performance and Biologic Stability
Joshua Katz
Favorite
Kaushal, Neeraj
St. John's University
Application of Minimal Physiologically Based Pharmacokinetic Model for Insulin: A Population Analysis
Neeraj Kaushal
Favorite
Keire, David
US Food and Drug Administration
Registration Phase Control Strategies for Mutagenic Impurities Including Nitrosamines
David Keire
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Kelly, Kathleen
Bristol-Myers Squibb Company
Analytical Challenges For siRNA - Trials And Tribulations Of Externalizing Method Development And Testing
Kathleen Kelly
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Kenny, Patrick
Thermo Fisher Scientific
Software Solutions for Successful Pharmaceutical LC-MS and GC-MS Impurity Analysis, Characterization - and Quality Control
Patrick Kenny
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Kerwin, Bruce
Just-Evotec Biologics
Shocking Data on Parcel Shipments of Protein Solutions
Bruce Kerwin
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Khairuzzaman, Akm
U.S. Food and Drug Administration
A Regulatory Perspective on 3D Printing in Drug Development & Emerging Health Care
Akm Khairuzzaman
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Khatri, Purvesh
Stanford University
Learning Across Viruses and Preparing for the Next Pandemic
Purvesh Khatri
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King, Lindsay
Pfizer Inc.
Prologue: Applying Context of Use in Biomolecular Assays
Lindsay King
Favorite
Symposium: Will the Context of Use for Each Assay Please Stand Up?
Lindsay King
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Kiplinger, Jeffrey
Cohere Business Strategies
Entrepreneurial Growth for Consultants, Contractors, and Suppliers
Jeffrey Kiplinger
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Kirschbrown, Whitney
Genentech
PK-Based Clinical Bridging from IV to SC Route of Administration, the Perjeta/Herceptin Story
Whitney Kirschbrown
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Koerner, Philip
Phenomenex
U/HPLC Reversed-Phase Method Development: Selecting a Reproducible Starting Point
Philip Koerner
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Konagurthu, Sanjay
Thermo Fisher Scientific
Roundtable Discussion: The Amorphous Solid Dispersion Ecosystem: Current Challenges and Future Opportunities
Sanjay Konagurthu
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Konicek, Donna
Insmed Inc
Evaluation of Inhaled Lipoglycopeptide Dry Powder Formulation Against Pulmonary MRSA
Donna Konicek
Favorite
König, Jörg
Institute of Experimental and Clinical Pharmacology and Toxicology Department of Clinical Pharmacology and Clinical Toxicology Friedrich–Alexander University Erlangen–Nürnberg
SLC13A5/Sodium-Coupled Citrate Transporter in Metabolic Diseases
Jörg König
Favorite
Koo, Otilia
Bristol-Myers Squibb Company
Latest Developments In Excipients That Are Relevant To Formulation, Analytical and Manufacturing: Overview of PLGA Polymeric Excipients (Ticketed Event)
Otilia Koo
Favorite
Value of Excipient Function to Drug Product Performance
Otilia Koo
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Kordane, Rihab
Certara
Roundtable Discussion: Best Practices for Overcoming CDISC Roadblocks
Rihab Kordane
Favorite
Kovac, Villiam
Globalworx GmbH
Panel Discussion on Supplier Qualification: A Quality Risk-Based Approach on How to Select, Assess, Approve, and Monitor Suppliers of Materials, Components, and Services
Villiam Kovac
Favorite
Krause, Mary
Drug Product Development / Bristol Myers Squibb
High Concentration Formulation Development of an Fc Fusion Protein: A Case Study
Mary Krause
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Krause, Philip
U.S. Food and Drug Administration
Introduction to Safety and Efficacy Endpoints
Philip Krause
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Krumme, Markus
Novartis
Continuous Manufacturing and Other Approaches to Remove Tech Transfer / Upscaling
Markus Krumme
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Krysiak, Pawel
M6P Therapeutics
Emerging Therapeutic Modalities: Challenges and Considerations in Developing Successful Programs
Pawel Krysiak
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Kueltzo, Lisa
National Institutes of Health (NIH)
Criticality of Pre-Formulation Data in Accelerated Development of Recombinant Vaccines
Lisa Kueltzo
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Kurtyka, Bogdan
U.S. Food and Drug Administration
Process Modeling for Robust Drug Product Manufacturing
Bogdan Kurtyka
Favorite
Kurz, Markus
Novartis Pharma AG
Meeting the Challenge: A Road Map to Progress from Milligrams to Tons in Oligonucleotide Manufacturing
Markus Kurz
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Kusko, Rebecca
Immuneering
Re-Understanding AI for Drug-Development: Handling Data integrity & QC-related issues
Rebecca Kusko
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L
Laffan, Dave
AstraZeneca, Chemical Development
Designing Large Scale Oligonucleotide Manufacturing for Long Term Viability
Dave Laffan
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Lakhani, Vinal
DILIsym Services
Hepatotoxicity of Compound V Evaluated with Quantitative Systems Toxicology
Vinal Lakhani
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Lala, Mallika
Merck & Co., Inc.
Pembrolizumab Q6-Week Dosing: Model-Informed Selection and Approval of an Extended Dosing Regimen in Immuno-Oncology
Mallika Lala
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Lauritsen, Kristina
U.S. Food and Drug Administration
Keynote: Regulatory Perspectives on Drug-Device Combination Products
Kristina Lauritsen
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Lavelle, Amy
PPD Laboratories
Rapid Fire: Will the Context of Use for Each Assay Please Stand Up?
Amy Lavelle
Favorite
Lavet, Lorraine
Korn Ferry
How To Build A Diverse Organization Where You Work: Advice for Scientists
Lorraine Lavet
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Lawson, Kenneth
Arcus Biosciences
Discovery of AB680: A Potent and Selective Inhibitor of CD73
Kenneth Lawson
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Lester, Todd
BioAgilytix
Bioanalysis of Biosimilars – Leveraging the past to Shape the Future
Todd Lester
Favorite
Rapid Fire: Are You Ready For The Laboratory Of The Future?
Todd Lester
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Levons, Jaquan
Bristol Myers Squibb
Transforming Drug Development Through Digital Engineering
Jaquan Levons
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Lewen, Nancy
Owasso Pharmacon LLC
USP Elemental Impurities Update
Nancy Lewen
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Liang, Jun
Genentech, Inc.
Discovery and Development of Selective Estrogen Receptor Degraders (SERD)
Jun Liang
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Liau, Brian
Agilent Technologies
Efficient Methods for Analysis of Monoclonal Antibody Critical Quality Attributes
Brian Liau
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Li, Chunze
Genentech, Inc.
Payload-mediated DDI Framework for Antibody-drug Conjugates: An IQ Consortium Perspective
Chunze Li
Favorite
Li, Jinjiang
Nevakar Pharma inc.
A Quick Screening Tool for Drug-Device Combination Product Development
Jinjiang Li
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Lin, Henry
Merck & Co., Inc.
Rapid Fire: Advances in Process Control, Modeling and Analytics
Henry Lin
Favorite
Lin, Tracey
University of Southern California
C1 Analogues Have Improved Anti-Cancer Activity and Accumulation in TNBC Cell Line
Tracey Lin
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Listro, Tony
Foster Delivery Science, Inc.
Extrusion Technologies for Pharmaceutical Dosage Forms
Tony Listro
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Li, Tonglei
Purdue University
LIVE Special Poster Collection —Modeling and Simulation - With Dr. Tonglei Li
Tonglei Li
Favorite
Liu, Qi
U.S. Food and Drug Administration
Regulatory Perspective on Integrating Big Data and RWE into the Drug Development and Regulatory Framework
Qi Liu
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Liu, Weixi
Jordi Labs
Reducing Uncertainty using a Multidetector Approach in Extractables and Leachables
Weixi Liu
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Liu, Xiaofei
US Food and Drug Administration
Artificial Intelligence/Machine Learning : An Emerging Bioanalytical Solution
Xiaofei Liu
Favorite
Liu, Xin
Triastek, Inc.
Melt Extrusion Deposition(med) 3D Printing- the Next-Generation Pharmaceutical Manufacturing Technology
Xin Liu
Favorite
Liu, Yanqiu
Genentech
Understanding the Anti-Drug Antibody (ADA) for a Bispecific Antibody Agonist
Yanqiu Liu
Favorite
Liu, Zhichao
US Food and Drug Administration
Computational Drug Repositioning for Noonan and LEOPARD Syndromes
Zhichao Liu
Favorite
Li, Wenkui
Novartis Institutes for BioMedical Research, Inc.
An Industry Perspective of Evolving Strategies and Key Focus Areas in Metabolite Bioanalysis
Wenkui Li
Favorite
Prospective Metabolite Studies for Accelerating Preclinical Development
Wenkui Li
Favorite
Li, Xiaoling
University of the Pacific
Rapid Fire: Bugs, Drugs, and the Microbiome and Novel Oncotargets and Treatments
Xiaoling Li
Favorite
Lochhead, Jeff
University of Arizona
Intranasal Delivery
Jeff Lochhead
Favorite
Long, Brian
BioMarin Pharmaceutical Inc.
Bioanalytical Methods & Strategies to Gene Therapy
Brian Long
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Louie, Steven
BioIVT
Gene Therapy: Inserting Old Genes into a New Modality! : Clinical Perspectives for Gene Therapy (Part 2) (Ticketed Event)
Steven Louie
Favorite
Gene Therapy: Inserting Old Genes into a New Modality! : Manufacturing and Regulatory Perspectives on Gene Therapy (Part 3) (Ticketed Event)
Steven Louie
Favorite
Gene Therapy: Inserting Old Genes into a New Modality! : Non-Clinical ADME-Tox and Bioanalytical Strategies Addressing Gene Therapy (Part 1) (Ticketed Event)
Steven Louie
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Q&A and Concluding Remarks
Steven Louie
Favorite
Workshop Introduction
Steven Louie
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Lowes, Steve
Q Squared Solutions
Prologue: Boldly Going Where No LC/MS Assay Has Gone Before
Steve Lowes
Favorite
Symposium: To Boldly Go Where No Assay Has Gone Before!
Steve Lowes
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Lucas, Lauren
Auburn University
Targeting BRAF WT Metastatic Melanomas: Identifying ERBB4 Mutant Alleles as Biomarkers and Targets for Novel Combinatorial Treatment Strategies
Lauren Lucas
Favorite
Lukka, Pradeep
The University of Tennessee Health Science Center
Rapid Fire: Model Informed Drug Development: 2020 and Beyond
Pradeep Lukka
Favorite
Real-world Data in Support of Lacosamide Dosing in Understudied Pediatric Patients
Pradeep Lukka
Favorite
Luo, Linlin
Merck & Co., Inc.
Clinically Relevant Pcs for ADA Assays: Monoclonals vs Polyclonals?
Linlin Luo
Favorite
M
Maciel Tabosa, M. Alice
University of Bath
Assessing Topical Drug Bioavailability in the Skin Using Raman Spectroscopy
M. Alice Maciel Tabosa
Favorite
Mahler, Hanns-Christian
Lonza Group AG
Prologue: Formulation Development Challenges of Emerging Modalities
Hanns-Christian Mahler
Favorite
Symposium: Formulation Development Challenges for Emerging Modalities
Hanns-Christian Mahler
Favorite
Mains, Jenifer
Lonza Pharma & Biotech
Advances in Process Control, Modeling and Analytics
Jenifer Mains
Favorite
Malec, Paige
Covance Laboratories
Development/Validation of an Endogenous Compound in Accordance with ICH-M10
Paige Malec
Favorite
Malicki, Heather
WuXi Advanced Therapies
Emerging Therapeutic Modalities: Challenges and Considerations in Developing Successful Programs
Heather Malicki
Favorite
Mandlekar, Sandhya
Genentech, Inc.
Keynote: Use of Small Molecules to Make Giant Leaps in Immuno-oncology
Sandhya Mandlekar
Favorite
Symposium: Novel Small Molecules in Oncology: Targeted Covalent Inhibitors and Protein Degraders
Sandhya Mandlekar
Favorite
Maniruzzaman, Mo
The University of Texas at Austin
A Regulatory Perspective on 3D Printing in Drug Development & Emerging Health Care
Mo Maniruzzaman
Favorite
Centralized Manufacturing of 3D-Printed Dosage Forms: A Foundation for Commercial Scale
Mo Maniruzzaman
Favorite
Hot Topic: 3D Printing in Advanced Drug Delivery
Mo Maniruzzaman
Favorite
Hot Topic: 3D Printing in Pharmaceutical/Biomedical Applications
Mo Maniruzzaman
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Manoharan, Palanikumar
PPD Global Central Lab
COVID-19 Trials: Strategies to Ensure Success
Palanikumar Manoharan
Favorite
Marathe, Punit
Syngene International Limited
COVID Therapeutics Using DNA and RNA Based Vaccines
Punit Marathe
Favorite
Keynote: The Continued Evolution of ‘Synthetics’ as Therapeutics
Punit Marathe
Favorite
Keynote: The Next Frontier in ADME Science: Predicting and Verifying Tissue Drug Concentrations
Punit Marathe
Favorite
Marks, Peter
U.S. Food and Drug Administration
Keynote: Evaluating The Safety And Efficacy Of Cell And Gene Therapies In Development
Peter Marks
Favorite
Marr, James
Merck & Co., Inc.
Parameters Affecting the Digestion Efficiency of a Monoclonal Antibody
James Marr
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Marroum, Patrick
AbbVie, Inc.
Role of Modeling and Simulation in Biopharmaceutics
Patrick Marroum
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Marshall, Jean-Claude
Pfizer Inc.
Challenges for the Implementation and Decision Making Based on Biomarkers as a Surrogate Endpoint in Clinical Trials
Jean-Claude Marshall
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Masih, Shab
Genentech
Biotransformation in vivo of an Fc-fusion Protein Impacts Its PK
Shab Masih
Favorite
Mattei, Aimee
EpiVax Inc
WhIM-Immunogenicity Modeling of Potential Impurities in Synthetic Peptide Drugs
Aimee Mattei
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Matys, Katie
PPD Laboratories
Clinical Bioanalytical Assay Method Development and Validation
Katie Matys
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Maudhuit, Audrey
Fluid Air Inc.
Gentle Drying for Thermosensitive Active: Electrostatic Spray Dryer
Audrey Maudhuit
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McDonald, Karen
University of California, Davis
Plant Molecular Foundries for Biotherapeutics in Space
Karen McDonald
Favorite
McMahon, Lance
University of Florida
Keynote: Novel Treatment Strategies for Treatment of Hematopoietic Malignancies in the Context of the Bone Marrow Microenvironment
Lance McMahon
Favorite
Symposium: Novel Oncotargets
Lance McMahon
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McNally, Jim
BioAgilytix
Roundtable Discussion: Bioanalysis of Gene & Cell Therapies
Jim McNally
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Mehta, Devangi
Immunologix Laboratories
Do You Know What You Are Measuring? Developing Biomarkers That Have Clinical Impact
Devangi Mehta
Favorite
Staging Biomarker Development
Devangi Mehta
Favorite
Meibohm, Bernd
University of Tennessee Health Science Center
Keynote: Quantitative Systems Pharmacology to Guide Translational Research of Novel Biological Modalities
Bernd Meibohm
Favorite
Meier, Werner
Revitope Oncology
Next-generation of T-cell Redirecting Antibodies
Werner Meier
Favorite
Melenhorst, J. Joseph
University of Pennsylvania
Keynote: Translational Sciences in CAR T-cell Therapies: Staying the Course for Success
J. Joseph Melenhorst
Favorite
Meng, Guangnan
PerkinElmer, Inc.
Roundtable Discussion: AAV Purity Analysis Modernized in a New Decade
Guangnan Meng
Favorite
Mess, Jean-Nicholas
Altasciences
Quantitation of Antiviral Immunotherapeutic Monoclonal Antibodies by Mass Spectrometry
Jean-Nicholas Mess
Favorite
Mhlanga, Musa
Radboud Institute for Molecular Life Sciences, Radboud University
Keynote: Single Cell Profiling of Coding & Noncoding RNA as Predictive Inflammatory Biomarkers
Musa Mhlanga
Favorite
Michaelis, Marc
Syntegon
Small Batch Continuous Production at a 9 Sigma Level
Marc Michaelis
Favorite
Micheli, Janine
PPD Laboratories
Strategies for Regulated Cell and Gene-therapy Based Enzyme Activity Assays
Janine Micheli
Favorite
Midde, Krishna
PPD Laboratories
Challenges in Developing a Biomarker Assay for α-Synuclein Quantification
Krishna Midde
Favorite
Milton, Mark
Novartis
Immune Response and Immunogenicity in Gene Therapy
Mark Milton
Favorite
Mirza, Tahseen
U.S. Food and Drug Administration
Keynote: Flexible Manufacturing in a Rigid Regulatory Environment
Tahseen Mirza
Favorite
Symposium: Next Generation Manufacturing Enabling Speed to Patient
Tahseen Mirza
Favorite
Mitra Ghosh, Taraswi
Auburn University
Regulation of Cancer Pathways Following Metronomic Dosing in Prostate Cancers
Taraswi Mitra Ghosh
Favorite
Mitra, Amit
Auburn University
Repurposing Novel Secondary Drugs For Treating Drug-Resistant Cancer Stem Cells
Amit Mitra
Favorite
Mitra-Kaushik, Shibani
Sanofi
Analytics for Advanced Therapies
Shibani Mitra-Kaushik
Favorite
Mittal, Sachin
Merck and Co Inc
Monoclonal Antibody Bioavailability Prediction After Subcutaneous Administration: Challenges and Opportunities
Sachin Mittal
Favorite
Rapid Fire: Manufacturing and Analytical Challenges of Emerging Therapeutic Modalities and Novel Delivery System
Sachin Mittal
Favorite
Mlugu, Eulambius
Muhimbili University of Health and Allied Sciences
Effectiveness of Sulfadoxine–Pyrimethamine For Intermittent Preventive Treatment of Malaria and Adverse Birth Outcomes in Pregnant Women
Eulambius Mlugu
Favorite
Mnkugwe, Rajabu
Karolinska Institutet
Efficacy and Safety of Praziquantel and Dihydroartemisinin-piperaquine Combination for Treatment and Control of Intestinal Schistosomiasis: A Randomized, Open-label, Non-inferiority Clinical Trial
Rajabu Mnkugwe
Favorite
Mody, Hardik
Janssen Research and Development, LLC
Selecting FIH Starting Dose for Adoptive T Cell Therapies and PK/PD Considerations
Hardik Mody
Favorite
Moller, Laure
Meso Scale Discovery
Development of a High-Throughput SARS-CoV-2 Strain-Typing Assay
Laure Moller
Favorite
Moore, Christine
Merck & Co., Inc.
Keynote: Flexible Manufacturing in a Rigid Regulatory Environment
Christine Moore
Favorite
Moreton, Chris
FinnBritt Consulting
Panel Discussion on Supplier Qualification: A Quality Risk-Based Approach on How to Select, Assess, Approve, and Monitor Suppliers of Materials, Components, and Services
Chris Moreton
Favorite
Prologue: Poor Solubility – Where Do We Stand 25 years After the “Rule of Five”
Chris Moreton
Favorite
Morris, Marilyn
University at Buffalo, State University of New York
Prologue: Introduction to Novel Roles of Emerging Transporters
Marilyn Morris
Favorite
Symposium: Novel Roles of Emerging Transporters
Marilyn Morris
Favorite
Morrison, John
Rapid Fire: Preclinical Biomarker Studies: Connecting Discovery and Clinical Development
John Morrison
Favorite
Morris, Susan
Susan Morris Coaching
Giving Actionable Feedback, Part 1
Susan Morris
Favorite
Morris, Tina
American Association of Pharmaceutical Scientists
LIVE Special Poster Collection — Characterizing Oligonucleotide Therapeutics – With Dr. Tina Morris
Tina Morris
Favorite
LIVE Special Poster Collection — Measurement Approaches for Large Molecules – With Dr. Tina Morris
Tina Morris
Favorite
Moura, Cláudia
Hovione SA
Universal-Low-Dosage DPI Platform for Delivery of Small Molecules and Biopharmaceuticals
Cláudia Moura
Favorite
Mudie, Deanna
Global Research and Development, Lonza
A Novel Architecture for High Drug-loaded Amorphous Solid Dispersion Tablets; Assessment of in Vitro and in Vivo Performance, Stability and Manufacturability
Deanna Mudie
Favorite
Mukherjee, Dwaipayan
AbbVie, Inc.
Role of Modeling and Simulation in Biopharmaceutics
Dwaipayan Mukherjee
Favorite
Muldoon Jacobs, Kristi
U.S. Pharmacopeia (USP)
Post Approval Phase Strategies to Control Mutagenic Impurities Including M7 and Nitrosamines
Kristi Muldoon Jacobs
Favorite
Mullberg, Jurgen
Bristol-Myers Squibb Company
Rapid Adventitious Agent Testing - Accelerating Clinical Timelines / Speed to Patient
Jurgen Mullberg
Favorite
Müller, Daniel
MyBiotech GmbH
Continuous Cell Disruption and Extraction Using Microjet Reactor (MJR) Technology
Daniel Müller
Favorite
Murthy, Narasimha
University of Mississippi
Lipid-based Excipients for Skin Permeation by In Vitro Permeation Studies
Narasimha Murthy
Favorite
Muslehiddinoglu, Jale
Johnson&Johnson
Prologue: Manufacturing and Analytical Challenges of Emerging Therapeutic Modalities and Novel Delivery Systems
Jale Muslehiddinoglu
Favorite
N
Nagaraja Shastri, Prathap
Janssen Research and Development, LLC
Keynote: Preclinical Validation of T Cell Bispecific Antibodies
Prathap Nagaraja Shastri
Favorite
Rapid Fire: Making the Immune System Behave: Vaccines, Immunotherapies and Other Treatments
Prathap Nagaraja Shastri
Favorite
Symposium: Translational and Functional Considerations for Bi-specifics
Prathap Nagaraja Shastri
Favorite
Narain, Niven
BERG LLC
Prologue: Clinical Development and Adaptive Design in the AI Era: A Reality Check
Niven Narain
Favorite
Symposium: Clinical Pharmacology Driving Innovative Trial Design
Niven Narain
Favorite
Narasimhan, Nachu
Merck & Co., Inc.
Role Of CSTDs In Post Production Handling Of Biologics
Nachu Narasimhan
Favorite
Needham, Shane
Alturas Analytics Inc
Is Your Bioanalytical Lab Ready for a Pandemic?
Shane Needham
Favorite
MRM Based Peptide Quantification Using a Novel Triple Quadrupole Instrument
Shane Needham
Favorite
Nelson, Robert
Covance Inc.
Be Specific - Biomarker Assay Validation in Context: Case Studies (Part 3) (Ticketed Event)
Robert Nelson
Favorite
Do You Have a Validated Assay for Biomarker X? Making Haste, Slowly, in Bioanalysis of Biomarkers
Robert Nelson
Favorite
Neubert, Hendrik
Pfizer Inc.
Keynote: Is Your Protein Biomarker Mass Spectrometry Lab Ready For The Next Horizon?
Hendrik Neubert
Favorite
Newman, Alice
Merck Research Laboratories
Rapid Fire: Innovation and Acceleration of Preclinical Development
Alice Newman
Favorite
Residual Protein Risks in Apis Synthesized from Biocatalytic Routes
Alice Newman
Favorite
Nguyen, Juliane
University of North Carolina at Chapel Hill
The Future of Space Medicine
Juliane Nguyen
Favorite
Ni, Yan
Passage Bio
Keynote: Evaluating The Safety And Efficacy Of Cell And Gene Therapies In Development
Yan Ni
Favorite
Nolan, Katrina
Merck & Co., Inc.
Case Study: Bioanalytical Strategy as the Basis of Licensure for a New Multivalent Pneumococcal Conjugate Vaccine
Katrina Nolan
Favorite
O
Ogunjimi, Abayomi
University of Iowa
Micropore Closure Time After Dermal Microneedle Application in Subjects of Diverse Ethnic/racial Skin Types
Abayomi Ogunjimi
Favorite
O'Hagan, Derek
GlaxoSmithKline plc
Prologue: Advances In Formulation and Delivery For Vaccines
Derek O'Hagan
Favorite
Symposium: Advances and Innovation in Formulation Development
Derek O'Hagan
Favorite
Okusanya, Olanrewaju
U.S. Food and Drug Administration
What Next After Your FIH Dose for T-cell Bispecifics
Olanrewaju Okusanya
Favorite
Olsen, Bernard
Olsen Pharmaceutical Consulting, LLC
Product Registration Control Strategies For Non-Mutagenic Organic Impurities
Bernard Olsen
Favorite
Oprea, Tudor
University of New Mexico School of Medicine
Computer-Aided Drug Repositioning for COVID-19: An Iterative Exercise in Patience and Due Diligence
Tudor Oprea
Favorite
Otey, David
Speaking of Solutions, LLC
Communicating Science, Fast and Slow: A Strategy for Being Heard
David Otey
Favorite
P
Pace, Samantha
Bristol-Myers Squibb Company
Prologue: Novel Drug Delivery Techniques for Biologics
Samantha Pace
Favorite
Packer, Robert
PerkinElmer, Inc.
Roundtable Discussion: Analytical Instrumentation in the Pharma QAQC Lab – Molecular and Atomic Spectroscopy, and Chromatography/Mass Spec.
Robert Packer
Favorite
Panacucci, Rick
QED Therapeutics
Flexible Manufacturing for Pediatric Patients
Rick Panacucci
Favorite
Pasas-Farmer, Stephanie
Ariadne Software, LLC
Artificial Intelligence/Machine Learning : An Emerging Bioanalytical Solution
Stephanie Pasas-Farmer
Favorite
Prologue: A Look into the Future of the LC/MS/MS Bioanalytical Laboratory
Stephanie Pasas-Farmer
Favorite
Symposium: Are you ready for the laboratory of the future?
Stephanie Pasas-Farmer
Favorite
Paskiet, Diane
West Pharmaceutical Services, Inc.
Early Phase Control Strategies for Extractables & Leachables
Diane Paskiet
Favorite
Patel, Dipal
Bristol-Myers Squibb Company
Prologue: Challenging Species Dependent PK/ADMET and Implications of Emerging Tools for Preclinical Development
Dipal Patel
Favorite
Symposium: Challenging Species Dependent PK/ADMET and Implications of Emerging Tools for Preclinical Development
Dipal Patel
Favorite
Patil, Rajesh
LIVE Special Poster Collection — Niche Advances in Drug Delivery – With Dr. Saileta Prabhu and Dr. Rajesh Patil
Rajesh Patil
Favorite
Pattijn, Sofie
ImmunXperts
Technical Challenges and Interference Related To I-O Immunogenicity Assays
Sofie Pattijn
Favorite
Patwardhan, Ketaki
Evonik
Microbiome Based Oral Targeting Formulation- Functional Excipients and Delivery Technologies
Ketaki Patwardhan
Favorite
Paudel, Amrit
Graz University of Technology
Keynote: Integrating Multi-Disciplinary Science For The Hot Melt Extrusion (HME) Process and Product: Towards a Fast Track Road Map From Design To Clinical Batch
Amrit Paudel
Favorite
Pavliak, Viliam (Vilo)
Gates Medical Research Institute
The Case Study on the Development of Multicomponent Glycoconjugate Vaccine
Viliam (Vilo) Pavliak
Favorite
Payne, Joe
Arcturus Therapeutics
Building the Next Generation of RNA Medicines
Joe Payne
Favorite
Peck, Richard
F Hoffmann la Roche Ltd
Precision Dosing for COVID-19: Combining M&S and Real World Data to Optimise Dosing for All Patients
Richard Peck
Favorite
Perettie, Cindy
Foundation Medicine
How To Build A Diverse Organization Where You Work: Advice for Scientists
Cindy Perettie
Favorite
Peterman, Scott
Thermo Fisher Scientific
Software Solutions for Successful Pharmaceutical LC-MS and GC-MS Impurity Analysis, Characterization - and Quality Control
Scott Peterman
Favorite
Piccoli, Steven
SunPharma Advanced Research Center
Start with the Answer and Work Backwards! [the Devious Guide to Biomarker Assay Development and Validation]
Steven Piccoli
Favorite
Poland, Gregory
Mayo Clinic and Foundation
Presentation on COVID-19 with Dr. Gregory Poland
Gregory Poland
Favorite
Polli, Joseph
GlaxoSmithKline
LIVE Special Poster Collection — Hepatoxicity / Liver Metabolism – With Dr. Joe Polli
Joseph Polli
Favorite
Potts, Ryan
Amgen, Inc.
Structural Basis for Substrate Recognition and Chemical Inhibition of Oncogenic MAGE Ubiquitin Ligases
Ryan Potts
Favorite
Poudel, Ishwor
Auburn University
3D-Printed Drug-Loaded Polymeric Implants Using Thermoplastic Extrusion
Ishwor Poudel
Favorite
Prabhu, Saileta
Takeda
LIVE Special Poster Collection — Niche Advances in Drug Delivery – With Dr. Saileta Prabhu and Dr. Rajesh Patil
Saileta Prabhu
Favorite
Prausnitz, Mark
Georgia Institute of Technology
Keynote: Development of Microneedle Technology for Simplified Vaccination, Long-Acting Contraception and Wearable Diagnostics
Mark Prausnitz
Favorite
Prulliere, Frederic
Agilent Technologies
Discover Raw Material ID through Opaque Containers
Frederic Prulliere
Favorite
Puddipeddi, Madhu
Prelude Therapeutics
Symposium: Advances in Process Control, Modeling, and Analytics
Madhu Puddipeddi
Favorite
Purkis, Jessica
Roundtable Discussion: Best Practices for Overcoming CDISC Roadblocks
Jessica Purkis
Favorite
Q
QIAN, JIE
PPD - Richmond, VA
Significant Lot-to-Lot Variability in Multiplex Kits and The Associated Complications
JIE QIAN
Favorite
Quinney, Sara
Indiana University School of Medicine
Real World Evidence for Drug Interactions
Sara Quinney
Favorite
R
Rafidi, Hanine
Genetech
Molecular Structure Affects Kidney Filtration of Biologics
Hanine Rafidi
Favorite
Rahman, Ziyaur
Texas A&M University
Selective Laser Sintering 3D Printing Method for Pharmaceuticals Manufacturing
Ziyaur Rahman
Favorite
Raines, Kimberly
US FDA
Risk to Quality and Structured Biopharmaceutics Assessment
Kimberly Raines
Favorite
Raju, Vijay
Novartis
Digital Lab – a Human Centric Design Approach to Enable Modeling and Predictive Analytics
Vijay Raju
Favorite
Ramakrishna, Sujatha
U.S. Pharmacopeia (USP)
Roundtable Discussion: Pharmaceutical Industry’s Role in USP Monograph Development
Sujatha Ramakrishna
Favorite
Ramamoorthy, Anuradha
U.S. Food and Drug Administration
Prologue: Integrating Big Data and Real World Evidence in Clinical Pharmacology
Anuradha Ramamoorthy
Favorite
Symposium: Clinical Pharmacology Driving Innovative Trial Design
Anuradha Ramamoorthy
Favorite
Raney, Sam
U.S. Food and Drug Administration
Bioequivalence of Complex Topical Generics: In Vitro & in Vivo
Sam Raney
Favorite
Raw, Andre
US FDA
Overview of KASA and Risk to Quality and Structured Product Assessment Initiatives
Andre Raw
Favorite
Rayner, Craig
Certara
Prologue: The Role of MIDD in Drug Development for COVID
Craig Rayner
Favorite
Symposium: Model Informed Drug Development: 2020 and Beyond
Craig Rayner
Favorite
Repka, Michael
University of Mississippi
Hot Topic: 3D Printing in Advanced Drug Delivery
Michael Repka
Favorite
Reynolds, Kellie
Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, OTS, CDER, FDA
Keynote: From Ebola to COVID-19 – The Global Impact of Clinical Pharmacology in the Development of Investigational Drugs During Infectious Disease Outbreaks
Kellie Reynolds
Favorite
Reza, Syed
NOF Corporation
Self-Adjuvating Lipid Nanoparticle mRNA Vaccine Elicits T-Cell Responses and Protects Against Immune Challenge
Syed Reza
Favorite
Rhodes, David
Finch Therapeutics Group
Product Development for Microbiome Therapeutics – Concepts for a New Paradigm
David Rhodes
Favorite
Riccardino, Giulia
Thermo Fisher Scientific
Comprehensive GC-MS and LC-MS Solutions to Meet the Needs for Confident and Compliant Analysis of Nitrosamine Impurities
Giulia Riccardino
Favorite
Richardson, Norman
BASF
Lipid-based Excipients for Skin Permeation by In Vitro Permeation Studies
Norman Richardson
Favorite
Rieg, Timo
University of South Florida
SGLT2 Inhibitors
Timo Rieg
Favorite
Rivera, Brian
Phenomenex
Method Development Strategies for Protein Characterization by Intact/Subunit HPLC
Brian Rivera
Favorite
Roberts, Brian
EpiVax, Inc.
Addressing Immunogenicity of Impurities for Peptide Accelerated New Drug Applications
Brian Roberts
Favorite
What Contributes to Immunogenicity? The API, Formulation, or the Impurities?
Brian Roberts
Favorite
Rogalski-Salter, Taryn
Gates Medical Research Institute
Global Licensure Strategy
Taryn Rogalski-Salter
Favorite
Ronaldson, Patrick
University of Arizona College of Medicine
Keynote: The Permeability of the Blood-Brain Barrier to Peptides, Regulatory Proteins, and Antisense: Physiological Foundations and Pharmacological Implications
Patrick Ronaldson
Favorite
Symposium: Taming the Blood-Brain-Barrier in CNS Drug Discovery
Patrick Ronaldson
Favorite
Transporter-Mediated Delivery of Small Molecules Across the Blood-Brain Barrier
Patrick Ronaldson
Favorite
Rutkove, Seward
Harvard Medical School
Keynote: Biomarkers of Muscle and Nerve Health: In and Out of the Box
Seward Rutkove
Favorite
S
Sadekar, Shraddha
Genentech-Roche
Delivery of Biologics to the Brain
Shraddha Sadekar
Favorite
Keynote: Translational Sciences in CAR T-cell Therapies: Staying the Course for Success
Shraddha Sadekar
Favorite
Symposium: Translational PKPD of Gene & Cell Therapy
Shraddha Sadekar
Favorite
Sailes, Helen
Bristol Myers Squibb
Keynote: New Modalities, Transitions in Routes of Administration and Needs in Drug Delivery & Analytics
Helen Sailes
Favorite
Symposium: Manufacturing and Analytical Challenges of Emerging Therapeutic Modalities and Novel Delivery Systems
Helen Sailes
Favorite
Salem, Aliasger
University of Iowa
Keynote: Biodegradable Polymeric Particles as Adjuvant and Vaccine Delivery Systems
Aliasger Salem
Favorite
Salian, Vrishali
University of Minnesota
Molecular Mechanisms of Cerebrovascular Inflammation in Alzheimer’s Disease
Vrishali Salian
Favorite
Salphati, Laurent
Genentech, Inc.
Humanized Transporter Models - Overview and Prospects
Laurent Salphati
Favorite
San Luis, Yanyn
The Win Woman
Negotiate Like a Boss
Yanyn San Luis
Favorite
Sanchez-Felix, Manuel
Novartis
Keynote: New Modalities, Transitions in Routes of Administration and Needs in Drug Delivery & Analytics
Manuel Sanchez-Felix
Favorite
Sanduja, Sandhya
U.S. Food and Drug Administration
Regulatory Considerations and Expectations for Translational PKPD Aspects of Cell and Gene Therapies
Sandhya Sanduja
Favorite
Sansare, Sameera
University of Connecticut
Artificial Neural Network as Predictive Tool for Continuous Liposomes Processing
Sameera Sansare
Favorite
Scherder, Tara
SynoloStats
Statistical Solutions for Cell and Gene Therapy Data Challenges
Tara Scherder
Favorite
Methods for Specification Determination with Small Sample Sizes
Tara Scherder
Favorite
Schiel, John
National Institute of Standards and Technology (NIST)
Mass Spectrometry as a Disruptive Technology for CGT Analytics
John Schiel
Favorite
Schlesinger, Erica
Seran Biosciences
LIVE Special Poster Collection — Gene Therapy Drug Delivery – With Dr. Annette Bak
Erica Schlesinger
Favorite
Schmidt, Stephan
University of Florida
Bridging the Gap Between in Vitro, Animal, and Human via Modeling and Simulation
Stephan Schmidt
Favorite
Schoneker, David
Black Diamond Regulatory Consulting
Untangling the Confusion About What Excipient Suppliers and Users Need to Know About Nitrosamines and Excipients
David Schoneker
Favorite
Schulz, Wade
Yale School of Medicine
Keynote: Crypto for Healthcare: Transparent End-to-End Data Integrity with Blockchain
Wade Schulz
Favorite
Schuster, Joachim
Lonza Drug Product Services
In Vivo Protein Stability - What Happens After Administration?
Joachim Schuster
Favorite
Scotcher, Daniel
University of Manchester
Physiologically-Based Modelling Creatinine-Drug Interactions Via Renal-Transporters in Health and Disease
Daniel Scotcher
Favorite
Scott, Lisa
Accentuate
Conquer the Curse of Knowledge and Build Better Bridges
Lisa Scott
Favorite
Cruising to Clear Speech: Navigate Your Way to Successful Speaking
Lisa Scott
Favorite
Shah Brown, Ami
Inovio Pharmaceuticals
Rapid Advancement of a COVID-19 Vaccine into Phase 1 Clinical Testing: Leveraging a Platform Technology
Ami Shah Brown
Favorite
Shah, Rakhi
US FDA
Risk to Quality and Structured Manufacturing Assessment
Rakhi Shah
Favorite
Shah, Ronak
Bristol Myers Squibb
Industry User Perspective: Overview of PLGA’s Composition and Characterization Used for Formulation Development
Ronak Shah
Favorite
Shakleya, Diaa
US Food and Drug Administration
Regulated Bioanalysis: Requirements and Expectations
Diaa Shakleya
Favorite
Shanmugam, Srinivasan
Adare Pharmaceuticals, Inc.
Patient-Centric Dosage Forms: Strategies for Compliance in Special Populations
Srinivasan Shanmugam
Favorite
Sharma, Amar Deep
University of Missouri-Kansas City
Exploring Off The Label Usage of Drugs Through Pharmacovigilance
Amar Deep Sharma
Favorite
Rapid Fire: Novel Therapeutic Modalities - Clinical Pharmacology Considerations
Amar Deep Sharma
Favorite
Sheehan, Catherine
U.S. Pharmacopeia (USP)
Latest Developments in Excipients That are Relevant to Formulation, Analytical and Manufacturing: Overview of Excipient GMPs and Supplier Qualification (Ticketed Event)
Catherine Sheehan
Favorite
Shen, Jim
Bristol-Myers Squibb Company
Bioanalytical Laboratory Automation: Where We Came From, Where We Are ,and Where We Are Going?
Jim Shen
Favorite
Shepard, Kimberly
Lonza
Methanol-Assisted Secondary Drying to Accelerate Residual-Solvent Removal in Spray-Dried Polymers
Kimberly Shepard
Favorite
Shih, Mack
US Food and Drug Administration
Chemical and Conformational Stability of Biotherapeutics: An Innovative Approach
Mack Shih
Favorite
Shinde, Vaishali
Millennium: The Takeda Oncology Company
Assessment of Novel Technology For High-Plex Immuno-Profiling of Human Biopsies
Vaishali Shinde
Favorite
Shivva, Vittal
Genentech, Inc.
Prologue: Introduction to Cell and Gene Therapies
Vittal Shivva
Favorite
Sidwell, Richard
Recro
Developing Modified Release Versions of Immediate Release Solid Dosage Forms
Richard Sidwell
Favorite
Sikkema, Dan
Quanterix Corporation
The Most Sensitive Immunoassay Just Got More Sensitive: How a 100-fold Increase in Sensitivity of Simoa Was Achieved
Dan Sikkema
Favorite
Silva, Joshua
University of Southern California
Novel Pharmacotherapy Combination Targeting Alcohol Abuse and Alcoholic Liver Disease
Joshua Silva
Favorite
Silver, Pamela
Department of Systems Biology, Harvard Medical School
Designing Living Diagnostics and Therapeutics
Pamela Silver
Favorite
Simkins, Anita
BioAgilytix Labs, L.L.C
Is Your Bioanalytical Lab Ready for a Pandemic?
Anita Simkins
Favorite
Simmons, Erica .
B2S Life Sciences
Utilizing Octet Platform for Characterizing Critical Reagents in Support of Drug Development for Contemporary Biotherapeutics
Erica . Simmons
Favorite
Sinha, Vikram
Merck & Co., Inc.
Keynote: The Next Decade in Clinical Pharmacology: Do We Re-invent Ourselves?
Vikram Sinha
Favorite
Sinko, Balint
Pion Inc.
The Absorption Driven Drug Formulation Concept
Balint Sinko
Favorite
Smith, David
University of Michigan, College of Pharmacy
Concerted Optimization by PEPT2 and PHT1 for the Uptake of Bacterial Ligands into the Cytosol of Macrophages
David Smith
Favorite
Smith, Ebony
Ebony Smith & Associates, Inc.
Essential Coaching Skills for Leaders
Ebony Smith
Favorite
Smith, Pamela
Improved Pharma, LLC
Synchrotron-Based Formulation Development
Pamela Smith
Favorite
Smyth, Hugh
University of Texas at Austin
Important Development Considerations in the Delivery of Nucleic Acids and Proteins to the Respiratory Tract
Hugh Smyth
Favorite
Song, BenBen
Pall Biotech
Roundtable Discussion: Analytical Advances in Detecting, Quantifying and Monitoring Extractables / Leachables From Single-use Systems
BenBen Song
Favorite
Sood, Anil
MD Anderson Cancer Center
Overcoming Obstacles in RNAi Therapy: From Nanoliposomes to Extracellular Vesicles
Anil Sood
Favorite
Staack, Roland
Roche Pharma Research and Early Development
Comparability of Immunogenicity Assays. Wishful Thinking or Achievable Goal?
Roland Staack
Favorite
Stamoran, Cornell
Catalent, Inc.
Patient-Focused Drug Design: A Structured Approach to Dose Form Design
Cornell Stamoran
Favorite
Stanimirovic, Danica
National Research Council of Canada
Engineering and Pharmacology of Blood-Brain Barrier-Crossing Antibodies
Danica Stanimirovic
Favorite
Stegemann, Sven
Graz University of Technology
Keynote: Advances in Dosage Form Design for Biologics
Sven Stegemann
Favorite
Keynote: Dosage Form Development Challenges for Advanced Therapeutic Medicinal Products
Sven Stegemann
Favorite
Keynote: Formulation Development Challenges For New Vaccine Candidates Targeted For Use In Low- and Middle-Income Countries
Sven Stegemann
Favorite
Keynote: Integrating Multi-Disciplinary Science For The Hot Melt Extrusion (HME) Process and Product: Towards a Fast Track Road Map From Design To Clinical Batch
Sven Stegemann
Favorite
Keynote: Regulatory Perspectives on Drug-Device Combination Products
Sven Stegemann
Favorite
Symposium: Advances and Innovation in Formulation Development
Sven Stegemann
Favorite
Symposium: Drug Delivery and Device Development
Sven Stegemann
Favorite
Symposium: Formulation Development Challenges for Emerging Modalities
Sven Stegemann
Favorite
Steiner, Richard
GEA Process Engineering N.V.
Prologue: Advances in Process Control, Modeling, and Analytics
Richard Steiner
Favorite
Stevenson, Lauren
Immunologix Laboratories
Be Specific - Biomarker Assay Validation in Context: Bringing COU into Practice (Part 4) (Ticketed Event)
Lauren Stevenson
Favorite
Be Specific - Biomarker Assay Validation in Context: Foundations of Context of Use (Part 1) (Ticketed Event)
Lauren Stevenson
Favorite
Closing Remarks
Lauren Stevenson
Favorite
Common Challenges in the Real World
Lauren Stevenson
Favorite
Introduction: Setting the Stage for COU
Lauren Stevenson
Favorite
Keynote: Biomarkers of Muscle and Nerve Health: In and Out of the Box
Lauren Stevenson
Favorite
Strelow, John
Eli Lilly and Company
The Role of Kinetics in The Interpretation and Improvement of Target Engagement for Covalent Drug Discovery Efforts
John Strelow
Favorite
Subramaniam, Prasad
Bristol Myers Squibb
Rapid Fire: Drug Delivery and Devices Development
Prasad Subramaniam
Favorite
Subramanyam, Meena
Takeda
LIVE Special Poster Collection — Biomarker, Utility, Experimental – With Dr. Meena Subramanyam
Meena Subramanyam
Favorite
Sukumaran, Siddharth
Janssen R&D
Prologue: Introduction to Local Delivery of Biopharmaceuticals
Siddharth Sukumaran
Favorite
Symposium: Design & Development Considerations for Local Delivery of Biopharmaceuticals
Siddharth Sukumaran
Favorite
Suman, Julie
Next Breath, a division of Aptar Pharma
Intranasal Immunization: Promises and Challenges
Julie Suman
Favorite
Surapaneni, Sekhar
Bristol Myers Squibb
A Practical Example: The Ozanimod Experience
Sekhar Surapaneni
Favorite
Svanbäck, Sami
Solubility Company
Redefining Early-Stage Physicochemical Measurement
Sami Svanbäck
Favorite
Svilenov, Hristo
Technical University of Munich
Refoldability and Aggregation During Long-term Storage of Therapeutic Antibodies
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Swanson, Michael
Merck & Co Inc
Critical Quality Attributes: Establishing Biologically Relevant Thresholds/controls During Process Development
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MHC-Class II Presentation of Modified Peptides from a Monoclonal Antibody
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Tang, Huaping
Merck & Co., Inc.
Rapid Fire: Preclinical Development of Novel Therapeutic Modalities and Approaches
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Tannenbaum, Stacey
Astellas Pharma Global Development
Prologue: The Role of MIDD in Drug Development For Clinical Bridging and Alternate Dosing
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Symposium: Model Informed Drug Development: 2020 and Beyond
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Terry, Frances
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Rapid Fire: Advances in Preclinical Development of Immuno-Therapeutics
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Terry, Linda
GlaxoSmithKline plc
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Evolving Team Mindset to Meet COU
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Thakkar, Shraddha
US Food and Drug Administration
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Thakkar, Shraddha
US FDA/CDER/OTS/OCS
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Thomas, Saji
Par pharmaceuticals and endo international company
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Thompson, Christopher
Novartis
Non-Clinical ADME-Tox Profiling of Gene Therapy
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Thompson, Emily
CRB
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Tice, Tom
Evonik
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Timmerman, Philip
EBF
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Tong, Weida
US Food and Drug Administration
AI for Regulatory Science Research at FDA
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Traverso, Giovanni
Massachusetts Institute of Technology
Novel Devices for Oral Delivery of Macromolecules
Giovanni Traverso
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Smart Devices for Oral Delivery of Biologics
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Trimm, Kevin
Certara
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Tse, Francis
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Emerging Therapeutic Modalities: Challenges and Considerations in Developing Successful Programs
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Tsume, Yasuhiro
Merck & Co., Inc.
GI Physiology and Condition to in Vitro Dissolution Methodologies as Intro
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Tzvetkov, Mladen
University of Greifswald
OCT1 as an Emerging Transporter
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Ullmann, Martin
Fresenius Kabi
Biomolecular Assay Automation: The Past, the Present, and the Future
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Unadkat, Jashvant
University of Washington
Keynote: Past, Present, and Future of Transporters
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Vaidyanathan, Jaya
FDA
Prologue: Clinical Pharmacology of Novel Modalities
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Vale, Nobel
Bristol-Myers Squibb Company
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van de Merbel, Nico
PRA Health Sciences
Recent Developments in LC-MS-based Bioanalysis of Biopharmaceutical Drugs
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van der Graaf, Piet
Certara
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BASF
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PRA Health Sciences
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