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On Demand
Prologue: Using Potency Readouts to Establish Critical Quality Attributes and Inform Vector Characterization Priorities
Location: Online Only
Prologue Speaker: Hangtian Song, PhD – Bristol-Myers Squibb Company
Manufacturing & Analytical Characterization
On Demand
Prologue: Big Data Approaches to Understanding Particle Properties
Location: Online Only
Prologue Speaker: Mike Tobyn, PhD (he/him/his) – Bristol Myers Squibb
Manufacturing & Analytical Characterization
On Demand
Prologue: Flexible Manufacturing at Merck
Location: Online Only
Prologue Speaker: Anna Jenks (she/her/hers) – Merck & Co., Inc. - Rahway NJ
Manufacturing & Analytical Characterization
On Demand
Prologue: LNP's: Formulations that Pushed Back COVID-19
Location: Online Only
Prologue Speaker: Rajiv Nayar, PhD – HTD Biosystems Inc.
Manufacturing & Analytical Characterization
On Demand
Prologue: Mechanistic Models in Manufacturing
Location: Online Only
Prologue Speaker: Indrajit Jagtap (he/him/his) – Intelimek LLC
Manufacturing & Analytical Characterization
On Demand
Prologue: Regulatory Considerations for Continuous Manufacturing
Location: Online Only
Prologue Speaker: Scott M. Krull, PhD (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:00 AM – 10:00 AM MT
Stability and Palatability of Flavor Excipients--A Winning Combination for Veterinary Drug Formulation
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker: Darcy L. Forber, DVM, CVA, CVCH (she/her/hers) – Pet Flavors
Partner Presentation Speaker: Scott Karolchyk, MS, RPh, FAPC – Pet Flavors
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
9:00 AM – 11:00 AM MT
Symposium: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 1
Location: 155 E, Salt Palace Convention Center
Moderator: Sai Chamarthy
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:00 AM – 11:00 AM MT
Symposium: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 2
Location: 155 F, Salt Palace Convention Center
Moderator: Michael Lowinger, PhD (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:00 AM – 9:30 AM MT
Accelerating Development of Vaccines for Low- and Middle-Income Countries
Location: 155 F, Salt Palace Convention Center
Speaker: Alex Langford, MS – Pfizer Inc
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:00 AM – 9:30 AM MT
Digital Toolbox for Advanced Continuous Pharmaceutical Manufacturing
Location: 155 E, Salt Palace Convention Center
Speaker: Ravendra Singh, PhD (he/him/his) – Rutgers University
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:30 AM – 10:00 AM MT
Developing Robust Lyophilization Processes for Biopharmaceuticals through Process Understanding
Location: 155 F, Salt Palace Convention Center
Speaker: Brecht Vanbillemont, PhD – Coriolis Pharma Research GmbH
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:30 AM – 10:00 AM MT
Perspectives of the State of Continuous Manufacturing of Pharmaceuticals
Location: 155 E, Salt Palace Convention Center
Speaker: David Acevedo, PhD (he/him/his) – FDA
Manufacturing & Analytical Characterization
Monday, Oct 21st
10:00 AM – 10:30 AM MT
GMP-Ready Continuous & Controlled Pharmaceutical Freeze-Drying
Location: 155 F, Salt Palace Convention Center
Speaker: Thomas De Beer, PhD – Ghent University
Manufacturing & Analytical Characterization
Monday, Oct 21st
10:00 AM – 10:30 AM MT
Integrated Continuous Drug Substance Manufacturing from Biomass-Derived Building Blocks
Location: 155 E, Salt Palace Convention Center
Speaker: Torsten Stelzer, PhD (he/him/his) – University of Puerto Rico
Manufacturing & Analytical Characterization
Monday, Oct 21st
10:30 AM – 11:00 AM MT
Development of Spray Drying Processes Grounded on Innovative Approaches
Location: 155 F, Salt Palace Convention Center
Speaker: Clara Sa Couto, PhD (she/her/hers) – HOVIONE FARMACIENCIA S.A.
Manufacturing & Analytical Characterization
Monday, Oct 21st
9:30 AM – 10:30 AM MT
Speaker Spotlight: Managing Solid Form Transformation in Drug Product: Analytical & Biopharmaceutical Considerations
Location: Spotlight Stage B, Aisle 1100, Exhibit Hall
Spotlight Speaker: Umesh Kestur, PhD – Bristol-Myers Squibb Company
Moderator: Sai Chamarthy
Manufacturing & Analytical Characterization
Monday, Oct 21st
11:00 AM – 12:00 PM MT
Oligo mapping of Large RNA Therapeutics by Novel Enzyme Specificities
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Bala Addepalli, Ph.D. – Waters Corporation
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
11:15 AM – 12:00 PM MT
Beyond Classification: Combining AI and Particle Imaging to Analyze Shifts in Particle Morphology
Location: Spotlight Stage C, Aisle 2800, Exhibit Hall
Chalk Talk Presenter: Eric Gottlieb – SentrySciences, Inc.
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
11:15 AM – 12:00 PM MT
Case study: Leveraging Hot Melt Extrusion to Improve Bioavailability, Reduce Pill Burden, and Increase Shelf Life
Location: Spotlight Stage B, Aisle 1100, Exhibit Hall
Chalk Talk Presenter: Sebastien Branchu, PhD – AbbVie Inc.
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
12:00 PM – 1:00 PM MT
Navigating Complexities: Overcoming Multi-Level Challenges in Modern Chromatography Labs
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker: Cornelia Vad – Agilent Technologies
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
12:30 PM – 1:30 PM MT
Analytical Strategies for Complete Characterization and Purification of Synthetic Oligonucleotides
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Parul Angrish, PhD – Agilent
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
1:30 PM – 2:30 PM MT
Keynote: Unveiling Potential: A SWOT Analysis of Innovation in Manufacturing and Analytical Characterization
Location: 155 E, Salt Palace Convention Center
Keynote Speaker: Rodolfo Pinal, Ph.D. – Purdue University
Moderator: Sai Chamarthy
Manufacturing & Analytical Characterization
Monday, Oct 21st
1:30 PM – 2:30 PM MT
Keynote: Zero Waste Sustainable Pharmaceutical Manufacturing
Location: 155 F, Salt Palace Convention Center
Keynote Speaker: Shweta Singh, PhD (she/her/hers) – Purdue University
Moderator: Michael Lowinger, PhD (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 21st
1:30 PM – 2:30 PM MT
NDSRI Risk Assessment and Trace-Level Analysis of N-Nitrosamines
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker: Moritz Perscheid – LGC
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
2:00 PM – 3:00 PM MT
Hydroxypropyl Beta-Cyclodextrin as a Safer Alternative for Viral Inactivation in Bioprocessing
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Shiqi Hong, PhD (she/her/hers) – Roquette
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
2:00 PM – 3:00 PM MT
Sustainable Innovation for Manufacturing Amorphous Solid Dispersions
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker: Adi Kaushal
Manufacturing & Analytical Characterization
Sponsored By
Monday, Oct 21st
3:00 PM – 4:00 PM MT
Rapid Fires: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 1
Location: 155 E, Salt Palace Convention Center
Rapid Fire Moderator: Parind M. Desai, PhD – GSK
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:00 PM – 4:00 PM MT
Rapid Fires: Innovation in Pharmaceuticals/Biopharmaceuticals Manufacturing and Characterization 2
Location: 155 F, Salt Palace Convention Center
Rapid Fire Moderator: Kevin Gurney, Ph.D. (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:00 PM – 3:15 PM MT
Advance to Primary Drying Directly After Annealing Without Re-Freezing
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Gregory A. Sacha, Ph.D. – Simtra BioPharma Solutions
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:00 PM – 3:15 PM MT
Establishing a Harmonized Physicochemical Profiling Platform for Therapeutic Oligonucleotides
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Kohsaku Kawakami, Ph.D. (he/him/his) – National Institute for Materials Science
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:15 PM – 3:30 PM MT
N-glycan Analysis of Protein Therapeutics to Support Real-Time Sialylation Monitoring
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Ferdoushi Akter, Ph.D. – Merck
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:15 PM – 3:30 PM MT
Probing Molecular Packing of Amorphous Pharmaceutical Solids
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Zhenxuan Chen, PhD (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:30 PM – 3:45 PM MT
Characterization of Forced-Degraded Antibodies Using Advanced Analytics for Higher-Order Structure-Assessment
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Nithya Srinivasan, PhD – Amgen
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:30 PM – 3:45 PM MT
LDIR Imaging: Track Evolution of Polymorphic Transformation of Ritonavir Tablets
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Yeakub Zaker, PhD (he/him/his) – U S Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:45 PM – 4:00 PM MT
Characterization of Particles from Nonprescription Spray Drug Products
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Lucy Nandy, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:45 PM – 4:00 PM MT
Performance Verification in Dissolution Testing: An Exploration in Apex Vessels
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Li Tian, PhD (she/her/hers) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:30 PM – 4:30 PM MT
Hot Topic: Advancements and Challenges in Oral Peptide Delivery with Permeation Enhancers
Location: 155 A, Salt Palace Convention Center
Hot Topic Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:30 PM – 3:50 PM MT
Advances and Challenges in Oral Peptide Delivery
Location: 155 A, Salt Palace Convention Center
Hot Topic Speaker: Stephen T. Buckley, PhD (he/him/his) – Novo Nordisk A/S
Manufacturing & Analytical Characterization
Monday, Oct 21st
3:50 PM – 4:10 PM MT
Interesting Biopharmaceutics Questions from Development of an Oral Macrocyclic Peptide
Location: 155 A, Salt Palace Convention Center
Hot Topic Speaker: Filippos Kesisoglou, Ph.D. (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 21st
4:10 PM – 4:30 PM MT
Impact of Absorption Region on Permeation Enhancer-Based Oral Peptide Delivery System: A Case Study
Location: 155 A, Salt Palace Convention Center
Hot Topic Speaker: Siyuan Huang, PhD (he/him/his) – Eli Lilly and Company
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:00 AM – 10:00 AM MT
Characterization of Single Use System Components for Extractables & Leachables
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker: Eric Hill, MS MBA – BA Sciences
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Oct 22nd
9:00 AM – 10:00 AM MT
Hot Topic: Phase-Appropriate Strategies for Gene and Cell Therapy Regulatory Compliance
Location: 155 A, Salt Palace Convention Center
Hot Topic Speaker: Allison Radwick, RPh, PhD (she/her/hers) – USP
Hot Topic Moderator: Rajiv Nayar, PhD – HTD Biosystems Inc.
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:00 AM – 11:00 AM MT
Symposium: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 1
Location: 155 E, Salt Palace Convention Center
Speaker: Scott M. Krull, PhD (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:00 AM – 11:00 AM MT
Symposium: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 2
Location: 155 F, Salt Palace Convention Center
Moderator: Indrajit Jagtap (he/him/his) – Intelimek LLC
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:00 AM – 9:30 AM MT
A Semi-Mechanistic Model for Wet Bead Milling of Pharmaceutical Nanosuspensions
Location: 155 F, Salt Palace Convention Center
Speaker: Gulenay Guner, PhD – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:00 AM – 9:30 AM MT
Biopharmaceutical Manufacturing 4.0
Location: 155 E, Salt Palace Convention Center
Speaker: Anurag Singh Rathore, PhD – Indian Institute of Technology
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:30 AM – 10:00 AM MT
A Framework Enabling Large Language Models into Regulatory Environment
Location: 155 BC, Salt Palace Convention Center
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:30 AM – 10:00 AM MT
Leveraging Simulations to Analyze and Predict Device Injection Time
Location: 155 F, Salt Palace Convention Center
Speaker: Julien Singer, PhD (he/him/his) – BD
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
10:00 AM – 10:30 AM MT
Combining Machine Learning and Simulation for OSD Manufacturing Process Optimization
Location: 155 E, Salt Palace Convention Center
Speaker: Stefan Pantaleev, MEng – Altair Engineering
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
10:00 AM – 10:30 AM MT
Virtual Prototyping of Powder Blender Scale-Up and Shell Design
Location: 155 F, Salt Palace Convention Center
Speaker: Luca Orefice, PhD (he/him/his) – MercuryLAB
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
10:30 AM – 11:00 AM MT
Using AI to Evaluate GMP Health of Drug Manufacturing Sites
Location: 155 E, Salt Palace Convention Center
Speaker: Jerry L. Chapman, BS (he/him/his) – Redica Systems
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
10:30 AM – 11:00 AM MT
Using Big Data Analysis to Better Characterize Excipient Variability
Location: 155 F, Salt Palace Convention Center
Speaker: Pauline H.M Janssen, PhD (she/her/hers) – Groningen University / DFE Pharma GmbH & Co. KG
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
9:30 AM – 10:30 AM MT
Risk in Pharmaceutical Quality: Role of the Documentary and Reference Standard. Case Studies.
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Naiffer Romero, MSc, MPH (he/him/his) – US Pharmacopeia
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Oct 22nd
9:30 AM – 10:30 AM MT
Role of Key Raw Materials in Improving Yield and Safety in Biomanufacturing
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker: Sreejit Menon – Croda Inc.
Partner Presentation Speaker: Garima Sinha, PhD – Croda Pharma
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Oct 22nd
11:00 AM – 12:00 PM MT
Integrated Lifecycle Approach for Deterministic Container Closure Integrity in Biopharmaceuticals
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Jennifer L. Riter, MBA – Kindeva Drug Delivery
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Oct 22nd
12:00 PM – 1:00 PM MT
Extractable Leachable Analysis from Standardized Chromatography to Mass Spectral Databases
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker: David A. Weil, PhD (he/him/his) – Agilent
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Oct 22nd
1:30 PM – 2:30 PM MT
Keynote: Digital Transformation: A Look Ahead at Unlocking Productivity
Location: 155 E, Salt Palace Convention Center
Keynote Speaker: Kevin Macias, Doctor of Philosophy – Eli Lilly
Moderator: Sai Chamarthy
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
1:30 PM – 2:30 PM MT
Keynote: Digital Transformation: A Paradigm Shift in Pharmaceutical Manufacturing
Location: 155 F, Salt Palace Convention Center
Keynote Speaker: Mohan Boggara, PhD – Sanofi
Moderator: Indrajit Jagtap (he/him/his) – Intelimek LLC
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
2:30 PM – 3:30 PM MT
Speaker Spotlight: Lifecycle Management Strategies for Liposomal Formulations
Location: Spotlight Stage B, Aisle 1100, Exhibit Hall
Spotlight Speaker: R. Jayachandra Babu, Ph.D. (he/him/his) – Auburn University
Moderator: Amit K. Tiwari, Ph.D.
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:00 PM – 4:00 PM MT
Rapid Fires: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 1
Location: 155 E, Salt Palace Convention Center
Rapid Fire Moderator: Li Tian, PhD (she/her/hers) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:00 PM – 4:00 PM MT
Rapid Fires: Digital Tools to Accelerate Drug Development, Manufacturing and Analysis 2
Location: 155 F, Salt Palace Convention Center
Rapid Fire Moderator: Parind M. Desai, PhD – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:00 PM – 3:15 PM MT
Application of AI/ML for Risk Assessment of ASOs Aggregation
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Mack Shih, Ph.D. – FDA
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:00 PM – 3:15 PM MT
Predicting in-vitro Dissolution Performance via Optical Porosity Measurement
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Andreas Kottlan, PhD (he/him/his) – Research Center Pharmaceutical Engineering GmbH
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:15 PM – 3:30 PM MT
Contamination Detection of CHO-Cell-Culture Using Capacitance Spectroscopy and Flow-imaging Microscopy
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Mahdi Mubin Shaikat, MS – Duquesne University School of Pharmacy - Graduate School of Pharmaceutical Scien
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:15 PM – 3:30 PM MT
Streamlining Loss-in-Weight Feeding Process Development Using Predictive Tools
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: João Henriques, MS – Hovione PharmaScience SA
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:30 PM – 3:45 PM MT
Monitoring Upstream Biomanufacturing Processes from Their Internal Cellular Metabolic Activity
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Nicholas Trunfio, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:30 PM – 3:45 PM MT
Rapid in-line Process Analysis of Physical Tablet Properties with THz-TDS
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Moritz Anuschek, M.S. – Novo Nordisk AS
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:45 PM – 4:00 PM MT
Bioreactor Analyte Characterization and Intracellular Metabolite Modeling for Understanding Impacts
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: David N. Powers, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 22nd
3:45 PM – 4:00 PM MT
Quality by Design in the Continuous Manufacturing of Oral Films
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Leonie-Lara Dorothea Uth – Heinrich Heine University Düsseldorf
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:00 AM – 11:00 AM MT
Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 1
Location: 155 E, Salt Palace Convention Center
Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:00 AM – 11:00 AM MT
Symposium: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 2
Location: 155 F, Salt Palace Convention Center
Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:00 AM – 9:30 AM MT
Advanced Applications of Infrared and Raman Spectroscopy in Pharmaceutical Characterization
Location: 155 E, Salt Palace Convention Center
Speaker: Huzeyfe Yilmaz, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:00 AM – 9:30 AM MT
Data Control and Data Security Management in Pharmaceutical Quality Assurance
Location: 155 F, Salt Palace Convention Center
Speaker: Kim Huynh-Ba, M.S., PMP, FAAPS – Pharmalytik
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:30 AM – 10:00 AM MT
Advances in PAT for Steriles Drug Product Manufacturing
Location: 155 E, Salt Palace Convention Center
Speaker: Parind M. Desai, PhD – GSK
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
9:30 AM – 10:00 AM MT
Apply Various Model Systems for Comprehensive Risk Assessment of Aggregates
Location: 155 F, Salt Palace Convention Center
Speaker: Cathie (Dong) XIANG, Master (she/her/hers) – Amgen Inc
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:00 AM – 10:30 AM MT
Distributed Manufacturing: Personalization of 3DPrinted Intravaginal-Rings by Droplet Deposition Modeling
Location: 155 F, Salt Palace Convention Center
Speaker: Ahmed S. Zidan, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:00 AM – 10:30 AM MT
Leveraging Synchrotron Tomography Analysis to Engineer Better Spray Dried Particles
Location: 155 E, Salt Palace Convention Center
Speaker: Tatiana Marcozzi, MA – Johnson and Johnson Innovative Medicine
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:30 AM – 11:00 AM MT
A Game-Changing Quality Control Strategy: The Multi-Attribute Method
Location: 155 E, Salt Palace Convention Center
Speaker: Kevin Carrick, PhD (he/him/his) – United States Pharmacopeia
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:30 AM – 11:00 AM MT
Personalized Transdermal Patches: Adhesion Testing Using Innovative Skin Mimetic Substrates
Location: 155 F, Salt Palace Convention Center
Speaker: Mandip Singh sachdeva, PhD, FAAPS – Florida A & M University
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:00 AM – 11:00 AM MT
Speaker Spotlight: Overcoming Challenges in Manufacturing and Scale-up of CGT (Cell and Gene Therapy)
Location: Spotlight Stage B, Aisle 1100, Exhibit Hall
Spotlight Speaker: Raghu Malapaka, PhD – AGC Biologics
Moderator: Sai Chamarthy
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
10:30 AM – 11:30 AM MT
Analytical Method Advances in Measuring Nitrites in Pharmaceutical Excipients
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker: Koudi Zhu, MS – IFF Pharma Solutions
Manufacturing & Analytical Characterization
Sponsored By
Wednesday, Oct 23rd
1:30 PM – 2:30 PM MT
Keynote: Challenges with New Modalities: Hitting the Stride from Day 1
Location: 155 F, Salt Palace Convention Center
Keynote Speaker: Jennifer Chadwick, PhD – Jennifer Chadwick
Moderator: Anuji Abraham, PhD – Bristol-Myers Squibb Company
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
1:30 PM – 2:30 PM MT
Keynote: Innovation Through Advanced Manufacturing: What We Can Learn From the Future
Location: 155 E, Salt Palace Convention Center
Keynote Speaker: Xiaoming Xu, PhD (he/him/his) – US Food and Drug Administration
Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:00 PM – 4:00 PM MT
Rapid Fires: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 1
Location: 155 E, Salt Palace Convention Center
Rapid Fire Moderator: Kevin Gurney, Ph.D. (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:00 PM – 4:00 PM MT
Rapid Fires: Challenges and Lessons Learned in Commercializing (Manufacturing and Product Quality Analysis) Novel Modalities 2
Location: 155 F, Salt Palace Convention Center
Rapid Fire Moderator: Li Tian, PhD (she/her/hers) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:00 PM – 3:15 PM MT
Collison-Induced-Unfolding for Stability and Similarity of Biotherapeutics/Biosimilars, Where We Are?
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Mack Shih, Ph.D. – FDA
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:00 PM – 3:15 PM MT
Tiny Trojans: Recent Progress on Drug Nanocrystals as Highly-Loaded Nanovectors
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Alejandro J. Paredes, Ph.D. – Queen's University Belfast
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:15 PM – 3:30 PM MT
Monoclonal Antibody Quality from Different Cell Substrates with Identical Processes
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Xin Bush
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:15 PM – 3:30 PM MT
Quantitative NMR (qNMR) Spectroscopy for Excipient Profiling and Deformulation: Case-Studies
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Isha Saraf, Ph.D. – Research Center Pharmaceutical Engineering
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:30 PM – 3:45 PM MT
Advanced Manufacturing: Personalized Therapy by Tailoring Geometry of 3D-Printed Intravaginal-Rings
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Ahmed S. Zidan, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:30 PM – 3:45 PM MT
Mitigating Aggregation in pH Sensitive Monoclonal Antibodies During Viral Inactivation
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Shiqi Hong, PhD (she/her/hers) – Roquette Asia Pacific Pte. Ltd.
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:45 PM – 4:00 PM MT
3D-Printed Skin-Mimetic Substrates and Solid-State NMR Improves Patch Adhesion Evaluation
Location: 155 E, Salt Palace Convention Center
Rapid Fire Speaker: Keb Mosley-Kellum, MS – Florida A&M University College Of Pharmacy & Pharmaceutical Sciences - Tallahass
Manufacturing & Analytical Characterization
Wednesday, Oct 23rd
3:45 PM – 4:00 PM MT
Measurement and Control of Host Cell Proteins for Biopharmaceutical Development
Location: 155 F, Salt Palace Convention Center
Rapid Fire Speaker: Xuanwen (Shawn) Li, PhD – Merck & Co. Inc.
Manufacturing & Analytical Characterization