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Monday, Nov 10th
9:00 AM - 11:00 AM
CT
Symposium: Advancements in Manufacturing and Characterization of Pharmaceuticals/ Biopharmaceuticals 1
Location: 301 ABC
Moderator:
Zack Zhiqiang Guo, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
9:00 AM - 11:00 AM
CT
Symposium: Advancements in Manufacturing and Characterization of Pharmaceuticals/ Biopharmaceuticals 2
Location: 302 ABC
Moderator:
Yi Gao, PhD (she/her/hers)
– AbbVie Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
9:00 AM - 9:30 AM
CT
Applied Solutions to Overcome the Challenge of Dosing Particle-Engineered Powders
Location: 301 ABC
Speaker:
Irene Rossi, PhD
– Harro Hoefliger
Manufacturing & Analytical Characterization
Monday, Nov 10th
9:30 AM - 10:00 AM
CT
Develop, Scale-Up, and Clinical Study High-Drug-Loading Nano for BCS IV
Location: 302 ABC
Speaker:
Miki (Mengqi) Yu, Ph.D.
– AbbVie, Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
9:30 AM - 10:00 AM
CT
Formulating High Drug Load Amorphous Dispersions Through Co-Precipitation
Location: 301 ABC
Speaker:
Tze Ning Hiew, PhD
– University of Iowa
Manufacturing & Analytical Characterization
Monday, Nov 10th
10:00 AM - 10:30 AM
CT
Drug-Polymer Nanoparticle Formation by “Flash Precipitation” Process
Location: 302 ABC
Speaker:
Robert K. Prud'homme, A renowned faculty in chemical and pharmaceutical engineering
– Chemical and Biological Engineering, Princeton University
Manufacturing & Analytical Characterization
Monday, Nov 10th
10:00 AM - 10:30 AM
CT
Lifecycle Management Strategies – Rethinking Product Development Through Lipid-Based Formulations
Location: 301 ABC
Speaker:
Eduardo E. Jule, PhD (he/him/his)
– Evolve Consulting
Manufacturing & Analytical Characterization
Monday, Nov 10th
10:30 AM - 11:00 AM
CT
Advanced Characterization of Polymorphic Diastereoisomers for Robust Crystallization Control
Location: 301 ABC
Speaker:
Anuji Abraham, Ph.D.
– Bristol-Myers Squibb
Manufacturing & Analytical Characterization
Monday, Nov 10th
10:30 AM - 11:00 AM
CT
Twin-Screw Extruders Prepare High Drugload Nanosized Dispersible Amorphous Solid Dispersions
Location: 302 ABC
Speaker:
Yiwei Tian, BEng MSc PhD
– Queen's University Belfast
Manufacturing & Analytical Characterization
Monday, Nov 10th
9:30 AM - 10:15 AM
CT
Lipid-Based Formulations as Catalysts for Early-Phase Clinical Success
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Amruta Mhashilkar, MD, PhD, MBA
– Catalent
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
10:30 AM - 11:30 AM
CT
Impact of Milling and Humidity on α-Lactose Monohydrate Stability
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker:
Dan Galvin
– NETZSCH Premier Technologies, LLC
Partner Presentation Speaker:
Ligia Elena de Souza, Ph.D
– NETZSCH Gerätebau GmbH
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
12:30 PM - 1:15 PM
CT
Navigating the Biotherapeutic Commercialization Landscape
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Kelly Donovan
– KBI Biopharma
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
12:30 PM - 1:30 PM
CT
Achieve Superior Results in Biologic Characterization using Agilent’s Infinity III LC with Pro iQ Single Quad
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker:
Sue D’Antonio
– Agilent Technologies
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
1:30 PM - 2:30 PM
CT
Keynote: Manufacturing Innovations in Oral Solids and Inhaled Products - Current Status and Future Vision
Location: 301 ABC
Keynote Speaker:
Paul Wan Sia Heng, PhD (he/him/his)
– National University of Singapore
Moderator:
Bhavishya Mittal, PhD (he/him/his)
– BioDuro
Manufacturing & Analytical Characterization
Monday, Nov 10th
1:30 PM - 2:30 PM
CT
Keynote: High Concentration Biologic Products: Manufacturing Challenges and Mitigation Strategies
Location: 302 ABC
Keynote Speaker:
Nicole Buist, PhD (she/her/hers)
– Merck & Co.
Moderator:
Andre Hermans, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
2:45 PM - 3:30 PM
CT
Softgel and Fast-Dissolving ODT Platforms: Driving Lifecycle Management Through Patient-Centric Design
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Karunakar (Karu) Sukuru, R.Ph., Ph.D (he/him/his)
– Catalent
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
3:00 PM - 4:00 PM
CT
Rapid Fires: Deep Dive: Characterization, Regulation & Innovation in Advanced Therapeutics
Location: 302 ABC
Rapid Fire Moderator:
Zhao Liu, PhD
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:00 PM - 4:00 PM
CT
Rapid Fires: Manufacturing Evolved: Continuous Processes, Precision Analytics & Complex Formulations
Location: 301 ABC
Rapid Fire Moderator:
Mahdi Mubin Shaikat, MS
– Duquesne University School of Pharmacy - Graduate School of Pharmaceutical Scien
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:00 PM - 3:15 PM
CT
Distinguishing Excipient Functionality of Lubricants and Anti-Adherents
Location: 302 ABC
Rapid Fire Speaker:
Changquan Calvin Sun, Ph.D.
– University of Minnesota
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:00 PM - 3:15 PM
CT
Novel Purification Methods for Manufacturing of Complex Lipid Nanoparticle Formulations
Location: 301 ABC
Rapid Fire Speaker:
Tristan Kovacic, MSci
– Sartorius BIA Separations
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:15 PM - 3:30 PM
CT
Continuous ASD Tablet Manufacturing: Integrating Hot Melt Extrusion & Compaction
Location: 301 ABC
Rapid Fire Speaker:
Martin Spoerk, Dr. (he/him/his)
– Research Center Pharmaceutical Engineering GmbH
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:15 PM - 3:30 PM
CT
Hypoxia-Mimetic and Pulsed-Electrical Stimulation Amplify NK-Exosome Manufacturing and Immunomodulatory Activity
Location: 302 ABC
Rapid Fire Speaker:
Aakash Nathani, MS (he/him/his)
– Florida A&M University
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:30 PM - 3:45 PM
CT
Development of Continuous Twin Screw Wet Granulation and Drying
Location: 301 ABC
Rapid Fire Speaker:
Amy Le
– Abbvie
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:30 PM - 3:45 PM
CT
Regulatory and Analytical Considerations for PFAS Testing in Pharmaceutical Industry
Location: 302 ABC
Rapid Fire Speaker:
DUJUAN LU, PhD (she/her/hers)
– SGS Phama
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:45 PM - 4:00 PM
CT
Comparison of Time-Gated and Traditional Raman Spectroscopy in Upstream Bioprocess
Location: 301 ABC
Rapid Fire Speaker:
Mahdi Mubin Shaikat, MS
– Duquesne University School of Pharmacy - Graduate School of Pharmaceutical Scien
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:45 PM - 4:00 PM
CT
Probing Protein-Protein Interactions in High-Concentration mAb-Formulations to Navigate Viscosity Challenges
Location: 302 ABC
Rapid Fire Speaker:
Mingyue Li, PhD
– Pfizer Inc.
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:30 PM - 4:30 PM
CT
Hot Topic: CMC and Manufacturing Strategies for Lipid Nano-Particles Enabled Medicines
Location: 220 / Cantilever Room
Hot Topic Moderator:
Sanyogitta Puri, PhD
– Novo Nordisk
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:30 PM - 4:30 PM
CT
Rewriting the Rules: How Digital Tools Are Disrupting Drug Development
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker:
Anil Kane, PhD
– Thermo Fisher Scientific
Partner Presentation Speaker:
Sanjay Konagurthu, Ph.D.
– Thermo Fisher Scientific
Manufacturing & Analytical Characterization
Sponsored By
Monday, Nov 10th
3:30 PM - 3:45 PM
CT
Blueprint to Engineering and Scaling LNPs for Clinical Development
Location: 220 / Cantilever Room
Hot Topic Speaker:
Annette Bak, PhD, MBA, FAAPS
– AstraZeneca
Manufacturing & Analytical Characterization
Monday, Nov 10th
3:45 PM - 4:00 PM
CT
Manufacturing Considerations for mRNA LNP-Based Drug Products
Location: 220 / Cantilever Room
Hot Topic Speaker:
Tina Van Geen Hoven
– Pfizer
Manufacturing & Analytical Characterization
Monday, Nov 10th
4:00 PM - 4:15 PM
CT
Strategies for Manufacturing and Analysis of Lipid-Based Nanomedicines and Vaccines
Location: 220 / Cantilever Room
Hot Topic Speaker:
Mitra Mosharraf, PhD, M.B.A. (she/her/hers)
– HTD Biosystems Inc
Manufacturing & Analytical Characterization
Monday, Nov 10th
4:15 PM - 4:30 PM
CT
Next Generation LNP Pharmaceuticals Analytics: Intact Chromatography for Comprehensive Characterization
Location: 220 / Cantilever Room
Hot Topic Speaker:
Tristan Kovacic, MSci
– Sartorius BIA Separations
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:00 AM - 10:00 AM
CT
Hot Topic: Predictive Scale-Up/Scale-Down for Pharmaceuticals/Biopharmaceuticals
Location: 220 / Cantilever Room
Hot Topic Moderator:
Sheetal S. Pai-Wechsung, Ph.D. (she/her/hers)
– Pfizer Inc
Hot Topic Speaker:
Nima Yazdanpanah, PhD (he/him/his)
– Procegence
Hot Topic Speaker:
Mahaveer Satra, MS
– MathWorks
Hot Topic Speaker:
David Spencer, PhD (he/him/his)
– AbbVie
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 1
Location: 301 ABC
Moderator:
Carl Allenspach, PhD
– Bristol Myers Squibb
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:00 AM - 11:00 AM
CT
Symposium: Navigating the Complexities of Novel Modalities and Delivery Systems 2
Location: 302 ABC
Moderator:
Pallavi P. Pawar, PhD (she/her/hers)
– Gilead Sciences
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:00 AM - 9:30 AM
CT
Analytical Insights into Bispecific Antibodies Manufactured Through Co-Culture/Column-based Redox
Location: 301 ABC
Speaker:
Jay (Jukyung) Kang, PhD (she/her/hers)
– Pfizer
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:00 AM - 9:30 AM
CT
Extrusion-Based 3D Printing Approaches for Rapid Prototyping of Orodispersible Films
Location: 302 ABC
Speaker:
R Jayachandra Babu Babu, PhD (he/him/his)
– Auburn University
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:30 AM - 10:00 AM
CT
A Novel Laboratory-Scale Pneumatic Tube System (PTS) to Assess the Impact of Hospital PTS Transportation on the Product Quality of Therapeutic Monoclonal Antibodies
Location: 302 ABC
Speaker:
Kashappa Goud Desai, PhD
– GSK
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
9:30 AM - 10:00 AM
CT
Navigating Challenges of High Concentration Protein Therapeutics: Advanced Analytical Approaches
Location: 301 ABC
Speaker:
Hanmi Xi, PhD (she/her/hers)
– Merck and Co Inc
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
10:00 AM - 10:30 AM
CT
Case Study on Manufacturing Scalability: Gelation Impact on Lyophilization
Location: 302 ABC
Speaker:
Hima Bindu Gottam, MS, MBA, RAC (US) (she/her/hers)
– University of Iowa, Pharmaceuticals
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
10:00 AM - 10:30 AM
CT
Recommendations for Biosimilar Manufacturers on Analytical and Functional Comparability Assessments
Location: 301 ABC
Speaker:
Anurag S. Rathore, PhD
– Indian Insitute of Technology Delhi
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
10:30 AM - 11:00 AM
CT
Analytical Control Strategy for Half-Life Extension Features of Biotherapeutics
Location: 302 ABC
Speaker:
Kevin Gurney, PhD (he/him/his)
– Merck Research Laboratories
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
10:30 AM - 11:00 AM
CT
Overcoming Challenges in Characterizing (Degraded) Surfactants through Advanced Chromatographic Methods
Location: 301 ABC
Speaker:
Simon Eisele, PhD (he/him/his)
– Coriolis Pharma Research GmbH
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
11:00 AM - 12:00 PM
CT
Amorphous Solid Dispersion Development for Straightforward to Challenging Compounds
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker:
Corey Bloom, PhD (he/him/his)
– Lonza
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
11:00 AM - 12:00 PM
CT
Safe Handling of Potent APIs at CMOs, CDMOs, and CROs
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker:
Janet Gould, PhD, DABT, CIH (she/her/hers)
– SafeBridge Consultants, Inc
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
11:15 AM - 12:00 PM
CT
Proven Control Strategies for ADC/mAb Potency and HCP Analysis
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Jessica Bridges Weaver, MRes (she/her/hers)
– BioAgilytix Labs
Chalk Talk Presenter:
Reema Davis, PhD
– BioAgilytix
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
11:15 AM - 12:00 PM
CT
Rapid Sterility Testing: Ensuring Safety and Speed for Short-Life Products
Location: Spotlight Stage C, Aisle 3800, Exhibit Hall
Chalk Talk Presenter:
Nina Moreno, MBA, SM (NRCM) (she/her/hers)
– Nelson Labs
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
12:00 PM - 1:00 PM
CT
Enhancing Analytical Performance with AQbD: Tools, Strategies, and Applications
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker:
Pawel Bigos, BS
– Waters Corporation
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
1:30 PM - 2:30 PM
CT
Keynote: Designing, Formulating, and Manufacturing Molecules for Long-Acting Therapies
Location: 302 ABC
Keynote Speaker:
William Rowe, BS, PhD (he/him/his)
– Gilead Sciences
Moderator:
Pallavi P. Pawar, PhD (she/her/hers)
– Gilead Sciences
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
1:30 PM - 2:30 PM
CT
Keynote: Pharmaceutical Novel Modalities: Opportunities and Challenges
Location: 301 ABC
Keynote Speaker:
Otilia M. Koo, PhD, FAAPS (she/her/hers)
– Novo Nordisk
Moderator:
Paul Wan Sia Heng, PhD (he/him/his)
– National University of Singapore
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
2:45 PM - 3:30 PM
CT
Integrating PBPK Modeling and Developability Assessment to Guide Early Phase Formulation Strategy
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter:
Maksim Khotimchenko, PhD
– Catalent
Manufacturing & Analytical Characterization
Sponsored By
Tuesday, Nov 11th
3:00 PM - 4:00 PM
CT
Rapid Fires: Shaping Biologics: From Molecules to Manufacturing Excellence
Location: 301 ABC
Rapid Fire Moderator:
Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)
– Therapeutics360 Consulting Group
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:00 PM - 4:00 PM
CT
Rapid Fires: Smart Science for Complex Formulation: From Nano to Manufacturing
Location: 302 ABC
Rapid Fire Moderator:
Andre Hermans, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:00 PM - 3:15 PM
CT
Avoiding Adducts: Improving Oligonucleotide MS Data Through Ion Source Optimization
Location: 301 ABC
Rapid Fire Speaker:
Brian Domanski
– Shimadzu Scientific Instruments, Inc.
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:00 PM - 3:15 PM
CT
TLR7-Adjuvanted Ionizable Lipid Nanoparticles for mRNA Vaccine Delivery
Location: 302 ABC
Rapid Fire Speaker:
Bishal Misra, MS (he/him/his)
– West Virginia University
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:15 PM - 3:30 PM
CT
ADA-SCID Manufacturing and Outcomes: Predictive Analytics Case Study
Location: 301 ABC
Rapid Fire Speaker:
Michelle Tseng, PhD (candidate), SCYM(ASCP)CM (she/her/hers)
– Therapeutics360 Consulting Group
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:15 PM - 3:30 PM
CT
From Milligrams to Manufacturing: Efficient Formulation Screening for Drug-Eluting Implants
Location: 302 ABC
Rapid Fire Speaker:
Andreas Bramböck, MSc (he/him/his)
– MeltPrep
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:30 PM - 3:45 PM
CT
Recent Progress in High-Throughput Formulation of Nanocrystals at Laboratory Scale
Location: 302 ABC
Rapid Fire Speaker:
Lucia Lopez Vidal (she/her/hers)
– Queen's University Belfast
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:30 PM - 3:45 PM
CT
Strategy for Bridging Methods for an Accelerated Late-Stage mAb
Location: 301 ABC
Rapid Fire Speaker:
Mania Dorrani, PhD (she/her/hers)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:45 PM - 4:00 PM
CT
Case Study: Viral Inactivation in Bioprocessing Using Hydroxypropyl Beta-Cyclodextrins
Location: 302 ABC
Rapid Fire Speaker:
TAO PENG, PhD
– Roquette Asia Pacific Pte Ltd
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:45 PM - 4:00 PM
CT
Molecular Modeling Assisted Critical Quality Attribute Assessment
Location: 301 ABC
Rapid Fire Speaker:
Zoey Zheng, PhD (she/her/hers)
– Amgen
Manufacturing & Analytical Characterization
Tuesday, Nov 11th
3:30 PM - 4:30 PM
CT
Advanced Apparatus and Method for Powder Blend Segregation Testing
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker:
Sanni Raju, PhD (he/him/his)
– GlobePharma, Inc.
Manufacturing & Analytical Characterization
Sponsored By
Wednesday, Nov 12th
9:00 AM - 10:30 AM
CT
Symposium: Predictive Tools and Applications in Manufacturing and Product Quality 2
Location: 302 ABC
Moderator:
Sanjaykumar Patel (he/him/his)
– Merck and Co Inc
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
9:00 AM - 9:30 AM
CT
Extractables and Leachables: Ensuring Safety Through Science and Strategy
Location: 302 ABC
Speaker:
Subathra Ramamoorthy, MS, RPh
– Veranova
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
9:30 AM - 10:00 AM
CT
Properties of Polymeric Materials in Solution Elucidated by Viscosity Measurements
Location: 302 ABC
Speaker:
David Trowbridge, PhD
– Cannon Instrument Company
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
10:00 AM - 10:30 AM
CT
Mechanistic Models of Compaction Property Prediction for APIs and Formulations
Location: 302 ABC
Speaker:
Shubhajit Paul, PhD (he/him/his)
– Boehringer Ingelheim
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
9:00 AM - 11:00 AM
CT
Symposium: Predictive Tools and Applications in Manufacturing and Product Quality 1
Location: 301 ABC
Moderator:
Kashappa Goud Desai, PhD
– GSK
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
9:00 AM - 9:30 AM
CT
Accelerating Long-Acting Injectable Development Using Novel In-Vitro & Preclinical Models
Location: 301 ABC
Speaker:
Pallavi P. Pawar, PhD (she/her/hers)
– Gilead Sciences
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
9:30 AM - 10:00 AM
CT
Granulation Process Scaleup Using Growth Regime Mapping and Multivariate Modeling
Location: 301 ABC
Speaker:
Rajesh Annesh Kulkarni, MS
– Eli Lilly and Company
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
10:00 AM - 10:30 AM
CT
A Novel Combined Physics-Based and ML Virtual Cocrystal Screening Model
Location: 301 ABC
Speaker:
Yuriy Abramov, PhD
– Porton USA/J-Star Research
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
10:30 AM - 11:00 AM
CT
Phased & Focused: Regulatory Compliance Strategies for Advanced Therapies
Location: 301 ABC
Speaker:
Claudia Lin, Ph.D (she/her/hers)
– Pharmatech Associates, a USP Company
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
10:30 AM - 11:30 AM
CT
Wurster Fluid-Bed Technology: A Deep Dive into Particle Coating in Pharmaceutical Manufacturing
Location: 360 Stage #1, Exhibit Hall
Partner Presentation Speaker:
Tasneem Gandhi, n/a
– Glatt Air Techniques Inc.
Manufacturing & Analytical Characterization
Sponsored By
Wednesday, Nov 12th
1:30 PM - 2:30 PM
CT
Keynote: Digital Twin Technologies to Accelerate Development, Reduce Wet Work and Optimize Process Performance
Location: 301 ABC
Keynote Speaker:
Brian Rhodes
– GSK
Moderator:
Bhavishya Mittal, PhD (he/him/his)
– BioDuro
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
1:30 PM - 2:30 PM
CT
Keynote: Unsupervised AI-based Image Analysis of Cell Therapy Products: A New Non-Invasive Characterization Approach for QC
Location: 302 ABC
Keynote Speaker:
Christopher P. Calderon, PhD
– Ursa Analytics, Inc.
Moderator:
Zack Zhiqiang Guo, PhD (he/him/his)
– Merck & Co., Inc.
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
3:00 PM - 4:00 PM
CT
Rapid Fires: Predictive Power: Modeling, AI & Regulatory Design in Drug Development
Location: 301 ABC
Rapid Fire Moderator:
Li Li, PHD (she/her/hers)
– Merck
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
3:00 PM - 3:15 PM
CT
Predicting Drug Release from Long-Acting Implants: Mechanisms, Modeling, and Simulation
Location: 301 ABC
Rapid Fire Speaker:
Ziyue Zhong, MS
– University of Texas at Austin
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
3:15 PM - 3:30 PM
CT
Revealing Isotopic Patterns of Drug Products and Commonly Used Excipients
Location: 301 ABC
Rapid Fire Speaker:
Else Holmfred, PhD
– Stanford University
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
3:30 PM - 3:45 PM
CT
Regulatory-Driven CQA Specification Setting Using Innate Immunogenicity Assay for Peptide-Therapeutics
Location: 301 ABC
Rapid Fire Speaker:
Sayani Banerjee, PhD
– EpiVax, Inc.
Manufacturing & Analytical Characterization
Wednesday, Nov 12th
3:45 PM - 4:00 PM
CT
Machine Learning-Driven Formulation and Process Design for Solid Dosage Forms
Location: 301 ABC
Rapid Fire Speaker:
Metin Celik, PhD (he/him/his)
– PTI - Pharmaceutical Technologies International
Manufacturing & Analytical Characterization