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ON DEMAND
Prologue: Advancing Analytical Capabilities to Enable Cross Modality Pharmaceutical and Vaccine Innovations
Location: On Demand
Prologue Speaker: Wei Xu, PhD (she/her/hers) – Merck
Manufacturing & Analytical Characterization
ON DEMAND
Prologue: Embracing Innovation: Harnessing Emerging Technologies for Enhanced Pharmaceutical Quality
Location: On Demand
Prologue Speaker: Geng Tian, PhD (he/him/his) – US FDA
Manufacturing & Analytical Characterization
ON DEMAND
Prologue: Emerging Applications of Data Driven and Hybrid Modelling in Pharmaceutical Manufacturing
Location: On Demand
Prologue Speaker: Gabriele Bano, PhD (he/him/his) – GSK
Manufacturing & Analytical Characterization
ON DEMAND
Prologue: Emerging Trends in Continuous Manufacturing of Pharmaceuticals
Location: On Demand
Prologue Speaker: Lawrence De Belder, MSc (he/him/his) – Pharmatech Associates Inc.
Manufacturing & Analytical Characterization
ON DEMAND
Prologue: From Modality-Specific to Boundaryless Analytics – Delivering the Pipeline of Tomorrow
Location: On Demand
Prologue Speaker: Jason Cheung, PhD – Merck
Manufacturing & Analytical Characterization
ON DEMAND
Prologue: Modelling and Predictive Design in Pharmaceutical Development
Location: On Demand
Prologue Speaker: Simeone Zomer, DR – GSK
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:00 AM – 11:00 AM ET
Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1
Location: 205 AB West
Moderator: Jason Rodriguez, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:00 AM – 11:00 AM ET
Symposium: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2
Location: 206 AB West
Moderator: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
API Co-Processing for Enhanced Solid Oral Dosages
Location: 205 AB West
Speaker: Rajesh Dave, PhD (he/him/his) – NJIT
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
Impact of Raw Materials Variation On Continuous Feeders Performance
Location: 206 AB West
Speaker: Sara Fathollahi, PhD – DFE Pharma
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Mixing Systems for Floating and Settling Particles for Sterile Drug Products
Location: 205 AB West
Speaker: Parind Desai, PhD – GlaxoSmithKline
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Troubleshooting Difficult Formulations For Continuous Twin-Screw Wet Granulation
Location: 206 AB West
Speaker: Michael R. Thompson, PhD (he/him/his) – McMaster University
Manufacturing & Analytical Characterization
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
Development and Control Strategy for a Semi-Continuous Granulation Process
Location: 206 AB West
Speaker: Yasmin Suessenbach, PhD (she/her/hers) – Bayer AG
Manufacturing & Analytical Characterization
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
Novel 3D Printing Techniques to Assess Adhesion Testing for Patches
Location: 205 AB West
Speaker: Mandip Singh Sachdeva, PhD, FAAPS – Florida A & M University
Manufacturing & Analytical Characterization
Monday, Oct 23rd
10:30 AM – 11:00 AM ET
Development and Scale-Up of HDAd Process Using iCELLis® Bioreactor Platform
Location: 205 AB West
Speaker: Jyoti Amatya, MS (she/her/hers) – Cytiva
Manufacturing & Analytical Characterization
Monday, Oct 23rd
10:30 AM – 11:00 AM ET
Optimization of Design Space for Continuous Manufacturing of Extended-Release Tablets
Location: 206 AB West
Speaker: Ahmed S. Zidan, Ph.D – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 23rd
9:30 AM – 10:30 AM ET
Speaker Spotlight: The Path to Peak Performance: PAT Solutions for Advanced Process Control in Continuous Pharmaceutical Manufacturing
Location: Spotlight Stage B Exhibit Hall West A4-B3
Spotlight Speaker: Thomas De Beer, PhD (he/him/his) – Ghent University
Manufacturing & Analytical Characterization
Monday, Oct 23rd
12:30 PM – 1:30 PM ET
Leveraging Advanced Raman and UV-Vis Techniques in Pharmaceutical Manufacturing Processes
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Yanqia Wang, PhD – Agilent
Manufacturing & Analytical Characterization
Presented By
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: Crossing Modalities: Analytical Adventures at the Interface of Small and Large Molecules
Location: 206 AB West
Keynote Speaker: Narayan Variankaval, PhD – Merck & Co
Moderator: Jason Rodriguez, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: Crystal and Particle Engineering Strategies in Pharmaceutical Product Development and Manufacturing
Location: 205 AB West
Keynote Speaker: Jukka Rantanen, PhD (he/him/his) – University of Copenhagen
Moderator: Sushrut Marathe, PhD (he/him/his) – GSK
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Exploring Chromatography Methods for the Analysis of Oligonucleotide Therapeutics
Location: 360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: Sandeep kondaveeti, PhD (he/him/his) – Agilent
Manufacturing & Analytical Characterization
Presented By
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 1
Location: 205 AB West
Rapid Fire Moderator: Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Manufacturing and Emerging Technologies in Pharmaceuticals and Biopharmaceuticals 2
Location: 206 AB West
Rapid Fire Moderator: Natalia Subelzu, Ph.D. (she/her/hers) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:00 PM – 3:15 PM ET
Atmospheric Freeze Drying – Towards a More Sustainable Lyophilization Process
Location: 205 AB West
Rapid Fire Speaker: Alf Lamprecht – University of Bonn
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:00 PM – 3:15 PM ET
The Risks Triggering FDA’s Pre-Approval Inspection for a Manufacturing Facility
Location: 206 AB West
Rapid Fire Speaker: MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:15 PM – 3:30 PM ET
Ambient Temperature Preservation of Biomolecules Using Capillary-Mediated Vitrification Process
Location: 205 AB West
Rapid Fire Speaker: Sankar Renu, PhD (he/him/his) – Upkara, Inc
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:15 PM – 3:30 PM ET
How Twin-Screw Wet Granulation Factors Impact Granules and Tablets Attributes
Location: 206 AB West
Rapid Fire Speaker: Piero Piccinni, MSc (he/him/his) – Aptuit (an Evotec Company)
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:30 PM – 3:45 PM ET
Layered Microneedles for Protein Delivery from Coacervate
Location: 205 AB West
Rapid Fire Speaker: Nathaniel S. Wright, M.S. – Cornell University
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:30 PM – 3:45 PM ET
Personalized Pediatric Dosing Enabled by 3D Printing- A Case Study
Location: 206 AB West
Rapid Fire Speaker: Jayeeta Sengupta, PhD (she/her/hers) – TNO
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Novel Strategies for Process-Related Impurity Clearance during Biologics Manufacturing
Location: 205 AB West
Rapid Fire Speaker: Aba Acquaah, BS (she/her/hers) – Merck Research Laboratories
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Pharma 4.0: Digital Manufacturing of Advanced Continuous Pharmaceutical Tablet Manufacturing
Location: 206 AB West
Rapid Fire Speaker: Ravendra Singh (he/him/his) – Rutgers University
Manufacturing & Analytical Characterization
Monday, Oct 23rd
3:30 PM – 4:30 PM ET
Customization of Functional Capsules: An Enteric Delivery Case Study
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Vincent Jannin, PhD (he/him/his) – Lonza
Manufacturing & Analytical Characterization
Presented By
Monday, Oct 23rd
3:30 PM – 4:30 PM ET
Hot Topic: Product and Process Design for Long Acting Injectable (LAI) Formulations
Location: 308 AB West
Hot Topic Speaker: Sujatha Sonti, Dr – GSK
Hot Topic Moderator: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1
Location: 205 AB West
Moderator: Sayantan Chattoraj, PhD – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2
Location: 206 AB West
Moderator: Thomas De Beer, PhD (he/him/his) – Ghent University
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
Recent Advances in Machine Learning for Characterizing Subvisible Particles
Location: 206 AB West
Speaker: Chris P. Calderon, PhD – Ursa Analytics
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
Small Molecule Drug In Silico Crystal Structure and Property Predictions
Location: 205 AB West
Speaker: John C. Shelley, PhD – Schrodinger, LLC
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
Computational Approaches to Salt Screening: Case of Aripiprazole Salts Crystallization
Location: 205 AB West
Speaker: Yuriy Abramov, PhD – J-Star Research | Porton
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
Deep Learning Models to Reduce False Rejects in Pharmaceutical manufacturing
Location: 206 AB West
Speaker: Vijay Yadav – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
Continuous Manufacturing: Optimizing Quality and Efficiency Improvement Using AI
Location: 206 AB West
Speaker: Rupesh Malhotra, MS – Vertex Pharmaceuticals
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
Next Generation Lab-Scale Transport Validation: Fluid Behavior and Quality Impacts
Location: 205 AB West
Speaker: Florian Rosenthal, MSc ETH (he/him/his) – F. Hoffman - La Roche Ltd.
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
A Novel Digital Twin of End-to-End Continuous Manufacturing of Injectable
Location: 205 AB West
Speaker: Ravendra Singh (he/him/his) – Rutgers University
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
Scale-Down Modeling of Bioreactor Operations for Monoclonal Antibody Production
Location: 206 AB West
Speaker: Ou Yang, PhD – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
9:30 AM – 10:30 AM ET
Next-Generation Bioprocessing Strategies to Improve Speed, Cost and Tech Transfer
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Shendi Lu – IDBS
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
11:00 AM – 12:00 PM ET
Improvements to PS80 Determination in Drug Product Formulations
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Joseph P. Campbell, PhD (he/him/his) – Prolytix - Essex Junction, VT
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
11:00 AM – 12:00 PM ET
Safely Handling Potent APIs to Protect Workers/Product Protection at CMOs/CDMOs/CROs
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Robert G. Sussman, PhD, DABT (he/him/his) – SafeBridge Regulatory & Life Sciences Group
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
11:15 AM – 12:00 PM ET
AI for Subvisible Particle Image Analysis Delivers Actionable Data
Location: Spotlight Stage A Exhibit Hall West A4-B3
Chalk Talk Presenter: Eric Gottlieb, BSc, MBA – SentrySciences, Inc.
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
12:30 PM – 1:15 PM ET
Considerations in the Development of Potency Assays for ATMPs
Location: Spotlight Stage B Exhibit Hall West A4-B3
Chalk Talk Presenter: Jeff Patrick, PhD (he/him/his) – BioAgilytix - Durham, NC
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
12:30 PM – 1:30 PM ET
Subvisible Particle Analysis Using Flow Imaging Microscopy and Light Obscuration
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Austin Daniels, PhD (he/him/his) – Yokogawa Fluid Imaging Technologies
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: In Vitro In Vivo Correlation (IVIVC) for Long Acting Injectable (LAI) Formulations
Location: 205 AB West
Keynote Speaker: Diane J. Burgess, Ph.D. (she/her/hers) – University of Connecticut
Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: Process Modelling and Digital Twin Development for Bioprocessing of mAbs
Location: 206 AB West
Keynote Speaker: Marianthi Ierapetritou, PhD (she/her/hers) – University of Delaware
Moderator: Ou Yang, PhD – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
2:00 PM – 3:00 PM ET
Extractable Leachable Analysis from Sample Preparation to Compound Identification
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: David A. Weil, PhD (he/him/his) – Agilent
Manufacturing & Analytical Characterization
Presented By
Tuesday, Oct 24th
2:30 PM – 3:30 PM ET
Speaker Spotlight: Achieving Scientific Agility in a Rigid Matrix
Location: Spotlight Stage B Exhibit Hall West A4-B3
Spotlight Speaker: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs
Moderator: Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 1
Location: 205 AB West
Rapid Fire Moderator: MD ABDULLAH A. MAHMUD, Doctor of Philosophy in Pharmaceutical Sciences (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Advanced Modelling and Predictive Approaches in Drug Development, Manufacturing and Analysis 2
Location: 206 AB West
Rapid Fire Moderator: Diaa Shakleya, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:00 PM – 3:15 PM ET
Amorphous Solid Dispersion Physical Stability: Historical Examples and Shelf-Life Assessment
Location: 206 AB West
Rapid Fire Speaker: Anura Indulkar, PhD – AbbVie
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:00 PM – 3:15 PM ET
PAT to Support Continuous Manufacturing: from Development to Commercialization
Location: 205 AB West
Rapid Fire Speaker: Xiaoqing Hua, PhD (she/her/hers) – Merck & Co, Inc
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:15 PM – 3:30 PM ET
Simulation and Troubleshooting of Mixing Systems for Secondary Biopharm Manufacture
Location: 205 AB West
Rapid Fire Speaker: Elaheh Ardalani, PhD (she/her/hers) – GSK
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:15 PM – 3:30 PM ET
Using Surface Dissolution Imaging to Understand Weakly Basic Drug Dissolution
Location: 206 AB West
Rapid Fire Speaker: Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:30 PM – 3:45 PM ET
In-Depth Characterization of Polysorbate 80 Degradation in Biologics Drug Products
Location: 205 AB West
Rapid Fire Speaker: Rong-Sheng Yang, M.S. (he/him/his) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:30 PM – 3:45 PM ET
Nitrosamines Mitigation Strategies in Drug Product
Location: 206 AB West
Rapid Fire Speaker: Diaa Shakleya, PhD – US Food and Drug Administration
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:45 PM – 4:00 PM ET
Strategic Modular Approaches to Continuous Manufacturing
Location: 205 AB West
Rapid Fire Speaker: Andrew Birkmire – GEA Pharma Systems
Manufacturing & Analytical Characterization
Tuesday, Oct 24th
3:45 PM – 4:00 PM ET
Ultra-High-Resolution Optical Coherence Tomography for Investigating Very Thin Pharmaceutical Coatings
Location: 206 AB West
Rapid Fire Speaker: Moaaz Abdelhamid, M.Sc. – RCPE GmbH
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:00 AM – 11:00 AM ET
Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1
Location: 205 AB West
Moderator: Selen Stromgren, PhD (she/her/hers) – FDA/Office of Regulatory Affairs
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:00 AM – 11:00 AM ET
Symposium: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2
Location: 206 AB West
Moderator: Caitlin Wood, Ph.D. (she/her/hers) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:00 AM – 9:30 AM ET
Predictive Analytics in the Design and Development of Long Acting Injectable (LAI) Drug Products
Location: 205 AB West
Speaker: Sayantan Chattoraj, PhD – GSK
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:00 AM – 9:30 AM ET
Submicron Particles in Injectable Biologics: Risks and Measurement Techniques
Location: 206 AB West
Speaker: Dennis Yang, PhD (he/him/his) – Eli Lilly and Company
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
Impact of Molecular Mobility on ADCs Degradation in Lyophiles
Location: 206 AB West
Speaker: Ehab Moussa, PhD – AbbVie Inc.
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
Regulatory Expectations in Extractables and Leachables Testing of Combination Products
Location: 205 AB West
Speaker: Dujuan Lu, PhD – SGS Health Sciences
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
A Novel Control Strategy for PS-80 Degradation in Citrate Buffer Based on An Iron-Catalyzed Oxidation Study
Location: 205 AB West
Speaker: Chengbei Li, PhD (she/her/hers) – Merck & Co., Inc.
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
Cross Modality Considerations for Host Cell Protein Controls
Location: 206 AB West
Speaker: Fengqiang Wang, PhD (he/him/his) – Merck and Co Inc
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
10:30 AM – 11:00 AM ET
Application of Asymmetric Flow Field-Flow Fractionation (AFFF) and Capillary Electrophoresis (CE) for the Characterization of Liposomal Formulations
Location: 206 AB West
Speaker: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
10:30 AM – 11:00 AM ET
Leveraging Statistical Methods Across the Analytical Procedure Lifecycle
Location: 205 AB West
Speaker: Tara Scherder, MS – SynoloStats
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
9:30 AM – 10:30 AM ET
Characterization of Polymer Molecules by Automated Viscosity Measurement
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: David Trowbridge, PhD, MS – Cannon Instrument Company
Manufacturing & Analytical Characterization
Presented By
Wednesday, Oct 25th
10:00 AM – 11:00 AM ET
Speaker Spotlight: Emerging Trends and Future Outlook for Advanced Manufacturing
Location: Spotlight Stage B Exhibit Hall West A4-B3
Spotlight Speaker: Fernando Muzzio, Ph.D. – Rutgers - The State University of New Jersey
Moderator: Sushrut Marathe, PhD (he/him/his) – GSK
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
10:30 AM – 11:30 AM ET
How to Mitigate Risks to Pharmaceutical Quality? Role of Reference Standards
Location: 360 Stage #1 Exhibit Hall West A4-B3
Partner Presentation Speaker: Yu Tang, PhD (she/her/hers) – United States Pharmacopeial Convention
Manufacturing & Analytical Characterization
Presented By
Wednesday, Oct 25th
11:00 AM – 12:00 PM ET
Advancements in Oral Solid Dose Technologies for Potent Treatments
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Anshul Gupte, PhD – Catalent
Manufacturing & Analytical Characterization
Presented By
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: High Resolution Analytical Tools to Enhance Regulatory Science
Location: 205 AB West
Keynote Speaker: Jason Rodriguez, PhD – US Food and Drug Administration
Moderator: Thilak Mudalige, Ph.D. (he/him/his) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: Novel NK and CAR-NK Expansion Platforms (Feeder Cells vs. No Feeder Cells)
Location: 206 AB West
Keynote Speaker: Dongfang Liu, MD/PhD (he/him/his) – Rutgers University-New Jersey Medical School
Moderator: Sayantan Chattoraj, PhD – GSK
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 1
Location: 205 AB West
Rapid Fire Moderator: Devin Swiner, PhD (she/her/hers) – Merck & Co., Inc
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: Novel Modalities and Cross-Modality Considerations in Manufacturing and Analysis 2
Location: 206 AB West
Rapid Fire Moderator: Nahid S. Kamal, PhD (she/her/hers) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:00 PM – 3:15 PM ET
Non-Compendial Small Volume Dissolution for Early-Stage Formulation Model Development
Location: 206 AB West
Rapid Fire Speaker: Ishai Nir (he/him/his) – Distek, Inc.
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:00 PM – 3:15 PM ET
The Impact of ICH Q12 and Established Conditions
Location: 205 AB West
Rapid Fire Speaker: Diane Goll, MS – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:15 PM – 3:30 PM ET
Formulation Variables Affecting CQAs of Dissolvable Microneedles
Location: 206 AB West
Rapid Fire Speaker: Nahid S. Kamal, PhD (she/her/hers) – US Food and Drug Administration
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:15 PM – 3:30 PM ET
Hierarchical Approach to Raw Material Variability in Drug Product Lifecycle
Location: 205 AB West
Rapid Fire Speaker: David J. Goldfarb, PhD – Merck & Co, Inc
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:30 PM – 3:45 PM ET
Non-Sterile Drug Product Manufacturing: Recent FDA Focus on Controlling BCC
Location: 206 AB West
Rapid Fire Speaker: Jason Carbol – Dow Development Labs
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:30 PM – 3:45 PM ET
USP’s Iterative Approach on Modern Analytical Methods for Polymeric Excipients
Location: 205 AB West
Rapid Fire Speaker: Peng Zhang, PhD (he/him/his) – United States Pharmacopeia (USP)
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:45 PM – 4:00 PM ET
Evaluation of Predicting Long-Term Release Rate of the Islatravir Implant
Location: 205 AB West
Rapid Fire Speaker: Hyunho Kang, PhD – Merck & Co, Inc - Rahway, NJ
Manufacturing & Analytical Characterization
Wednesday, Oct 25th
3:45 PM – 4:00 PM ET
Ultra-Precise Control of Active Ingredient Content Using a Novel Process
Location: 206 AB West
Rapid Fire Speaker: Eva Pontrelli (she/her/hers) – University of Michigan
Manufacturing & Analytical Characterization