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Preclinical Development
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Manufacturing and
Bioprocessing
Formulation and Quality
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Manufacturing and Bioprocessing
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Monday, Nov 5
8:30 am
Prologue: Nanoparticles – Small Size, Enormous Potential
Location: 147 AB, WEWCC
Stefan Siegrist, PhD – Novartis; Sven Stegemann, PhD – Lonza; Dawn Downey, PhD – Eli Lilly & Company
Monday, Nov 5
8:30 am
Prologue: Prior Knowledge and Smart Risks
Location: 145 AB, WEWCC
Reed Harris – Genentech Roche; Atanas Koulov, PhD – Lonza AG; Sambit R. Kar, PhD – Bristol-Myers Squibb
Monday, Nov 5
9:00 am
Industry Perspective on Using Prior Knowledge During Product and Process Development
Location: 145 AB, WEWCC
Jette Wypych – Amgen
Monday, Nov 5
9:00 am
Process Controls, Manufacturing, and Engineering Challenges – Biomolecular
Location: 145 AB, WEWCC
Atanas Koulov, PhD – Lonza AG; Sambit R. Kar, PhD – Bristol-Myers Squibb
Monday, Nov 5
9:30 am
Regulatory Considerations with Using Prior Knowledge for New Submissions
Location: 145 AB, WEWCC
Joslyn Brunelle, PhD – FDA
Monday, Nov 5
10:00 am
Novel Approaches to Robust Process Control
Location: 145 AB, WEWCC
Olga Friese, PhD – Pfizer WRD
Monday, Nov 5
10:30 am
Criticality Assessment of Quality Attributes
Location: 145 AB, WEWCC
Tapan Das – Bristol-Myers Squibb Company
Monday, Nov 5
9:00 am
Nanoparticles that Enhance Cancer Vaccine Efficacy
Location: 147 AB, WEWCC
Aliasger K. Salem, PhD – University of Iowa
Monday, Nov 5
9:00 am
Process Controls, Manufacturing, and Engineering Challenges – Chemical
Location: 147 AB, WEWCC
Sven Stegemann, PhD – Lonza
Monday, Nov 5
9:30 am
Characterization and Evaluation of Drug-loaded Nanoparticles, Revisited
Location: 147 AB, WEWCC
Yoon Yeo, PhD – Purdue University
Monday, Nov 5
10:00 am
Modulating the Function of Cancer-derived Exosomes through Repackaging
Location: 147 AB, WEWCC
Juliane Nguyen, PhD – University of Buffalo
Monday, Nov 5
10:30 am
Targeting Solid Tumors using Nano-engineered Mesenchymal Stem Cells
Location: 147 AB, WEWCC
Swayam Prabha, PhD – University of Minnesota
Monday, Nov 5
10:30 am
Development of a Rapidly Disintegrating Levetiracetam Orodispersible Tablet by 3-Dimensional-Printing
Location: Learning Lounge 2, Exhibit Hall A/B, WEWCC
Jennifer Zieverink – Aprecia; Kelly E. Caputo, PhD – Aprecia Pharmaceuticals
Monday, Nov 5
1:30 pm
Keynote: Engineering First Principles Applications to Pharmaceutical Manufacturing
Location: Ballroom A, WEWCC
Bernard McGarvey, PhD Chemical Engineering – Eli Lilly and Company; Sven Stegemann, PhD – Lonza; Dawn Downey, PhD – Eli Lilly & Company
Tuesday, Nov 6
8:30 am
Prologue: Innovations vs. Novelties in Biologics
Location: 145 AB, WEWCC
Karoline Barbara Bechtold-Peters, PhD – Novartis. Pharma AG
Tuesday, Nov 6
8:30 am
Prologue: Regulatory Considerations for Adopting Continuous Manufacturing Processes and Emerging Technologies
Location: 147 AB, WEWCC
Celia N. Cruz, PhD – FDA/CDER/OPQ/OTR/DPQR; Arya Jayatilaka, PhD – Pfizer, Inc.; Claudia Corredor, Dr. – Bristol-Myers Squibb Company
Tuesday, Nov 6
9:00 am
Implementation of Next-generation Technologies in Biomanufacturing
Location: 145 AB, WEWCC
Nitin Rathore, PhD – Amgen Inc
Tuesday, Nov 6
9:00 am
Continuous Manufacturing and Connected Processes Supporting End-to-End Approaches and Adapting to the Non-blockbuster Era – Biomolecular
Location: 145 AB, WEWCC
Karoline Barbara Bechtold-Peters, PhD – Novartis. Pharma AG
Tuesday, Nov 6
9:30 am
Novel Approaches for Robotics Use in Sterile Products
Location: 145 AB, WEWCC
Markus Stuebchen, Graduate Process Engineer – F. Hoffmann - La Roche Ltd.
Tuesday, Nov 6
10:00 am
Approaches to Regulating Innovation: CMC Challenges and Opportunities
Location: 145 AB, WEWCC
Nina S. Cauchon, PhD – Amgen Inc
Tuesday, Nov 6
9:00 am
New Drug Product Development Using Continuous Manufacturing
Location: 147 AB, WEWCC
Giustino Di Pretoro, PhD – J&J
Tuesday, Nov 6
9:00 am
Continuous Manufacturing and Connected Processes Supporting End-to-End Approaches and Adapting to the Non-blockbuster Era – Chemical
Location: 147 AB, WEWCC
Arya Jayatilaka, PhD – Pfizer, Inc.; Claudia Corredor, Dr. – Bristol-Myers Squibb Company
Tuesday, Nov 6
9:30 am
Academic Research Opportunities to Support Continuous Manufacturing
Location: 147 AB, WEWCC
Fernando Muzzio, PhD – Rutgers University
Tuesday, Nov 6
10:00 am
Continuous Manufacturing Control Strategy for Oral Drug Product Manufacturing
Location: 147 AB, WEWCC
Ahmad Almaya, PhD – Lilly
Tuesday, Nov 6
10:30 am
Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations
Location: 147 AB, WEWCC
James DiNunzio – Merck & Co., Inc.
Tuesday, Nov 6
1:30 pm
Keynote: Continuous Manufacturing and the Role of Models in Implementing Continuous Manufacturing
Location: 147 AB, WEWCC
Sharmista Chatterjee – FDA; Arya Jayatilaka, PhD – Pfizer, Inc.; Claudia Corredor, Dr. – Bristol-Myers Squibb Company
Tuesday, Nov 6
1:30 pm
Keynote: Strategies and Visions for Continuous Biologics Manufacturing from End to End
Location: 145 AB, WEWCC
Joseph E. Shultz – Novartis Pharma AG; Karoline Barbara Bechtold-Peters, PhD – Novartis. Pharma AG
Tuesday, Nov 6
3:00 pm
Recent Advances in Gene Therapy Products with Specific Focus on Oncology Related Areas
Location: 207 A, WEWCC
Iryna Sanders, PhD – Pfizer
Tuesday, Nov 6
3:00 pm
Immuno-Oncology: Advancement from Infancy to Products - Manufacturing & Bioprocessing
Location: 207 A, WEWCC
Sandeep Nema; Satish K. Singh, PhD, FAAPS – Lonza AG
Tuesday, Nov 6
3:30 pm
Advances in the Manufacture of Large DNA Viruses for Use as Oncolytic Therapies
Location: 207 A, WEWCC
Steve Thorne, PhD – Western Oncolytics Ltd
Tuesday, Nov 6
4:00 pm
CMC Considerations for the Development of Early Phase CAR-T Cell Programs
Location: 207 A, WEWCC
Marianna Sabatino, MD – Arcellx
Tuesday, Nov 6
4:30 pm
CMC Challenges of Gene/Cell Therapy Products from Manufacturing, Characterization and Formulation Perspectives
Location: 207 A, WEWCC
Kimberly Schultz, PhD – US FDA
Tuesday, Nov 6
3:00 pm
Cost-efficiency Considerations: the Vision
Location: 207 B, WEWCC
Julian Quodbach, PhD – Institute of Pharmaceutics and Biopharmaceutis, Heinrich Heine University Duesseldorf; Test User
Tuesday, Nov 6
3:00 pm
Rapid and Cost-Effective Delivery of New Drugs to Patients - Manufacturing & Bioprocessing
Location: 207 B, WEWCC
Karoline Barbara Bechtold-Peters, PhD – Novartis. Pharma AG; Carl Allenspach – Bristol-Myers Squibb
Tuesday, Nov 6
3:30 pm
3D Printing as an Approach to Design and Manufacturing of Pharmaceutical Products
Location: 207 B, WEWCC
Joerg Ogorka, PhD – SANDOZ International GmbH
Tuesday, Nov 6
4:00 pm
3D Printing for Rapid Prototyping of Pharmaceutical Devices in Development
Location: 207 B, WEWCC
Martin McLoughlin, PhD – Bristol-Myers Squibb
Tuesday, Nov 6
4:30 pm
3D Printing in Pharmaceutical Development and Manufacturing: Technological Requirements, Critical Elements, and Process Controls in the Development of Novel Dosage Forms
Location: 207 B, WEWCC
Timothy S. Tracy, PhD – Aprecia Pharmaceuticals
Wednesday, Nov 7
8:30 am
Prologue: Approaches to Master CMC of the Future
Location: 145 AB, WEWCC
Linda Narhi, PhD – Amgen; Tim Menzen, Dr – Coriolis Pharma
Wednesday, Nov 7
8:30 am
Prologue: Flexibility in Pharmaceutical Manufacturing - The Path to Achieving Six Sigma
Location: 147 AB, WEWCC
Vishal C. Nashine, PhD – Celgene; Arya Jayatilaka, PhD – Pfizer, Inc.; Dorys Argelia Diaz
Wednesday, Nov 7
9:00 am
Current State of Pharmaceutical Manufacturing – Two Sigma
Location: 147 AB, WEWCC
Raymond D. Skwierczynski, PhD – Skwierczynski Consulting
Wednesday, Nov 7
9:00 am
Approaches to Master CMC of the Future - Chemical
Location: 147 AB, WEWCC
Arya Jayatilaka, PhD – Pfizer, Inc.; Dorys Argelia Diaz
Wednesday, Nov 7
9:30 am
Adaptive Processes in Pharmaceutical Development and Manufacturing
Location: 147 AB, WEWCC
Markus Krumme – Novartis
Wednesday, Nov 7
10:00 am
Knowledge Integration - Application of Artificial Intelligence and Machine Learning Tools in Manufacturing
Location: 147 AB, WEWCC
Rahul R. Kaushik, PhD – Nektar Therapeutics
Wednesday, Nov 7
10:30 am
Flexibility in Formulation
Location: 147 AB, WEWCC
Brian Carlin – DFE Pharma
Wednesday, Nov 7
9:00 am
Case Studies for Mabs
Location: 145 AB, WEWCC
Marisa Joubert, PhD – Amgen
Wednesday, Nov 7
9:00 am
Approaches to Master CMC of the Future – Biomolecular
Location: 145 AB, WEWCC
Linda Narhi, PhD – Amgen
Wednesday, Nov 7
9:30 am
Regulatory Input on Risk Assessments
Location: 145 AB, WEWCC
Susan Kirshner, PhD – FDA
Wednesday, Nov 7
10:00 am
The Application of Risk Assessments for the Design and Development of Devices for Biological Products
Location: 145 AB, WEWCC
Manfred Maeder – Novartis Pharma AG
Wednesday, Nov 7
10:30 am
Specific Considerations on Risk Assessments and QbD for Biosimilars
Location: 145 AB, WEWCC
Stan Speaker, MS – Pfizer, Inc.
Wednesday, Nov 7
10:30 am
FDA Perspective: How Regulators Address Innovation
Location: 143 ABC, WEWCC
Kurt Brorson, Ph.D – Food and Drug Administration
Wednesday, Nov 7
1:30 pm
Keynote: Advancing the Science of Oral Solid Dosage Form Development and Performance
Location: 147 AB, WEWCC
Gregory E. Amidon, PhD – University of Michigan College of Pharmacy; Arya Jayatilaka, PhD – Pfizer, Inc.
Wednesday, Nov 7
1:30 pm
Keynote: Global Regulatory Strategies for Biotech Products
Location: 145 AB, WEWCC
Bruce Meiklejohn, PhD – Meiklejohn Consulting; Linda Narhi, PhD – Amgen
Monday, Nov 5
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Biomolecular
Location: 145 AB, WEWCC
Divya Patel – University of Maryland, College Park; Walid Abdelwahab, Ph.D. – University of Montana
Monday, Nov 5
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Chemical
Location: 147 AB, WEWCC
Pradeep Valekar, MS Pharmaceuics – Duquesne University; Anuja D. Paprikar, MS – St. Johns University; Pavan Kumar Nukala, MS – St. John's University
Tuesday, Nov 6
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Biomolecular
Location: 145 AB, WEWCC
Ipshita Menon, M.Pharm – Mercer University; Waleed Faisal, PhD – University College Cork; Akash Patil, Mr. – University of Mississippi
Tuesday, Nov 6
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Chemical
Location: 147 AB, WEWCC
Ana Isabel Fraguas-Sanchez, MSc – Complutense University of Madrid; Karina Esparza, B Pharm – University of Illinois at Chicago
Wednesday, Nov 7
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Biomolecular
Location: 145 AB, WEWCC
Divya Patel – University of Maryland, College Park; Maurice M. Horton, PharmD – University of North Carolina at Chapel Hill; Mohamad M. Kronfol, B.Pharm – Virginia Commonwealth University
Wednesday, Nov 7
3:00 pm
Rapid Fire Presentations: Manufacturing and Bioprocessing – Chemical
Location: 147 AB, WEWCC
Khatoon Alasaad – University of Toledo; Sulaiman Alhudaithi, M.S. – Virginia Commonwealth University; Tasneem Gandhi, Masters – St. John's University
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