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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 B, 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
10:30 am

FDA Perspective: How Regulators Address Innovation

Location: 145 AB, WEWCC
Kurt Brorson, Ph.D – Food and Drug Administration
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
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
Sadik Kassim
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
Andrew M. Bryant – Novartis
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
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; Wenchun Feng, Ph.D – US Food and Drug Administration; 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; Akash Patil, Mr. – University of Mississippi; Waleed Faisal, PhD – University College Cork
Tuesday, Nov 6
3:00 pm

Rapid Fire Presentations: Manufacturing and Bioprocessing – Chemical

Location: 147 AB, WEWCC
Divya Patel – University of Maryland; 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; 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; Sulaiman Alhudaithi, M.S. – Virginia Commonwealth University; Tasneem Gandhi – St. John's University