Manufacturing Strategy

Manufacturing Strategy 00:00 - 00:30

Streamline Biologics Process Characterization and Control Strategy Development

Lihua Yang,PhD - Senior Principal Research Scientist, AbbVie

Manufacturing Strategy 00:30 - 01:00

Comparability Studies to Support Manufacturing Process Change, Enhancing Product Quality and Accelerating Timeline to Commercial Launch

Wenqin Ni - Senior Principal Scientist, Pfizer

Manufacturing Strategy 01:00 - 01:30

Streamlining and Fast-Tracking Mammalian Tech Transfer to Ensure High Quality Commercial Supply

Tillmann Schnierda - Director, Commercial Development, Mammalian, Lonza

Manufacturing Strategy 01:30 - 02:00

Maximizing the Impact of Digital Twins in Bioprocess Development and Manufacturing

Maximilian Krippl - Head of Consulting, Novasign GmbH

Manufacturing Strategy 02:00 - 02:30

Considerations for drug developers on manufacturing data capture with a view to an anticipated structured review by Regulators for IND and BLA Filings

Jeffrey Mocny - Vice President, Scientific Project Leader, Abzena

Manufacturing Strategy 02:30 - 03:00

Successful Global Launch with a Risk-based Approach to Tech Transfer

Jesse Richter - Executive Director, Global Tech Ops - Tech Transfer and Validation, AstraZeneca

Manufacturing Strategy 03:00 - 03:30

Transitioning RNA Synthesis to Continuous Modes Using Modeling

Nathan Stover - Researcher, Braatz Group, MIT

Manufacturing Strategy 03:30 - 04:00

Overview of Analytical Control Strategy and Life Cycle Management for Biologics Products

Udayanath Aich, Ph.D. - Associate Director, Bristol Myers Squibb

Manufacturing Strategy 04:00 - 04:30

Novelty and Complexity of Continuous Manufacturing for Automation and Data Management

Elise Woodall - Automation Engineer, AstraZeneca

Manufacturing Strategy 04:30 - 05:00

Challenges and Excitement of Global mRNA Technology Transfer

Qian Ruan, Ph.D - Senior Vice president of TechOps and Supply Chain, Arcturus Therapeutics

Manufacturing Strategy 05:00 - 05:30

Digital-Twin-Assisted Manufacturing: Guideline to Accelerate Development Timelines and Automated Process Control

Mark Duerkop - Chief Executive Officer, Novasign, Austria

Manufacturing Strategy 05:30 - 06:00

Process Development and Operational Benefits of a Factory Digital Twin

Steve Harding - President, Advanced Process Combinatorics, Inc.
Joseph Pekny - Professor, Chemical Engineering, Purdue University

Manufacturing Strategy 06:00 - 06:30

Intensification of Downstream Manufacturing of Recombinant Adeno-Viral Vectors using Continuous Processing

Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals

Manufacturing Strategy 06:30 - 07:00

Regulatory Science Perspective on Implementing Industry 4.0

James Coburn - Senior Advisor for Emerging Technologies, FDA

Manufacturing Strategy 07:00 - 07:30

When a Template isn't Templated: Bioprocessing in the World of Vaccines

Chase Orsello - Global Head, Bioprocess Development, Sanofi

Manufacturing Strategy 07:30 - 08:00

Harmonizing Material Management Strategies from Development to Commercial Manufacturing

Dale R.Mowrey - Associate Director of Material Science, Teva Pharmaceuticals

Manufacturing Strategy 08:00 - 08:30

Continuous Manufacturing: Untangling Process Intensification on Custom Built Platforms

Juan Manuel Marin-Celis - Bio-Separations Scientist, Merck

Manufacturing Strategy 08:30 - 09:00

Adaptability of AI/ML for the BioPharma Industry

Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals
Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
Marinna Madrid - Co-Founder & Chief Product Officer, Cellino
Mark Duerkop - Chief Executive Officer, Novasign, Austria
William Whitford - Founder, Oamaru BioSystems

Manufacturing Strategy 09:00 - 09:30

Unlocking the Potential of Microbial Systems: CASPON, an Alternative Approach to Manufacture Next Generation Peptides

Cécile Brocard - Director Downstream Development, DevOps Austria, Boehringer Ingelheim RCV GmbH & Co KG

Manufacturing Strategy 09:30 - 10:00

Agility and Flexibility in Supply Chain Management: Harnessing Digital Innovation to Drive Rapid Response to Market Volatility and Unexpected Challenges

Imara Charles - VP, Process and Digital Excellence, Global Supply Chain, Bristol Meyers Squibb