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8:00 am Registration & Welcome Coffee

8:15 am Chair’s Opening Remarks

8:30 am Opening Address: The New Launch: CBER’s Advanced Manufacturing for Complex Biologics Products

  • Manuel Osorio Senior Scientist & Program Lead for Emerging Technologies, FDA/CBER

9:00 am Continuous Manufacturing as a Default Platform for Oral Solid Drug Products

9:30 am The Possibility of End-to-End Implementation of Continuous Manufacturing – From Development to Supply

  • Justin Moser Director – Advanced Manufacturing Technology, Merck & Co., Inc.

10:00 am Panel Discussion: Is Continuous Manufacturing for Legacy Product Only? Can we be Courageous and Use it for NDA?

10:45 am Speed Networking & Morning Coffee

Small Molecules Stream

Biologics Stream

11.45 am End-to-End Continuous Flow Chemistry Process to Increase Production Efficiency

 

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Miguel Gonzalez, Senior Director, Chemical Engineering, Asymchem

12.05 pm Application of Continuous API Manufacturing Technologies at Pfizer

 

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Nathan Domagalski, Senior Principal Scientist, Pfizer Inc

11.45 am Towards Continuous Drying Technologies for Parenterals

 

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Sune Klint Anderson, Principal Scientist, Janssen R&D

12.15 pm A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses

 

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Thomas de Beer, Head of Laboratory of Pharmaceutical Process Analytical Technology, University of Ghent

12:45 pm Networking Lunch

1:15 pm

13.15 pm Flexible API Supply Technologies; Pfizer’s Strategy for API Continuous Development and Manufacturing

 

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Nick Thomson, Senior Director, Chemical Research & Development, Pfizer Inc.

13.45 pm CDC-50: A Case Study on 120-Hour of Continuous Direct Compression to Drive Process Flexibility, Yield, Recovery & Overall Equipment Efficiency

Richard Steiner, Business Development Manager, Continuous Technologies, GEA

14.00 pm Commercializing New Chemical Technologies in Flow

 

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Kaid Harper, Senior Scientist, AbbVie

 

 

 

 

 

13.15 pm Design of Jetted Protein A Resins for Continuous Chromatography

 

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Hans Johansson, Global Applications Director, Life Sciences, Purolite

13.35 pm Continuous Bioprocessing for Exosomes Manufacturing – Upstream Case Study from Codiak Biosciences

 

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Senior Representative, Sanofi

14.05 pm From Small Molecules to Biologics - why synTQ can support your continuous manufacturing?

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Senior Representative, synTQ

14.15 pm Multi-Column Chromatography Going Mainstream

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Gerard Gach, Chief Marketing Officer, YMC Process Technologies

2:45 pm Afternoon Networking Tea & Poster Session

3:30 pm Creating a Common Language and Framework to Support Continuous Manufacturing Globally

  • Ganapathy Mohan Executive Director, Head of External Affairs (Quality), Merck & Co., Inc.

4:00 pm Continuous Downstream Processing – Where Are We in Regard of Comparability and Regulatory Challenges?

  • Klaus Kaiser Head Downstream Development, Product Supply, Pharmaceuticals, Bayer AG

4:30 pm Roundtable Discussion:

5:15 pm Chair’s Closing Remarks & End of Day 1

5:30 pm Poster Session