The Annual Bio Manufacturing & Process

Innovation Leaders SummitUSA 2014 (MANU-BIO)

R e v e r e H o t e l B o s t o n C o m m o n10-11/06/ 2014

The Annual Manu-Bio Leaders Summit is the leading biological manufacturing meeting for decision makers & thought leaders In bioprocessing, operations,

QbD, bio-similars, up stream and down stream, PAT, chromatography, quality, compliance and supply chain. 

Delivering up to 30 compelling presentations, engaging panel discussions & numerous networking opportunities through networking dinners, lunches, best

practice round tables discussions & scheduled meetings over a 2 day period.

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Blueprint Towards

Biological Manufacturing

Excellence & Bio-Process Innovation.

K e y B i o S p o n s o r s 2 0 1 4

Chairman - Dr. Uwe GottschalkGroup VP Purification TechnologiesSartorius Stedim Biotech

GBX Summits Ltd researches and produces the world's most exclusive and innovative summits in life sciences, outsourcing and manufacturing Industries.

We provide the world's most prominent decision makers and solution providers a unique platform to bench mark, network, learn and exchange cutting edge ideas to procure and re-examine key challenges and objectives now and in the crucial years to come.

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THE GBX SUMMIT FORMAT Morning Keynotes

• End User Programme• Open Panel Discussion

Meetings• Prior Contact• Pre Scheduled• 7 Guaranteed Meetings

• Innovation WorkshopsTwo Way Discussions

• End User Audience• Best Practice Sessions• Cohesive Environment• Networking Gala Dinner

Day 2 Chairman - Jesús ZurdoHead of Innovation Biopharma Development, Lonza Biologics plc

G l o b a l P a r t n e r s , P r e v i o u s & C o n fi r m e d S p o n s o r s

08:45 Chairpersons Welcome Address followed by keynote:

10:00 Morning Break / Meetings Exchange

13:30 Networking Lunch Buffet at the Exhibition Area

12:30 Scheduled Meetings 12:50 / 13:10 / 13:30

11:30 Innovation is still the Key for the Future of Biomanufacturing:A case against status quo, aka Platform Approach

11:00 Developing Efficient Strategies to To Achieve Well Controlled Cell Culture Perfusion Processes - Title to be updated

10:30 Flexible Biopharmaceutical Production Facilities

09:30 The Lifecycle Approach to Process Validation

09:00When to Innovate? What are the Barriers? What are the Challenges?The impact of new developments and their potential to deliver more cost effective processes

Dr. Uwe GottschalkGroup VP Purification TechnologiesSartorius Stedim Biotech

Sponsored By Sartorius Stedim

Please follow your meetings schedules.

Dr. Sadettin Ozturk Head of Process and Analytical Development MassBiologics

Lada Laenen Managing Principal Scientist, Cell Culture and Microbiology, Genzyme

Scott Kaplan Senior Director of Project Development Pharmadule Morimatsu, Inc.

Kim Wong Director, Facilities & cGMP Support, Bioprocess Research & Development, Sanofi Pasteur

12:00 The future of Biosimilar Manufacturing Andreas HerrmannCEO, Alvotech

08:30 Registration

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Day One

15:30 Afternoon Break / Meetings Exchange

Closing Remarks - Followed by Drinks Reception

16:30 Modularity: Real World Solutions and Applications

16:00 A QbD Approach for the Continuous BioManufacturing of mAbs

15:00 Revolutionary Column-Free Purification Platform

Jesse McCool, Ph.D. Senior Vice President of R&D

Sponsored By Sartorius Stedim

George WikerVice President, M+W Group

Maurizio CattaneoPresident, BioVolutions

Oleg Shinkazh CEO, Chromatan

17:30

14:30

Rick Johnston, Ph.D. Principal, Bioproduction Group

Real-Time Scheduling of Clinical Biomanufacturing Facilities17:00

OPEN LEADERS PANEL DISCUSSION:Potential Disruptions in Bio-Manufacturing

Sadettin Ozturk, Mass Biologics Ronald Neeleman, SanofiOleg Shinkazh, ChromatanMaurizio Cattaneo, President, BioVolutions

Leveraging Innovation to Achieve Manufacturing Excellence across Mammalian and Microbial Biologics Processes

Jesse McCool, Ph.D. Senior Vice President of R&D Services, Cytovance Biologics, Inc.

08:45 Registration & Networking

10:00 Morning Break / Meetings Exchange

11:30 How “Continuous” Manufacturing will Transform Biotherapeutic Manufacturing

11:00 Leveraging Selectivity to Maximise Downstream Process Productivity

10:30 The Future of Vaccine Manufacturing

09:30 Leveraging Innovation to Enhance Manufacturing and Development Efficiency

09:00 Technical Innovation in Biopharma - When and Where to Make Investments

Exhibition Area / Driving Innovation

Prof. Bernhardt L. Trout Director, Novartis-MIT Center for Continous Manufacturing, Co-Chair, Singapore-MIT Alliance, Chemical and Pharmaceutical EngineeringProf. Department of Chemical Engineering, MIT

Sherif Hanala, Sr. Global Product Manager Process Chromatography Bio-Rad Laboratories

Ronald NeelemanSenior Director Vaccine Innovation and Viral Expert, Sanofi Pasteur

Veena WarikooScientific Director Purification Development Genzyme

Henrik Andersen Executive Director Bio-Process Development ZymoGenetics a BMS company

12:00 Scheduled Meetings 12:00 / 12:30

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Day Two

15:00 Assessment, Monitoring and In-process Control of Critical Raw MaterialVariability in Mammalian Cell CultureTitle to be updated

14:30 Development of Innovative and Cost Effective Solutions in Bioprocessing

Seongkyu Yoon, Assistant Professor and DirectorMassachusetts BioManufacturing Center, University of Massachusetts Lowell

Amita Goel Founder and CEO of Celltheon Corporation

12:50 Networking Lunch Buffet at the Exhibition Area

14:00 Developability and Early Risk Management as an Enabler to Increase Preclinical and Clinical Success

Jesús ZurdoHead of Innovation Biopharma DevelopmentLonza Biologics plc

16:30 End of Conference

15:30 Open Panel Discussion: Regulatory Considerations for Antibody Drug Conjugates Technology

Tom Rohrer, Senior Director of ADC Biochemical Technology, Lonza TBCBoris Napadensky, VP Engineering, Chromatan TBC

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“The GBX format is different from any other biotech/pharma networking summit. The attendance is high quality. This is an ideal setting to have effective discussions with Pharma and Biotech decision-makers. I would recommend it to any Industry CEO.” René LABATUT is the Vice President of Global

Manufacturing Technology in Sanofi Pasteur