Key Bio Sponsors 2014 Towards Biological Manufacturing ... Dr. Uwe Gottschalk ... Amita Goel...
Transcript of Key Bio Sponsors 2014 Towards Biological Manufacturing ... Dr. Uwe Gottschalk ... Amita Goel...
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.
ww
w.g
bx
sum
mit
s.co
m
w w w . m a n u b i o . c o m
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.
ww
w.g
bx
sum
mit
s.co
m
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
Day
On
e K
ey N
ote
s &
T
hem
es I
n D
iscu
ssio
n
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
Day
Tw
o K
eyn
ote
s
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
Day
Tw
o I
nn
ova
tio
n
Key
No
tes
Day Two Afternoon
w w w . m a n u b i o . c o m
“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