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Wolfgang Noe, Ph.D
Vice President, Biopharmaceutical
Development, Biogen Idec
During Wolf Noe ’s 16-year career at Boehringer Ingelheim, he played a leading role in cell culture process development, cell culture based manufacturing, and manufacturing alliances with various organisations. Wolf has also been involved in many European based committees, such as ESACT, where he played a pivotal role in the industrial cell culture society. He joined IDEC in 2001 as head of Process Sciences where he focused mainly on developing high titer processes in upstream and downstream on monoclonal antibodies.
After the merger between Biogen and IDEC in late 2003, Wolf was promoted to the role of Vice President of Biopharmaceutical Development for Biogen-IDEC development for both east and west coast locations.
Since then, Wolf has focused on an integrative, forward-looking approach in process development, and integrating all required disciplines to a new frontier (cell culture, protein purification, formulation, analytical development), considering all new regulatory initiatives such as QbD, PAT, DoE, et al. |
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Dr. Fadel Hamed
Associate Director, GT Operational
Excellence, Genentech, Inc.
Fadel has an extensive background in the strategy and execution of process improvements initiatives. His Lean Six Sigma experience started in the semiconductor industry where he was a pioneer in introducing process improvement principles into the high volume high product mix manufacturing environment.
Over the last seven years, Fadel worked in the biotech industry at Amgen and Genentech.
As an innovator, Fadel has been transforming the culture in biotech to ensure the successful deployment of Lean Six Sigma mindset.
Fadel’s background combines skills in operations, manufacturing , quality, technical management, and strong leadership. He is a frequently requested speaker at International conferences. Fadel holds a doctorate in mechanical engineering from UC Berkeley and he is an ASQ certified six sigma black belt and quality engineer. |
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Tony Orchard
Vice President,
Marketing - Pall Life Sciences
Tony is globally responsible for market strategy and business development in the BioPharmaceutical Division of Pall. After graduating from University College London ( Chem. Eng. Hons) he worked in membrane technology, pioneering a number of applications in food, biotech and industrial markets. Since joining Pall in 1988 he has led product management and been closely involved in the development and introduction of new platform technologies for aseptic filtration, engineered and single use process systems, TFF, chromatography and process analytical technology. |
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Barbara A. Paldus, Ph.D
CEO
Finesse Solutions
Barb was most recently the CTO of Picarro, a company she founded in 1998. At Picarro, she was responsible for technology strategy, research, and business development, which led to a solid-state Cyan laser product in 2003 and cavity ring-down spectroscopy products in 2004. Barb is currently a partner at Skymoon Ventures. Barb received both her Ph.D. (1998) and M.S.E.E. (1994) degrees in electrical engineering from Stanford University, and her BS (1993) in electrical engineering/applied mathematics from the University of Waterloo. |
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Dr. Arunakumari
Senior Director of Process Development
Medarex
Dr. Arunakumari is Senior Director of Process Development at Medarex, the worldwide developer of human antibody therapeutics. In her role, she oversees the development, scale up and transfer of cell culture and purification processes. Her extensive 16 years experience in management roles at Enzon, Bristol Myers-Squibb, and Medarex, have been instrumental in integrating upstream and downstream processes and achieving 6 g/l in productivity.
She significantly improved over all facility output, batch processing time and cost of goods by developing simple non-protein A purification processes in fewer processing steps and column cycles. Her technique not only optimized conditions to remove all process related contaminants on ion exchange resin comparable to that of affinity chromatography, but also modified the process schemes to require less validation. These improvements were carried out simultaneous to a pipeline project in process development and managed to scale up ‘ion exchange-processes' to handle up to 5000 liters of cell culture harvest. Alahari's critical contribution to Medarex platform technology produced 14 different humabs between the manufacturing facility and Contract Manufacturing Organizations. |
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Dr. Felix Oehme
Group Leader Biological Development
Bayer HealthCare AG
Head of a biochemical laboratory at Bayer Schering Pharma, Global Biological Development, Wuppertal
Responsibilities:
Development of downstream production processes for clinical manufacturing of protein therapeutics & Project management. |
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Majid Mehtali, PhD
CSO, Vice-President R&D
Vivalis SA, Nantes, France.
Majid Mehtali is since 2003 the Chief Scientific Officer and General Manager of Vivalis. He is a graduate of the European School of biotechnology in Strasbourg and received his PhD at the University of Strasbourg, France.
He started his career in 1984 at RHONE-MERIEUX (currently MERIAL) in Lyon . He then joined TRANSGENE SA (France) as Head of the Virology-Immunology Department (1988-1993) and Head of Gene Therapy Research (1993-1999). From 1999 to 2001, Dr Mehtali worked for the Dutch biotechnology company CRUCELL as Vice-President Research.
From 2001 to 2003, Dr. Mehtali has been Chief Scientific Officer and General Manager at DELTAGEN-EUROPE, the European subsidiary of DELTAGEN Inc., a US-based functional genomic and drug discovery company. |
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Aziz Cayli, PhD, MBA,
Chief Executive Officer
Cellca
A biotechnologist with extensive industrial experience in the design
of protein production processes. Having worked as a Research Assistant
for Cell Culture Process Development at Roche Diagnostics GmbH in
Penzberg, Germany, Dr. Cayli then became Manager of Cell Culture
Technology at Boehringer Ingelheim in Biberach, a position he held for
5 years. During this time, he was responsible for the development of
new manufacturing processes for use at 15,000 l production scale. |
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Dr. Christine Mitchell-Logean
Head of Bioprocess Expertise and
Innovation, Biotech Bulk Center of Expertise
Merck Serono SA
Christine Mitchell-Logean holds a Ph.D in Chemical and Biochemical Engineering and is also a Six Sigma Blackbelt. She has worked for several years at Bristol Myers Squibb on the development of new cell culture processes as cell culture development group leader. She moved to Serono in 1999 where she developed serum free biotechnology processes and held a position of manufacturing project leader supporting production process improvement projects, technical transfer and investigations. She has also held a position as process development project leader working on the design of lean manufacturing processes. Today she is Head of Bioprocess Expertise and Innovation at Merck Serono and searches for best practices to standardise and to improve current processes. She is also currently focused on evaluating new technologies for Bioprocessing. |
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Future Technologies In Biologics Manufacturing -Transform Bioprocess Productivity And Over Come The Challenges Of Speed, Survival And Innovation
