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2012 Speakers Include:

Mark J. Krupka
Mark J. Krupka
Vice President & Technical Director
Ecological Laboratories, Inc
USA

Dr Barbara A. Paldus
Dr Barbara A. Paldus
CEO
Finesse Solutions

Jay Stout
Jay Stout
Director
Merck

Marc Proctor
Marc Proctor
Director Technical Service
Medimmune

Chun Zhang
Chun Zhang
Director, Cell Culture Process Development
Shire

Dr Keith Chidwick
Dr Keith Chidwick
Pharmaceutical Assessor
MHRA

Dr Daniel Bracewell
Dr Daniel Bracewell
Lecturer in Biochemical Engineering
UCL

Dr. Ingrid Bause
Dr. Ingrid Bause
Head of Quality Engineering Compliance Quality
Novartis

Pascal Reber
Pascal Reber
VP/GM
Genzyme

William Botha
William Botha
Director, OpEx & PMO
Genzyme

Tim Palberg
Tim Palberg
Global Project Leader
Bayer

Simon Chalk
Simon Chalk
Director
Biophorum

Michael Hoffman
Michael Hoffman
Regional Process Excellence Lead
Roche

David Balbuena
David Balbuena
Head Process Development
Merck Serono

Justin O. Neway
Justin O. Neway
Vice President & Chief Science Officer
Aegis Analytical Corporation

Justin O. Neway, Ph.D., Executive Vice President and Chief Science Officer for Aegis Analytical Corporation, has over 30 years of experience in biotechnology and pharmaceutical process developmen... [ view bio ]

Professor Elaine Martin
Professor Elaine Martin
Senior Lecturer
Newcastle University

James Sutter
James Sutter
Manager, BPS DSP
Merck Serono

Alex Eon-Duval
Alex Eon-Duval
Biotechnology Production Director
Merck Serono

Dr. Bernhard Roth
Dr. Bernhard Roth
Manufacturing Science and Technology - Head Virology
Novartis

Edgar Sur
Edgar Sur
Director of Operational Excellence, Product Supply Biotech/Product Supply NA
Bayer

Past Biological Production Forum Speakers Include:

Dr Rick J Rutter
Dr Rick J Rutter
Vice President Pharmaceutical Sciences
Pfizer Inc
USA

Dr Thibaud S Stoll
Dr Thibaud S Stoll
Head Global Biopharmaceutical Operations
Novartis Pharma AG
Switzerland

Operational Excellence has the potential to bring huge benefits and prepare the biopharmaceutical industry for its current and upcoming challenges, provided it is implemented in a radical way. In... [ view bio ]

Dr Jochen Schaub
Dr Jochen Schaub
Senior Scientist Systems Biotechnology, Bioprocess Development & Innovation
Boehringer Ingelheim Pharma GmbH & Co.
Germany

Dr Ralf Gleixner
Dr Ralf Gleixner
Sr. Director of BPS Quality Systems
Merck Serono S.A. -
Switzerland

Dr. Ralf Gleixner is Senior Director Biotech Process Sciences Quality Systems, Merck Serono SA, Vevey, Switzerland. He graduated from the University of Mainz as a Pharmacist in 1985 and obtaine... [ view bio ]

Dr Tarkan Dogru
Dr Tarkan Dogru
Head of Operational Excellence Hunningue
Novartis
Switzerland

Novartis BioPharmOps site at Huningue (Alsace) was originally designed as a monoproduct facility. With the increased portfolio of biopharmaceutical products, the Huningue operation is undergoing... [ view bio ]

Dr John Madsen
Dr John Madsen
Head Processing and Manufacturing Operations
Novavax
USA

John Madsen received his Ph.D. in Biomedical Sciences from the University of Texas Health Science Center, Houston/MD Anderson Cancer Center, Department of Cell Biology. His post-doctoral work at ... [ view bio ]

Dr Timothy Lee
Dr Timothy Lee
Deputy Director, Business Excellence Industrial Operations
Sanofi Pasteur
Canada
Dr Alain Bernard
Dr Alain Bernard
VP Biopharma Process Sciences (BPS)
UCB SA
Belgium

Dr John Gasdaska
Dr John Gasdaska
Senior Director Protein Sciences
Biolex Therapeutics

Marc Kinnelly
Marc Kinnelly
Head of Manufacturing
Medimmune
USA

Dr Serj Vartanian
Dr Serj Vartanian
Global Quality Systems Manager MBB BioScience
Baxter Healthcare Corporation
USA

Dr Alessandro Butte
Dr Alessandro Butte
Director Downstream Processing
Lonza
Switzerland

Dr Ulrich Rümenapp
Dr Ulrich Rümenapp
Contract Manufacturing Biotech, Head Biotech Projects
Bayer Schering Pharma AG
Germany

Frederico França Giunchetti
Frederico França Giunchetti
Head of Engineering
Sandoz do Brasil Industria Farmaceutica Ltda
Brasil

Marten Paasman
Marten Paasman
R&D Program manager
DSM BioSolutions

Reduction of time to market and risk is key in todays market dynamics. DSM BioSolutions has developed a fast-track scale-up approach: By application of a broad range of microbial expression syste... [ view bio ]

Jon Reid
Jon Reid
Global Director BioProcess Containers
Thermo Scientific

Dr Amit Mehta
Dr Amit Mehta
Snr. Engineer/Group Leader Late Stage Purification
Genentech
USA

Mark Proctor
Mark Proctor
Director, Technical Service
Medimmune Ltd.
Uk

Kim Sandell
Kim Sandell
Director, Operations Management & Operational Excellence
Pfizer
Sweden

Dr Johannes Blümel
Dr Johannes Blümel
Head of Virus Safety Section
Paul-Ehrlich-Institut, Federal Agency for Vaccines and Biomedicines
Germany

Recent contamination events with porcine circovirus, vesivirus and murine parvovirus have highlighted the necessity for implementing an integrated control strategy at biotechnological production.... [ view bio ]

Burkhard Wandelt
Burkhard Wandelt
BTO Shift Head
Merck Serono
Switzerland

The presentation introduces the Merck Serono Project “Large Scale Biotech Production”, the currently worldwide biggest investment project building a biotech production plant at the s... [ view bio ]

Noortje Maassen MSc.
Noortje Maassen MSc.
Scientist
Janssen Biologics B.V.
The Netherlands

For our customers it is of utmost importance that we can always guarantee product quality as well as availability. The regulations of the agencies guard that the customer needs are met by means ... [ view bio ]

Dr. Ingrid Bause
Dr. Ingrid Bause
Head of Quality Engineering Compliance Quality
Novartis Vaccines and Diagnostics GmbH
Germany

Irwin Hirsh
Irwin Hirsh
QbD Business Development Specialist
NNE Pharmaplan A/S

Irwin Hirsh has worked in the pharmaceutical filed since 1998 in many different capacities including lead compound discovery, development, production and quality. Before Joining NNE Pharmaplan I... [ view bio ]

Philipp Zumoberhaus
Philipp Zumoberhaus
Engineering Manager
Endress+Hauser Process Solutions AG

Dr Alex Eon-Duval
Dr Alex Eon-Duval
Biotechnology Production Director
Merck Serono

The presentation describes the current Merck Serono QbD approach to the validation of a drug substance manufacturing process for an Fc fusion protein. The presentation will focus on the applicat... [ view bio ]

Gerd Kern
Gerd Kern
Product Manager – Ion Exchange Chromatography,Biopharm Process Solutions
Merck Millipore.

Tomo Miyabayashi
Tomo Miyabayashi
Vice President
Asahi Kasei Bioprocess Inc.

Tomoyuki (Tomo) Miyabayashi is currently Vice President of Science and Technology at Asahi Kasei Bioprocess Inc.. His responsibilities are to develop advanced technologies in bioprocess field and... [ view bio ]

Dr Chris Illidge
Dr Chris Illidge
Senior Scientist
UCB
UK

Jacques Clemens
Jacques Clemens
Vice President
Asahi Kasei Bioprocess Europe NV/SA

BS Biochemistry. 10 years laboratory research and diagnostics regarding allergy at Sanquin, NL; Spent 16 years with Pharmacia Biotech (now GE Healthcare) developing engineering business in Europe... [ view bio ]

Steve Delity
Steve Delity
President and CEO
Rapid Micro Biosystems
USA

Steve has more than 20 years of leadership experience and joined Rapid Micro Biosystems from PerkinElmer Life and Analytical Sciences, where he most recently led a business with responsibility fo... [ view bio ]

Dr Chris Illidge,
Dr Chris Illidge,
Senior Scientist
UCB
UK
Dr Kevin Bailey
Dr Kevin Bailey
Vice President Preclinical Manufacturing and Process Development
Regeneron Pharmaceuticals Inc
USA

Robert Seymour
Robert Seymour
Purification Development Scientist
Eden Bio Design
UK

Amelie Raveneau
Amelie Raveneau
Application Specialist Purification Technologies South Europe,
Sartorius Stedim Biotech

What is the safety level needed to handle the molecule of interest? Batch versus campaigns? Volume levels? All these types of questions will lead to a choice between re-usable or disposable techn... [ view bio ]

Frank Meyeroltmans
Frank Meyeroltmans
Head of Product Management Crossflow
Sartorius Stedim Biotech

What is the safety level needed to handle the molecule of interest? Batch versus campaigns? Volume levels? All these types of questions will lead to a choice between re-usable or disposable techn... [ view bio ]

Dr. Thomas Müller-Späth
Dr. Thomas Müller-Späth
Senior Scientist
ETH
Switzerland

Continuous chromatographic processes are under repeated evaluation in the biopharmaceutical industry due to their advantages in therapeutic protein downstream processing which include high produc... [ view bio ]

Dr Kit Erlebach
Dr Kit Erlebach
Head of Technical Operations
MSD
UK

Kit Erlebach (Head of Technical Operations) has a first degree from Nottingham University in Chemical Engineering and a PhD from Cambridge University in Chemical Engineering and is a Chartered Ch... [ view bio ]

Dr Daniel Bracewell
Dr Daniel Bracewell
Lecturer in Biochemical Engineering
UCL

Dr Justin O Neway
Dr Justin O Neway
Vice President & Chief Science Officer
Aegis Analytical Corporation

Successful Quality by Design (QbD) requires effective collaboration between Process Development, Manufacturing and Quality Assurance teams which are often spread across multiple time zones and co... [ view bio ]

Matthew Pietrzykowski,
Matthew Pietrzykowski,
Lead Scientist, General Electric's Global Research Laboratory
GE Healthcare

François Prautois
François Prautois
Global Industry Manager Life Sciences
Endress+Hauser S.A.
France

Jon Reid
Jon Reid

Thermo Fisher Scientific

Yann d’Aramon
Yann d’Aramon
Sales Vice-President - DELMIA Production Operations EMEA
DELMIA

Dirk Tillich
Dirk Tillich
European Sales Director
Finesse

Single-use bio-processing applications are still in great need of reliable key process parameter measurements for pH, dissolved oxygen (DO), and temperature, as traditional electrochemical sensor... [ view bio ]

Brett Littlefield
Brett Littlefield
Senior Separation Technology Specialist
Pall Life Sciences

Dr. Grant E Boldt
Dr. Grant E Boldt
Director European Business Development for SAFC Contract Manufacturing Services
SAFC

Currently, Grant Boldt oversees all the contract manufacturing business development activities at SAFC for both small and large molecules in the EU. He and his team have several years of experien... [ view bio ]

Frank Wilde
Frank Wilde
Leiter Geschäftsbereich / Head of Business Unit
MW Group