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2012 Speakers Included:

If you would like to be considered, please contact Melissa Young Sing Conference Producer, World Trade Group North America T: +1 416 214 1144

Andy Skibo
Andy Skibo
EVP Operations
Medimmune
USA

Andrew D. Skibo holds the role of executive vice president of operations at MedImmune as of 2011. In this role he will lead various projects, work with external partners, and continue to strength... [ view bio ]

Joerg Heidrich
Joerg Heidrich
S.V.P., Head of Global Product Supply Biotech, and Site Head - Berkeley
Bayer Healthcare Pharmaceuticals

A recognized leader in the field of biomanufacturing and a Bayer veteran, Mr. Heidrich has dedicated more than 20 years of his professional career to the management of various manufacturing opera... [ view bio ]

Sanjeev Majoo
Sanjeev Majoo
Director, Global Strategic Sourcing
Amgen Inc.
USA

Sanjeev Majoo , currently Director, Global Strategic Sourcing at Amgen Pharmaceuticals, has been proven performer in the biopharmaceutical industry for the past 15 years with increasing responsib... [ view bio ]

Reuben Domike, Ph.D.
Reuben Domike, Ph.D.
Research Affiliate
M.I.T. Sloan School of Management

Dr. Reuben Domike is a research affiliate with the Center for Biomedical Innovation at the M.I.T. Sloan School of Management and an assistant professor at the UPEI School of Business. ReubenR... [ view bio ]

Manfred Bruch, Ph.D.
Manfred Bruch, Ph.D.
Head Partner Management
F. Hoffmann-La Roche Ltd
Basel

Dr. Manfred Bruch leads the group which selects and keeps relations to companies Roche is licensing production to. He also manages the group overseeing all production transfers in the Roche manuf... [ view bio ]

John Stubenrauch, MBA, Ph.D.
John Stubenrauch, MBA, Ph.D.
Merck BioVentures Chief of Staff
Merck & Co
USA

John Stubenrauch has 15 years of experience in the Pharmaceutical industry. He joined Merck in 1996 within the Merck Manufacturing Division (MMD) and has had a variety of Technical Operations ro... [ view bio ]

Devrim Hodach
Devrim Hodach
Head of Development ADC/Biologics CMOs
Genentech
USA

Devrim Hodach is the Head of Development CMOs for Biologics and Antibody Drug Conjugates (ADCs) in Contract Manufacturing Unit at Genentech. In this role, she leads selection and management of th... [ view bio ]

Bernie Huyghe, Ph.D., RAC
Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer
USA

I currently work in the Biotherapeutics and Vaccines Outsourcing group for Pfizer where we coordinate external development activities. Prior to joining Pfizer, I worked for both small start-up bi... [ view bio ]

Ken Hamilton
Ken Hamilton
Director of Process Engineering
Genentech
USA

Ken Hamilton has twenty five years’ experience in the biopharmaceutical industry. He earned his B.Sc. from the University of Manchester, and his M.Sc. and Ph.D. from the University of Wales... [ view bio ]

Bob DiVasto
Bob DiVasto
Vice President, Manufacturing and Supply
Cadence Pharmaceuticals
USA

Bob is responsible for all manufacturing and supply chain operations at Cadence Pharmaceuticals including the development and execution of Cadence’s unique “owner driven” outsou... [ view bio ]

Andrew Knudten
Andrew Knudten
Sr. Director & Global Head of Contract Manufacturing and Strategy
Novartis Vaccines and Diagnostics, Technical Operations
USA

•Joined Novartis in February of 2009 •20 years of experience in the biotech/ pharmaceutical industry in both large Pharma and venture capital/startup biotech (Novartis, Amgen, Dekalb... [ view bio ]

Kevin Pegels
Kevin Pegels
VP Global Supply Chain Management
BayerHealthcare – Biotech
USA

Pierre-Alain Ruffieux
Pierre-Alain Ruffieux
Head Global Manufacturing & Biologics Quality Assurance
Novartis Pharma AG
Basel, Switzerland.

Pierre-Alain Ruffieux is the Head of Global Manufacturing & Biologics QA for Novartis Pharma. In 2003, he joined Novartis where he hold different positions in Process Development, Manufactu... [ view bio ]

Marc Better
Marc Better
Executive Director, Process Science
Boehringer Ingelheim

Marc Better, Ph.D. is Executive Director, Process Science at Boehringer Ingelheim in Fremont, CA. Marc joined Boehringer Ingelheim through the acquisition of the Amgen Fremont facility in March ... [ view bio ]

Michael Hausladen
Michael Hausladen
Director of Manufacturing
Bristol-Myers Squibb
USA

Hans Engels
Hans Engels
President & CEO
DSM Pharmaceuticals, Inc.
USA

Since February 2008 Hans has served as President and Business Unit Director for DSM Pharmaceuticals in Greenville, NC (USA) where he has full P&L responsibility, including all operations and ... [ view bio ]

Michael Teasdale
Michael Teasdale
Senior Director, Operational Excellence
Baxter Bioscience
USA

Michael Teasdale is Senior Director, Operational Excellence for Baxter BioScience, a 5 billion dollar biotech division of Baxter. He has been in this role since 2002, driving strategic planning, ... [ view bio ]

David Allen
David Allen
Senior Director Technology
Eli Lilly and Company
USA

Dr. David Allen is currently the Senior Directory of Technology for the Indianapolis Parenteral Operations for Eli Lilly and Company. David joined Eli Lilly and Company in 1994 from The Upjohn C... [ view bio ]

Stacy Springs
Stacy Springs
Director, Biomanufacturing Research Program
MIT Center for Biomedical Innovation
USA

Dr. Stacy Springs is the Director of the Biomanufacturing Research Program (BioMAN) at the MIT Center for Biomedical Innovation. BioMAN is a collaborative research program between academia, gove... [ view bio ]

Paul Marshall
Paul Marshall
SVP Operations
Amylin Pharmaceuticals Inc.
USA

Mr. Marshall has served as our Senior Vice President, Operations since December 2008. He previously served as Vice President, Operations from December 2006 to December 2008. Prior to joining Amyl... [ view bio ]

Justin O. Neway, Ph.D.
Justin O. Neway, Ph.D.
Vice President and 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 ]

Andy Ramelmeier
Andy Ramelmeier
VP Manufacturing, Process Development and Facilities
BioMarin
USA

Dr. R. Andrew “Andy” Ramelmeier is Vice President, Manufacturing, Process Sciences and Facilities, at BioMarin Pharmaceutical, Inc, a profitable biotechnology company specializing in ... [ view bio ]

Curran Simpson
Curran Simpson
Sr. Vice President, Operations
Human Genome Sciences
USA

Curran M. Simpson joined HGS in March 2003 as Vice President, Manufacturing Operations. He was promoted to Senior Vice President, Operations, in December 2005. Prior to joining HGS, Mr. Simpson w... [ view bio ]

Tim Noetzel
Tim Noetzel
Manager of Fermentation
Roche Diagnostics, Inc.

Tim is currently Manager of Fermentation for Roche Pharma Biotech Production in Penzberg, Germany. In this role he leads a team responsible for seed train cultivation, fermentation process analyt... [ view bio ]

Dr. Stephen Taylor
Dr. Stephen Taylor
Commercial Director and Vice President
Fujifilm Diosynth Biotechnologies
UK

Dr Stephen C. Taylor is Commercial Vice President of Fujifilm Diosynth Biotechnologies in the UK with responsibility for commercial and business development activities. Prior to this he was B... [ view bio ]

Dr. Brian Lee
Dr. Brian Lee
President & CEO
PBS Biotech, Inc.

Dr. Brian Lee is the president and co-founder of PBS Biotech Inc., a Camarillo, California based single-use bioreactor and bioprocessing solutions company. Dr. Lee graduated from Seoul Nation... [ view bio ]

Elizabeth Dunn
Elizabeth Dunn
Director of Validation
Boehringer Ingelheim

Denise L. McDade
Denise L. McDade
Sr. Director Quality Assurance
Teva Pharmaceuticals
USA

Denise McDade is Senior Director Quality Assurance at Teva Pharmaceuticals, where she is repsonsible for Quality Sytems, QA Manufacturing, QA Docuementation and Change Control, Product Release an... [ view bio ]

Dato’ Dr. Mohd Nazlee Kamal
Dato’ Dr. Mohd Nazlee Kamal
CEO
Malaysian Biotechnology Corporation
& Chairman
Malaysian Bio-XCell
Malaysia

With 25 years of diverse industry background in biotechnology including 10 years of executive management experience, Nazlee brings in strong acumen in both the technical and business aspects of b... [ view bio ]

Claude Hatfield
Claude Hatfield
Senior Vice President, Operations & Compliance
VelQuest
USA

Claude Hatfield is Senior Vice President, Operations & Compliance at VelQuest, which he co-founded. Claude is responsible for all compliance activities and operations including project manage... [ view bio ]

Rick Johnston Ph.D.
Rick Johnston Ph.D.
Principal
Bioproduction Group (Bio-G)

Rick Johnston, Ph.D. is a pioneer in the field of risk assessment and planning for the world’s largest biopharmaceutical organizations. Dr Johnston leads Bioproduction Group’s technic... [ view bio ]

Julie Sperry
Julie Sperry
Chief Commercial Officer
Rapid Micro Biosystems

Julie brings more than 30 years experience in healthcare, pharmaceutical and manufacturing operations. Ms. Sperry previously served in various General Management, Sales and Marketing leadership r... [ view bio ]

John Bonham-Carter
John Bonham-Carter
Vice President, Sales & Business Development
Refine Technology

The first business John founded was a free-ads newspaper in the south of France, called Annonces Vertes. After a period with a satirical political magazine in London, the Insider, he moved into t... [ view bio ]

Dr. Barbara Paldus
Dr. Barbara Paldus
CEO
Finesse Solutions, Inc
USA

As cell culture titers continue to increase, more processes will leverage the benefits of single-use bioreactors. In order to accelerate the adoption process of single-use upstream systems, from ... [ view bio ]

Dr. Aleš  Štrancar
Dr. Aleš Štrancar
CEO
BIA Separations
Republic of Slovenia

Ales Strancar, the CEO of the Company and one of the main inventors of the CIM Convective Interaction Media® (new generation of chromatographic support), after finishing MSc at University of... [ view bio ]

Karen L. Oliver
Karen L. Oliver
Director, Global Accounts
World Courier
USA

Karen has supported the clinical study industry throughout her 15 year tenure at World Courier by preparing transportation recommendations for complex multinational pharmaceutical projects. Kar... [ view bio ]

Christie Williams
Christie Williams
Black Belt, Director Account Management
Fujifilm Diosynth Biotechnologies
USA

Christie Williams is currently Director, Account Management at Fujifilm Diosynth Biotechnologies, Inc. and a certified Lean Six Sigma Black Belt. In her current role, Christie is responsible for ... [ view bio ]

John Hollenbach
John Hollenbach
President & CEO
Doe & Ingalls
USA

 

2011 Speakers Included:
Andy Skibo
Andy Skibo
EVP Operations
Medimmune
USA

Andrew D. Skibo holds the role of executive vice president of operations at MedImmune as of 2011. In this role he will lead various projects, work with external partners, and continue to strength... [ view bio ]

Joerg Heidrich
Joerg Heidrich
S.V.P., Head of Global Product Supply Biotech, and Site Head - Berkeley
Bayer Healthcare Pharmaceuticals

A recognized leader in the field of biomanufacturing and a Bayer veteran, Mr. Heidrich has dedicated more than 20 years of his professional career to the management of various manufacturing opera... [ view bio ]

Sanjeev Majoo
Sanjeev Majoo
Director, Global Strategic Sourcing
Amgen Inc.
USA

Sanjeev Majoo , currently Director, Global Strategic Sourcing at Amgen Pharmaceuticals, has been proven performer in the biopharmaceutical industry for the past 15 years with increasing responsib... [ view bio ]

Manfred Bruch, Ph.D.
Manfred Bruch, Ph.D.
Head Partner Management
F. Hoffmann-La Roche Ltd
Basel

Dr. Manfred Bruch leads the group which selects and keeps relations to companies Roche is licensing production to. He also manages the group overseeing all production transfers in the Roche manuf... [ view bio ]

John Stubenrauch, MBA, Ph.D.
John Stubenrauch, MBA, Ph.D.
Merck BioVentures Chief of Staff
Merck & Co
USA

John Stubenrauch has 15 years of experience in the Pharmaceutical industry. He joined Merck in 1996 within the Merck Manufacturing Division (MMD) and has had a variety of Technical Operations ro... [ view bio ]

Reuben Domike, Ph.D.
Reuben Domike, Ph.D.
Research Affiliate
M.I.T. Sloan School of Management

Dr. Reuben Domike is a research affiliate with the Center for Biomedical Innovation at the M.I.T. Sloan School of Management and an assistant professor at the UPEI School of Business. ReubenR... [ view bio ]

Devrim Hodach
Devrim Hodach
Head of Development ADC/Biologics CMOs
Genentech
USA

Devrim Hodach is the Head of Development CMOs for Biologics and Antibody Drug Conjugates (ADCs) in Contract Manufacturing Unit at Genentech. In this role, she leads selection and management of th... [ view bio ]

Bernie Huyghe, Ph.D., RAC
Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer
USA

I currently work in the Biotherapeutics and Vaccines Outsourcing group for Pfizer where we coordinate external development activities. Prior to joining Pfizer, I worked for both small start-up bi... [ view bio ]

Kevin Pegels
Kevin Pegels
VP Global Supply Chain Management
BayerHealthcare – Biotech
USA

Andrew Knudten
Andrew Knudten
Sr. Director & Global Head of Contract Manufacturing and Strategy
Novartis Vaccines and Diagnostics, Technical Operations
USA

•Joined Novartis in February of 2009 •20 years of experience in the biotech/ pharmaceutical industry in both large Pharma and venture capital/startup biotech (Novartis, Amgen, Dekalb... [ view bio ]

Ken Hamilton
Ken Hamilton
Director of Process Engineering
Genentech
USA

Ken Hamilton has twenty five years’ experience in the biopharmaceutical industry. He earned his B.Sc. from the University of Manchester, and his M.Sc. and Ph.D. from the University of Wales... [ view bio ]

Bob DiVasto
Bob DiVasto
Vice President, Manufacturing and Supply
Cadence Pharmaceuticals
USA

Bob is responsible for all manufacturing and supply chain operations at Cadence Pharmaceuticals including the development and execution of Cadence’s unique “owner driven” outsou... [ view bio ]

Hans Engels
Hans Engels
President & CEO
DSM Pharmaceuticals, Inc.
USA

Since February 2008 Hans has served as President and Business Unit Director for DSM Pharmaceuticals in Greenville, NC (USA) where he has full P&L responsibility, including all operations and ... [ view bio ]

Michael Teasdale
Michael Teasdale
Senior Director, Operational Excellence
Baxter Bioscience
USA

Michael Teasdale is Senior Director, Operational Excellence for Baxter BioScience, a 5 billion dollar biotech division of Baxter. He has been in this role since 2002, driving strategic planning, ... [ view bio ]

Pierre-Alain Ruffieux
Pierre-Alain Ruffieux
Head Global Manufacturing & Biologics Quality Assurance
Novartis Pharma AG
Basel, Switzerland.

Pierre-Alain Ruffieux is the Head of Global Manufacturing & Biologics QA for Novartis Pharma. In 2003, he joined Novartis where he hold different positions in Process Development, Manufactu... [ view bio ]

Marc Better
Marc Better
Executive Director, Process Science
Boehringer Ingelheim

Marc Better, Ph.D. is Executive Director, Process Science at Boehringer Ingelheim in Fremont, CA. Marc joined Boehringer Ingelheim through the acquisition of the Amgen Fremont facility in March ... [ view bio ]

Michael Hausladen
Michael Hausladen
Director of Manufacturing
Bristol-Myers Squibb
USA

David Allen
David Allen
Senior Director Technology
Eli Lilly and Company
USA

Dr. David Allen is currently the Senior Directory of Technology for the Indianapolis Parenteral Operations for Eli Lilly and Company. David joined Eli Lilly and Company in 1994 from The Upjohn C... [ view bio ]

Stacy Springs
Stacy Springs
Director, Biomanufacturing Research Program
MIT Center for Biomedical Innovation
USA

Dr. Stacy Springs is the Director of the Biomanufacturing Research Program (BioMAN) at the MIT Center for Biomedical Innovation. BioMAN is a collaborative research program between academia, gove... [ view bio ]

Paul Marshall
Paul Marshall
SVP Operations
Amylin Pharmaceuticals Inc.
USA

Mr. Marshall has served as our Senior Vice President, Operations since December 2008. He previously served as Vice President, Operations from December 2006 to December 2008. Prior to joining Amyl... [ view bio ]

Justin O. Neway, Ph.D.
Justin O. Neway, Ph.D.
Vice President and 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 ]

Andy Ramelmeier
Andy Ramelmeier
VP Manufacturing, Process Development and Facilities
BioMarin
USA

Dr. R. Andrew “Andy” Ramelmeier is Vice President, Manufacturing, Process Sciences and Facilities, at BioMarin Pharmaceutical, Inc, a profitable biotechnology company specializing in ... [ view bio ]

Curran Simpson
Curran Simpson
Sr. Vice President, Operations
Human Genome Sciences
USA

Curran M. Simpson joined HGS in March 2003 as Vice President, Manufacturing Operations. He was promoted to Senior Vice President, Operations, in December 2005. Prior to joining HGS, Mr. Simpson w... [ view bio ]

Tim Noetzel
Tim Noetzel
Manager of Fermentation
Roche Diagnostics, Inc.

Tim is currently Manager of Fermentation for Roche Pharma Biotech Production in Penzberg, Germany. In this role he leads a team responsible for seed train cultivation, fermentation process analyt... [ view bio ]

Dr. Stephen Taylor
Dr. Stephen Taylor
Commercial Director and Vice President
Fujifilm Diosynth Biotechnologies
UK

Dr Stephen C. Taylor is Commercial Vice President of Fujifilm Diosynth Biotechnologies in the UK with responsibility for commercial and business development activities. Prior to this he was B... [ view bio ]

Elizabeth Dunn
Elizabeth Dunn
Director of Validation
Boehringer Ingelheim

Denise L. McDade
Denise L. McDade
Sr. Director Quality Assurance
Teva Pharmaceuticals
USA

Denise McDade is Senior Director Quality Assurance at Teva Pharmaceuticals, where she is repsonsible for Quality Sytems, QA Manufacturing, QA Docuementation and Change Control, Product Release an... [ view bio ]

Claude Hatfield
Claude Hatfield
Senior Vice President, Operations & Compliance
VelQuest
USA

Claude Hatfield is Senior Vice President, Operations & Compliance at VelQuest, which he co-founded. Claude is responsible for all compliance activities and operations including project manage... [ view bio ]

Dr. Brian Lee
Dr. Brian Lee
President & CEO
PBS Biotech, Inc.

Dr. Brian Lee is the president and co-founder of PBS Biotech Inc., a Camarillo, California based single-use bioreactor and bioprocessing solutions company. Dr. Lee graduated from Seoul Nation... [ view bio ]

Dato’ Dr. Mohd Nazlee Kamal
Dato’ Dr. Mohd Nazlee Kamal
CEO
Malaysian Biotechnology Corporation
& Chairman
Malaysian Bio-XCell
Malaysia

With 25 years of diverse industry background in biotechnology including 10 years of executive management experience, Nazlee brings in strong acumen in both the technical and business aspects of b... [ view bio ]

Rick Johnston Ph.D.
Rick Johnston Ph.D.
Principal
Bioproduction Group (Bio-G)

Rick Johnston, Ph.D. is a pioneer in the field of risk assessment and planning for the world’s largest biopharmaceutical organizations. Dr Johnston leads Bioproduction Group’s technic... [ view bio ]

Julie Sperry
Julie Sperry
Chief Commercial Officer
Rapid Micro Biosystems

Julie brings more than 30 years experience in healthcare, pharmaceutical and manufacturing operations. Ms. Sperry previously served in various General Management, Sales and Marketing leadership r... [ view bio ]

David Mitchell
David Mitchell
Director of Regulatory Affairs
DENDREON CORPORATION

David Mitchell is Director of Regulatory Affairs at Dendreon’s Atlanta Immunotherapy Manufacturing Facility. In April 2010, FDA approved PROVENGE® (sipuleucel-T), an autologous cellula... [ view bio ]

Heidi Hoffman
Heidi Hoffman
Director Manufacturing
Sutro Biopharma
USA

Heidi J. Hoffmann, Ph.D. Heidi Hoffmann, Director of Manufacturing at Sutro Biopharma, has over 17 years of experience in biotechnology, specializing in process development, technology transfe... [ view bio ]

John Bonham-Carter
John Bonham-Carter
Vice President, Sales & Business Development
Refine Technology

The first business John founded was a free-ads newspaper in the south of France, called Annonces Vertes. After a period with a satirical political magazine in London, the Insider, he moved into t... [ view bio ]

Dr. Barbara Paldus
Dr. Barbara Paldus
CEO
Finesse Solutions, Inc
USA

As cell culture titers continue to increase, more processes will leverage the benefits of single-use bioreactors. In order to accelerate the adoption process of single-use upstream systems, from ... [ view bio ]

Dr. Aleš  Štrancar
Dr. Aleš Štrancar
CEO
BIA Separations
Republic of Slovenia

Ales Strancar, the CEO of the Company and one of the main inventors of the CIM Convective Interaction Media® (new generation of chromatographic support), after finishing MSc at University of... [ view bio ]

John Hollenbach
John Hollenbach
President & CEO
Doe & Ingalls
USA

Karen L. Oliver
Karen L. Oliver
Director, Global Accounts
World Courier
USA

Karen has supported the clinical study industry throughout her 15 year tenure at World Courier by preparing transportation recommendations for complex multinational pharmaceutical projects. Kar... [ view bio ]

Christie Williams
Christie Williams
Black Belt, Director Account Management
Fujifilm Diosynth Biotechnologies
USA

Christie Williams is currently Director, Account Management at Fujifilm Diosynth Biotechnologies, Inc. and a certified Lean Six Sigma Black Belt. In her current role, Christie is responsible for ... [ view bio ]