Laura Bush is the Editor in Chief of BioPharm International, where she provides expert-related technical and regulatory insights that are currently affecting the biopharmaceutical sector. Before joining BioPharm in November 2005, Ms. Bush spent almost three years as managing editor of Pharmaceutical Technology, another leading publication highlighting pharmaceutical industry trends. Her combination of experience in pharmaceutical publishing, alongside a project management role for the Asia Pacific Latin America region within a division of Pfizer (previously Pharmacia Corporation), has contributed to Laura’s established reputation within the biotech community. In addition, she has also facilitated sessions at various high-level conferences on a global scale. A graduate of McGill University in Montreal, Canada, Ms. Bush spent the first part of her career as a technical translator for an international law firm in Madrid, Spain.

Sue Steven joined Genentech in 2006 as Senior Director, Process Research and Development, where she leads a cross functional group responsible for CMC project management, resource management, operational excellence, and CMC training. Prior to Genentech, Sue was Senior Director of Global Product Lifecycle Management at Invitrogen, where she was responsible for program management, strategic planning, resource management and integration of acquisitions within R&D. Additionally, she led the annual list price team responsible for over 30,000 products in North America, Europe and Asia. Sue's 14 years of experience in the Pharmaceutical industry involves her most recent role at Centocor, a division of Johnson & Johnson, where she built the portfolio Management and Resource management groups within R & D. Prior to this this, Sue held various management positions at top companies, including Glaxosmithkline, where she was Director in both the Virology Department and the Pharmaceutical R & D Divisions. Sue’s presentation will discuss how to impact the bottom line through innovative process excellence techniques. Specifically, she will be addressing how Genentech is applying Class A principles within process development, including the use of PD Activity Maps, resource capacity models, as well as leveraging innovation projects and specific examples of how these have led to successful outcomes in the production process.

Dr. Sourav Kundu is Associate Director for Process and Clinical Operations at Amgen, the top biopharmaceutical company worldwide. In his current role, he leads manufacturing support at one of the Amgen's largest biopharma manufacturing facilities. Dr. Kundu's team is responsible for process improvements, process scale-up and technology transfer, and implementation of new tools and technologies in a manufacturing setting, as well as providing critical day-to-day technical support to a high volume manufacturing operation. Dr. Kundu is also a part of Amgen's commercialization strategy team for technology transfer, which plays an integral role in developing and streamlining Amgen's technology transfer process. His team has successfully explored, developed and implemented novel technologies such as computational fluid dynamics and PAT-like technologies to increase manufacturing reliability and efficiency. In over 15 years of professional experience, Dr. Kundu has held various management and technical positions at other biopharmaceutical and medical diagnostics companies, including Aventis and Dade Behring.

Dr. Gottschalk joined Sartorius in 2004 as Vice President of Purification Technologies, where he has several years of global experience in the bioseparation of products. Prior to Sartorius, Uwe held senior-level positions at several top-tier biopharmaceutical companies, including Bayer Health Care, where he was instrumental in leading the production of monoclonal antibodies and recombinant proteins from a wide variety of expression systems. He has various publications in the area of biotechnology and somatic Gene Therapy and is currently on the Editorial Advisory Board of Biopharm International. Dr. Gottschalk is widely renowned in the biopharmaceutical industry on a global scale and has made significant contributions in the areas of purification and addressing the key issues frequently encountered in downstream processes.

Mary Kuhn is Senior Vice President of Operations at Talecris Biotherapeutics, where she is responsible for overseeing all operations from plasma procurement to final product release of Talecris’ plasma therapeutics products for the global marketplace. She manages the manufacturing operations at Talecris’ facilities in Clayton, North Carolina, and the Precision Pharma facility in Melville, NY. Mary and her team are currently integrating technological advances and improved efficiencies to further increase manufacturing capacity. As an example of the ongoing efforts, construction is nearing completion for a new purification facility to be used in the manufacture of a future Alpha-1 augmentation therapy. In addition, new robotics are being validated to automate the process for opening and emptying plasma donations into the manufacturing pool. Mary’s Keynote will focus on incorporating tools needed to efficiently manage a commercially-focused operation.

Kevin Bailey has over twenty years of professional experience in research, development, scale-up and manufacturing of pharmaceutical and protein therapeutics. As Vice President of Preclinical Manufacturing and Process Development at Regeneron Pharmaceuticals, he is responsible for development of bioreactor, recovery and purification processes for numerous recombinant antibodies and other proteins. He works closely with research groups to facilitate discovery and development efforts by providing large amounts of purified proteins for in vitro and in vivo testing. He is responsible for development and transfer of clinical and commercial manufacturing processes to Regeneron’s Rensselaer manufacturing facility and ensuring successful start-up. He received his Ph.D. in Biochemical Engineering from Rutgers University in 1987 and has taught graduate and undergraduate biochemical engineering courses at Stevens Institute of Technology, as well as a professional course in bioreactor process design.

Alan Taggart joined MedImmune as vice president, government program management in September 2006. In this role, he is responsible for coordinating and managing MedImmune’s government projects, including the recently awarded $170 million Health and Human Services cell culture contract. He is also responsible for identifying and capitalizing on additional government contracting opportunities. Previously, Mr. Taggart was a management consultant at Pittiglio Rabin Todd & McGrath (PRTM) where he led several significant cross-functional business process change efforts to decrease product development cycle time and improve operational efficiencies. Prior to that, he spent several years at Bausch and Lomb as a manufacturing and project manager. Mr. Taggart began his career as an engineer at McDonnell Douglas.

Mark is currently Director of Validation for Bayer Healthcare in Berkeley, CA. In his current role, he has overall responsibility for validation of process manufacturing for biotech products, including Bayer’s Kogenate-FS, a recombinant Factor VIII product for infusion. Mark has over 17 years experience in validation, encompassing process, equipment, cleaning, utilities and software. He has held progressively senior positions, including working in both Europe and USA. In addition, Mark was a Director with KMI/PAREXEL, providing strategy, validation and quality systems consulting to the healthcare industry He received his Bachelor’s Degree in Pharmacology from the University of Liverpool, England and his Master of Science Degree in Biomolecular Technology from Leicester University, England. He is also an active member of ISPE and PDA and speaks frequently on topics ranging from Validation approach to Design Space, through to electronic records compliance and 21CFR Part 11.

Dr. Sabouni is Global Vice President, Pharmaceutical Science and Process Development at Stiefel Laboratories, where he is responsible for API synthesis and characterizations, formulation development, analytical method development and validation, tech transfer, and process development activities. He brings in nearly 25 years of experience in pharmaceutical development to Stiefel Laboratories. Prior to joining Stiefel, he served as Vice President of Pharmaceutical and Product Development at DSM Pharmaceuticals. Dr. Sabouni has also worked with Pfizer, Medeva Pharmaceuticals, and Sepracor. He belongs to the American Association of Pharmaceutical Scientists and the International Society for Pharmaceutical Engineering. Dr. Sabouni's presentation will highlight key strategies used in maintaining successful relationships with external manufacturing facilities during expansion efforts. The presentation will involve actual implementation of these efforts in Stiefel's various manufacturing facilities that include Mexico, Brazil, Ireland, Singapore and Pakistan.

Robert Gronke is a Principal Scientist in the Product Development Department at Biogen Idec, Inc. For the past 18 years, he’s been involved in the purification development, team leadership and new technology assessment for recombinant biopharmaceuticals including Biogen Idec’s commercial and clinical products. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare.

Dr. Mark A. Snyder is Manager of the Process R&D Applications Group in the Process Chromatography Division of Bio-Rad Laboratories. Dr. Snyder received his Ph.D. in biochemistry at the University of California, Berkeley, with Dr. Daniel E. Koshland, Jr., and did post-doctoral work in molecular biology with Dr. J. Michael Bishop at the University of California, San Francisco. He spent five years at Scios (then California Biotechnology) on basic fibroblast growth factor cloning and purification, followed by four years as Manager of Process Development at XOMA. Immediately prior to coming to Bio-Rad last year, Dr. Snyder spent thirteen years at Bayer HealthCare where he was Associate Director of Process Sciences in charge of the Purification Process Development Group. He led the team which developed and Bayer’s current-generation recombinant Factor VIII purification process and transferred it into manufacturing. His team also successfully developed and implemented a variety of phase I-II purification processes for other protein therapeutics, some of which are currently in late-stage clinical trials. Dr. Snyder has also played significant roles in process troubleshooting and optimization, process improvements, process validation, viral clearance studies and comparability protocol execution, and in authoring license application CMC sections and inspection responses.

Dr. Sadettin Ozturk is the head of bioprocess technology at Centocor R&D Inc. His group is responsible for process and technology development, process scale-up and optimization for cell culture based pharmaceuticals. Prior to joining Centocor Inc., Sadettin worked at GlaxoSmithKline as Senior Technology Manager where he led cell culture activities in Biopharmaceutical Technologies Department. His group was responsible for technology and process transfer from R&D to Production, process scale-up and optimization, technical support to Manufacturing, and implementation of new technologies. He developed processes and technology at Bayer Corporation, Berkeley, CA (1993-2000) as Manager of Manufacturing Technology. His previous experience involves Verax Corporation (1989-1993), and he was involved in various research projects at University of Michigan, FMC Corporation, Michigan Biotechnology Institute, and University of Oldenburg, Germany. Sadettin received his Ph.D. degree from the University of Michigan, Ann Arbor. His research interests are in high-density cell culture optimization, instrumentation and process control. Sadettin published over 50 research articles in the area of Chemical and Biochemical Engineering. He is a member of several societies including European Society of Animal Cell Technology (ESACT), American Association for the Advancement of Science, New York Academy of Sciences, American Chemical Society and American Institute of Chemical Engineering.

Mr. Graham-Brown is currently responsible for global marketing communications, marketing research and business support, divisional business development and strategic planning, segment management, and the coordination and execution of division-wide projects. Prior to joining Millipore, Mr. Graham-Brown was head of Bioprocess Marketing at GE Healthcare Protein Separations. Mr. Graham-Brown received his BPharm degree from Kings College London and an MBA from McGill University, Montreal. He is a qualified pharmacist from the UK.

Prior to joining Millipore, Mr. Westman was the President and CEO of NovAseptic, and was responsible for the start-up of NovAseptic America, a wholly-owned subsidiary of NovAseptic. Mr. Westman is responsible for the introduction of Millipore's disposable initiative Mobius™ and as such responsible for incorporating and reflecting Millipore's process know-how in the disposable offering. Mr. Westman holds a M.Sc. in Chemical Engineering, with a Biotechnology focus, from the Royal Institute of Technology in Stockholm, Sweden. He has been a member of ISPE since 1997.

Dr. Hora is Vice President of Process Development at PDL Biopharma and has over 20 years of cumulative drug development experience with biopharmaceutical leaders Chiron, Glaxosmithkline, and Wyeth and has over 20 patents, 30 publications, and 50 presentations to his credit. In his prior role as VP of Process and Product Development at Chiron, he led a team of 110-170 senior scientists and engineers in design, development and implementation of process, analytics, formulation, and device technologies for antibody, protein, and small molecule drugs. Dr. Hora's group has been instrumental in scaling up dozens of biopharmaceutical processes for phase 3 clinical and commercial production and post-licensure changes. Dr. Hora has spearheaded technology creation for dozens of biopharmaceutical substances. Under his leadership, overall processes were designed, scaled up, and implemented whilst closely working with the manufacturing counterparts to ensure that the final process was robust and consistent during day-to-day operations.

William Botha is Director of Pharmaceutical Manufacturing at the Los Angeles facility of Baxter Bioscience, the first, largest, and most modern plasma fractionation facility in the world. He is responsible for approximately $ 400M of production revenue, overseeing a staff of 200 reports. William has an extensive background in lean initiatives, from Director of Lean Enterprise at Rockwell Automation, to Lean Master in 2004 at Baxter Bioscience, where he was responsible for rolling out lean principles across Europe and the U.S. In 2006, he was appointed as the Director, Pharmaceutical Manufacturing at the Los Angeles site, where he created the structure and management systems for the business unit, and alongside his Quality partner, has reduced the average lead times and their standard deviations by significant amounts in just eight months. Customer fulfillment has improved by more than fifty percent across all product families while discards, costs and deviations have also dropped. A dynamic and inspiring speaker, he has presented the tricks and traps of effective, high impact change to industry audiences worldwide.

Dr. Arunakumari is Senior Director of Process Development at Medarex, the worldwide developer of human antibody therapeutics. Her responsibilities include development and transfer of cell culture and purification processes to internal manufacturing and outside CMOs. Alahari's extensive 15-year management experience at Bristol Myers-Squibb, Enzon and Medarex, have been instrumental in integrating upstream and downstream processes. She has significantly improved facility output and batch processing time by developing simple non-protein A purification processes in fewer processing steps and column cycles. Her recent technique has optimized conditions to remove all process related contaminants and modified the process schemes to require less validation. These groundbreaking projects 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 also produced 12 different humabs between the manufacturing facility and CMOs.

Ian Sutherland is Director of the renowned Brunel Institute of Bioengineering, where his distinguished research and development efforts have been at the forefront of significant techniques including portable insulin infusers, the treatment of infertility, the study of pelvic blood flow and development of space flight hardware for NASA. Following his significant collaborations at NASA, Ian shifted his focus towards the biopharmaceutical sciences, where he is currently developing novel methods in purifying drugs and getting them to market in a rapid manner and in close collaboration with the pharmaceutical industry. Ian's presentation will shed light on latest Counter-Current Chromatography methods through High Performance Liquid techniques that have been used to overcome a broad range of purification problems by yielding 100% sample recovery and high loading capacity. The principles of these technologies will be explained along with their scale-up potential, predictability and versatility. Recent research progress will also be reviewed along with progress in developing commercially available robust systems for the purification of biopharmaceuticals and other biologics.

As Vice President and Head of Technical Operations, Dr. Mahler oversees the manufacturing of Bayer’s leading recombinant hemophilia A therapy, Kogenate and leads a staff of over 500 employees at the Bayer biomanufacturing facility in Berkeley, Calif. Dr. Mahler has more than 10 years of experience in biological manufacturing processes involving mammalian, bacterial and viral systems. He began his career with Bayer in 1994 as a manufacturing manager for the Animal Health Division in Buenos Aires, Argentina and then as a regional production manager for the Animal Health Division in Leverkusen, Germany. Following that, Dr. Mahler became the director of media and fermentation for Bayer HealthCare in Berkeley where he implemented key performance indicators, lean manufacturing techniques and continuous improvement programs. Dr. Mahler recieved his Ph.D in Biochemistry from the University of Buenos Aires in Argentina.

Dr. Staby is current Head of Protein Separation at Novo Nordisk, the global leader of insulin production and diabetes care. His extensive experience in both scale-up and scale-down approaches in process development has resulted in efficient and timely process optimisation methods that have been utilized in various clinical trials. He has been involved in numerous projects that have significantly optimized process development methods and improved the biopharmaceutical industry pipeline as a whole. His presentation will outline innovative techniques of scaled-down, high-throughput screening used as stand-alone or combined methods with mathematical modelling that speed up the process optimisation for chromatography purification and how they have yielded accurate, rapid results and overcome specific regulatory issues.

David Peers is Manager of the Recovery MSATS group at Genentech’s Vacaville, California manufacturing facility. He joined Genentech in 1986 after receiving his B.S. in Physiology and Cell Biology from the University of California, Santa Barbara. David has over 21 years of Biopharmaceutical Manufacturing and Process Development experience. He had developed manufacturing processes for a wide range of protein therapeutics including growth factors, soluble receptors, immunoadhesins, full length antibodies, and antibody drug conjugates (ADCs). In 1997, he joined Genentech’s Manufacturing Science and Technology group where he was responsible for providing technical support to Manufacturing operations as well as for leading technology transfers across Genentech’s manufacturing network as well as to external CMOs. These projects included responsibility for developing facility fit and utilization plans, design and implementation of Process Validation programs, and authoring comparability assessments and license application CMC sections. David is currently focused on the successful startup and licensure of Vacaville’s site expansion project and on identifying cost effective capacity improvement strategies for the existing Vacaville facility.

Dr. Zhongyu Zhu is a research scientist in SAIC Frederick Inc, National Cancer Institute at Frederick, NIH. For the past ten years, Dr Zhu has been involved in numerous projects that mainly focused on the diagnosis and human antibody based biotherapeutics development for infectious disease and cancer utilizing phage display based technologies. His recent research efforts led to the identification of highly potent cross reactive fully human neutralizing antibodies against SARS and Henipah viruses. He also played major roles in the development of stable cell line for human antibody production and fermentation. He is currently involved in the development of human antibody drug targeting human IGF and IGF receptor pathway for cancer treatment.