Register Early and Save up to $300 (See page ... - IBC Life Sciences

More documents

Recommendations

Info

Recovery & Purification Wednesday, September 22, 2010 • Main Conference 7:15 Registration and Coffee Rapid Vaccine Development and Production Strategy Discussion Forums 8:00 Chairperson’s Remarks Gary J. Welch, Director, Process Science, Abbott Bioresearch Center Advances in Process Monitoring and Control in Downstream Processing 8:15 Evaluation of Raman Spectroscopy for Purification Operations Raman spectroscopy is one of the powerful quantitative techniques that is amenable to analysis of biological process solutions. It is capable of providing accurate quantitation of multiple components in a solution with minimal sample preparation, and often able to be used as an in-line or at-line monitoring tool. Evaluation of this technique for preparation and release of buffers, control of excipient levels during formulation and other downstream operations will be presented. Natraj Ram, Ph.D., Senior Group Leader, Purification, Technical Operations, Abbott Bioresearch Center 8:45 On-line HPLC as a PAT for Controlling Product Collection from Process Scale Chromatography Columns Large scale chromatography is a widely used unit operation in peptide and protein manufacturing. Variability in the elution of these process columns makes it difficult to know precisely where to start and stop collecting the product pool. On-line HPLC based analyzers are a PAT that provides product purity information enabling automated control of product pool collection with increased yield, decreased product variability, and decreased cycle time. Rick E. Cooley, Market Development Manager, Process Analytics, Dionex Corporation 9:15 Using Multivariate Batch Process Monitoring and Soft Sensors for Advanced Process Control in Commercial Scale Purification Operations Multivariate Biopharmaceutical Batch Process Modeling and Monitoring is evolving as a key Process Analytical Technology (PAT) to enable real-time design space monitoring to support Quality-by-Design paradigm. The use of this technology for bioprocess supervision, troubleshooting, process understanding, and control at commercial-scale manufacturing will be summarized. Incorporating this technology with the use of soft-sensors will also be discussed, with industrial examples. Thomas Mistretta, M.S., Senior Engineer, Process Development, Amgen Inc. 9:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by Cell Culture & Upstream Processing Chairperson: Susan Casnocha, Ph.D., Research Fellow, Bioprocess R&D, Culture Process Development, BioTherapeutics Pharmaceutical Sciences, Pfizer Integrating In-Line Process Monitoring and Control Technologies in Upstream Processing 10:30 Fully Automated Mammalian Cell Culture via Multi-Functional Off-Line Analyzer and Online Sampling System Mammalian cell culture based bioprocesses require considerable labor-intensive operator support, including maintenance and monitoring of culture conditions as well as data compilation. This work demonstrates the integration of a multi-functional analyzer and online sampler into existing commercial control and in-house data management system for fully automated bioreactor control, monitoring, feeding, and standardized data management in a bioprocess development environment. Gayle Derfus, Engineer II, Oceanside Pharma Technical Development, Genentech, Inc. 11:00 Achieving Process Robustness through Process Analytical Technology (PAT) Implementation Examples of PAT applications in Biologics Manufacturing at Abbott Bioresearch Center (ABC) will be presented. Evaluation of various biosensors in cell culture process demonstrates applications in monitoring cell growth and cell metabolism. Biosensor was successfully implemented in Production Reactors at ABC and shown to be more consistent compared to offline measurements. In addition, on-line sensor enables tighter process control and reduces variability, achieving process robustness. Li Malmberg, Ph.D., Director, Technical Operations, Biologics Manufacturing, Abbott Laboratories 11:30 Understanding the Latest Automated Online Analytics as a QbD Tool in Fermentation Processes Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for program updates. Stefan Steigmiller, Ph.D., Senior Project Manager, PAT, Bayer Technology Services GmbH, Germany 12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing Poster presenters are requested to stand by their posters for discussion. Plenary Session Critical Industry Issues 1:45 Chairperson's Remarks Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc. 2:00 Flexible Manufacturing for a Diverse Biologics Portfolio The manufacture of biologics has changed dramatically over the last 10 years. Multi-product production has become possible, and the continued development of single-use systems has enabled dramatic reduction in capital costs and reduced cycle times. This presentation will focus on the conceptual analysis of production of a broad portfolio of lowvolume biologics for biodefense, and the challenge and opportunities associated with such a design exercise. Previous examples will also be presented, and the future challenges for diverse product facility and portfolio designs. Phillip Gomez, Ph.D., Director, PRTM Management Consultants 2:30 Patient-Driven Delivery Devices: Is your Company Playing to Win This presentation will outline the keys to winning in delivery devices starting in discovery through process optimization to formulation development, container closure selection, and device design. The presentation will outline how to truly understand customer needs, and why winning in delivery devices is really about the integration of process optimization, the formulation, the container, and the device technology. James J. Collins, Jr., P.E., M.B.A., Vice President, Drug Delivery and Device R&D, Eli Lilly and Company 3:00 Prevnar 13: The Story Behind the Vaccine Prevnar 13 was approved this year by Europe and the United States and is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevnar – approved in the United States in 2000 - plus an additional six serotypes (1, 3, 5, 6A, 7F, and 19A). Hear about challenges faced during manufacturing/network design and operation. Willard Waterfield, Ph.D., Senior Director, Manufacturing Sciences & Technology, Andover and Pearl River, Pfizer GMS 3:30 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by 8:10 Chairperson’s Remarks Ulrich Valley, Head, Technology Development, Novartis Vaccines & Diagnostics, Inc., Germany Keynote Presentation 8:30 Global Vaccine Production Challenges: Emerging Immunotherapeutics, Manufacturing Flexibility and Reducing COGS Manufacturers have to face the challenges of being able to answer the many challenges of a growing and changing global vaccines business. The amplitude of the challenges ranges from a need to develop innovative and/or sophisticated approaches to properly address the complexity of immune system and the patient interaction, to strong economical pressures to make products affordable for broader population. To best serve patient interest, staying economically efficient, manufacturers need to re-invent themselves to be agile in a highly changing and regulated environment. Pierre Fournier, Ph.D., Associate Vice President, Manufacturing Technology International, Sanofi Pasteur, France Lessons Learned from the 2009 Flu Season to Guide Rapid Vaccine Development and Manufacturing Scale Up 9:15 CASE STUDY Cell Culture Based Pandemic Flu Production Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Ulrich Valley, Head, Technology Development, Novartis Vaccines & Diagnostics, Inc., Germany 9:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by Process Development for Novel Vaccines and Immunotherapeutics 10:30 CASE STUDY Process Development and Clinical Manufacturing for Autologous Dendritic Cell Immunotherapies One of the challenges to developing robust autologous RNA and dendritic cell processing methods is the variability in the biological starting materials. Despite this variability, Argos Therapeutics has been able to develop robust processes for manufacturing autologous dendritic cell immunotherapies for both oncology and infectious diseases. These processing methods have been successfully employed for Phase 2 clinical trials in renal cell carcinoma and human immunodeficiency virus indications. Tamara Monesmith, Director of Manufacturing and Process Development, Argos Therapeutics 11:00 CASE STUDY Rapid Production of a Novel VLP Vaccine The Vaccine Research Center (VRC) develops vaccines against a wide range of viral diseases. Chikungunya is a mosquito-borne viral disease that is growing in severity due to a recent expansion in its host species. Rapid development of a Phase I clinical process for a VLPbased vaccine has been initiated at the VRC. Optimization of an early phase manufacturing process based on transient transfection along with purification strategies will be presented. Richard M. Schwartz, Ph.D., Chief, Vaccine Production Program Lab, Vaccine Research Center, National Institutes of Health 11:30 CASE STUDY Rapid Analytical, Process and Regulatory Strategies for Seasonal and Pandemic Flu Vaccines Responding to the genetic drift in seasonal and pandemic influenza viruses requires process modifications by vaccine manufactures to produce an efficacious vaccine. The changes that are made to analytical techniques and process steps must occur within a short timeline (as little as 8 weeks) and satisfy the regulatory requirements of a licensed vaccine. This presentation will provide an outline to how these requirements have evolved for recombinant hemagglutinin-based vaccine candidates (FluBlok® and PanBlok®). Robert Boulanger, Ph.D., Manager, Production, Protein Sciences Corporation Special Presentation 12:00 Defending Biosimilar Competition: Bioprocess IP Protections for Next Generation Vaccines and Immunotherapeutics Recent legislation has brought the prospect of biosimilars much closer to reality. One of the keys to forestalling "generic" competition for biologics lays in the ability to develop a comprehensive IP portfolio that targets not only the biologic and its administration but its method of manufacture as well. We will walk through a hypothetical and examine the issues involved in putting together such an IP strategy and give examples of some useful techniques in light of recent case developments. George A. Xixis, Partner, Nutter McClennen & Fish LLP 12:30 Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing Poster presenters are requested to stand by their posters for discussion. Process Development and Analytical Characterization for Vaccine Production 2:10 Chairperson’s Remarks Rasappa Arumugham, Ph.D., Senior Director, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc. 2:15 CASE STUDY Analytical Characterization for Conjugate and Protein Vaccines Rasappa Arumugham, Ph.D., Senior Director, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc. 2:45 CASE STUDY Particle and Endotoxin Control in Form/Fill Tubing Manifolds for Vaccines Single-use tubing manifolds used in sterile formulation and filling of vaccines may be a potential source of particles and endotoxins. A method was qualified for determining particulate matter and endotoxin content in radiation-sterilized singleuse tubing manifold systems, to set appropriate limits and monitor levels over multiple manufacturing lots, and to establish a master surrogate system enabling representative product auditing. Test method development and qualification is described, along with data collected over time from multiple system designs and lots. Michael Moussourakis, Technical Manager, Pall Life Sciences 3:15 CASE STUDY Scale-up of an Intensified Process for rAd35 Adenovirus Production using the PER.C6® Cell Substrate Given the uncertainties attendant to the CAPEX commitment required to develop a facility for a 10,000-liter bioreactor process and the unprecedented need to develop a viral vaccine manufacturing process at 10,000L scale under BSL 2 conditions, our approach is to focus on intensification of the rAd35 manufacturing process. This presentation will highlight our progress in upstream development. We will show a 10-fold intensification at bench scale and in 50L single-use bioreactors. Ciska Dalm, Ph.D., Senior Scientist, Upstream Process Development, Crucell, The Netherlands 3:45 Networking Refreshment Break in Exhibit and Poster Hall Sponsored by Sponsored by 10:30 Continuous Disposable Multi-Column Chromatography: Emerging Technology Tto Enable More Efficient Downstream Processing BioSMB is an emerging technology that refines traditional multicolumn chromatography techniques via disposable components into a viable option for biopharmaceutical purification. Continuous processes are shown to reduce chromatographic media, reduce buffer and WFI consumption while increasing flexibility and manufacturing efficiencies. Advance registration is required for this special roundtable. Please indicate when you register that you wish to attend this session. This interactive session will be divided into four round table sessions focused on educating attendees on topics relating to BioSMB: Station 1: Economic Modeling of Multi- Column Chromatography Applications Facilitator: Peter Latham, President, BioPharm Services US Station 2: QA Discussion of Areas Relating to Multi-columns Operations Facilitator: Art Rankis: Quality and Regulatory Consultant Station 3: Modeling your Clinical Manufacturing Process Facilitator: Marc Bisschops, Scientific Director, Tarpon Biosystems Station 4: Adoption of New Technologies into Organizations, Facilitator: TBD “BPI offers a highly effective forum to share and showcase cutting-edge advances in process development and manufacturing.” – Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences, Inc. “A must attend conference every year!” – Rochelle Shapland, Process Development Associate, Alexion Pharmaceuticals Inc. Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event 8
Wednesday, September 22, 2010 (continued) • Main Conference Keynote Presentations Chairperson: Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec 4:00 Sustainable Commercial Cell Culture Operations Developing a cell culture process which delivers a product with defined and acceptable critical quality attributes is but the first, and in many respects the easiest, element in the product lifecycle. Maintaining performance, ensuring the currency of the technical foundation and improving productivity and efficiency become the key challenges in having a sustainable operation. Knowledge is perishable; establishing routine can maintain performance but inhibit improvement; and everything ages. Hear about the systems that can be put in place to deal with these concepts across People, Process and Infrastructure. W. Blair Okita, Ph.D., Senior Vice President, Manufacturing Sciences and Technical Operations, Genzyme Corporation 4:45 Finding a Home for Process and Product Development In order to compete in today’s cost-conscious world, the biotechnology industry needs to reinvent itself. Recognition of Manufacturing Technology and Product Development as a critical strategic element in this reinvention process and putting in place organizational design which enables their contributions are key to ultimate success. Process and product development are effectively carried out within the biotechnology industry under a number of different organizational designs (OD). The presentation will address, through example and guiding principles, where OD can enable game-changing outcomes. S. Robert Adamson, Ph.D., Advance Biotech Consultants; former Senior Vice President Product and Process Development, Wyeth Biopharma 5:30 Networking Cocktail Reception in Exhibit and Poster Hall Sponsored by Rapid Vaccine Development and Production 4:30 CASE STUDY Production and Downstream Processing of Norovirus Virus-Like Particles Norovirus infection is the most common cause of acute gastroenteritis in the U.S., estimated to afflict 23 million people per year. To generate a bivalent vaccine that confers broad protection against this disease state, the baculovirus expression system has been used for production of two distinct norovirus virus-like particles (VLPs). Downstream processing using orthogonal chromatography methods results in highly purified norovirus VLPs. cGMP manufacturing to support Phase I clinical trials has recently been completed. Ross Taylor, Ph.D., Director, Process Development, LigoCyte Pharmaceuticals, Inc. 5:00 From Bench to Bag: Deployment and Implementation of Novel Solutions for Vaccine Production Classical purification processes for Ad5 adenoviral viral vectors, such as density gradient centrifugation, are laborious, time consuming and scale limiting. A recent upsurge in interest in rapid, flexible and scalable vaccine production has demanded a radical rethink. From small-scale process development through to cGMP manufacture using disposable and novel technologies for both the production and purification; this presentation is a case study in the development and implementation of a manufacturing process provides specific solutions to the manufacture of adenoviral vectors and offers a general approach for other vaccine platforms. Andrew Clutterbuck, Purification Development Team Leader, Eden Biodesign Ltd., United Kingdom 5:30 Networking Cocktail Reception in Exhibit and Poster Hall Sponsored by Recovery & Purification Thursday, September 23, 2010 • Main Conference 7:00 Coffee Cell Culture & Upstream Processing Plenary Session – Integration of Upstream and Downstream Processing 8:00 Chairperson’s Opening Remarks Konstantin Konstantinov, Ph.D., Vice President, Technology Development, Genzyme Corporation 8:15 Challenges and Efficiencies Gained by Integrating Upstream and Downstream Drug Substance PD In the thirty-five years since the Asilomar conference on rDNA, the biopharmaceutical industry has undergone significant expansions both in terms of scale and the frequent need to support multiple sites. Cost pressures have resulted in tighter budgets and timelines for development, tech transfer, and commercialization. Yet most PD organizations look pretty much the same as they did decades ago. We will present some novel approaches to organizing and integrating PD activities that we feel will be required to maintain competitiveness in the years ahead. Gene Schaefer, Ph.D., Senior Director, API-Large Molecule Development, Johnson & Johnson 8:45 Optimizing Interfaces and Hand-offs between Upstream and Downstream Processing Biopharmaceuticals are inherently complex, with product quality and business relevant parameters affected by the various unit operations and their respective linkage. Strategies to optimize the overall efficiency of bioprocess development and manufacturing need to address in particular the technical and organizational interfaces between upstream and downstream processing. An integrated approach will be discussed. Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & Purification Department, Global Biological Development, Bayer HealthCare 9:15 Linking Upstream and Downstream Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Jonathan Coffman, Ph.D., Principal Engineer III, Pfizer Biotherapeutics 9:45 Networking Refreshment Break in Exhibit and Poster Hall Recovery & Purification Breakthroughs to De-Bottleneck Downstream Processing Chairperson: Jens H. Vogel, Ph.D., Global CMC Development Team Leader & Head, Isolation & Purification Department, Global Biological Development, Bayer HealthCare 10:30 Evaluation of Single Pass TFF to Debottleneck Downstream Processing of Monoclonal Antibodies Single Pass Tangential Flow Filtration (SPTFF) is a novel technology that can significantly improve downstream processing capacity and yields. In this presentation, we will compare SPTFF with conventional TFF and show proofof-concept data on reducing pool volumes with multiple monoclonal antibody molecules. An implementation strategy to debottleneck downstream capability in commercial manufacturing will also be discussed. Jemelle Dizon-Maspat, Senior Research Associate, Genentech, Inc. 11:00 Downstream Breakthroughs in Downstream Processing of High Titer and Cell Density Harvests Use of the PER.C6® cell line resulted in 27 g/L of antibody in XD®, and 10 g/L in Fed-Batch. These high titers and accompanying high cell densities create challenges for downstream processing. Here we present high capacity and single use technologies developed to answer some of these challenges. These techniques enable speed, flexibility, and smaller facilities. The final product quality is equal or better to traditional processes. Blanca Lain, Senior Scientist, Downstream Process Development, Percivia, LLC 11:30 Process Design and Facility Fit Optimization Models for Higher Titer Purification of Monoclonal Antibodies Genentech has developed two generations of facility fit models covering a commercial manufacturing network with 6 production sites. We present an overview of the models which, based on equipment and operational constraints, identify site-specific bottlenecks, recoverable titer ranges and optimal processing parameters. We further show how their use has enabled the design of a very high productivity (Kg/batch) process concept. Nuno Fontes, Ph.D., Senior Engineer, Group Leader, Genentech, Inc. 7:15 Technology Workshop (Light Continental Breakfast Will Be Served) Are Your ANIMAL FREE Raw Materials Really Animal Free This workshop discusses the approach BD Biosciences-Advanced Bioprocessing is taking to address this question. Michael J. Titus, Ph.D., Director, Quality Management & Regulatory Compliance, BD Biosciences -Advanced Processing Cell Culture & Upstream Processing Accelerating & Optimizing Cell Culture & Process Development Chairperson: Charles Sardonini, Ph.D., Associate Director, Process Engineering/Development, Genzyme Corporation 10:30 CASE STUDY Rapid Generation of High- Producing Clonal Cell Lines for Recombinant Monoclonal Antibody Manufacture Timelines, throughput and quality are of the utmost importance in generating monoclonal antibody producing CHO cell lines. We improved both factors by implementing the ClonePixFL for clonal picking and the 24 µm reactor system to mimic the conditions in a bioreactor. Optimal use of these systems led to increased quality and throughput and decreased timelines within our cell line development process. Jolanda Gerritsen, Technical Expert, Cell Line Development, Genmab, The Netherlands 11:00 Scale Down Approaches to Facilitate CHO Clone Development for High-Level mAb Expression With increasingly diverse portfolios of biotherapeutics, more efficient methods for creating and screening high expressing stable cell clones are starting to be used. The ability to screen multiple clones expressing multiple recombinant protein and mAb candidates for each therapeutic project is becoming a requirement in order to identify the appropriate clone / mAb combination for effective drug development. Increasingly, shaking microwell and microbioreactor scale down models are being used to facilitate such clone selections leading to increased predictability of Bioprocessing. Strategies, Issues and case studies will be described to illustrate this approach. Gareth Lewis, Ph.D., Scientist II, MedImmune, United Kingdom 11:30 Boosting Yield, Speeding Up Process Development and Improving Quality by Process Intensification in Mammalian Cell Culture The challenges for protein manufacturing are time to market, cost of goods, and reduction of the financial risks. Process intensification can achieve these goals. Using DSM Biologics XD® process culture strategy viable cell densities over 150 million cells/mL, ten-fold to fed-batch, are achieved with CHO and other cell lines, yielding up to 27 g/L of product with right quality. Gerben Zijlstra, Ph.D., Senior Scientist, R&D, DSM Biologics, The Netherlands Emerging Analytical Requirements Emerging Analytical Requirements and their Impact on Process Development and Manufacturing 8:00 Chairperson’s Remarks Ciaran Brady, Ph.D., Associate Director, Biopharmaceutical Development, Human Genome Sciences Inc. 8:15 FDA Expectations Regarding Bioburden Control in Biotech Processes Microorganisms can affect product quality attributes and lead to process and product failures. A well designed process can be derived from the systematic use of scientific and riskbased approaches, prior knowledge and the implementation of a pharmaceutical quality system. Elements of a well designed biotech process and appropriate control strategies for microbial control will be discussed. Patricia F. Hughes, Ph.D., Biotech Manufacturing Team, Office of Compliance, CDER, U.S. Food and Drug Administration 8:45 New, Unpublished Data CASE STUDY Methods for Analysis of Subvisible Particles and the Utility in Biopharmaceutical Process Evaluations Tristan Marshall, Research Associate III, Human Genome Sciences 9:15 Acidic Variants of Antibodies: Characteristics and PK Properties Paul Motchnik, Ph.D., Associate Director, Protein Analytical Chemistry, Genentech, Inc. 9:45 Networking Refreshment Break in Exhibit and Poster Hall 10:30 Analytical Strategies for Monitoring Impurities Encountered in Bioprocessing Monitoring of residual impurities encountered in bioprocessing can be quite challenging. Due to the range of potential impurities (antibiotics, surfactants/antifoams, etc.), many different analytical approaches may need to be employed. This presentation will explore some of the approaches taken to monitor low level impurities. Jon S. Kauffman, Ph.D., Director, Method Development & Validation and Biopharmaceutical Services, Lancaster Laboratories 11:00 The Potency Assay -- Still Relevant after All These Years The potency assay is the one product release/stability test that assesses the “bioactivity” of a specific lot at a specific time for biological/biotech therapeutics and therefore is required for these products. This talk will discuss how the role of potency assays has changed over time. It will also focus on common issues and timing (1) for choosing a potency assay from several candidate bioassays, (2) for developing, validating and maintaining this assay and (3) for trying to use this assay to assess neutralizing antibodies in patients or animals. Sally Seaver, Ph.D., President, Seaver Associates, LLC 11:30 Audience Interactive Panel Discussion with All Session Presenters Site Tour to Amgen’s BioNext Facility Thursday, September 23 • 4:00 pm – 6:30 pm Space is limited to first 50 conference registrants Amgen’s manufacturing plant in West Greenwich, RI, is a fourstory, 364,000-square-foot building that contains state-of-the-art manufacturing, production, warehousing, utilities, and office space areas. Built in 2004 to provide manufacturing capacity for Enbrel®, the plant operates 24 hours a day, seven days a week. The plant provides a controlled environment for the manufacture of bulk drug substance. Tour participants will walk through the plant and view through windows some of the production suites, including upstream and downstream manufacturing areas, and will hear from Amgen staff about processes in these areas. Space is limited and available to the first 50 conference registrants on a first come first served basis. A wait list will be creted after it has been sold out. Pre-registration is required. Please be sure to indicate when you regisater that you wish to attend. Flat, Closed-toed shoes must be worn; no high heels are allowed. 9 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com Strategy Discussion Forums Sponsored by 10:30 Smart Flexibility: What Creates the Right Degree of Flexibility and Cost Reduction in Different Phases of Manufacturing What could be done technically may not make sense for the business while what the business may desire may not be technically feasible. Between manufacturing for early clinical trials and regular manufacturing post approval there are 2 or 3 distinctly different scenarios that each have their own needs and preferred setups. Dependent on whether a facility already exists or not, whether it is time or costs that drive selection of the most suitable path to production, and whether or not capital is a scarce resource, the priorities will differ significantly, and the best solutions for flexibility and cost optimization will be widely divergent. The discussion group will collect experiences and insights from panelists and the audience to provide the various facets of "truth" on this topic. Moderator: Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden Panelists: Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley Carol D. Basey, Senior Manufacturing Technical Specialist, Genentech, Inc. Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc. Robert J. Steininger II, Senior Vice President, Manufacturing, Acceleron Pharma Chris M. Brodeur, Senior Manager, Operations, Commercial Expansion Head, BioMarin Pharmaceutical Inc.
Page 1 and 2: Companies that Continue to Attend Y
Page 3 and 4: Conference: September 20-24, 2010 E
Page 5 and 6: Monday, September 20, 2010 • Pre-
Page 7: Wednesday, September 22, 2010 • M
Page 11 and 12: Friday, September 24, 2010 • Main
Page 13 and 14: Meet the People Behind the Products
Page 15 and 16: Co-Located Conference Paid delegate

Register Early and Save up to $300 (See page ... - IBC Life Sciences

Create successful ePaper yourself

Delete template?

Save as template?