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Day One Monday, December 8, 2008 | DAY ONE | DAY TWO | DAY THREE | | ||||
| 8:00 | Registration and Coffee | |||
| 9:00 | Chairperson's Opening Remarks James Weidner, Director, Process Engineering, Amgen Inc. | |||
| Keynote Presentations | ||||
| 9:15 | An Integrated Approach to Global Operations: Making Biotech Manufacturing and Operations Strategically Relevant in Today's Global Biotechnology Environment The dominant design for biotechnology operations is well established. Our changing business environment creates significant challenges to this design, as well as opportunities. These changes include globalization of the industry, introduction of biosimilars, increased pricing/cost pressures, and increased supply chain and regulatory complexity. Can the dominant design be transformed? Can we innovate within our operational design? This presentation describes how a globally integrated biotech operation is a strategic tool for competing in this environment. John Cox, Senior Vice President, Global Manufacturing, Biogen Idec | |||
| 10:00 | Translation of Operational Excellence Methodologies from Theory to Action, Results and Sustainability Too often viable Operational Excellence programs are left at the Yellow Belt training floor, slowly undoing themselves or being undone by organizations that are not ready for them. Most initiatives go through a series of waxing and waning phases, where they are either re-energized or abandoned by the organization. The presentation will highlight what sustains a viable program in even the most resistant culture, while also emphasizing common pitfalls which can often drive failure in the most supportive environment. Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc. | |||
| 10:45 | Exhibit and Poster Hall Opens with Networking Refreshment Break | |||
| Shared Session: Regulatory Updates, Risk Management and Validation | ||||
| 11:15 | Risk Based Validation and Inspection Readiness Risk management best practices have been leveraged in order to implement a risk based validation program based upon system impact analysis (SIA), preliminary hazard analysis (PrHA), and failure mode effects analysis (FMEA). Additionally, these same principles have also been applied to evaluate a plant's level of inspection readiness, including a prioritization process for high level risks. This has enabled us to streamline and focus our validation efforts and thereby enhance our inspection readiness. Christa Hartmann, Ph.D., Director, Corporate Quality, Genentech, Inc. | |||
| 11:45 | Practical Experience from Execution of Risk-Based Commissioning and Qualification Risk is a term that is interpreted in a wide variety of ways by suppliers and end-users worldwide. There are a number of recent recommendations and guidances on the subject. This presentation will, based on practical experience and examples, outline the core values that have to be shared by all players in order to for a qualification to succeed. Magnus Jahnsson, Head of Function QA/HSE, Pharmadule AB, Sweden; Former Scientific Administrator, Inspections Sector, EMEA | |||
| Technology Workshop | ||||
| 12:15 | Microbiological Performance of Commercially Available Single-Use Connectors Kerry Roche Lentine, Manager, Virology and Microbiological Sciences, Bioprocess Division, Millipore Corporation | |||
| 12:45 | Networking Luncheon and Poster/Exhibit Viewing | |||
| Disposables and Facilities | ||||
| Implementation of Disposable Technologies | ||||
| 2:00 | Chairperson's Remarks Kellen Mazzarella, Engineer I, Process Development Engineering, Genentech, Inc. | |||
| 2:15 | Developing a Supplier Innovation Roadmap to Speed Development and Implementation of Disposables Technology For organizations to remain competitive and gain sustainable cost reductions they must drive innovation and accelerate their rate of implementation of novel technologies. Disposables are one area where organizations can reduce their total cost of ownership. This presentation will focus on a five-step roadmap that Bayer Healthcare has used to accelerate innovation in their Flexible Manufacturing facility in Berkeley, California and is now launching at other sites globally. Jennifer Maynard, Black Belt Operational Excellence, Bayer Healthcare | |||
| 2:45 |
To set up a new pilot scale cell culture facility, 250L HyClone Single–Use Bioreactors (SUBs) were selected. The SUBs were integrated into a DeltaV based control system that was designed for 2L development bioreactors and have since been used in the production of 6 different CHO derived antibodies. Excellent comparability has been achieved for material produced from the SUBs and the 2L development model. Terrence Allotta, Engineer I, Process R&D, Genentech, Inc. | |||
| 3:15 | Networking Refreshment Break with Poster/Exhibit Viewing | |||
| 3:45 |
Biogen Idec is evaluating disposable technology to create additional flexibility. Analysis of mass transfer and mixing characteristics were applied to evaluate design attributes and scalability for Hyclone's 1000L disposable Single Use Bioreactor (SUB) system as compared to smaller disposable and stainless steel systems. Scalability based on physical system parameters as well as cell culture process performance will be addressed. To complement the system performance attributes, a cost modeling exercise is discussed to encompass a full system assessment. Kelly R. Wiltberger, Manager, Cell Culture Development, Biogen Idec | |||
| 4:15 |
Biolex's LEX systemSM using lemna offers an opportunity to reduce the risk and cost associated with building and operating a biologics manufacturing facility for a wide variety of proteins. A closed upstream biologics production system using disposable bag technology adapted to the LEX system will be presented. Glen Williams, Senior Vice President, Technical Operations, Biolex Therapeutics | |||
| 4:45 |
Single-use products such as process containers integrated with filters are being increasingly employed in biotech in order to enhance the operational flexibility of manufacturing plants. Centocor R&D, Inc. used lean process improvement principles and collaborated with a key vendor to develop and implement an innovative and flexible filtration concept that meets the needs of a majority of end-users. Bryan Shingle, Manager, Clinical Material Services, Clinical Drug Substance Manufacturing, Centocor | |||
| 5:15 | Networking Reception in Poster and Exhibit Hall Sponsored by IBC Life Sciences | |||
| 6:15 | Site Tour to Catalent Pharma Solutions Catalent Pharma Solutions is one of the leading providers of biotech services including bioassay development, GPEx® mammalian cell line engineering, analytical and formulation development, mammalian cell culture process development leading to and including cGMP manufacture, analysis of extractable and leachables, and sterile manufacturing. On the tour, attendees will see the clinical trials manufacturing suite, formulations development facility for sterile and inhalation products, analytical laboratories, including extractables and leachables analysis, viral clearance building and large-scale MDI manufacturing suite. They will have the opportunity to interact with key technical staff. Refreshments will be served. Buses depart the Washington Duke Inn & Golf Club at 6:15 pm and return at 9:45 pm. Space is limited to approximately 50 attendees and available on a first come, first served basis. Please indicate when you register if you wish to attend. | |||
| Operational Excellence | ||||
| Applying Lean Principles for Cost Reduction | ||||
| 2:00 | Chairperson's Remarks Robert Bottome, Director, South San Francisco Production Operational Excellence, Genentech, Inc. | |||
| 2:15 | Lean Plants of the Future – Application of Lean Tools to Biotech Production Breakthroughs in cell culture technology are eliminating the bottlenecks in upstream production and have the potential to transform many production processes. These improvements will dramatically impact how biotech plants are operated and how future plants are designed. This talk will highlight how lean tools in combination with new technologies can be applied to optimize overall production in biotech plants. Robert Caren, Associate Director, Manufacturing Sciences and Technology, Genentech, Inc. | |||
| 2:45 | The Keys to Sustaining High Performance This presentation is a lively overview of the elements necessary to create and sustain a high performance process throughout an organization. The key non-negotiable elements are an auditable communication strategy; a defined business focus process; an accountability process; and a defined behavioral effectiveness process. Participants will receive specific implementation methodology which they can begin practicing immediately upon return to the workplace. Shane Yount, Senior Partner, Competitive Solutions, Inc. Tim Tousey, Manager of Operational Excellence, Zebulon Site, GlaxoSmithKline | |||
| 3:15 | Networking Refreshment Break with Poster/Exhibit Viewing | |||
| 3:45 |
Learn about Amgen's systematic way of enabling staff to identify and eliminate waste in manufacturing and transactional processes through the use of Value Stream Mapping, mentoring staff via change agents and engagement of management as champions. Dave Bain, Director, Industrial Engineering, Amgen | |||
| 4:15 |
When biotech and pharma companies need to reduce costs they usually deploy a program called "operational excellence" or "continuous improvement" instead of working the problem directly. This presentation shows how to achieve cost reduction targets and improve compliance without distracting the organization with wasteful program deployment. Chris S. Driscoll, Principal, Tunnell Consulting | |||
| 4:45 |
As the operating environment for biopharmaceutical manufacturing and development continues to change, one of the key challenges will be the ability to lead a new way of thinking in a GMP environment. Without proper support, planning and communication, sustainable change in the culture will not occur. The goal of this presentation is to provide an overview of the key steps and lessons learned that can be used to lead change when launching an Operational Excellence Program. David Sadi, Associate Director, Operational Excellence, Biogen Idec | |||
| 5:15 | Networking Reception in Poster and Exhibit Hall Sponsored by IBC Life Sciences | |||
| 6:15 | Site Tour to Catalent Pharma Solutions Catalent Pharma Solutions is one of the leading providers of biotech services including bioassay development, GPEx® mammalian cell line engineering, analytical and formulation development, mammalian cell culture process development leading to and including cGMP manufacture, analysis of extractable and leachables, and sterile manufacturing. On the tour, attendees will see the clinical trials manufacturing suite, formulations development facility for sterile and inhalation products, analytical laboratories, including extractables and leachables analysis, viral clearance building and large-scale MDI manufacturing suite. They will have the opportunity to interact with key technical staff. Refreshments will be served. Buses depart the Washington Duke Inn & Golf Club at 6:15 pm and return at 9:45 pm. Space is limited to approximately 50 attendees and available on a first come, first served basis. Please indicate when you register if you wish to attend. | |||
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Day Two Tuesday, December 9, 2008 | DAY ONE | DAY TWO | DAY THREE | | ||||
| 8:15 | Morning Coffee | |||
| Disposables and Facilities | ||||
| Current Perspectives on Extractables and Leachables | ||||
| 8:45 | Chairperson's Remarks Jerold Martin, M.Sc., Senior Vice President, Pall Life Sciences; BPSA Director and Chair, Standards and Guidance Committee, Bio-Process Systems Alliance (BPSA) | |||
| 9:00 | Incorporating Industry Best Practices into Development of an Extractable/Leachable Program Extractables and leachables present in components such as pre-filled syringes, bioprocess systems etc. are a concern due to potential effects on product quality and safety. The development of an extractable/leachable program based on a risk-assessment approach and a consolidation of industry best practices is discussed. Integrating analytical and safety assessment information into design of an extractable/leachable program is presented. Aditya Wakankar, Ph.D., Associate Scientist, Pharmaceutical Development, Genentech, Inc. | |||
| 9:30 |
A case study is presented whereby Bioprocess Containers (BPCs) from two suppliers were characterized as drug substance storage containers for a monoclonal antibody biopharmaceutical. The impact that the BPCs had over time on the various physical parameters of the molecule and the follow up investigation into the cause behind one particular observation will be presented. Richard Strong, Ph.D., Scientist II, Analytical Development, Biogen Idec | |||
| 10:00 | Development of Supplier-Generated Extractables Data for Integrated Single-Use Systems Single-use process system components represent a source of leachable compounds that may migrate into process fluids and final product. Regulatory requirements call for characterization of leachables in final dosage containers. We will describe an approach to supplier-generation of extractables data that can be applied from individual components and to complex multi-component systems. A systematic study of extractables from a single-use system was conducted using model solvents via novel concepts, practical design, and analytical detection. Christopher J. Mach, Global Product Manager, Allegro Single Use Systems, Pall Life Sciences | |||
| 10:30 | Networking Refreshment Break with Poster/Exhibit Viewing | |||
| 11:00 | Audience Interactive Panel Discussion Extractables and Leachables Session Presenters will convene to answer questions from the audience and address other Disposables issues. Additional topics for discussion will be application of industry best practices, standardization needs, disposal practices, regulatory experiences and current challenges to implementation of single use manufacturing. Audience participation is encouraged. Moderator: Jerold Martin, Pall Life Sciences Panelists: Christopher J. Mach, Pall Life Sciences Richard Strong, Ph.D., Biogen Idec Aditya Wakankar, Ph.D., Genentech, Inc. | |||
| Technology Workshop | ||||
| 11:30 | High Performance Disposable Capture Chromatography
Disposable buffer bags, tubing, aseptic connectors, and viral clearance filters have demonstrated their value vs. conventional reusable technologies. Natrix Separations has developed a high performance membrane-based single use capture chromatography technology to provide users with further options for the implementation of single use systems in their bioprocesses. This workshop will discuss applications for single use capture chromatography technology with an emphasis on the interplay between applications, product format and membrane chemistries.Chris Shields, Marketing Director, Natrix Separations, Inc. | |||
| 12:00 | Lunch and Presentation Sponsored by | |||
| Allegro™ Flexible Solutions: An overview of Pall Single Use Technologies, Systems and Capabilities This presentation will cover the Allegro™ single use program at Pall Life Sciences using specific system design examples from upstream to formulation and filling. We will cover in greater detail some of our core technologies including the Allegro biocontainers and Kleenpak™ sterile connector. Pall is the process knowledge and system design experts whose renowned application and validation support, delivers a complete solution for end users. Christopher J. Mach, Global Product and Marketing Manager, Allegro Single Use Systems, Pall Life Sciences | ||||
| Logistical Considerations | ||||
| 1:15 | Chairperson's Remarks Melody Scott, Process Engineer III, Biogen Idec | |||
| 1:30 | Production of Viral Products in a Multi-Product cGMP Environment The FDA has recently stated that technology advances now allow manufacturers to control the risk of cross contamination when processing biological products and the Code of Federal Regulations has been amended to allow processing of live vaccines in multi-product facilities. This presentation will describe the design and construction of a vaccine production "facility within a facility" which has been successfully inspected by the EMEA and which has passed numerous CMO customer audits. Roger Lias, Ph.D., President, Eden Biodesign, Inc. | |||
| 2:00 | Developing Disposable Shipping Mechanisms: Overcoming Challenges Inherent in a Fragile System Utilizing disposables for the storage of bulk drug substance is an attractive option as it provides several potential operational and financial benefits. However, shipping this bulk remains a challenge. This talk will examine the challenges in shipping bulk stored in bioprocess bags as well as mechanisms for overcoming these challenges. Design, testing, and implementation of shipping strategies will be discussed. Kellen Mazzarella, Engineer I, Process Development Engineering, Genentech, Inc. | |||
| 2:30 | Reduce, Reuse, Recycle, and Then What? Converting Waste-to-Energy The persistent need for reliable and safe waste disposal coupled with the nation's thirst for clean renewable energy has reinvigorated America's waste-to-energy industry. While achieving net reductions of greenhouse gases, waste-to-energy can help solve many of the nation's waste issues while providing an increasingly valuable energy commodity. The presentation will highlight the opportunities and challenges of developing these facilities with emphasis on needs of the biopharmaceutical industry. Ted Michaels, President, Integrated Waste Services Association | |||
| 3:00 | The Current Limitations on the Use of Disposables in Clinical Manufacturing For new and existing manufacturing facilities disposables offer adaptability to changing demand and (in most cases) lower fixed costs. They also provide the opportunity for lower contamination rates, reduced SIP and CIP requirements, and less validation. This presentation will review the current disposable technology, and address the limitations in cost, solution preparation, fermentation, and purification techniques. Joshua Froimson, Associate Director, Site Support, Abbott Bioresearch Center | |||
| 3:30 | Networking Refreshment Break with Final Opportunity for Poster/Exhibit Viewing | |||
| Enhancing Productivity, Flexibility and Economics of Biopharm Manufacturing Facilities and Operations | ||||
| 4:00 |
In large biopharmaceutical manufacturing facilities with concurrent operations, shared equipment (CIP skids, transfer panels) and common resources (utilities, labor) can introduce hard-to-predict scheduling conflicts. This presentation describes how control system process data was used to generate a detailed scheduling model, identify facility bottlenecks at varying run rates, and predict facility capacity limitations for a future product. Carnley L. Norman, Ph.D., Principal Engineer, Amgen | |||
| 4:30 |
Simulation played a key role in the design of a new biotech facility. Capacity analysis, beginning at the conceptual stage and continuing as the project evolved, helped guide design decisions. A simulation model addressed the inherent complexities arising from process dynamics, physical constraints, and data uncertainties. The deliverable is a sustainable facility model which is integrated into the business workflow. Richard G. Dargatz, P.E., Engineering Consultant, Engineering Tech Center, Eli Lilly and Company | |||
| 5:00 | Disposable Perfusion Bioreactor Technology for Manufacturing Therapeutic Proteins A fully disposable perfusion bioreactor system has been developed for manufacturing therapeutic proteins. A large scale development laboratory with 200L scale has been established with this technology for pilot scale runs and preclinical material production. The speed of implementation as well as the flexibility and economics of operations for this disposable technology will be discussed. Gan Wei, Ph.D., Director, Bioengineering, Shire Human Genetic Therapies | |||
| Operational Excellence | ||||
| 8:45 | Chairperson's Remarks Siddharth J. Advant, Ph.D., Principal & Head, West Coast Office, Tunnell Consulting | |||
| Impact of Raw Materials on Cost Reduction | ||||
| 9:00 | Optimization of Resin and Membrane Use in Commercial Biopharmaceutical Manufacturing Chromatography resins and ultrafiltration membranes often are the major contributors to the manufacturing costs for biopharmaceutical products. Strategies for extending the use of resins and membranes from pre-commercial to commercial manufacturing will be described. Additionally, approaches to optimize resin and membrane lifetime in commercial manufacturing will be examined. These simple initiatives can minimize waste and substantially reduce cost of goods for biopharmaceutical products. Sourav K. Kundu, Ph.D., Director, Process Development, Amgen | |||
| 9:30 |
Establishment of appropriate shelf-life dating for raw materials, resins and disposable components is critical for the manufacture of biopharmaceuticals. Extension of shelf-life dating is often desirous to provide for increased warehouse flexibility, decreased re-evaluation costs, or scrap exposure related to safety stock. Hear a review of quality, technical and compliance considerations related to extension of expiration dating as a case study. Freddie W. West, Senior Scientist, Process Development, Amgen | |||
| Design for Manufacturability | ||||
| 10:00 | Validation and Six Sigma 'Design for Six Sigma' relies in part on the skillful use of design of experiments to reveal which variables are robust in the face of variation across specification limits and which variables need to be carefully controlled. This talk explains how the validation process can be used to define a quantitative 'sweet spot' that can serve as the basis for meaningful control charts and set-up rituals that significantly reduce process variability. Robert Bottome, Director, South San Francisco Production Operational Excellence, Genentech, Inc. | |||
| 10:30 | Networking Refreshment Break with Poster/Exhibit Viewing | |||
| 11:00 |
Learn about the structured 3-week diagnostic approach taken at Abbott Laboratories to determine areas of waste reduction at an API plant. This assessment uses several tools to analyze the key areas of operation of the site in order to identify opportunities for improvement and establishes an implementation approach for them. Elizabeth Fabián, Business Excellence Lean Program Manager, Global Pharmaceutical Operations, Abbott Laboratories | |||
| Technology Workshop | ||||
| 11:30 | High Performance Disposable Capture Chromatography
Disposable buffer bags, tubing, aseptic connectors, and viral clearance filters have demonstrated their value vs. conventional reusable technologies. Natrix Separations has developed a high performance membrane-based single use capture chromatography technology to provide users with further options for the implementation of single use systems in their bioprocesses. This workshop will discuss applications for single use capture chromatography technology with an emphasis on the interplay between applications, product format and membrane chemistries.Chris Shields, Marketing Director, Natrix Separations, Inc. | |||
| 12:00 | Lunch and Presentation Sponsored by | |||
| Allegro™ Flexible Solutions: An overview of Pall Single Use Technologies, Systems and Capabilities This presentation will cover the Allegro™ single use program at Pall Life Sciences using specific system design examples from upstream to formulation and filling. We will cover in greater detail some of our core technologies including the Allegro biocontainers and Kleenpak™ sterile connector. Pall is the process knowledge and system design experts whose renowned application and validation support, delivers a complete solution for end users. Christopher J. Mach, Global Product and Marketing Manager, Allegro Single Use Systems, Pall Life Sciences | ||||
| 1:15 |
This presentation describes the evolution of the JJ Pilot Plant as a clinical manufacturing facility. Bioreactor conversion, bag technology, product change over, and campaign planning are discussed. Joseph K. McLaughlin, Associate Research Fellow, Bioprocess R&D, Pfizer Inc | |||
| Process Analysis for Production Efficiency | ||||
| 1:45 | Chairperson's Remarks Joshua Froimson, Associate Director, Site Support, Abbott Bioresearch Center | |||
| 2:00 | BioPharma's New Paradigm in Operational Excellence (OpEx): How New Process Design Tools Support the Goals of Quality by Design (QbD) and Process Analytical Technology (PAT) The biopharmaceutical industry is transitioning to a new model of production efficiency through OpEx. Borrowing from such principles as "lean manufacturing" and "Six Sigma", and incorporating QbD, OpEx is applied through such initiatives as QRM and PAT. Developments in cell biology, process analytics and information technology are providing the real enablement of these strategies in bioproduction. William G. Whitford, Senior Manager, Technical Development Collaborations, Thermo Fisher Scientific | |||
| Audience Interactive Panel Discussion | ||||
| 2:30 | Impact of Operational Excellence on the Design of Platform Processes and Facilities The pressure to reduce cost during development and commercialization of biologics has put an increased emphasis on developing platform processes as well as the design of appropriate facilities. This interactive session will look at the interaction between these two components and what opportunities exist to simultaneously build operational excellence into the design of processes and facilities. Moderator: Siddharth J. Advant, Ph.D., Principal & Head, West Coast Office, Tunnell Consulting Panelists: Robert Bottome, Director, South San Francisco Production Operational Excellence, Genentech, Inc. Robert Caren, Associate Director, Manufacturing Sciences and Technology, Genentech, Inc. Parrish Galliher, Founder and Chief Technology Officer, Xcellerex, Inc. Sourav K. Kundu, Ph.D., Director, Process Development, Amgen Gan Wei, Ph.D., Director, Bioengineering, Shire Human Genetic Therapies | |||
| 3:30 | Networking Refreshment Break with Final Opportunity for Poster/Exhibit Viewing | |||
| 4:00 |
Statistical modeling, especially multivariate analysis, is an important component of QbD. We have used this statistical approach to characterize a late-stage cell culture process for monoclonal antibody production. We also used scale-up/scale-down models to define process scale-up parameters. The benefits and challenges in this modeling-based process validation will be discussed. NingNing Ma, Ph.D., Senior Principal Scientist, Pfizer Inc | |||
| 4:30 | Improving Biomanufacturing Excellence Based on Process Analytical Technology (PAT) / Quality By Design This presentation describes several applications of PAT and QbD approaches in bioprocess development and manufacturing for (1) monitoring, (2) controlling, (3) real-time release and (4) optimization. Examples from various cases will be presented, including new process analytic concepts for bioprocess monitoring, design of experiments, and multivariate data analysis. Participants will gain valuable insight and a useful roadmap for leading their organizations to make the necessary changes for PAT and QbD. Glenn Restivo, Life Sciences Specialist, Siemens | |||
| 5:00 | Using the Past to Design the Future: Using Empirical Data and Simulation Modeling in Process Design We present empirical data showing cycle time and unit operation variability in a number of biotech plants. Modeling this variability using simulation modeling is vital to understanding how processes can be improved in the context of an entire plant's operations. Several examples from major biotech firms are discussed, where simulation modeling was implemented to quantify the impact of new technologies. Rick Johnston, Co-Director, Center for Biopharmaceutical Operations, University of California, Berkeley | |||
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Day Three Wednesday, December 10, 2008 | DAY ONE | DAY TWO | DAY THREE | | ||||
| Site Tour to Golden LEAF BTEC Facility: A World-First and World-Class Training Facility
The Golden LEAF Biomanufacturing Training and Education Center (BTEC), a part of NC State University, is the product of a collaboration between industry, government and academia. The BTEC start-up was principally funded by the Golden LEAF Foundation, with on-going funding from the state Legislature and extensive funding and support by North Carolina Bioscience companies. BTEC is a state-of-the-art simulated cGMP production facility dedicated to providing hands-on training for undergraduate, graduate and industry professionals. The 82,000 square foot facility features vial-to-vial bioproduction which includes upstream production with yeast, bacterial and animal cell culture, harvest and recovery, purification, bulk formulation, aseptic fill finish and analytical testing. Students produce biomolecules at multiple scales, culminating in a large scale production in a simulated cGMP environment. Because this is a teaching facility it gives tour goers the opportunity to have unprecedented access to clean rooms and industry relevant equipment. Come find out what makes BTEC unique to not only North America, but also the world. Buses depart from the Washington Duke Inn & Golf Club at 8:00 am and return at approximately 12:30 pm, making a stop at Raleigh-Durham International Airport at approximately 11:45 am. Space is limited to approximately 50 attendees and available on a first come, first served basis. Please indicate when you register if you wish to attend. | ||||
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