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Wednesday, March 26, 2008
Meals & Special Events
Keynotes, General Sessions, Meals
SE-1: Biotech 2008: A 20/20 Vision of 2020 11:30AM - 12:30PM (Wednesday, March 26, 2008)
G. Steven Burrill, CEO of Burrill and Company, has been a biotech investment visionary for over 40 years. He is an active advisor and catalyst in the growth and prosperity of the biotechnology industry and works closely with the industry''s most notable companies. Burrill will present an analysis of key activities taking place in the life science industry sectors with highlights on recent advances in technology and scientific activity. He will also explore the emergence of biotechnology as a global industry and the impact this will have on the future of healthcare.
SE-5: Lunch - Wednesday, March 26 12:30PM - 1:45PM (Wednesday, March 26, 2008)
Conference Luncheon, Wednesday, March 26, 12:30 pm - 1:45 pm. Included in Full Conference Pass or the Wednesday One Day Pass price. Available for purchase to all other badgeholders for $45.00.
SE-4: Opening Night Reception 5:00PM - 6:30PM (Wednesday, March 26, 2008)
Join us for drinks and hors d’oeuvres as we celebrate the opening of INTERPHEX2008 in the Grand Hall of the Pennsylvania Convention Center.
Technology Enablers
T-4: Anti-Counterfeiting: A Multi-Layered Approach to Detection and Prevention 9:00AM - 10:00AM (Wednesday, March 26, 2008)
General:
With 10% of worldwide pharmaceuticals counterfeit, this is a growing problem that only gets worse as criminal enterprises get more sophisticated. This session covers multi-faceted approach to tackling this problem. Many of the techniques taught here also help address gray market and diversion problems.
• The problems of counterfeiting and diversion • Multi-layered protection • Overt, Covert, Forensic approaches – e.g. Polychromatic markings, Pen or Light revealable Inks, Ingestible Authentication Markers, Nano-patterning, etc. • Field audit programs • RFID and ePedigree
Speaker:
Bill McBeath - Managing Director, Research and Advisory Service Supply Chain Risk Management, Marsh
T-1: The Role of Industrial Automation in Qualified & Non Qualified Building Automation Solutions 9:00AM - 10:00AM (Wednesday, March 26, 2008)
A paradigm shift has occurred; The building has become part of the process, and,conversely, the same equipment that manages your manufacturing process today can also manage your facility's environment. What if you could lower your cost of ownership through a more integrated approach to BAS/QBAS? By managing the environment using the same control platform as the process, you could make better use of your training budget,eliminate "locked in" long term support agreements in favor of a more flexible "Menu Selection" of support services, and improve your bottom line. In addition, validation of any system can be a challange. Regulatory compliance is not easy. But if the same approach is adopted in terms of control to the environment, as is the process, you will create an element of commonality in respect of the documentation and protocols employed. Learn more about integrating your environmental management into your production process in this session and become the master of your domain!
T-2: Benefits of Integrating Production and Quality Information 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session case study will review a successful integration of real time quality results from laboratory information systems to production systems. The case study will stress the importance of using ISA standard S88 and S95 in concert to achieve successful interoperability. Today's manufacturing execution system platforms offer an opportunity to integrate data from production and quality systems resulting in improved productivity and traceability. Genealogy tracking of production ingredients in manufacturing is a common requirement for production MES systems; however, the linkage of product data to laboratory test results is often lacking or not in real time. A key goal of any MES implementation should be to optimize laboratory operations to support production. Industry standards have emerged as guidelines to understanding how this data should be exchanged in a real time production
T-5: Results of Serialized 2D Barcoding Pilot to Support Item-Level Track & Trace 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Talk and discussion around the results and lessons learned from a serialized barcode pilot conducted with Catalent Pharma Solutions and Secure Symbology.
Speaker:
Richard Smith - Director of Engineering , SecureSymbology
John Vignola - Manager, Business Development, Catalent Pharma Solutions
T-6: What Do We Really Mean By Security for RFID -- And How Much Is Enough? 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Many pharmaceutical manufacturers and distributors are looking to RFID as a solution for protecting, authenticating and tracking their products. Critical concerns around security and privacy, including HIPAA compliance, are being raised with the growing push towards adoption of RFID technology. Many people think of securing the pharmaceutical supply chain as “encrypting” data when in fact many different security tools may be used in different combinations. The level of security that is appropriate for particular pharmaceutical applications such as anti-diversion, e-pedigree, track & trace and cold chain management will also vary and must be balanced against the apparent risks. This talk will cover the spectrum of functions that can provide security for RFID such as encryption, authentication and other data protection methods. It will also discuss how security functions can help provide privacy protection and how security and privacy differ. The latest developments in security solutions from the RFID industry will also be reviewed.
Speaker:
Louis Parks - President & CEO, SecureRF Corporation
T-3: WORKSHOP: Automation of 'Plug and Play' Process Skids and Components in a Biopharm Facility 2:00PM - 4:00PM (Wednesday, March 26, 2008)
To enhance the flexibility and usability of biopharma pilot, clinical, and production facilities, moveable and portable process skids, tanks, chromotography units, and other modular process components are employed. The integration of these components into a process control system can be challenging and difficult. With proper planning, development of detailed user requirements, and an in-depth knowledge of S88, the proper automation strategy can be developed. The author will develop the automation strategy for a "prototype" biopharm process during this session. An interactive approach will be taken with the attendees, with the goal of identifying the major considerations of defining an automation strategy for "plug and play" components.
T-7: Meet California ePedigree Law with 2D Item-Level Mass Serialized Codes and/or RFID 3:15PM - 4:15PM (Wednesday, March 26, 2008)
The California ePedigree Law is set to go into effect January 1, 2009 with major wholesalers expecting an ePedigree solution in place by July 2008 to fill the supply chain. With a fixed date, supported by penalties for non-compliance, pharmaceutical manufacturers have an extremely short time to prepare. There are three primary options for Pharmaceutical Manufacturers to consider: a 2D Mass Serialized Bar Coding Solution (item-level and case level with parent/child), a 2D/RFID Hybrid Solution, or a full-RFID solution. Unless you are already down the RFID path, it might be difficult to prepare your infrastructure, launch a Pilot, and deploy a full RFID solution in the time required. Many pharmaceutical brand owners are choosing a 2D bar coding option for the item level coupled with RFID at the case level as a means to get started. In parallel, they are beginning to evaluate an item level RFID option to support wholesalers needs for electronic tracking and tracing of products throughout their operation, removing ‘line of sight' bar code read requirements. At this session, attendees will learn how they can: Meet the California ePedigree Law using one of the above options (comparative benefits and challenges) Leverage the benefits and use of 2D mass serialized bar coding Integrate 2D mass serialized codes at the item level on labels and folding cartons Write item-level codes to a case-level 2D bar-code or UHF RFID tag to create a parent/child relationship between item level units within the case Pilot, integrate, and deploy a 2D Solution, Hybrid Solution, or a Full RFID Solution with a comprehensive network of best in class product and service providers (includes software, hardware, packaging line & quality specifications updates, and packaging components) Leverage the flexibility of 2D bar coding for product authentication and other layered overt, covert, or forensic options
Speaker:
Craig Curran - Director, Strategic Initiatives, Nosco, Inc.
Basics & Building Blocks
B-1: Materials of Construction for the Biopharmaceutical Industry 9:00AM - 10:00AM (Wednesday, March 26, 2008)
The biopharmaceutical industry requires reliable and high quality materials and procedures for the fabrication of components and the erection of systems that include equipment, instrumentation, and piping components. This seminar will focus on aspects of material selection (metallic and non-metallic systems), their performance parameters, the various industry standards, codes and regulations related to the fabrication and application of components, and more importantly, what are the myths and realities associated with these aspects of the industry. We will visit controversial and sometimes misunderstood subjects such as flow velocities, joining methods, product contact surfaces issues such as passivation of stainless steel, the phenomenon of “rouge”, electropolishing, etc.
B-2: Understanding Powder Flow for Formulation Development and Production Process Design 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Powder flow through bins, hoppers and feeders has an enormous impact on common problems such as “no flow” due to stable powder arches and ratholes, erratic flow or a feed rate limitation . Poor flow can lead to reduced production rates and reliance on operators for process control. Understanding powder flow is critical avoiding these problems, and can be used as the basis for new equipment purchases or assigning product production to existing process areas. Examples behavior for common powders will be discussed, including some typical materials of interest to the biopharmaceutical community such as cell culture medias and buffers , as compared to more common powders such as (e.g., sugar, microcrystalline cellulose).
Speaker:
Roger Barnum - Senior Consultant, Jenike & Johanson, Inc.
B-3: Basics and Building Blocks of C & Q 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Commissioning and Qualification (C&Q) costs and schedules are of increasing concern for capital projects. The paradigm is shifting with the increased focus on science and risk based approaches to C&Q and the new ASTM Standard for specification design and verification of pharmaceutical manufacturing facilities and equipment. This paper provides an insight into these new developments and their impact on the execution of C&Q and the potential for cost reduction. The increased focus on risk and risk assessment, use of good engineering practices and implication of the standard will be discussed with some examples.
This session provides an overview of cleaning validation strategies and methods for pharmaceutical processes. Principles and concepts employed in the design and implementation of an effective cleaning validation program, cleaning validation study design and implementation, analytical techniques, establishment of acceptance criteria, and single versus multi-product issues will be presented. This session is designed to provide a basic knowledge of cleaning validation for personnel who are new to the industry or experienced personnel who want to review cleaning validation technology. Validation personnel, engineering, operations and quality assurance personnel and anyone who designs, executes and evaluates cleaning processes and cleaning validation studies will benefit from this program.
C-1: Implementing a Global Risk Assessment Process 9:00AM - 10:00AM (Wednesday, March 26, 2008)
This presentation will share experiences of participating in a global team to develop and implement a Computer System Validation Risk Assessment process, in a large R&D organization. An overview of the content of the Risk Assessment Guidance documentation and supporting tools, present the outcome of the process (with examples) and lessons learned.
C-2: Breaking Down Barriers for the FDA's Quality by Design 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Recent research conducted by Conformia for the FDA through FDA-Conformia CRADA, revealed that one of the biggest challenges and opportunities stems from the way in which critical product/process science knowledge is captured, stored and retrieved. One of the biggest causes of the difficulties is the ability to access, track and leverage knowledge from R&D -- i.e. experimental data and conclusions that are often buried in multiple silos across the product/process lifecycle. It's often a mystery as to the who, what, where, why and how of development This is particularly important in light of FDA's forward vision for Pharmaceutical development based on ICH Q8 and Q9 an encapsulated in concepts such as Quality by Design. These forward driving approaches necessitate companies being able to submit very good high quality information supporting the science and understanding across the product / process lifecycle.
C-3: Cleaning Validation in Non-Sterile Solid Dosage Production 2:00PM - 3:00PM (Wednesday, March 26, 2008)
This presentation describes practical approach for Cleaning Validation in Non-Sterile Solid Dosage Production, including development of governing documents, assignment of responsibilities, usage of the project management tools in performance and completion of the tasks and other cornerstones of this fundamental activity. What makes this presentation unique is presentation of the multiple case studies that include development and validation of cleaning methods. Most importantly, presentation describes usage of Process Cleaning Records, as an efficient, validatable procedure that assures consistent successful cleaning.
Igor Gorsky - Associate Director, Validation, Global Pharmaceutical Technology, Shire Pharmaceuticals, Inc.
C-4: Real Lessons from the Validation of Enterprise Solutions 3:15PM - 4:15PM (Wednesday, March 26, 2008)
The session would provide updated insights on how to balance the critical business objectives that drive any Enterprise System (ERP, CRM etc) project with the need to cost-effectively validate the system and ensure that business processes are regulatory compliant. Using real-life project examples and input from a end-user, the interactive workshop would be organized to seek input from conference delegates and provide practical and pragmatic answers to questions posed during the session.
David Stokes - Global Head of Life Sciences, Business & Decision
Biotechnology
Sponsored By:
BIO-5: Major Benefits of Single Use Systems in the Biopharmaceutical Industry 9:00AM - 10:00AM (Wednesday, March 26, 2008)
The evolution of single use bioprocess technology in the biopharmaceutical Industry has resulted to be a major asset for the cell cultivating fermentation, fluid processing and fluid delivery industries. The major benefits of single use systems are: • Equipment cost reduction • Facility cost reduction • Commissions and validation cost reduction Operational efficiencies will be improved by reducing equipment assembling and disassembling time. Additionally, they will result in reducing the following utility systems: • cleaning and CIP usage • clean steam (SIP) and autoclave usage • WFI and compressed air usage • Liquid waste generation
Ahmad Shahidi - Senior Technical Consultant, Parsons
BIO-1: Diagnostic Reagent Facility Expansion--A Case Study 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Siemens Medical Solutions Diagnostics (Formerly Bayer Healthcare, Diagnostic Divsion) and Jacobs have been working together on a project to expand their existing facility in Walpole, MA. The prime driver for this project was the extremely robust growth in the Immunodiagnostics business. This growth, which is expected to continue unabated, is expected to continue over next several years. As a result significant additional capacity is needed in order to be able to service the growing marketplace. The expansion effort has been approached by Siemens, in an extremely logical manner. The first step was to establish the maximum manufacturing capacity of the existing facility and when additional capacity should be brought on line to ensure continuity of supply to their customers. This was done by developing both a demand forecast and a highly complex dynamic capacity model of the existing manufacturing facility. From the modeling exercise a variety of business options were evaluated and the management team elected the Walpole facility expansion option. This case study will present a complete story of development and delivery of this fast track project in a step wise fashion beginning with conceptual design, preliminary engineering, project capital appropriation, and going on to detailed design and construction. This presentation will provide insight into prime project implementation issues encountered and how a partnership between the local authorities, the Siemens integrated execution team, which includes the key service providers of Engineering, Procurement, Construction Management and Commissioning/Qualification services is leading to the completion of a state of the art model project.
Michael Canary - Director of Engineering, Siemens Medical Solutions Diagnostics
BIO-6: Implementation of a Disposable, Single Use, Scalable, Mixing System for Buffer Preparation in a Multipurpose Biopharmaceutical Environment 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Traditional stainless steel mixing systems used in biopharmaceutical processing applications require a considerable time be allowed for cleaning, sterilization and validation following a mixing run. With increasing pressure within the industry to both reduce fixed costs, and maximize operational facility time, reducing the time required for these actions is becoming a high priority. At the facility in question we sought to implement disposable systems for buffer preparation to both reduce these direct and indirect costs, but to also increase manufacturing flexibility. This is important both for the implementation of new projects, but especially for contract manufacturing activities. A new non-invasive, single use, disposable, liquid/liquid and liquid/powder mixing system was evaluated that potentially circumvents these time consuming and costly steps. In part 1 of the experimental program the mixing system was tested to determine its suitability for use for the scalable and homogeneous mixing of sodium chloride which was selected as a typical buffer system. In part 2, the design of the disposable component of the system was reviewed, suggestions were made to the manufacturer to optimize both design and functionality, further evaluation of the modified disposables were undertaken, and the systems compatibility for use in a cGMP environment was investigated.
Derek Pendlebury - Director Sales and Marketing, ATMI LifeSciences
BIO-2: Bioreactor Specification 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This presentation will provide instruction and points to consider for scope definition, equipment specification and procurement of pilot & production scale bioreactor systems. The session will focus on elements of equipment specification that are unique to cell culture and fermentation processes - requirements for axenic processing, CIP/SIP, single-use components, bioreactor instrumentation, vessel agitators, feed systems, sampling, media filtration, perfusion and recovery.
BIO-3: Critical Factors in Mimic Brand Product Formulation for Drug R&D 2:00PM - 3:00PM (Wednesday, March 26, 2008)
In this highly competitive generic drug business, the key to be the winner in the market is to have products delivered to the pipeline continuously in a cGMP facility. However, the actual situation is that the generic drug formulation which can pass bioequivalent (BE) requirements is only about 40% to date on average. Therefore, it is very critical to have the right tools and knowledge in developing the successful formulation to be able to compete with market. In this presentation, we would like to start with the concept of “in-vitro to in-vivo” simulation based on Fraction Dose Absorbed. It is a mathematical model which describes the factors determining the drug absorption. With this proven successful model in drugs absorption, we will then discuss the correlation of these critical factors to the drug formulation development. These critical factors to be discussed including: particle size, active-excipients compatibility, drug pH, stability, GI tract hydrodynamics and pH variation, transient concentration, BE approaching and dissolution, BE study, and finally formulation processes. With these critical factors considered in the drug development, one should be confident in obtaining a BE formulation to mimic brand products, and therefore be able to compete with market.
Joe Chou, PhD - Vice President, Pharmtel Corporation
BIO-7: WORKSHOP: The Complete, Single-Use Biopharmaceutical Process: If or When? 2:00PM - 3:30PM (Wednesday, March 26, 2008)
Presented By:
Single-use technologies are gaining increasing acceptance for biopharmaceutical processing. As the application of disposable technologies has expanded from its earliest applications in filtration to other uses such as cell culture, bioprocess containers, connection devices, and transfer lines, the question is raised of whether it is possible, now or in the future, to have a fully disposable biopharmaceutical manufacturing process. Three industry speakers will present their experiences implementing disposable technologies, including advantages and disadvantages, implementation challenges and limitations, where the greatest barrier may lie (e.g., sensors, chromatographic separations), and whether a fully disposable process is in even desirable. Following the presentations, the speakers will join Laura Bush, Editor in Chief of BioPharm International, in a panel discussion of the issue, including an interactive conversation with the audience.
Moderator:
Laura Bush - Editor in Chief, BioPharm International
Speaker:
Geoffrey Hodge - VP Process Development and Technology, Xcellerex, Inc.
Peter Watler, PhD - Vice President, West Coast Operations, JM Hyde Consulting, Inc.
BIO-4: Design Alternatives for Multi Product Cell Culture Facilities 3:15PM - 4:15PM (Wednesday, March 26, 2008)
Designing a multi product cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of larger scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in a modern call culture facility.
Klaus Hermansen - Senior Specialist, Consulting, nnepharmaplan
Facilities & Engineering
F-4: Hot Topics in Pharmaceutical Containment 9:00AM - 10:00AM (Wednesday, March 26, 2008)
In recent years the understanding of the containment of potent pharmaceutical containment has developed rapidly.
This presentation provides answers; in the form of examples, case studies and scenarios, to the current containment “hot topics”:-
• How to carry out a risk based approach to containment selection?
A proven, systematic risk based approach is presented along with examples of where it has been used for lab, primary (API) and secondary facilities.
This approach is used to systematically identify containment issues on existing and new plants and at the design stage. These containment issues cover:- • Normal operation, • Support activities such as equipment cleaning • Non-operational activities such as planned maintenance • Unplanned/infrequent operations such as breaking out contaminated equipment. • Fault and emergency conditions
The methodology includes:-
• Risk based methods to identify the activities and operations that pose the biggest risk of operator exposure. • Using the two basic containment principles to achieve cost effective, layered turn-up/turn-down containment • How the final choice of containment solution is rarely selected on containment performance alone.
• Do vendor guarantees and performance testing ensure adequate containment?
Containment equipment is typically purchased against a vendors guarantee that testing has shown it can achieve the containment performance required by the customer. This presentation gives real example of how to maintain as-new performance from containment systems and examples of how far containment performance can fall if this is not done.
• Are dedicated high potency facilities really required to control the cross contamination risk?
The potential risks of product cross contamination from high potency products have frequently led these products being manufactured in dedicated or segregated facilities. The ISPE RiskMAPP document aims to address the question of whether this is necessary or whether a rational, risk based approach can be used to justify the decision of whether to dedicate or not. In this presentation, case studies and scenarios are presented that quantify the cross contamination risk and illustrate the types of facility that represent the highest risk.
• How to minimise the environmental impact of high containment facilities?
High containment facilities are designed to provide a tightly controlled environment and all routes for people, material, products, waste and ventilation into and out of that environment are similarly tightly controlled. This presentation gives examples and case studies of how this tight control can be achieved without excessive energy consumption.
F-1: Turning Green into Gold - CANCELLED 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Companies have a great opportunity to turn pressure to operate in an environmenatlly sustainable manner into profit. Not only can they make cost savings from energy and materials/ waste reduction programmes, companies can use sustainability as a competitive leaver to increase market share. This session will examine how turning 'green into gold'requires a deep understanding of commercial cost / benefit versus environmental impacts across the end to end supply chain. Examples from pharmaceuticals and other sectors such as consumer products will be used to illustrate how a true understanding of the sweet spot between product and process requirements, technical feasibility and commercial reality can lead to increase in profit and improvement of our world - CANCELLED
F-5: How to Gain a Competitive Edge Through Process Understanding 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session will highlight a proven approach and methodologies to ‘process understanding’ as an essential component of a successful manufacturing strategy. It will include a series of practical case study examples that will highlight the specific tools and techniques that have been applied successfully by leading global Pharma/Fine Chemical companies to deliver substantial business benefits in excess of US $200 million. It will also focus on the value and benefits of process understanding as a mechanism for companies to be able to respond positively to the changing and increasingly stringent demands of regulators in the pharmaceutical manufacturing environment.
Speaker:
Prabir Basu, PhD - Executive Director, National Institute for Pharmaceutical Technology and Education (NIPTE)
F-2: Integrating Clean Power that Saves Maintenance, Space and the Environment 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Facility reliance on battery-based UPS systems is falling out of favor with the advent of more reliable forms of back-up power. Costly and frequent maintenance/replacement, spotty reliability, expensive HVAC requirements, fire hazards, spill containment, personnel health and safety hazards, excessive space demands, floor loading and environmental impact leave a lot to be desired. Flywheel power protection systems -- a technology that's been around for some time -- has now reached true commercial viability, solving the problems challenging facilities everyday. The latest generation flywheel systems “harden” battery arrays by protecting them from virtually all usage. Facilities are elimating their battery headaches altogethe by using flywheels to directly bridge to generators. This presentation provides examples and examines how and why modern UPS flywheel systems are delivering better energy, space, environmental and cost advantages over problematic battery-based systems.
Speaker:
Johnny Gonzales - Vice President Sales & Services, Pentadyne Power Corporation
F-3: Energy Prices Have Changed Everything & What the Heck is Sustainability? 2:00PM - 3:00PM (Wednesday, March 26, 2008)
The game has changed. The major increase in the cost of energy in the last few years has caused decisions made as little as three years ago to now be incorrect. In addition, the national yearning for “green” and “sustainability” and the response from major corporations and some states, not to mention the international community, have created a need and opportunity for action. But what actions, and what the heck is sustainability? This paper will start from the beginning, defining sustainability, and carry through to what it means for the corporations in this industry. More importantly it will identify opportunities for reducing greenhouse gases (air emissions), reducing energy consumption, and increasing the bottom line. The opportunities to be presented will cover air and water pollution control, site remediation, manufacturing/processing, waste management, and buildings; and the audience will experience a practical summary of sustainability and green that will stimulate ideas to explore in their individual areas of responsibility.
Richard Toro - Director, Environmental Services, Brown and Caldwell
F-6: WORKSHOP: A Cost Reduction Case Study of a Potent Compound Aseptic Filling Line 2:00PM - 4:00PM (Wednesday, March 26, 2008)
Session will present case studies of sterile fill finish facility layouts. Both traditional Grade A and Grade B areas will be compared with modifications that can be acheived with isolator technology. Facility and equipment design differences associated with handling both potent and non-potent compounds will be discussed. The design consideration for containment, cross contamination, and aseptic design will be discussed.
Speaker:
Stephen Errico - Director, Facilities Management & Engineering, Eisai, Inc.
Christa Myers - Chemical Process Engineer, CRB Consulting Engineers
David Ross - Project Manager, Yonkers Industries, Inc.
Manufacturing
M-1: Disposable Containment Technologies for Bulk Solids 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Flexible disposable technologies become more and more important regarding the cleaning and containment. This presentation shows possibilities and solutions about the integration of flexible disposable technologies in new and already existing plants. Additionally it is pointed out that flexible disposable technologies can reduce production costs pending upon optimal planning. Case studies for the API and Pharma will be presented.
Richard Denk - Director of Pharma department, HECHT Anlagenbau GmbH
M-2: Pitstops for Your Process 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Pitstops for your process NASCAR and Formula 1 teams know that "If you ain't running, you ain't racing". They focus on making their pitstops as quick and effective as possible. In manufacturing one might translate this as "If you ain't producing, you ain't profiting". Changeovers, including cleaning, sometimes take as long as 30-40 hours to complete. This presentation will show how to convert changeovers into pitstops. Using ESEE principles, it will show how to Eliminate, Simplify and Externalize Exactly! to reduce changeover times by 50% or more while improving the quality of the changeover. This presentation will be useful to anyone involved in changeover of manufacturing or packaging processes. Attendees will take away a methodology for identifying improvement opportunities. They will also take away a number of practical examples and tips that can be applied in their plants.
M-5: Ensuring the Safety Of Platinum Cured Silicones in the Manufacturing Process 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Presentation of new research results about the risks of cytotoxic extractables generated in the pharmaceutical manufacturing process leaching into finished product.
Speaker:
Mark Rawet - Tubing Business Manager, Watson-Marlow Bredel Pumps
M-6: Bulletproofing Your Pharmaceutical Manufacturing Process: How to Rapidly Find Problems and Fix Them Right the First Time 2:00PM - 3:00PM (Wednesday, March 26, 2008)
When Bristol Myers Squibb was faced with frequent Quality Events at its Mayaguez, Puerto Rico facility, discovering the root cause of the problems often involved trial and error problem solving methods – and a good deal of wasted time and resources. After hiring consulting firm Kepner-Tregoe, Inc. (KT), Bristol Myers Squibb implemented the KT problem solving and analysis methodology as part of its Quality Events Investigation Process. Over the span of the first five months of implementation, 53 employees were trained in the KT methodology. The results were impressive: • Quality Events have been reduced by 25% compared with 1QTR 2006 • Investigation closings have been reduced by 7% compared to 2006YTD • All Quality Events have been investigated using KT principles • Investigation teams are more focused, disciplined, and confident in using the problem solving tools in their investigations • KT implementation has given an increased level of exposure and leadership to employees who have facilitated KT sessions
Speaker:
Michael Curran-Hays - Global Vice President, General Enterprise Practice, Kepner-Tregoe, Inc.
M-3: Efficient Material Handling is the Key to 'Lean Manufacturing' 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Large Multinational Pharmaceutical companies are now faced with a business dilemma, with diminishing pipelines of blockbuster drugs and at the same time facing increasing competition from the international Generics industry in general and from Asia in particular, who are now producing good quality products at much lower costs. The pharmaceutical industry has always been grossly inefficient from a productivity perspective. It is too reliant on labour-intensive operations and spends more time cleaning than producing! This "cost" has previously been justified in the apparent pursuit of cGMP and quality, and in previous years of large profits – was not seen as a cause for concern. Now there is a need to minimise production costs and maximise production rates – "lowest cost per kg". Many multi-national drug companies are now looking at "lean manufacturing" philosophies, as developed by high volume industries with flexible production requirements, to achieve this. Lean terminology like "manufacture to order", "pull production "value stream mapping" are beginning to appear. However, Lean Manufacture is based on a removing the "7 deadly sins" of waste, which is more about efficient materials handling and logistics than it is on efficient processing. It is on this topic of materials handling that the pharmaceutical industry has a lot to learn (there has always been a focus on process). This presentation will discuss and compare potential new trends in the industry:- Continuous, Semi-continuous or Batch processing; Manufacture to Order or Campaign Manufacture; Solids Handling issues – guaranteed flow, control of flow, no bridging, venting displaced air, segregation of blended solids, degradation of tablets; continuous monitoring/PAT; Processing Efficiencies – Direct compression, Dry granulation, Wet granulation.
David Drew - Group Pharmaceutical Director, Matcon Ltd
M-4: Manufacturing Productivity Improvements Utilizing the Design Space and Process Analytical Technology (PAT) Concepts 3:15PM - 4:15PM (Wednesday, March 26, 2008)
This presentation will review the Design Space and PAT concepts and then will provide tangible examples of productivity improvements utilizing these concepts. Particular emphasis will be given to examples of improving productivity in biotechnology active pharmaceutical ingredient (API) processes. However, the basic concepts can be adapted to a wide range of manufacturing operations.
Speaker:
Fred Larimore - Director of Scientific Affairs, Cook Pharmica
Outsourcing
O-1: State of the Pharmaceutical Outsourcing Industry 2008 9:00AM - 10:00AM (Wednesday, March 26, 2008)
General:
2007 was another resounding year contract services providers. The drug development pipeline continued to expand, especially for early development candidates (Phase I and II), creating strong demand for clinical research and clinical supplies manufacturing and packaging. Major pharmaceutical companies accelerated their restructuring efforts, closing more facilities and confirming plans to outsource more of their development and manufacturing needs. Contract manufacturing and research organizations (CROs and CMOs) received record numbers of RFPs.
Along with the positive environment some significant risks remain, however. High profile drug candidates continue to struggle in late phase trials, and CMOs report that cancellations and delays are making it increasingly difficult to forecast revenues and utilization. Pharmaceutical companies and venture capital investors are paying higher valuations for evermore risky candidates and technologies, a trend that could ultimately threaten the flow of capital into the early stage pipeline as the implications of the bad deals are felt. European CMOs and CROs struggle in the face of the US dollar’s devaluation, tightening regulations, and imports from Asia. The penetration of low-cost Asian suppliers continues into all segments of the pharmaceutical services industry.
This session looks at the state of the industry and the opportunities and challenges facing CROs and CMOs and the sponsors that use their services. We will analyze the trends and discuss the implications for the CMO and CRO business models. OPEN TO ALL BADGEHOLDERS
O-2: Best Practices for Outsourcing in the Life Sciences - An Advanced Session on the Essential Considerations to Make the Outsourcing Relationship Work 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session provides an advanced discussion of key considerations and best practices for those involved in strategic relationships or considering implementing outsourcing programs in the life sciences industry. With nearly two decades of outsourcing experience, Michael Pillion of Morgan Lewis' highly-regarded outsourcing team and a client will provide a variety of legal and business of insights to include: the structuring of services relationships (including the key components of the outsourcing agreement and their interrelationships); the structured processes that help ensure a favorable negotiation outcomes; suitable exit strategies, and those unique considerations of ooutsourcing in a regulated environment. The audience will be able to leave more prepared to successfully understand the negotiation, documentation, selection, and execution/governance of a successful outsourcing relationship.
O-3: Optimizing R&D Outsourcing Business Model: From Preclinical to Development - A Case Study. 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Numerous pharmaceuticals and biotechnology companies are outsourcing pharmaceutical chemistry to CROs world wide to evade rising R&D cost pressures, regulatory challenges and shorter product life cycles. DOV Pharmaceutical Inc. is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system (CNS). We are one of the pioneers in the arena of drug discovery and development outsourcing. We collaborate with CROs and CMOs around the world for projects from early stage drug discovery, process development, custom manufacturing to clinical trials. In this case study, I will report on my personal experience in utilizing external technological expertise, evaluating and making technological decisions and forging strategic alignments with collaborators.
Zhengming Chen, PhD - Senior Director of Chemistry & CMC, DOV Pharmaceutical, Inc.
O-4: Innovation in Sourcing - Optimizing Your Outsourcing Strategy and Enabling a High Performance Governance Organization 3:15PM - 4:15PM (Wednesday, March 26, 2008)
Pharmaceutical and biotech organizations continue to face extreme revenue pressures as a result of shrinking “blockbuster” pipelines, near-term patent expirations, increased generic competition and a trend towards personalized medicine. Cost pressures also remain intense with customers, shareholders and regulators requiring increased customer service and compliance and reduced operational costs. Outsourcing (including offshoring) has become an established approach for many large and small organizations to assist in driving profitable growth from a manufacturing perspective and is starting to become more widely adopted for services as well. Yet, many firms have been disappointed by the results of outsourcing. Typically, outsourcing strategy and deals are poorly designed and/or executed and the governance organizations put in place to manage the outsourced functions or processes, after the deals are signed, are ill-equipped and/or lacking the key competencies needed to drive significant value creation from outsourcing. Also, many firms implement one-off deals, often in disparate areas of the business, without considering the impact on value creation (or destruction) at an enterprise level. The net business outcome is that there is often significant ‘value leakage' and unfulfilled expectations from outsourcing. So, how can organizations gain maximum benefit from outsourcing and deliver high performance, with valuable outcomes for both the buyers and providers of outsourced services, while mitigating the risks of value leakage? In this session, Chris Nuttall will describe best practice and innovations in how pharmaceutical and biotech organizations can optimize the outsourcing strategy at both an enterprise-wide level and a deal level and make that strategy sustainable by enabling a high performance governance organization. Drawing on more than thirteen years' of client experiences across both BPO and ITO, Chris will cover: • The typical challenges faced in optimizing the outsourcing strategy and enabling a high performance governance organization • Typical symptoms of under-performance and value-leakage and the underlying root causes • How to take a portfolio wide approach and formulate/implement an effective enterprise-wide outsourcing strategy, including aligning this across the organization from both ‘top down' and ‘bottom up' perspectives • How to create a balanced enterprise portfolio using a combination of outsourcing, in-house and captive delivery, alliances and shared services • How to recognize and meet the interests of all key stakeholders, including customers, employees, regulators and business partners • Typical business performance metrics that allow performance to be managed effectively • How to ensure that value creation can be sustained over time • Key lessons learned / takeaways for organizations that are both buyers and providers of outsourced services. The session will primarily take the perspective of buy-side organizations (i.e organizations that buy outsourced services) – this will allow both buyers and providers of outsourced services to establish an understanding of best practice and translate the findings into actions for their own organizations. The session will be illustrated throughout by case studies and real life examples.
SE-2: Innovation to Commercialization: Executive Life Science Panel Discussion 11:30AM - 12:30PM (Thursday, March 27, 2008)
Attend this high level panel discussion featuring CEOs from the three life science industries – medical device, pharma and bio - addressing current trends in innovation, global market challenges and collaborations across the industries as they impact future generations of product development and commercialization. Don’t miss out on the opportunity to connect with industry leaders as they share their insight and experiences!
SE-6: Lunch - Thursday, March 27 12:30PM - 1:45PM (Thursday, March 27, 2008)
Conference Luncheon, Thursday, March 27, 12:30 pm - 1:45 pm. Included in Full Conference Pass or the Wednesday One Day Pass price. Available for purchase to all other badgeholders for $45.00.
Technology Enablers
T-8: The Next Generation of Process Automation - The User's Requirements 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1970's, the Programmable Logic Controller revolutionized the machine control industry. In the early 1980's, proprietary Distributed Process Control systems and microprocessor-based sensors and actuators facilitated large-scale digital plant automation for the first time. Later that decade, the personal computer made application-based automation and control inexpensive and scaleable. The S88 and S95 standards, in conjunction with GAMP4 guidelines, has given a framework for developing, documenting, and maintaining automation and process control systems for the pharmaceutical industry. Over the past ten years, however, while the industry has seen the introduction of new applications and smarter sensors and actuators, the author feels, as do a large percentage of end users, that a new paradigm in automation and process control is needed. The recent “advances” in automation have mostly come from vendors who have created different flavors of existing technologies in order to maintain market share and sales targets. In the process, application spaces have become crowded, “data” has been generated by the terabyte without much focus on “information”, and there has been a slow, but noticeable shift back to proprietary hardware platforms and software applications. It is time that end users voice their User Requirements for this next generation of automation and process control. This session will highlight the requirements of end users specifically, independent of any vendor or automation platform. The author has developed a survey and will conduct interviews which will target hundreds of end users in the pharmaceutical industry asking for input as to what this new generation of automation and process control system should look like. This session will reflect the results of this industry-wide interviews and survey, not those of the author. This session will focus on the user's perspective for the next generation of I/O subsystems, automation controllers, information processors, data historians, batch execution engines, and manufacturing execution systems.
T-12: The Price of Excellence: Examining the Value of Investments in PAT 9:00AM - 10:00AM (Thursday, March 27, 2008)
This presentation will discuss the synergistic aspects of combining process analytical technology (PAT) and Lean manufacturing for operational excellence (OpX). A method for estimating the value of achieving excellence in your operations will be described using published case studies and performance benchmark data. Additionally, the cost-benefit tradeoffs of different technology and project management strategies will be explored. Managers considering incorporating PAT, Quality by Design (QbD), or OpX initiative into their operations are encouraged to attend.
T-9: cGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations 10:15AM - 11:15AM (Thursday, March 27, 2008)
Pharmaceutical R&D and Manufacturing has not changed its fundamental paper-based infrastructure in decades. The principle reason is that science by nature and regulatory requirements resist change. Recently, industry and FDA have been more aligned with respect to utilizing innovation and technology to bring manufacturing processes into the 21st century. Leading companies are adopting a new approach to automating the non-value added tasks associated with paper processes in QC and batch record management. The dominate strategy is utilizing innovative technologies (such as Electronic Notebooks) and building quality into the research, quality and compliance infrastructure. The paper will discuss the current situation in cGMP lab and production floor operations relative to FDA initiatives in manufacturing and the broad opportunity for electronic notebook processes. The paper will profile an innovative “method and SOP-centric” software platform, designed to electronically execute and manage laboratory protocols, and production batch records, yielding significant reductions in overall method execution cycle times and electronically capture all data and metadata in a common repository. In addition the GMP Electronic Notebook System provides a Lab Execution System (LES) layer within the GMP IT infrastructure to provide seamless integration of the data capture steps in operating a lab or batch record process to LIMS and ERP systems.
John Helfrich - Director, GMP Lab Automation Programs, VelQuest Corporation
T-13: Application of PAT in Product Development 10:15AM - 11:15AM (Thursday, March 27, 2008)
The Process Analytical Technology, PAT, initiative encourages innovation in pharmaceutical development, manufacturing, and quality assurance to enhance understanding and control of the manufacturing process. The challenge for many manufactures is to identify how best to address the opportunities that PAT offers. Broadley James, Emerson Process Management, and the University of Texas are working together to examine and quantify the potential to reduce cycle time and out-of-spec product through the use of high fidelity, dynamic simulation and multivariate analytics. The objective of this work is to show that the impact of PAT can be maximized through the integration of these tools during product development (PD). Experiments are being run using a CHO cell line and 7 liter bio-reactors. In this presentation, information will be provided on the capability developed for fidelity process modeling of the mammalian cell cultures. A design of experiments (DOE) is described that minimizes the time and tests required to identify model parameters. Examples will be presented to illustrate how this simulation capability in a virtual plant is being used to find the best approach in stepping process inputs and operating conditions and how the improvements found through simulation are verified through experimental test. Also, information will be presented on innovations in PCA/PLS analytics for fault detection and end point prediction of quality parameters. Details will be provided on work that is being done to verify detection of faults and accuracy of end point prediction of quality parameter. Plans for future work will be presented that include applying this simulation and analytic capability during scale up from 7 liter to 50 liter disposable reactors.
Yang Zhang - Research Assistant, University of Texas, Austin
T-10: RFID on the Packaging Level - How to get the Chip on the Box! 2:00PM - 3:00PM (Thursday, March 27, 2008)
RFID is an emerging technology to be used in volume for the identification and tracking of goods. For contactless communication with pallets, boxes and individual items an RFID label is applied onto the goods. Due to an intended one-way use the cost target for a smart label currently is five US cents or less. To achieve this ambitious goal the development of novel manufacturing strategies for RFID products is of major importance. Several attempts are made to streamline the production process with the goal to create a smart label on the packaging level. The improvements in printing of conductive inks for antennae in combination with pre-packaged RFID chips (so called straps) open new opportunities to move from a relative costly slap-and-ship approach to an integrated smart label production process on the packaging level.
T-14: Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT 2:00PM - 3:00PM (Thursday, March 27, 2008)
In the past, unacceptable product batches were prevented from entering the market only by laboratory testing of the finished product – posing risk to the public and wasting both time and money for pharmaceutical manufacturers. In the new regulatory environment, the challenge is to assure the appropriate quality outcome in “real time” by implementing appropriate systems into the process itself, assuring product quality while the batch is being manufactured versus relying on final product testing (RTQA). The increased emphasis on manufacturing process excellence through “Quality by Design” (QbD) requires manufacturers to make larger investments earlier in the product life cycle with the goal of developing a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. Manufacturers have the opportunity to develop a “Design Space” that takes into account the need for different Control Spaces to accommodate future changes in the scale, economics or other aspects of the commercial manufacturing process in the later stages of the product life cycle (ICH Q8). This, along with the adoption of QbD and a quality system as described in ICH Q10, will enable pharmaceutical manufacturers to achieve the “Desired State” of manufacturing. To realize the benefits of implementing QbD, it is critical that CPP and CQA be identified and understood during process development, so they can be measured and controlled in real-time during the manufacturing process. This requires a corporate culture of continuous improvement without the need for regulatory intervention to approve changes. It also calls for close collaboration between the process development and manufacturing teams to achieve a sufficient level of Process Understanding prior to regulatory approval of the commercial manufacturing process. And, of course, it requires the deployment of appropriate, enabling technologies. Such technologies provide a single point of on-demand access by multi-disciplinary users to all relevant data in multiple, disparate data sources (in the same environment with analytics) to identify and understand cause-and-effect relationships in process data and easily share results. Process improvement and QbD will become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time more productively on science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of QbD.
Speaker:
Justin Neway - Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
T-15: Implementing Process Analytical Technology in a Regulatory-Friendly, Single-Use Biomanufacturing Process 3:15PM - 4:15PM (Thursday, March 27, 2008)
We report successful implementation of new technologies for on-line monitoring and control of cell culture in a disposable, animal origin-free process. Recombinant human antibody was produced by a well-characterized cell line using a chemically-defined, animal origin-free culture medium and disposable, stirred-tank bioreactors. Traditional methods of monitoring process variables were compared.
Cory Card - Regional Technical Support Manager, Thermo Fisher Scientific
T-11: Implementing a Service Oriented Organization in IT 3:15PM - 4:15PM (Thursday, March 27, 2008)
Merck's Global Application Engineering & Operations organization adopted a Service Oriented Organization model to become more lean and flexible. Specifically, this company wanted to improve its ability to manage and share global IT capabilities, to deliver quantifiable cost benefits to the business and to deliver higher-value strategic services to its clients. To this end, Merck adopted a new IT Operating Model that was built on three key elements: 1. Shared Services Delivery Structure 2. Professional Services Organization Model 3. Running IT as a business Throughout the transformation, Merck's efforts were informed by the IT Process Improvement frameworks, ITIL and CMM. Concepts of Relationship Management, Service Level Management and Financial Management served as key enablers for the Operating Model. Additionally, Process maturity was seen as fundamental to the new operating mode. To this end, an assessment was conducted of the group's processes compared to the ITIL and CMM frameworks. A custom transformation plan was developed to help achieve the business goals on an accelerated timeline. This included the development of a unique, quantitative Maturity Model to measure progress toward the fully operational state. Merck achieved powerful benefits as a result of this program including cost savings of greater than $ 20 Million in the first year of operating in the new model. Using Merck's project as a case study, the speakers will discuss the following topics: · Merck's Goals · The Service Oriented Organization · How Process Improvement Supported the Strategy · The Transformation Approach · Using a Maturity Model · Results To Date / Lessons Learned
Joseph Solfaro - Executive Director, Global Applications, Merck
Basics & Building Blocks
B-5: Beyond CAPA: Using Risk Assessment to Streamline your CAPA Process 9:00AM - 10:00AM (Thursday, March 27, 2008)
In this session, we will talk about how to reduce the number of CAPAs within a quality and compliance system using Risk Assessment Methods. Session covers the concept of how applying Risk Assessment can filter out the critical from non-critical issues, techniques for identifying and automating Risk, the concept of Risk mitigation as a measure of verification and effectiveness, and real-world examples of how this Risk-Based CAPA process is being used.
B-6: PAT: The Key to Successful FDA Regulated Manufacturing in the 21st Century 10:15AM - 11:15AM (Thursday, March 27, 2008)
There have been a great many changes in the FDA's guidance for manufacturing in the past 5 years. The publication of their “Pharmaceutical cGMPs for the 21st Century” in 2002 caused the greatest change in compliance guidance since the issuance of the original GMP documents in the late 1970s. Gone are the requirements for mounds and mounds of paperwork that were required to show the exhaustive testing needed to meet the “old” GMP guidance, replaced by the new “design quality in” concept. This concept is not new, but the new guidance documents from the FDA give direction and insight into how the agency expects manufacturers to design this quality into their processes. The need to understand the manufacturing process and provide that feedback into the control system is at the core of this new approach, and PAT is the methodology that gives manufacturers this understanding and control. This presentation describes how PAT supports the quality by design, continuous operation in a regulated industry and real time product release initiatives that are being driven by the new FDA guidance
Supply Chain excellence has become a core requirement in today’s global outsourced pharmaceutical industry. This course covers the basics and summarizes best practices.
• Pharmaceutical Supply Chains unique challenges • Supply Chain Visibility, Trace & track, E-Pedigree • Cold Chain and condition monitoring • RFID and sensors • Regulations and Standards
B-8: RFID in Pharma and Life Sciences: What You Need to Know 3:15PM - 4:15PM (Thursday, March 27, 2008)
This one hour session will give you a comprehensive overview of what RFID is and how it works. You will learn what are the essential components needed to make up an RFID system, such as tags, readers, antenna, printers and software and how they interoperate with each other. We will discuss why RFID is being talked about so much and how it can potentially change your business. Topics covered include how RIFD can be used for Improved Inventory Management (Including Product Life Cycle), Mass Serialization, Product Authentication and E-Pedigree, Chain of Custody, Anti-Counterfeiting, Contamination Control, Compliance with Government Regulations and Product Recall Management. This session will showcase all of the latest Case Studies on how and where RFID is being piloted and deployed by some of the biggest and most innovative pharmaceutical companies in the world. Come and see for yourself how pharmaceutical companies around the world are using this powerful technology to transform their businesses, save money and insure patient safety.
Speaker:
John Jordan - President, WW Field Operations, TAGSYS RFID
C-5: Pharmaceutical Manufacturing - The Challenge of Global Regulatory Compliance 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the competitive pharmaceutical/ biotechnology industry, companies seeking to market products in new countries must strive to secure marketing authorization from government agencies in a smooth and timely fashion. A critical step to ensuring prompt approval is the need to demonstrate compliance with local regulatory agency manufacturing requirements. Inter-agency variations in regulatory demands can present significant challenges in navigating the approval process and assuring ongoing compliance. Prior knowledge or experience is essential to ensure the smooth implementation of processes and procedures that satisfy the needs of multiple international agencies and minimize the potential for costly production delays. First hand experience gained from multiple international submissions and manufacturing site inspections has established the need to: remain constantly apprised of regulatory changes; be mindful that differing interpretations of simple international guidelines that can hinder the approval process and beware the perils of taking compliance for granted. This presentation will provide an overview, discussing the challenges of simultaneously navigating both the demands of multiple international regulatory agencies with the differing and ever changing requirements across the pharmaceutical manufacturing continuum.
Speaker:
Kelly Davis - Manager of Regulatory Affairs, Baxter Healthcare Corporation
C-6: Utilizing Cpk to Understand Pharmaceutical Manufacturing Process Capability 10:15AM - 11:15AM (Thursday, March 27, 2008)
This session will be a discussion of data collection and application of statistical methods to help address the challenges of data starved first-time-quality projects. The foundation of the discussion will be the collection and aggregation of data from a variety of disparate sources including PLC, DCS, SCADA, Alarm & Event and manually entered data. Once the data has been acquired and consolidated a variety of statistical methods can be applied in order to drive enhanced online process visibility. Effectively, the statistical methods produce variables which reflect process capability that can be managed online and viewed like a traditional process variable. By applying analytical tools and product-based Cpk reporting to standard production data, greater process understanding is achieved.
Speaker:
Bart Reitter - Global Industry Manager - Life Sciences, GE Fanuc Intelligent Platforms
C-7: Case Studies in Laboratory Equipment Qualification 2:00PM - 3:00PM (Thursday, March 27, 2008)
This session will present three summaries of equipment qualification projects required by FDA regualtory action and discuss similarities and differences. It will also assess the overall level of compliance and overkill of each of the approaches and discuss how it related to the minimum level of validation expected.
Nancy Tomoney - Senior Validation Scientist, QPharma Corp/CSSC Inc.
Speaker:
Scott Collins - Senior Validation Manager, QPharma Corp/CSSC Inc.
C-8: Formulation and Process Design of Experiments: Quality by Design 3:15PM - 4:15PM (Thursday, March 27, 2008)
The session will provide an understanding of Design of Experiment (DOE) applications with respect to Formulation and Process Development during Drug Product Development. With an understanding of these applications and the data that is generated, companies can ensure predefined product qualtiy from the begining of drug development.
Ryan Doxey - Research Scientist II, Stiefel Research Institute
Biotechnology
Sponsored By:
BIO-8: WORKSHOP: Aseptic Processing and Manufacturing: From Compliance to Contamination to Control 9:00AM - 11:00AM (Thursday, March 27, 2008)
This session will cover a spectrum of issues related to aseptic processing and manufacturing. Dr. Vadheim will give an overview of regulatory and compliance guidelines as well as point to a scientific overview of critical issues pertaining to aseptic processing manufacturing. Dr. Ashtekar will focus primarily on success stories around the manufacturing of bacterial and viral derived vaccines as well as discuss potential microbial incursions into the manufacturing process. Dr. Sidhu will present case studies linking contamination issues to the aseptic environment as well as solutions for such. Mr. Guardino will focus on the latter as far as disinfectant challenge efficacy and case studies where manufacturing shutdowns have been resolved through the most effective disinfectant/sanitization challenge.
Moderator:
Jaspreet Sidhu, PhD - VP, Business Development and Pharmaceutical Microbiology, Molecular Epidemiology, Inc. (MEI)
Speaker:
Dilip Ashtekar, PhD - Chief Microbiologist for Operations and Director, Global Microbiology, Amgen
BIO-11: Drug Delivery of Biopharmaceuticals - What is Important for an Efficient Combination of Biologic, Pre-filled Syringe and Autoinjector? 10:15AM - 11:15AM (Thursday, March 27, 2008)
Injection is the most common route of administration for biopharmaceuticals. Product launches with pre-filled syringe systems facilitate life cycle strategies and improve patient convenience. As self-injection is increasing, biopharmaceutical companies go one step further and introduce their products with syringe-based autoinjectors. This means more components, more interfaces and higher complexity of the drug delivery system. How can these challenges be addressed in development projects? Key requirements are arising from the interfaces between biopharmaceutical, pre-filled syringe and autoinjector device. Highlighted in this presentation are - principles to select optimal syringe systems and autoinjector devices according to biopharmaceutical product and therapeutic class, - strategies to reduce interactions of biological molecules with leachables and silicone lubricant from pre-filled syringe systems (drug / device interface) and - technologies to establish syringe dimensions, break-out and gliding forces which are compatible with autoinjector specifications (device / device interface). The session points out which action items need to be agreed at an early stage of development between biopharmaceutical company, syringe supplier and autoinjector producer to lay out the road map for a successful product launch.
Speaker:
Arno Fries, PhD - Head of Sales North America, Gerresheimer Buende GmbH
BIO-12: Economics of Vaccine Production Using Virus-Like Particles 2:00PM - 3:00PM (Thursday, March 27, 2008)
Virus-like particles (VLPs) made by recombinant techniques using single use disposable equipment offer significant advantages over the traditional vaccine manufacturing approach. This manufacturing method results in lower capital and operating cost and greatly reduced time to market. This presentation provides an overview of the VLP manufacturing process and describes what a commercial facility might look like. Capital and operating costs are estimated and compared to conventional vaccine manufacturing processes. An update on the status of this developing technology is also provided.
Speaker:
Robert Bader - Sr Mgr Technology Pharmabio, Jacobs Engineering
James Robinson - Vice President of Preclinical and Quality Operations, Novavax, Inc.
BIO-9: The ASME-BPE Global Standard for the BioPharm Industry 2:00PM - 3:00PM (Thursday, March 27, 2008)
The session will provide an overview of the American Society of Mechanical Engineers - Bioprocess Equipment (ASME-BPE) standard and its implications for the biopharmaceutical industry. Mr. Zinkowski, who is Vice Chair of the BPE Standards Committee, will provide a brief overview of each part and structure of the BPE Standards committee, the inception & development of the standard, and the interface between the ISPE, P3A, 3A.
Speaker:
Rick Zinkowski - Vice Chair, BPE Standards Committee, American Society of Mechanical Engineers - Bioprocess Equipment
BIO-10: Shortening 'Time to Money' for BioPharma Facilities-Lessons from the Semiconductor Industry 3:15PM - 4:15PM (Thursday, March 27, 2008)
Shortening "time to money" is a critical factor for any new BioPharma facility. Important lessons can be learned from the Semiconductor Industry where the cost of new chip-making facilities range from $3.5B to $7B. Delays in production cost Chipmakers over $100M per week. Collaborative project management reduces or eliminates those delays. Shortening "Time to Money" for is a critical factor for BioPharma facilities.
BIO-13: Design Alternatives for Multi Product Vaccine Facilities 3:15PM - 4:15PM (Thursday, March 27, 2008)
Designing a multi product vaccine cell culture facility is a critical activity that must evaluate many factors in order to identify and meet all design objectives in a timely and cost efficient way. The design must ensure sufficient built in process capability and adaptability for the almost inevitable modifications that future processes will bring, while still keeping a limit on capital commitments. Then what are the design options to achieve requirements for product segregation, containment, work flows and GMPs and how have they been used in recent cell culture projects? Based on a series of large scale cell culture projects, the presentation uses case studies to illustrate design alternatives and discuss the pros and cons of these approaches. The case studies cover facility designs ranging from pilot plant to production scale and are selected to illustrate alternatives in modern vaccine facilities
F-7: WORKSHOP: Critical Utilities Case Studies: What Went Right, What Went Wrong! 9:00AM - 11:00AM (Thursday, March 27, 2008)
Various Operating companies, Consultants and Suppliers will present case studies on critical utilities. Each case study will examine a project and discuss lessons learned. Critical Utilities examined will include; WFI, Pure Steam, CIP/SIP.
Peter Vishton - Technology Engineer Pharma Water Systems, Wyeth
F-8: Key Considerations in Bioprocess Facility Fit 2:00PM - 3:00PM (Thursday, March 27, 2008)
A critical step in the development of a biopharmaceutical manufacturing process is the determination of process-facility fit. This involves evaluating whether a process may be economically carried out in a given facility. Some of the key considerations include the size and type of primary processing equipment, the availability and size of supporting equipment including media and buffer tanks and CIP skids, and utilities including especially purified water. Less tangible factors, such as worker productivity, may also play a role. This presentation will cover the key calculations that need to be made along with software that can speed the evaluation process. The calculations and techniques are illustrated by a case study in which two possible plants are compared for a monoclonal antibody process.
Charles Siletti - Director, Scheduling & Planning Applications, Intelligen, Inc.
F-9: Steps for Performing a Successful Facility Decontamination 3:15PM - 4:15PM (Thursday, March 27, 2008)
This presentation will start at the beginning of the process with general cleaning requirements to prepare the area for fumigation. It will then describe the three primary methods which are formaldehyde, hydrogen peroxide vapor, and gaseous chlorine dioxide. The room/area sealing requirements will be specified which includes doors, penetrations, and the HVAC system. The preparation of the area will include the ability of equipment and supplies to be decontaminated during the process. Fan locations, humidity requirements, generation points, decontaminant circulation and distribution, and air flows will be discussed. Aeration methods, time requirements, monitoring, and offgassing will be described as well as methods of determining when safe re-entry can occur. Pictures will be utilized to demonstrate activities and techniques to enhance the learning experience.
Mark Czarneski - Director of Technology, Clordisys Solutions, Inc
Manufacturing
M-7: Lean Enterprise: A Business Model that Drives Success 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1990's Baxter began implementing Lean Manufacturing principles in its manufacturing plants. See how this organization benefited from its early Lean implementations and some of the lessons they have learned over the past decade. Learn about the benefits of transforming Lean from a tool to a business model. Discover the opportunities created by dropping the term Lean Manufacturing and creating a Lean Enterprise.
Speaker:
Tony Johnson - Plant Manager, Baxter Healthcare Company
M-11: The Change from Fixed to Disposable: Discover Process Improvement Opportunities through a LEAN Six Sigma Lens 9:00AM - 10:00AM (Thursday, March 27, 2008)
Formal operational excellence initiatives and processes such as Lean & Six Sigma are gaining more widespread acceptance and implementation in biopharmaceutical manufacturing. Likewise some vendors of enabling technologies and equipment are applying the same methodologies to improve the quality and efficiency of their product and service offerings. We will explore the multifunctional endeavor of LEAN Six Sigma at GE focusing on the mistakes made along the way, and the return to employee involvement in complement to technologies. We will discuss the fundamentals of LEAN in detail and walk through case studies on LEAN implementations in bio manufacturing environments. A special focus will be given analyzing how the implementation of increasingly available ready to use, single use or disposable technologies enable LEAN manufacturing strategies resulting in greater speed flexibility and overall process agility in bio manufacturing operations.
Speaker:
Victor Bornsztejn - Global Growth Director, GE Healthcare, Life Sciences Service
Gerard Gach - Global Product Platform Director , GE Healthcare
M-12: Syringe Processing, from Filling through Packaging 10:15AM - 11:15AM (Thursday, March 27, 2008)
All aspects of Syringe Processing will be discussed, from E-Beam sterilization through filling, laser marking, inspection, labeling and packaging. Recent case studies will be presented on different line and equipment options.
Nancy St Laurent - Sr. Supervisory Process Engineer, Parsons Corporation
M-8: Analysis of Particle Size and Distribution in a CFC-free Aerosol Based Pharmaceutical Preparation 10:15AM - 11:15AM (Thursday, March 27, 2008)
Several medications used to treat respiratory diseases are delivered in powdered form. Particle size and distribution are critical parameters for demonstrating the efficacy for these drugs. Robust analytical procedures and instrumentation are required to ensure reproducible and cost-effective particle size and distribution test results. IVAX Pharmaceuticals in Ireland has expanded its particle size and distribution analyses for its product, QVAR. (Medication details below.) Until recently, an outside laboratory in the U.K. had conducted drug particle size and distribution analyses for IVAX. Given the increased sample volume coupled with a need for more timely receipt of test results, IVAX chose to conduct this testing in-house. IVAX purchased a liquid particle counter to conduct their particle size and distribution analyses. This paper will focus on IVAX's evaluation to opt for in-house testing as a cost-effective, reproducible method for assessing drug quality via particle size and distribution. We will present the final methodology selected by IVAX to ensure quality and cost effective particle counting analyses. QVAR, is a maintenance medicine used to reduce the frequency and severity of asthma attacks. It is currently the only CFC-free (free of the chlorofluorocarbons) aerosol corticosteroid for the treatment of asthma in the U.S. QVAR delivers the smallest medication particle size, 1.1 microns, of any drug in its category. This smaller particle size allows for greater lung deposition in the smallest airways of the lung.
Joseph Gecsey, Jr. - Life Sciences Business Development Manager, Hach Ultra Analytics
M-9: Blastoff: Best Practices & Lessons Learned for Successful Commercial Launch 2:00PM - 3:00PM (Thursday, March 27, 2008)
Launching a commercial product represents the penultimate event for a biotechnology or pharmaceutical company. However, there are considerable challenges in transitioning products from R&D to commercial excellence. Executing a successful launch program depends upon coordinating and bridging knowledge across virtually all corporate functions to effectively plan, organize, consider alternatives, reach consensus and ensure consistent communication and direction. This workshop will outline and discuss the commercial launch process and share insights and lessons learned from recent launches at companies including: LAUNCH TIMEFRAMES: Appropriate timing and critical time lines CROSS FUNCTIONAL APPROACH: How to engage the organization for launch and best organizational models for a launch team PARTNER SELECTION: Criteria to select effective manufacturing, packaging and distribution partners MULTI-YEAR BUDGETING: Cost to launch a new product and planning and budgeting for a multi-year launch effort CRITICAL NEW SKILLS & INFRASTRUCTURE: New people, processes and information systems needed to support a commercial launch.
Speaker:
Joan Bramer - Director, Commercial Launch Services, Maxiom Group
Andrew Komjathy - Vice President, Commercial Operations, North America, Shire Human Genetic Therapies
M-13: New Development in Hydrogen Peroxide Vapor (HPV) Decontamination of Rooms, Facilities, Isolators, and Various Pharmaceutical/Bio-tech Applications 2:00PM - 3:00PM (Thursday, March 27, 2008)
This is a summary presentation highlighting the recent advantages in bio-decontamination using Hydrogen Peroxide Vapor (HPV) technology on rooms, isolators, facilities, and various pieces of laboratory equipment. The major advantages of this process, and why many people will be interested, are: 1) Residue Free and No Secondary wipe down 2) Ability to execute decontamination in ambient room conditions without affecting temperature/relative humidity 3) Minimal Material Compatibility Issues and very effective on computers, microscopes, and precise electronic equipment 4) Efficacy against a wide range of organisms such as bacillus spores, mold, parvo virus, anthrax, tuberculosis, etc. 5) Validation/Verification of process using biological indicators 6) Limited Environmental Health & Safety concerns
Adam Warner - East Coast Sales Manager, BIOQUELL,Inc.
Speaker:
Kevin Trottier - Associate Director, Facilities & Engineering, Avant Immunotherapeutics, Inc.
M-10: Enteric Coatings, Review and Advances 3:15PM - 4:15PM (Thursday, March 27, 2008)
There have been significant advances in enteric coatings over the past 10 years, from tablet core engineering to subcoat considerations, to ingredient selection, processing equipment and controls. Processes once cumbersome and trouble prone can now be completed with simplicity and high confidence of success. Required weight gains can now be greatly reduced. Color can be incorporated in one coating step. New techniques can be applied to both aqueous and solvent coating, on both tablets and capsules, and in using both coating pan and fluid bed applications.
Stephen Levine - Group Leader, Scientific Affairs, Emerson Resources, Inc.
Outsourcing
O-5: Outsourcing Utilities to Focus on Core Business 9:00AM - 10:00AM (Thursday, March 27, 2008)
Outsourcing utilities to focus on core business» Manufacturing drugs is a long and a complex process which involves many skills. Nowadays, a drug manufacturing site needs numerous utilities in order to produce pills, tablets, capsules, vaccines etc. For example: a site will need potable water for lavatories, electricity for running the machines, compressed air for component activation, clean steam for process sanitisation, industrial steam for heating buildings/processes, chilled water for cooling tanks, vacuum for packaging lines, water for injection for making parenteral products. All this utilities are part of a drug manufacturing facility but are not the core business of the pharmaceutical company. This course will examine existing possibilities in outsourcing for a pharmaceutical industrial site, outline goals and objectives of both parties and the service provider's guarantees needed in order to be compliant with regulatory issues. - What kind of utilities can be found in a typical pharma plant? - Why is it important to focus on core business? - What does ‘outsourcing utilities' mean? - What are the solutions for the industrial site (O&M, BOT, ROT, AOT, BOOT,…)? - Key decision factors for choosing outsourcing - How to implement outsourcing without disrupting the plant operation? - How to consider assets, staff, quality and cost control? - How can outsourcing help a site to grow? - Does regulatory compliance match with contract guarantees & performance? - Industry feed back experiences
Johann Bonnet - Market Manager, Veolia Water Solutions & Technologies
O-6: Performance Measurement Techniques for Outsource/Contract Manufacturing 10:15AM - 11:15AM (Thursday, March 27, 2008)
Measuring the performance of your contract manufacturer is difficult task, especially as you have little control over the contract organization. As well, as a contract manufacturer your ability to differentiate against your competition is also a difficult task as the last differentiator you want to use is price. Our presentation will discuss the real world techniques used to collect/present data in format to allow the outsourcing company to retrieve near real time supply chain data as well as present key performance indicators (KPIs) and dash boards for each contract manufacturer. For the contract manufacturer our presentation will provide a view into how you can proactively present data to your customers that provide visibility and these KPIs to provide greater value as a business partner and position yourself against the competition.
John Postle - Vice President - Life Sciences, Court Square Group
O-7: Finding and Delivering Value Through Collaboration: Recent Research, Case Studies, and Practical Advice on How to Increase Value from Key Supplier Relationships 2:00PM - 3:00PM (Thursday, March 27, 2008)
On the Boeing 777, the specification control document for suppliers to build the electrical distribution system was 2500 pages. The equivalent documentation for the 787 Dreamliner was 25 pages. Drawing on recent Vantage Partners research from both buy-side and sell-side executives and relationship managers at hundreds of companies, this presentation will provide important insights on barriers to collaboration, and how to enable breakthrough partnerships with CROs, external manufacturers, and other supply chain partners. Learn how to companies inside and outside the pharmaceutical industry have tapped into the power of partnering with key suppliers, and how your organization can take collaboration to the next level.
O-8: Operational CMO Strategies for Competitive Advantage 3:15PM - 4:15PM (Thursday, March 27, 2008)
The presentation would contain two main themes including operational excellence and network optimization as well as competitive advantage strategies. The content would be present in general terms along with examples of how Patheon has been implementing these concepts in our operations as a dedicated CMO.
Speaker:
Steve Liberty - Senior VP of Operations, Canada, Patheon, Inc.
Friday, March 28, 2008
Meals & Special Events
Keynotes, General Sessions, Meals
SE-3: From Pandemics to Bioterrorism: The Role of Bio Manufacturing in Global Healthcare 9:00AM - 11:00AM (Friday, March 28, 2008)
General:
In a world where the threat of pandemics and/or bioterrorism is all too real, the role of pharmaceutical manufacturing professionals has never been more vital. Join us for a provocative panel discussion on the challenges and opportunities for our industry as well as current initiatives on the part of government and the private sector to protect the world's vulnerable populations. This session includes breakfast.
KeyNote:
Parrish Galliher - Founder, President and Chief Technology Officer, Xcellerex, Inc.
SE-7: Meet-and-Greet Luncheon - Friday, March 28 12:00PM - 1:00PM (Friday, March 28, 2008)
Conferees only will be able to stay and participate in a “Meet & Greet” luncheon. Conferees will get exclusive access to continue the conversations you began this week or catch up with those presenters they missed, and gain some valuable “food for thought” in the process. This is open to Full Conference and One Day Pass holders only.
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