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View Date: Wednesday, March 26, 2008
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-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-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-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-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-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.
